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    Top drugs and pharmaceutical companies of 2019 by revenues

    Top drugs and pharmaceutical companies of 2019 by revenues

    Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

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    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    Compliance to determine the success of Mylan’s merger with Pfizer’s Upjohn

    Compliance to determine the success of Mylan’s merger with Pfizer’s Upjohn

    This week, Mylan and Pfizer announced the merger of Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, to create a yet to be named new global pharmaceutical company.  The new company is expected to have 2020 revenues between US$ 19 and US$ 20 billion. What’s of even more significance is the fact that the new entity could outpace Teva to become the largest generic company in the world, in term of revenues.  Under the terms of the agreement, Pfizer’s shareholders would own 57 percent of the combined new company, and Mylan’s shareholders would own 43 percent.  The new company will be led by Mylan’s current chairman Robert J. Coury, who will serve as its executive chairman. Michael Goettler, who is currently the group president, will serve as the new company’s chief executive officer (CEO). And Mylan’s current president Rajiv Malik will continue to serve at the same post. Heather Bresch, Mylan’s current CEO, will retire from Mylan upon the close of this transaction. Mylan was worth four times as much four years ago   While the future of this amalgamation remains to be seen, it’s incredible how things have changed over the last four years. In 2015, Mylan had rejected a buyout offer from Teva at US$ 82 per share, which was a mix of approximately 50 percent cash and 50 percent in Teva stock, saying it was grossly undervalued. At the time, when Mylan’s executive chairman Coury had rejected Teva’s deal, he had written a 3,000 word letter saying that financially Teva’s offer did not even come close to qualifying as a proposal worth pursuing (the starting point of discussion for Mylan was a value in excess of US$ 100 per share). Mylan was internally known to refer to Teva’s stock as “toilet paper” which did eventually get a junk rating. As luck would have it, Mylan’s stock too has tanked significantly since Teva made that offer in 2015. This week, when Mylan announced its deal with Pfizer, Mylan’s shares were trading at around US$ 20 per share. Mylan’s failed endeavors to become a leading consolidator in generics   At the time of rejecting Teva’s offer, Mylan had launched its own hostile bid to acquire Perrigo. That turned out unsuccessful, and Mylan’s stock value started to drop. After Mylan failed to acquire Perrigo, Mylan’s CEO Heather Bresch had said when asked what she would do if Pfizer’s established products business became available: “We absolutely would look at it.” She further went on to say that as in the past, Mylan was seeking to become a leading consolidator in the generics drug industry.  The year 2015 was a tough year for Mylan. It had acquired nine injectable plants from Agila in 2013. Within four months of Mylan announcing its US$ 1.6 billion acquisition, a US Food and Drug Administration (FDA) inspection found problems in the manufacturing operations at an Agila plant in Bengaluru (India) and issued it a warning letter. Mylan continued with the acquisition and the deal was closed in December 2013. The acquisition ran into more trouble with the FDA in 2015, when Mylan received another warning letter, which indicated that the problems had expanded to two other plants. The Bengaluru plant (cited in 2013) was not able to address the concerns of the FDA inspectors and had also been included in the warning letter.  By December 2015, Mylan sent claims to Strides Shasun, the former owner of Agila Specialties, seeking compensation towards remedial measures it had initiated at the three Indian manufacturing facilities. And then came its EpiPen price-gouging faux pas   A year later, things started deteriorating even further as the firm faced much flak for raising the price of its blockbuster product — the life-saving epinephrine auto-injector EpiPen. During questioning by the House’s Oversight Committee, CEO Bresch’s ethics were questioned and her US$ 19 million pay package was also in the spotlight. Following this, the Mylan president Rajiv Malik, who leads all global commercial and operational activities at the company, was personally named as a defendant in a lawsuit that had pointed allegations against Mylan for taking part in an alleged generic price-fixing scheme. Deteriorating quality compliance standards   Post that, compliance became a key concern as its facilities in the United States and India were cited for data-integrity issues. Mylan also ran into additional problems over its manufacturing of valsartan, a commonly used blood pressure medicine that was found to contain cancer-causing impurities and had to be recalled. Meanwhile, Mylan’s EpiPen manufacturing partner — Pfizer — was battling its own quality problems and received a request from the US Attorney for Southern District of New York to provide documents as part of a probe into quality control issues at Meridian Medical Technologies for a failure to investigate “serious” problems associated with an unspecified number of patient deaths.  In 2017, Pfizer’s Meridian unit (that manufactures EpiPens for Mylan) had received a warning letter from the FDA, in which the agency said Meridian had failed to thoroughly investigate product failures, including EpiPen products that were associated with patient deaths and severe illnesses. The quality challenges have also led to continued shortages of the life saving device. By August last year, as Mylan continued to post disappointing results and slashed its full-year guidance, the company said it has formed a strategic review committee to look at every available option, given the fall in its US operations by 22 percent due to lower volumes on existing products. Pfizer’s ordeals with compliance issues at its generic units   When it comes to data-integrity issues at its generic drug businesses, Pfizer’s side of the story is equally sordid. Even today, it is far from its goal of becoming a major player in generics. In 2012, the firm announced a joint venture with China’s Hisun Pharmaceuticals, an API manufacturer founded in 1956. The Hisun-Pfizer joint venture, similar to its deal with Mylan signed this week, gave the firm a portfolio that included branded generic drugs in therapeutic areas such as infectious diseases, cardiovascular diseases and mental health. In 2015, Hisun ran into serious trouble with the FDA as data-integrity concerns emerged which resulted in the FDA issuing an import alert to its API factory. After a year of rumors swirling that Pfizer would exit the joint venture, it finally sold its 49 percent equity in late 2017. In February 2015, a few months before Hisun got placed on FDA’s import alert list, Pfizer’s Global Established Pharmaceutical (GEP) Business announced a US$ 17 billion acquisition of Hospira. When the deal was struck, Pfizer was aware of Hospira's manufacturing record as the company was issued FDA warning letters in four out of seven continents (Europe, North America, Asia and Australia). The executives of Pfizer had assured investors and regulators that they would quickly resolve issues at the plants. However, the problems persisted and in a 2017 earnings call, Pfizer’s CEO at the time Ian Read had said, “Within our Essential Health portfolio, we have been experiencing supply shortages with some products. The shortages are primarily for products from the legacy Hospira portfolio and are largely driven by capacity constraints and technical issues”. One operation that continued to bother the company was a facility in McPherson, Kansas. In 2017, Pfizer’s fill/finish manufacturing facility in McPherson received a warning letter from the FDA. The manufacturing problems at the McPherson plant also derailed the launch of a generic version of Teva’s Copaxone, which was being developed by Sandoz and Momenta. The drug was being finished at the McPherson plant, which was slapped the FDA warning letter. In January 2019, Pfizer went on to announce that two manufacturing sites in India, which were part of the Hospira acquisition, will cease manufacturing operations. At the time of the announcement, the sites located near Chennai (Irungattukottai) and Aurangabad employed 1,700 people.  The FDA warning letter for the operations at the Irungattukottai site stated that the agency had found the site’s microbiology laboratory was inaccurately reporting test results. Our view   Against an industry backdrop of lowering prices and increased competitiveness, mega-mergers drawn out in boardrooms have visions of an industry transformation with manufacturing and compliance coming across as mundane necessities. Post this deal, and also Pfizer’s previously announced consumer deal with GSK , it is clear that the big pharma giant is shifting its focus to become a “smaller, more focused, science-based company with a singular focus on innovative pharma”.  However, Pfizer’s endeavor to build a global generic powerhouse needs to be seen in light of Daiichi’s disastrous Indian adventure with its failed acquisition of Ranbaxy, Teva’s failure in Mexico with Rimsa and the more recent walk out of its acquisition of Akorn by Fresenius Kabi over data-integrity concerns. These instances indicate that manufacturing compliance has become critical to the success of these deals. Moreover, we also need to take note of Pfizer’s failed attempts to turnaround Hospira facilities, Mylan’s own stumbles with Agila, coupled with the ongoing compliance problems at Mylan’s US facility in Morgantown and Pfizer’s facility which manufactures the EpiPen. Given these instances, it would be safe to conclude that manufacturing compliance will play a pivotal role in deciding the outcome of the Mylan-Pfizer deal.  

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    #Phispers by PHARMACOMPASS
    01 Aug 2019
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    Mid 2018 – Recap of Warning Letters, Import Alerts and Non-Compliances

    Mid 2018 – Recap of Warning Letters, Import Alerts and Non-Compliances

    In our mid-2018 compliance review, we look at inspection challenges faced by companies across the world. In the first half of this year, manufacturing compliance challenges dominated headlines. But we also saw shortcomings at major pharmaceutical companies like Pfizer, Bayer and Akorn generate news. While China, India and the US continued to be the top three countries where regulators uncovered compliance issues, this year has also seen the FDA take action against many South Korean companies. The European authorities found concerns in India, Taiwan, Italy and Spain. However, there were no non-compliance reports issued to firms in China until the end of June 2018. While data-integrity violations and a failure to thoroughly investigate deviations continued to remain a major concern for inspectors, this year the real concern emanated from the supply of product to market (which had the potential to impact product quality or patient safety). Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! China: API with a cancerous impurity, vaccine scandal and data-integrity woes   The most recent regulatory non-compliance issue pertains to the European Medicines Agency (EMA) raising concern over the active pharmaceutical ingredient (API) valsartan supplied by China’s Zhejiang Huahai Pharmaceuticals. The concern was the impurity — nitrosodimethylamine (or NDMA) — detected by the company in their valsartan API. NDMA is classified as a probable human carcinogen and its presence was unexpected as it was not detected by routine tests carried out by Zhejiang Huahai. Zhejiang Huahai sold over US$ 50 million of the API in 2017 and supplies to most major manufacturers producing valsartan medicines available in the EU and United States. While a review is underway, national authorities across the EU, US and Asia are recalling medicines containing valsartan supplied by Zhejiang Huahai. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Vaccine scandal: A major vaccination scandal has sparked off a huge outcry in China as vaccine maker Changsheng Biotechnology was found to have falsified production data for its rabies vaccine. Changchun Changsheng Bio-tech Co, in Changchun, reported serious irregularities, including fabricating production records in the manufacture of rabies vaccines for human use, during an inspection by the State Drug Administration, China FDA said in a statement. Although there has been no evidence of harm from the vaccine, the firm has been ordered to halt production and recall rabies vaccines. And Chinese Premier Li Keqiang has urged severe punishment for the people involved, saying the incident had “crossed a moral line”. Data-integrity violations: This year, the FDA also posted the warning letter issued to Henan Lihua Pharmaceutical in China, a company that produces steroid APIs like hydrocortisone and prednisone. The warning letter highlighted data integrity concerns that landed Henan on FDA’s import alert list in March 2018. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! During the inspection, the FDA investigator observed numerous blank batch manufacturing records in an open cabinet in the firm’s manufacturing workshop office. Among these was multiple blank, product release forms marked with a red quality assurance release stamp stating ‘Permitted to Leave [the] Factory’. The FDA also posted a warning letter issued to Jilin Shulan Synthetic Pharmaceutical, a manufacturer of caffeine API in China. The letter revealed flagrant data-integrity violations. Another warning letter was issued by the FDA to API manufacturer Lijiang Yinghua Biochemical and Pharmaceutical, following an October 2017 inspection. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE!   United States: Drug shortages due to Pfizer’s manufacturing problems    Drug major Pfizer’s production problems continued to make headlines this year. An article in Fortune put the blame on Pfizer’s much-touted US$ 17 billion acquisition of Hospira in 2015 for turning the United States’ chronic drug shortage into a full-blown crisis.  According to the article, as of May 11 this year, Pfizer — which is the world’s largest maker of sterile injectable drugs — had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019. “The simple answer to why America currently has so many shortages of generic sterile injectable drugs: America’s leading manufacturer of generic sterile injectable drugs hasn’t been making them,” the article said. Mylan’s flagship product EpiPen is also likely to face shortages due to problems at Pfizer. Although Mylan owns the rights to the EpiPen, it subcontracts manufacturing of the auto-injector to Meridian Medical Technologies, a division of Pfizer. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! While Mylan is putting pressure on Pfizer to do more to tackle shortages of this life-saving medicine, Pfizer has struggled to meet demand for the EpiPen and the FDA had put the medicine on its official shortages list. In September last year, the FDA had issued a warning letter to Meridian Medical Technologies over serious component and product failures that had been associated with patient deaths.  Pfizer’s troubles are far from over as an FDA inspection of an ex-Hospira sterile manufacturing facility in India resulted in the issuance of a 32 page Form 483.  The same facility was issued a warning letter  by the FDA in 2013. Germany: FDA highlights contamination, data-integrity concerns at Bayer facility   In a shocking warning letter issued by the FDA to Bayer Pharma’s finished pharmaceuticals manufacturing facility located in Leverkusen, Germany, investigators found compliance shortcomings ranging from concerns over data-integrity to serious product contamination problems.   While reviewing a drug product manufacturing operation, FDA investigators found residue on equipment which seemed most likely from a drug product that had been previously processed in the same room. When Bayer tested the samples of the tablets being produced to “assess the potential of cross-contamination”, the testing confirmed contamination of the previously processed product inside the tablets which resulted in a recall of several lots of drug products. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Before the FDA inspection, Bayer had started its own data-remediation program to discontinue the practice of using “test” injections during testing. However, when the FDA investigators performed their own inspection, they found unreported data from in-process tablet weight checks. Bayer’s staff had programmed their in-process weight checker not to report values that varied more than a specified amount from the tablet target weight. The inspection was held between January 12 and 20, 2017, and responses submitted to the FDA in May and August 2017 failed to address the concerns of the agency. Fresenius aborted US$ 4.3 billion takeover of Akorn: ‘Blatant fraud’ or buyer’s remorse?   This year also saw German healthcare group Fresenius abandon its US$ 4.3 billion takeover of US generic drugmaker Akorn over data-integrity concerns. Illinois-based Akorn filed a lawsuit in the Delaware Chancery Court asking that Fresenius be required to “fulfill its obligations” under the buyout agreement. In a court filing made public, Fresenius alleged that its investigation uncovered “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations.” Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Akorn’s lawsuit acknowledged it investigated the possible submission of falsified data and fired an executive who was involved. Fresenius claims the executive involved in the fraud wasn’t fired. Instead, he was suspended and given a consulting position with a US$ 250,000 salary. The executive, whose name is redacted from the court filings, stands to receive a payout if the merger is consummated.  The most significant instance of a data integrity issue involves an ANDA for the drug product azithromycin that was pending with the FDA, which Akorn had submitted on December 21, 2012. The court will decide if the data-integrity concerns are truly legitimate or being blown out of proportion by Fresenius, who may be suffering from buyer’s remorse and wants to exit the deal.  The court agreed to put Akorn’s case on fast track and the trial is currently underway. South Korea: Teva’s potential blockbuster gets delayed due to problems at Celltrion   As Korea emerges as a force to reckon with in the emerging world of biosimilars, the USFDA's issuance of a warning letter to Celltrion (a major manufacturer of biosimilars that has also partnered with Pfizer for commercialization in the United States) came as a major setback.   In an inspection conducted by the FDA from May 22 to June 2, 2017, the investigators raised concerns over multiple poor aseptic practices during the set-up and filling operations. The warning letter highlights an example where during the aseptic filling of vials, an operator used restricted access barrier system (RABS) to remove a jammed stopper by reaching over exposed sterile stoppers in the stopper bowl. The RABS disrupted the unidirectional airflow over the stopper bowl, creating a risk for microbial contamination. After the operator removed the jammed stopper, the filling line was restarted, but the affected stoppers were not cleared. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! At Celltrion, the FDA raised concern over 140 complaints received between October 2015 to May 2017, which were identified to have occurred because of vial stoppers.  The deficiencies at Celltrion impacted Teva as the Korean company is the main API supplier for Teva’s migraine drug fremanezumab. Teva confirmed that the USFDA had extended the goal date of the Biologics License Application (BLA) for fremanezumab. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is currently set for September 16, 2018. The Celltrion warning letter was followed by an announcement by the US-based Evolus that a USFDA pre-approval inspection of  Daewoong Pharmaceutical’s plant in South Korea, where a botox biosimilar is being produced, resulted in 10 observations. Back in 2013, Daewoong had inked a contract with Evolus to export DWP-450 (a botulinum neurotoxin candidate), which was expected to be released in the US market around 2017-18. While Daewoong said it expects “no significant further actions”, Evolus’ SEC filing highlights that “any failure to adequately resolve the FDA’s observations at the Daewoong facility would likely cause FDA approval of DWP-450 to be delayed or denied”.  In May, the FDA declined to approve Evolus’ Botox rival citing deficiencies related to the chemistry and manufacturing of its potential treatment for frown lines. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE!   India: Data-integrity violations, invalidation of OOS results continue   Alkem has ‘no quality control unit’: After eight days of inspecting Alkem Laboratories’ finished formulation facility in India in March 2018, the FDA investigators concluded — “there is no quality control unit”. Alkem’s head of quality control (QC) and quality assurance (QA) confirmed out-of-specification (OOS) results for the assay for a batch of tablets. However, the company did not recall the product, which was distributed in the US market. Less than three weeks before the inspection, the “firm’s QC department deleted two-thousand one hundred one (2,101) files” on its computer network.  Alembic invalidated OOS results: In the seven days that the FDA investigator — Jessica L Pressley — spent at Alembic Pharmaceuticals’ oral solid dosage manufacturing facility in Tajpura, Gujarat, she uncovered that the firm invalidated 131 of the 140 OOS results (an invalidation rate of 94 percent) for products marketed in the US.  The firm attributed the invalidation to analyst errors. In 2017, the invalidation rate was 91 percent. The Form 483 shares a concern that the “OOS results that were invalidated by the firm’s QC unit were without rationale and supporting documentation.” Alchymars falsified lab data: A September 2017 inspection by the USFDA at Alchymars ICM SM Private Limited in India uncovered that the firm “was falsifying laboratory data”. During the inspection, the FDA investigator found that an analyst reported far fewer colony-forming units (CFU) in a water sample than those observed on the plate by the investigator.  The FDA raised serious concerns as Alchymars uses the water to manufacture APIs intended for use in sterile injectable dosage form drug products.  Alchymars is part of a group of companies and the factory is controlled by Trifarma in Italy, a company which was cited by the FDA for data-integrity violations in 2014. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE!   Our view   This year, concerns over pharmaceutical manufacturing spread beyond China, India and the United States as data integrity issues also emerged in Japan and Australia. In Taiwan, the failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas was a problem uncovered by both the FDA and EU inspectors. A firm in France released an over-the-counter (OTC) drug product without testing if the active ingredients conformed to specifications. PharmaCompass’ review of the observations indicates that as inspectors start adopting a more standardized approach towards inspections, the problems they uncover across countries are along similar lines.  At PharmaCompass, we believe that a review of our Mid-Year Non-Compliances in 2018 will provide you with the insights necessary to prepare and insulate your business from the concerns raised during regulatory inspections.  Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE!  

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    26 Jul 2018
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    Compliance Recap: Data-integrity threatens US $4.3 billion Fresenius-Akorn deal

    Compliance Recap: Data-integrity threatens US $4.3 billion Fresenius-Akorn deal

    In April last year, German drugmaker Fresenius Kabi had agreed to acquire Akorn, a manufacturer and marketer of prescription and over-the-counter pharmaceutical products based in the US, for approximately US$ 4.3 billion. The transaction was expected to close in early 2018. Fresenius’ CEO Stephan Sturm now says the German drug major may back out of its planned acquisition of Akorn if an independent probe into data integrity at Akorn yields evidence of wrongdoing. On Monday, Fresenius said it was conducting an independent investigation “using external experts, into alleged breaches” at Akorn of the US Food and Drug Administration’s (USFDA) data integrity requirements relating to product development. Strum also mentioned that if the allegations (of breaches into data integrity) prove to be untrue, the company will go ahead with the acquisition as planned. “To date, the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does not believe this investigation should affect the closing of the transaction with Fresenius,” Akorn said in a statement. Akorn shares plummeted by over 30 percent in after-market trading. Akorn has also been burdened by supply disruptions and competition for a range of products such as ephedrine injection for low blood pressure under anesthesia and lidocaine anesthetic ointment. With the acquisition of Akorn, Fresenius hopes to get a stronger foothold into the US, with access to a network of retail pharmacies and outpatient clinics as well as hospitals where it has traditionally marketed its products. The acquisition will also complement Fresenius’ Kabi medicines unit, which specializes in intravenous drugs. Akorn’s questionable compliance record   While the exact nature of observations into Akorn’s product development processes have not been published, an FDA inspection conducted in April 2017 at Akorn’s Decatur (Illinois) facility found particle contamination in washed vials. Although the FDA investigator shared his concern with an Akorn vice president, the company went ahead and released the vials for manufacture of the drug product.  Earlier, Akorn’s plan to expand its operations to India had backfired when one of the plants it had acquired was placed on FDA’s import alert list in 2015. Three years later, the plant is still on FDA’s import alert list. It has also not paid its GDUFA fee for FY 2018, indicating that the plant is unlikely to produce generic drugs for the US market. Fresenius’ long drawn battle with data-integrity   In 2008, Fresenius had acquired a 73 percent stake in India’s largest anti-cancer drug maker, Dabur Pharma. In 2013, its API manufacturing site received a warning letter from the USFDA over data-integrity concerns. And once again, in December 2017, Fresenius’ API plant received a warning letter for data-integrity concerns. Investigators found employees had halted and invalidated HPLC (high-performance liquid chromatography) analyses nearly 250 times when they believed the tests were going to end with out-of-specification (OOS) results. FDA issues warning letter to Alchymars ICM in India   A September 2017 inspection by the USFDA at Alchymars ICM SM Private Limited in India uncovered that the firm “was falsifying laboratory data”. During the inspection, the FDA investigator found that an analyst reported far fewer colony-forming units (CFU) in a water sample than those observed on the plate by the investigator.  The FDA raised serious concerns as Alchymars uses the water to manufacture APIs intended for use in sterile injectable dosage form drug products.  The FDA investigator also found damaged product contact surfaces and observed that the firm’s quality unit did not thoroughly investigate customer complaints. The company received complaints about black spots in finished API and OOS results for moisture content. In each case, the company classified the complaint as “minor and unjustified” without a thorough review.  The FDA also raised objection with regard to the equipment washroom which “was found in a filthy condition” and that the firm failed to “provide personnel with adequate clean washing and toilet facilities”.  In the warning letter, the FDA highlighted that some of the observations were repeat deviations from a previous inspection which was conducted in February 2015. Alchymars is part of a group of companies and the factory is controlled by Trifarma in Italy, a company which was cited by the FDA for data-integrity violations in 2014. Our view   Recent cases, such as Daiichi’s catastrophic acquisition of Ranbaxy, Teva’s problems with Rimsa in Mexico, Baxter’s challenges with Claris and Mylan’s struggles with Agila tell us that for the pharma company that is making the acquisition, data integrity challenges lead to a sticky situation. We view Fresenius’ independent investigation into data-integrity issues at Akorn in the backdrop of some of the M&A fiascos mentioned above. Fresenius’ reliance on such an investigation goes on to prove how learnings on quality violations in manufacturing operations have taken centerstage in pharmaceutical corporate decision making.  

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    #Phispers by PHARMACOMPASS
    01 Mar 2018
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    2017 – Recap of Warning Letters, Import Alerts and Non-Compliances

    2017 – Recap of Warning Letters, Import Alerts and Non-Compliances

    Data integrity continued to be a hot topic in the pharmaceutical industry through 2017. According to a recent analysis by GMP (good manufacturing practices) intelligence expert, Barbara Unger, approximately 65 percent of all US Food and Drug Administration (USFDA) warning letters issued in FY2017 (October 1, 2016 until September 30, 2017) included a data integrity component. However, in the previous year, this number was even higher — at 79 percent — implying there has been a decline in non-compliance incidents pertaining to data integrity in 2017. Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! 2017’s recurring concern – a failure to thoroughly investigate problems   In PharmaCompass’ 2016 compilation, serious charges of blatant data manipulation surfaced at organizations around the world.  In 2017, we witnessed a reduction in data-integrity violations uncovered at pharmaceutical manufacturers due to the absence of audit trail software in quality control testing equipment. However, the implementation of audit trails has resulted in the emergence of a new failing – the improper handling of out-of-specification (OOS) results. Failure “to thoroughly investigate any unexplained discrepancy or failure of a batch” became a recurring theme in concerns highlighted at major generic players like Mylan, Fresenius, Teva, Dr Reddy’s, Hetero Labs and Lupin. In the case of Fresenius’ oncology API plant in India, USFDA investigators found employees had halted and invalidated HPLC (high-performance liquid chromatography) analyses nearly 250 times when they believed the tests were going to end with OOS results.  The USFDA warned Fresenius SE after the company’s Indian plant that makes cancer-drug ingredients for the US market aborted hundreds of drug-quality tests. Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! The situation at Lupin wasn’t much better as the warning letter issued to its formulation manufacturing facilities in Goa and Indore (Pithampur Unit II) said the company failed to “thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all OOS results obtained at Pithampur and over 75 percent of them in Goa.  Failure to resolve recurring problems also led the USFDA to tell Meridian Medical Technologies, a division of Pfizer that makes the EpiPen injector device (sold by Mylan NV), that serious component and product failures had been associated with patient deaths. In its warning letter, the USFDA said the Pfizer unit failed to adequately investigate problems at its manufacturing facility in Brentwood, Missouri. It also did not take appropriate corrective actions before a USFDA inspection earlier this year. Meridian had received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies. Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! Non-compliances at finished drug producers outnumbered those at API facilities   During 2017, the number of finished pharmaceutical companies cited for compliance concerns significantly outnumbered the number of active pharmaceutical ingredient (API) producers. While the FDA issued 48 warning letters to drug product manufacturers, API producers received only 18 warning letters. The actions by the European regulators was similar — 15 non-compliance certificates were issued to finished drug producers, as compared to only two API manufactures who were found lagging behind in compliance standards. China, India and the United States continued to lead the countries where regulators found most shortcomings. As compared to the previous year, in 2017 regulators issued fewer non-compliance certifications as the FDA had been hampered by staffing shortages. As a result, the FDA’s inspections in India “dropped 27 percent in fiscal 2017 from a year earlier, to 185 from 252.”  Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! In 2017, EU and FDA started their mutual recognition program. But will it work?   2017 was also a landmark year for the US and European regulators as the USFDA and the European Medicines Agency (EMA) announced their program for mutual recognition of inspections of drug manufacturers, which became operational on November 1, 2017. The FDA will now recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet the USFDA requirements. This is an unprecedented move — prior to this, the USFDA had never recognized another country’s inspectorate. As part of the agreement, the European Commission (EC), the US FDA and the EMA signed a confidentiality commitment that allows the USFDA to share non-public and commercially confidential information, including trade secret information relating to inspections with European regulators. As the mutual recognition of inspections program goes live, there were examples of many companies that were found to be consistently out of compliance by both the FDA and regulators from the EU. Yet, there were cases where the regulators came to different conclusions about the state of a particular facility they had inspected. While European regulators had raised compliance concerns at Biocon, the company went ahead and got an FDA nod for its biosimilar of Roche’s blockbuster cancer drug — Herceptin. Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! The case of Qinhuangdao Zizhu — when WHO and FDA differed    In another case, an inspection conducted by the USFDA at Qinhuangdao Zizhu Pharmaceutical from November 28 to December 1, 2016 uncovered significant data integrity concerns and failures in the level of adherence to current good manufacturing practices (cGMPs) for APIs. In the warning letter issued to the firm, the laboratory analysts admitted to the FDA inspectors that they had been “setting the clock back and repeating analyses for undocumented reasons.”  At Qinhuangdao Zizhu, “initial sample results were overwritten or deleted” and the company “reported only the passing results from repeat analyses”. In addition to not having effective measures to control data within their computerized systems, the FDA investigators found that the firm “relied on incomplete information” to determine whether Qinhuangdao Zizhu’s drugs met established specifications. The investigators found “a recurring practice of re-testing samples until acceptable results were obtained” and that batch production records “contained blank or partially completed manufacturing data”. On March 8, 2017, Qinhuangdao Zizhu Pharmaceutical was placed on import alert by the USFDA. Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE! Almost a year prior to the USFDA inspection, in October 2015, the company had been inspected by a WHO Prequalification Team (PQT) for levonorgestrel, mifepristone and ethinylestradiol APIs. The inspection found “five major deficiencies including data integrity issues and several minor deficiencies”. The WHO, however, went ahead and closed its inspection as compliant, based on corrective and preventive actions (CAPAs) provided by the manufacturer. In view of the USFDA actions, and the fact that Qinhuangdao Zizhu Pharmaceutical is the only WHO-PQT prequalified source of levonorgestrel API (as was seen in a similar case at Mylan), the WHO approach towards the compliance position was to focus extensively on product quality.  READ: FDA and EU differ on cGMP standards at the same facilities: How will they mutually recognize inspections? Our view   As the US regulators push hundreds of new generic drugs to market in an effort to drive down prices of generic drugs in the United States, the industry should get ready for an increasing number of inspections in the coming years. Our compilation indicates that in 2017, while most companies had installed the infrastructure necessary to combat issues related to data-integrity, there were problems that were systemic in nature. These ‘systemic problems’ remain, and the industry must get ready as the FDA and European inspectors join hands to crack down on them.    PharmaCompass’ 2017 Recap of FDA Warning Letters, Import Alerts & EU Non-Compliances is an easy way to evaluate companies that have run into compliance challenges so that appropriate risk mitigation strategies can be adopted.  

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    11 Jan 2018
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    Teva’s rating cut to junk; Two Lupin facilities receive FDA warning letters

    Teva’s rating cut to junk; Two Lupin facilities receive FDA warning letters

    This week in Phispers, we look at the contrasting 2017 forecasts of Mylan and Teva, resulting from the FDA approval of Mylan’s generic Copaxone. Valeant decides to return the female libido pill business to Sprout Pharma. In India, two Lupin facilities receive FDA warning letters. And Torrent Pharma’s imminent acquisition of Unichem is set to make it the country’s fifth largest drug company. Meanwhile, Pfizer admits to have faltered on integrating Hospira and QuintilesIMS rebrands itself as IQVIA. Teva’s credit rating nosedives, as Mylan raises 2017 forecast with approval of Copaxone   Here’s the tale of two drug makers — Teva Pharmaceutical Industries and Mylan NV. Both have been facing tough times — Teva due to the declining prices of drugs and the high debt it incurred due to its US$ 40 billion acquisition of Allergan Plc’s generics business last year; and Mylan due to its struggles with its blockbuster emergency allergy shot EpiPen. But last week clearly favored Mylan. Teva saw its credit rating cut to junk by Fitch Ratings after the US Food and Drug Administration (FDA) approved two doses of Mylan’s generic version of Teva’s Copaxone. This multiple sclerosis drug happens to be Teva’s biggest product. As a result, Teva slashed its 2017 profit forecast for a third time.  Fitch predicted that Teva will have to either sell assets or find external sources of financing to meet its obligations. Mylan, on the other hand, raised its 2017 forecast as it expects to benefit from the ‘earlier-than-expected approval’ of its generic Copaxone. Even as Mylan hopes to benefit from its generic Copaxone, its challenges continue unabated. Its third-quarter results highlighted the company's struggles with declining sales of EpiPen. Sales of EpiPen fell by US$ 245.1 million on increased competition and higher governmental rebates following a settlement with the US Department of Justice. EpiPens, which contain the hormone epinephrine, are used to stave off allergic reactions that can be fatal. However, since mid-September this year, seven people have died as a result of failure of EpiPens to deploy correctly. In all, the FDA has received 228 reports of EpiPen or EpiPen Jr failures since mid-September. Teva’s JV with Guangzhou: Meanwhile, Teva is exploring growth through the world’s second-largest market for drugs — China. It is setting up a joint venture with Guangzhou Pharmaceutical Holdings to manufacture and sell its drugs in the Chinese market. It is awaiting approval from the local government. Two years after buying ‘female-Viagra’, Valeant plans to sell it back to Sprout   After buying the female libido pill business from Sprout Pharmaceuticals two years back for US$ 1 billion, this week Valeant Pharmaceuticals International said it plans to sell the business back to its original owner. The controversial pink pill — Addyi — made by Sprout was said to be a blockbuster drug, expected to command a US$ 2 billion market. However, Addyi proved to be a commercial disaster, with its sales being sluggish last year. What was worse, Valeant was sued on behalf of the former Sprout investors for its alleged failure to market Addyi successfully. The complaint had said that sales of the pill may have totaled less than US$ 10 million in 2016, far short of the US$ 1 billion targeted by July, 2017. Addyi, approved by the US FDA in August 2015 under intense pressure from patient advocacy groups, is meant to be taken daily. It is prescribed to activate sexual impulses, but carries a strong warning about its potential side effects — such as low blood pressure and fainting, especially when taken with alcohol. Many in the industry believe that the drug should never have been approved. Valeant has agreed to sell its subsidiary and Addyi to a new company “associated” with Sprout’s founders, for a royalty stream of only 6 percent on global sales of Addyi. In addition, Valeant said it will provide a US$ 25 million loan to fund initial operating expenses to the new company to get things started. And in exchange, Sprout is dropping its lawsuit claiming Valeant mismanaged the launch by pricing the drug too high. Valeant’s glaucoma drug: Last week, the US FDA approved Valeant’s long-delayed glaucoma drug — latanoprostene bunod ophthalmic solution. Christened Vyzulta, the solution was approved for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma. Valeant hopes to have the drug in the market before 2017-end, Joseph Papa, CEO of Valeant, said in a statement. Valeant acquired the drug through its US$ 8.7 billion buyout of Bausch + Lomb in 2013. The drug was licensed to Bausch + Lomb by France-based Nicox. Torrent to emerge fifth-largest Indian drug player after Unichem buyout   In India, Ahmedabad-headquartered Torrent Pharmaceuticals plans to acquire Unichem Laboratories’ domestic business for US$ 558 million (Rs 36 billion) by the end of this week. The deal would make Torrent the fifth largest player in the Indian market with a market share of 3.4 percent. According to a Reuters report, Torrent would buy more than 120 brands from Unichem in India and Nepal, along with its manufacturing plant in Sikkim. The board of Torrent is meeting on November 10 to approve the second quarter results. A formal announcement on the acquisition of Unichem is likely to come on that day. Unichem has not been able to leverage its slow-growing, mature brands. The deal includes the purchase of the brands like Unienzyme, Losar, Ampoxin and Telsar. The acquisition is likely to deliver synergies in both cost and revenues for Torrent’s branded drugs business in India. Torrent is expected to turnaround Unichem’s mature brand, just the way it had turned around Elder Pharma’s branded formulations, which it had acquired in 2014 for US$ 308 million (Rs 20 billion). Analysts expect Unichem to use the proceeds from the deal to ramp up its unprofitable international business. The transaction will strengthen Torrent’s position in cardiology, diabetology, gastro-intestinals and central nervous systems therapies, Torrent chairman Samir Mehta said. Despite record profits, Pfizer’s CEO says troubles with Hospira persist   American pharmaceutical giant Pfizer reported third-quarter profits last week, which more than doubled as its new drugs to treat cancer and other illnesses made up for the hit the company took due to patent expirations. Pfizer’s net income from the quarter stood at US$ 2.8 billion, compared with just under US$ 1.4 billion in the year-ago period. However, Pfizer’s Essential Health unit remained an area of concern, into which Hospira was folded. The third quarter revenue of this unit was down 11 percent, at US$ 5.06 billion. Pfizer had acquired Hospira in 2015 for US$ 15 billion. While praising other parts of the Essential Health unit (such as biosimilars and emerging markets), Pfizer CEO Ian Read pointed his finger at Hospira. “Within our Essential Health portfolio, we have been experiencing supply shortages with some products. The shortages are primarily for products from the legacy Hospira portfolio and are largely driven by capacity constraints and technical issues,” Read said. Pfizer has attributed a 12 percent operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from the former Hospira facilities. At the time of acquisition, the sterile injectables player Hospira was facing regulatory challenges. The executives of Pfizer had assured investors and regulators that they would quickly resolve issues at the plants. However, two years on, the problems still persist. Pfizer has sold or closed some of the troubled operations of Hospira. But one that has continued to bother the company is a facility in McPherson, Kansas. Earlier this year, Pfizer’s fill/finish manufacturing facility in McPherson received a warning letter from the US FDA. The manufacturing problems at the McPherson plant also derailed the launch of a generic version of Teva’s Copaxone, that was being developed by Sandoz and Momenta. The drug was being finished at the McPherson plant, which was slapped the FDA warning letter. Goodbye QuintilesIMS, Hello IQVIA   QuintilesIMS has rebranded itself and changed its name to IQVIA. Last year, Quintiles and IMS Health had merged. The merged entity — QuintilesIMS — had emerged as the world's largest pharma services provider, with a market value of almost US$ 18 billion and around 50,000 employees. The name change (to IQVIA) is effective from November 6, 2017; and beginning November 15, 2017, equity shares of the company will trade on the New York Stock Exchange (NYSE) under the new name and new ticker symbol ‘IQV’.  “IQVIA may be grounded in the intelligence and capabilities of I and Q, but it is ‘via’ the path forward that we hope to inspire and ignite real change for healthcare stakeholders,” a spokesperson told Endpoints News. Two Lupin facilities receive FDA warning letters   In another setback to Indian generic manufacturers trying to overcome concerns of non-compliance with good manufacturing practices (GMPs), Lupin informed the bourses that it had received a warning letter for its formulation manufacturing facilities in Goa and Indore (Pithampur Unit II). In April 2017, Lupin had received three Form 483 observations for its Goa  facility, and a month later six Form 483 observations for Pithampur. In June last year, a PharmaCompass article had asked the question — “Lupin’s FDA inspections, how serious are the concerns?”. In our review of FDA observations of previous inspections at Lupin, we had highlighted concerns over “instances where batches that generated ‘out of specification (OOS)’ results and failed in-process specifications, had the finished product released by the quality control unit (QCU) and distributed” without invalidating the OOS results. The recent warning letters indicate continued concerns at Lupin. The observations of the recent inspections specifically highlight Lupin’s continued “failure to thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all OOS results obtained at Pithampur and over 75 percent of them in Goa.    While Lupin does not expect any disruption in supplies, the company does anticipate a delay of new product approvals.  

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    #Phispers by PHARMACOMPASS
    09 Nov 2017
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    Lundbeck’s CEO to head Teva; Pfizer gets FDA warning letter for supplying faulty EpiPens

    Lundbeck’s CEO to head Teva; Pfizer gets FDA warning letter for supplying faulty EpiPens

    This week, Phispers brings you news about Teva, which finally found a CEO in Kare Schultz. Allergan transferred the patent of its best-selling eye drug Restasis to the Mohawk tribe in order to protect it from patent dispute. There was more news on EpiPen, as Pfizer received an FDA warning letter for Mylan’s flagship product. And, a leaked audio revealed how Insys lied to a patient who didn’t have cancer to sell a prescription opioid. Teva nabs Lundbeck’s CEO to revive its fortunes; to pay over US$ 44 million    After months of bad news, this week there was finally some good news from the much-troubled Teva. The Israeli generic drug giant finally managed to get a new chief executive officer for itself, after Erez Vigodman’s resignation in February this year. Teva poached Lundbeck’s Kare Schultz as its new CEO. Schultz, 56, will move to Israel and be based at Teva’s headquarters in Petach Tikva. In an SEC filing, Teva said Schultz is starting with a base pay of US$ 2 million. Along with several bonuses (including a signing bonus of US$ 20 million), his initial package adds up to over US $44 million. Schultz has 30 years of experience in global pharma business. After the acquisition of Allergan’s generic business — Actavis — last year, Teva has been saddled with huge debts. And the key question before the new CEO is whether he will maintain Teva as both a generics and specialty drugmaker, or split it in two or get out of the highly competitive generics business. During the last quarter (April to June), Teva posted revenues of US$ 5.7 billion, out of which US$ 3.1 billion came from generics and US$ 2.1 billion from its own branded drugs. About half the sales of its own medicines come from a blockbuster multiple sclerosis drug which is now facing competition from generics. Pfizer gets FDA warning letter for supplying faulty EpiPens to Mylan   The US Food and Drug Administration (FDA) has told Meridian Medical Technologies, a division of Pfizer that makes the EpiPen injector device (sold by Mylan NV), that serious component and product failures have been associated with patient deaths. In a warning letter issued on September 5, the FDA said the Pfizer unit failed to adequately investigate problems at its manufacturing facility in Brentwood, Missouri. It also did not take appropriate corrective actions before an FDA inspection earlier this year. Throughout last year, Meridian received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies. In March this year, tens of thousands of EpiPens were recalled worldwide after two reports of the shot failing to work in emergencies. In a note to Stat News, Pfizer said: “Between 2015 and now, we have shipped more than 30 million EpiPen Auto-Injectors globally. It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.”  “We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths,” it added. In a statement, Mylan said it is confident of the safety and efficacy of EpiPen products being produced at the Brentwood site. According to the FDA warning letter, in April 2016, a customer complained that an EpiPen failed to activate. Though Meridian confirmed the problem, in June 2016 it decided the defect was infrequent. Moreover, between 2014 and 2017, Meridian received 171 devices from patients who complained their devices failed to activate even when they followed the instructions. But Meridian only examined some of the devices and told the FDA inspectors they could not examine the rest without “approval by management”. The warning letter highlights that Meridian “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.” Allergan tries to protect eye drug by selling its patent rights to Mohawk tribe   Allergan played an unusual gambit last week to protect its best-selling eye drug — Restasis — from a patent dispute. It did that by transferring the patent of the drug to the Saint Regis Mohawk Tribe, a Mohawk Indian reservation in Franklin County, New York, United States. Under the deal, Allergan will pay the tribe US$ 13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive US$ 15 million in annual royalties as long as the patents remain valid. For the Mohawk tribe, the deal could generate a new revenue stream. Bob Bailey, Allergan’s chief legal officer told FiercePharma: “I have spent time with the chiefs and their primary motivation for doing this… is to diversify the stream of incomes that this tribe enjoys away from casinos and cigarettes, into longer term, more viable streams…”  If successful, the move will represent a new way for drug companies to circumvent the inter partes review, a procedure for challenging the validity of a United States patent before the United States Patent and Trademark Office. The move sent ripples across the pharmaceutical industry. Surely, if this strategy pays off, there will be other drug companies following suit. Many observers ridiculed the company on social media by calling the deal unscrupulous and sure to bring more criticism to the industry. The tribe has reportedly also taken ownership of patents owned by a technology company. Interestingly, last year, Allergan CEO Brent Saunders had won accolades for condemning predatory drug pricing by the likes of Martin Shkreli and emphasized the company’s commitment to research and development.  This week, in a Federal District Court in Marshall, Texas, Mylan challenged Allergan’s move. Netherland headquartered Mylan, in its court filing stated that Ireland headquartered Allergan is “attempting to misuse Native American sovereignty to shield invalid patents from cancellation.” Biocon’s Malaysia facility gets EU nod; Dr Reddy’s gets six major observations   Biocon, India’s leading biopharmaceutical company, had some good news to share, after its recent setbacks related to its biosimilar program. Its insulin facility in Malaysia — Biocon Sdn Bhd — received an EU GMP compliance certificate from the HPRA (Ireland), the representative European inspection authority. Biocon Malaysia is “one of Asia’s largest state-of-the-art integrated insulins manufacturing facilities, set up with an investment of about US$ 275 million, at the BioXcell Biotech Park in Johor, Malaysia,” Biocon said in a statement. Dr Reddy’s Vizag plant: Indian pharma major Dr Reddy’s said its plant in Vishakapatnam (India) has been issued six major observations related to good manufacturing practices (GMP) by the regulatory authority of Germany — Regierung von Oberbayern. In a statement issued to the Bombay Stock Exchange last week, the company said: “This is to inform you that on 7th September, 2017, the Regulatory Authority of Germany, concluded an audit for our formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations.” Products manufactured at this facility are not currently exported to the EU. The company will be submitting a Corrective and Preventive Action plan (CAPA) to the authorities, the company added. The Duvvada facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of its EU-GMP certification, the statement added. Meanwhile, Cadila Healthcare received zero observations from the USFDA for its Moraiya plant, situated in Gujarat (India). The FDA has issued zero observations for the unit after its re-inspection this year. Opioid crisis: Leaked audio reveals how Insys lied to a patient who didn’t have cancer   In the United States, an explosive audio revealed how opioids were being given by a drug company to a patient who didn’t have cancer. The audio was released by Senator Claire McCaskill’s office last week. It explains how many in America had been victims of the opioid crisis. According to Business Insider, the audio is a phone call between an employee from Insys, the Arizona-based maker of Subsys (an opioid pain medication given to cancer patients), and a pharmacy benefit manager (PBM).  In the US, PBMs are supposed to ensure that everyone who gets Subsys has cancer. But the patient in question, Sarah Fuller, didn't have cancer. An Insys employee tried to convince Fuller she had cancer, and succeeded. Fuller eventually died of a Subsys overdose on March 25, 2016. The audio accompanies a report from McCaskill’s office on the marketing and business practices of Insys. Since December 2016, several Insys executives, including a former CEO, have been arrested over the opioid issue. German Merck hires JP Morgan to divest its consumer health business   Germany’s Merck KGaA has hired JP Morgan to sell its consumer health business, which includes brands such as Seven Seas vitamins, the company said last week. The annual sales of Merck’s over-the-counter medicines and vitamin supplements are around US$ 1 billion. The divestment would help fund research into higher-margin prescription drugs, Merck said. The business could be worth around US$ 4.5 billion. According to news reports, Merck has already sounded out prospective buyers including Swiss food giant Nestle. Merck had held preliminary talks with Nestle in summer this year. Nestle reportedly favored a joint venture deal and no agreement could be reached.  According to Euromonitor International, the global market for consumer health products is worth around US$ 233 billion. Merck ranks 32nd in this sector, with a 0.4 percent share. J&J dumps hepatitis C drug development; Roche suffers R&D setback   Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C research, citing increased availability of a number of effective hepatitis C therapies. Its investigational hepatitis C treatment regimen — JNJ-4178 — is a combination of three direct acting antivirals. “The ongoing phase II studies with JNJ-4178 will be completed as planned, with no additional development thereafter,” Janssen said in a statement. Roche drug fails endpoints: Roche said its drug for geographic atrophy — lampalizumab — failed in first of two late-stage studies. Lampalizumab was once considered a potential mega-blockbuster that could bring in US$ 6 billion a year. Lampalizumab did not reduce mean change in geographic atrophy lesion area compared to a placebo at one year (48 weeks). Given the lack of efficacy, “further dosing in patients will be interrupted until the results from the second Phase III study are evaluated,” Roche said.

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    14 Sep 2017
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    FDA to share full inspection reports with EU; Difficult week for Teva, J&J, Mylan

    FDA to share full inspection reports with EU; Difficult week for Teva, J&J, Mylan

    This week, Phispers brings you the latest from the world of biosimilars, with Samsung Bioepis tying up with Japan’s Takeda, Biocon transferring its biosimilar business to a subsidiary, and South Korea’s Celltrion denying reports that its proposed biosimilar of Herceptin could face delays in Europe. Teva faced yet another bad week, with two Congressmen in the US attacking it over price increases of its multiple sclerosis drug. Meanwhile, Mylan and J&J will have to pay millions of dollars for cases against them. In vaccines, GSK faces flak for shortage of its Hepatitis B vaccine in the UK. And Pfizer won a pneumonia vaccine patent battle in India.   Biocon transfers biosimilar business to subsidiary; Samsung Bioepis ties up with Takeda   A lot has been going on in the world of biosimilars. Last week, in a stock exchange filing, Biocon said it has withdrawn the dossier for the biosimilar products — Fulphila® (pegfilgrastim) and Ogivri® (trastuzumab). Since the approval of its trastuzumab and pegfilgrastim applications would require re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon said in the statement. The announcement came a fortnight before the FDA was supposed to take a decision on the trastuzumab application. This week, the board of Biocon approved the transfer of the biosimilar business of the company to Biocon Biologics India, a step-down subsidiary of the company, subject to the consent of its shareholders. The transfer of the biosimilar business has been done by way of a ‘slump sale’ as a going concern — wherein a sale is done for a lump sum consideration without values being assigned to the individual assets and liabilities. Concerns also emerged over Biocon’s Herceptin biosimilar competitor — Celltrion — as it denied a news report that its proposed biosimilar of Herceptin (a breast cancer drug) could face delayed European approval due to late submission of data. With global sales of around US$ 7 billion a year, Herceptin is one of Roche’s best-selling drugs. According to the Celltrion, the European Medicines Agency (EMA) found no lapses during a pre-approval inspection of its product site and drug substance Herzuma — its copy version of Roche’s Herceptin. The South Korea-headquartered biopharmaceutical firm also managed to hand in the documents that it was required to provide after inspection.  “We don’t expect any major changes in approval procedures although the inspection date had been pushed back a little because of differing schedules,” a Celltrion official said. There was news that the EMA could postpone approval of Herzuma to 2018 as the company failed to submit documents on time. However, it seems like Celltrion’s Herzuma may get EMA’s nod this autumn. Any delays in approval procedures for Herceptin biosimilar candidates could have an impact on other drug makers eyeing the US$ 2 billion EU market for the original drug including another South Korean biosimilar firm — Samsung Bioepis — which filed for EU approval in September 2016. The biosimilar industry is keeping a close watch on which of the two South Korean firms is the first to get the nod for its Herceptin biosimilar, after Biocon withdrew its application last week. Meanwhile, Samsung Bioepis unveiled a new alliance this week — with Japan’s Takeda. Together with Takeda, Samsung Bioepis hopes to accelerate the development of effective therapies. The Japanese firm has been open to devising new alliances that will share the risk in order to broaden its overall drug development work.  More bad news for Teva as US Congressmen attack pricing of its flagship therapy   Two US Congressmen accused Teva of hiking the price of its flagship multiple sclerosis (MS) drug — Copaxone (glatiramer acetate) — by more than 1,000 percent since 1996.  Copaxone generated US$ 4.22 billion in sales last year. The Congressmen — Elijah Cummings and Peter Welch — want to fully investigate Teva’s pricing practices, while also calling out firms such as Novartis, Bayer and Biogen. According to the Congressmen, a year’s worth of 20 mg Copaxone was priced at US$ 8,292 in 1996. This increased to US$ 51,315 in 2012 and US$ 91,401 in 2017. Lack of generic competition permitted Teva to increase the price of the drug to such high levels. Cummings and Welch said they were launching an investigation into why prices for MS treatments have nearly quintupled since 2004. According to the National Multiple Sclerosis Society, the average annual cost of MS therapy rose to US$ 78,000 in 2016 from US$ 16,000 in 2004. Meanwhile, Teva is planning to tie up with other drugmakers to fund some of its development pipeline as it struggles with debts and expiring patents. Teva needs funds to develop new drugs, and striking alliances with big pharma players is one way of doing that. Earlier this month, Teva reported a steep drop in second-quarter earnings. Teva is saddled with debts of around US$ 35 billion, which it took on when it acquired Actavis (Allergan’s generic business) for US$ 40.5 billion last year. Sanofi gains millions via Mylan’s EpiPen settlement; J&J to pay US$ 417 million in baby powder case   Last week, Mylan NV and the US Justice Department finalized a US$ 465 million settlement to resolve claims that Mylan had defrauded taxpayers and overcharged the government by misclassifying its EpiPen emergency allergy treatment as a generic drug. EpiPen had become the center of a drug price-hikes controversy last year. The probe into the price of EpiPen followed a whistleblower lawsuit filed under the False Claims Act that rival drugmaker Sanofi SA filed in 2016. As a result of the settlement, Sanofi will receive US$ 38.7 million as a reward, authorities said. Meanwhile, lawmakers in the US say the settlement wasn’t tough enough. According to Democratic Senator Richard Blumenthal of Connecticut, the agreement was a “feeble fraction” of the US$ 1.27 billion that a government report found taxpayers may have overpaid for EpiPen over the last decade. Mylan had acquired EpiPen in 2007. It is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine. Mylan had raised the price of a pair of EpiPens to US$ 600, from US$ 100 in 2008. J&J baby powder case: A US court directed Johnson & Johnson to pay US$ 417 million to a woman who alleged that the company’s baby powder causes ovarian cancer.  In her lawsuit, 63-year-old Eva Echeverria had claimed that she used the talcum powder from the 1950s till 2016, and developed ovarian cancer in 2007. Echeverria alleged that J&J failed to warn consumers about the risks involved in using their talcum powder. The court awarded the woman US$ 68 million as compensatory damages, and US$ 340 million as punitive damages. Hikma raises price of diarrhea drug by 400 percent; Trump signs user fee law   Last week, the US saw another price-gouging incident. The US subsidiary of Hikma Pharmaceuticals Plc raised the price of a common diarrhea drug by more than 400 percent. Known as West-Ward Pharmaceuticals, the US division of Hikma is also charging more for five other medicines. According to a Financial Times report, the average wholesale price of a 60 ml bottle of liquid atropine-diphenoxylate, a common diarrhea drug also known as Lomotil, went from about US$ 16 a bottle to US$ 84. FDA Reauthorization Act: Last week, President Donald Trump signed the FDA Reauthorization Act of 2017 into law. With this, the FDA saw the end of a two-year long process that was threatening to disrupt its operations. The law comes at a time when the FDA, under the new commissioner Scott Gottlieb, is approving generics at a record pace. Though the legislation had been passed by both the houses of the Congress, it faced a number of threats, including Trump’s intent to fund the FDA entirely with user fees from companies. Between 2018 and 2022, the FDA is expected to collect US$ 9 billion in fees — US$ 8 billion for prescription drugs and US$ 1 billion for devices — based on the fee level set in the Senate bill. GSK faces flak for Hep B vaccine shortage in UK; Pfizer wins vaccine patent in India   In the UK, drug giant GlaxoSmithKline faced flak and an increasing number of questions over shortages of its vaccine for the deadly liver disease hepatitis B. The shortage of this vaccine in the UK has led to rationing. Earlier this month, Public Health England (PHE) took the rare step of advising doctors to limit prescription of the vaccine, citing a “global shortage”. This comes at a time when GSK’s supplies of the vaccine to the US appear to be unaffected. The disparity has led to suggestions from liver disease campaigners that GSK may be “prioritizing” the massive American market. Hepatitis B is considered a “silent killer” leading to 900,000 global deaths a year. However, the disease is more prevalent in the ­developing world and is rare in the UK. Meanwhile, the World Health Organisation (WHO), has said there is no global shortage of the vaccine. The WHO is responsible for monitoring stocks of vaccines worldwide. In India, Pfizer Inc was granted a patent for its powerful pneumonia vaccine —Prevenar 13. The decision bars other companies from making cheaper copies of the vaccine and allows Pfizer to exclusively sell it in India until 2026. The patent came as a blow to some health groups that said this would put the treatment out of reach of thousands in poorer nations. The move comes at a time when India is facing increased pressure from the US to tighten its patent laws. In a report published in June this year, the United States Trade Representative expressed concerns over India’s intellectual property laws. India has the largest number of pneumonia cases, and for Pfizer, this is a big gain. The decision also has international implications, as several poorer nations rely on India’s robust pharmaceutical industry to supply cheaper copies of medicines and vaccines. FDA to start sharing full inspection reports with European regulators   This week, the European Commission (EC), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) signed a new confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade secret information relating to inspections with European regulators. In March 2017, the United States and the European Union (EU) finally announced that they will be able to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.  The deal is expected to enable the US Food and Drug Administration (FDA) and the EU to avoid duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk. This confidentiality commitment is a step in the ongoing implementation of the mutual recognition of inspections program.  

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    #Phispers by PHARMACOMPASS
    24 Aug 2017
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    India-China border tension may impact billion dollar pharma deal; AZ’s investors worry as key cancer drug fails trial

    India-China border tension may impact billion dollar pharma deal; AZ’s investors worry as key cancer drug fails trial

    This week in Phispers, we analyze the situation at AstraZeneca, where its much anticipated lung cancer drug failed in clinical trials. In the US, there are reports that various generic players are looking to enter into M&A deals in order to safeguard themselves against regulatory crackdown on prices. The tension along the India-China border may lead to cancellation of the Fosun-Gland deal by the Indian government and in the US, the FDA is looking to cut nicotine in cigarettes to ensure they are non-addictive. AstraZeneca’s key lung cancer drug fails in first stage trial; gets investors worried   The year 2017 was supposed to be a pivotal year for AstraZeneca. The firm was supposed to display new marvels from its laboratories and march towards annual revenues of US$ 45 billion by 2023. This target was set when Pfizer’s takeover offer was rejected in 2014. But so far, the year has turned out horribly for AstraZeneca. Its key lung cancer drug — Imfinzi — flopped in clinical trials. Known as the ‘Mystic’ study, this was the most anticipated clinical experiment in the pharmaceutical industry this year. The study was key to proving the value of the group’s new drug pipeline, after it rejected a US$ 118 billion takeover bid by Pfizer in 2014.The news crashed the share price of AstraZeneca by 15 percent. Imfinzi, an immuno-oncology drug, was said to be a potential replacement for chemotherapy. However, all is not lost yet. The first stage of the trial merely measured the drug’s ability to prevent a cancer from becoming worse. The second stage, which looks at survival rates, is said to be more important. But for Pascal Soriot, AstraZeneca’s CEO, this came as an embarrassment. He faced a barrage of questions from analysts about future payouts of the company. He was forced to defend the company’s dividend strategies at post-result meets last week. Fears for AstraZeneca’s dividend were driven by the failure of the lung cancer. But there is hope for Astra in the future — another lung cancer pill, Tagrisso, has produced good data. And AstraZeneca is partnering with Merck on another immuno-oncology drug, Lynparza. Another downside for Astra in 2017 has been the uncertainties faced by the company regarding its top executives. It began in January this year, when Luke Miels, the head of AstraZeneca’s European operations, announced he is quitting the company to join GlaxoSmithKline. Recently, there were speculations regarding Soriot considering an offer to join Israeli drugmaker Teva as its head. He is learnt to have turned down the offer. Bleak US generics market forecast has drug makers scrambling for deals   In the US, generic drug makers are turning to M&As in order to safeguard themselves against a concerted effort by regulators to crack down on the steep prices of drugs. According to a Reuters report, Impax Laboratories, Perrigo and Alvogen have been talking to advisers about various strategic options for their generics businesses. These options range from acquisitions, as well as outright sale. Earlier, Reuters had reported that Mallinckrodt, one of the largest producers of the generic opioid painkiller oxycodone, has been exploring a sale of its specialty generics unit. In May, the CEO of Impax, which makes a generic version of the EpiPen allergy injection, said it was looking at deals. The US generics market is getting increasingly competitive. Last month, Novartis reported that sales at its Sandoz generics unit were down 4 percent. Generic drugs are cheaper versions of brand-name drugs. In the US, the government is targeting generics to cut the cost of prescription drugs. According to a 2016 report by the Journal of the American Medical Association, US consumers spend more than twice as much on drugs per capita compared to other industrialized nations. In order to bring down the prices of drugs, the US Food and Drug Administration (US FDA) has committed to eliminating the backlog of drug applications awaiting its approval. This could mean nearly 4,000 new drugs will come onto the market over the next few years, based on FDA estimates. Even today, small and mid-sized drug makers are under pressure as consolidation among generic drug distributors has made it less profitable for them to sell their drugs. India-China border skirmish may impact Fosun-Gland deal   The heightened tensions along the India-China border are likely to impact business. In the pharmaceutical industry, the Cabinet Committee on Economic Affairs (CCEA) in India is likely to reject Shanghai Fosun Pharmaceutical Group’s US$ 1.3 billion acquisition of Hyderabad-based Gland Pharma Ltd, says a Bloomberg report. However, a report in The Economic Times says the proposal was listed for CCEA’s consideration two weeks back. But the CCEA is yet to take a call on the Gland Pharma-Fosun deal. “It is wrong to say that the deal has been rejected,” the official said. The Gland Pharma-Fosun deal had been approved by the now-abolished Foreign Investment Promotion Board (FIPB) in March this year. And Fosun was to acquire 86 per cent stake in the injectable drugmaker.  According to IndiaSpend, China is today the 17th largest foreign direct investor in India, an improvement on the 36th rank it held in 2010. CRO Consolidation: LabCorp buys Chiltern, Evotec acquires Aptuit   Consolidation in the CRO industry continued unabated last week. LabCorp bought Chiltern for US$ 1.2 billion last week. Two years back, LabCorp had bought Covance for US$ 6.1 billion. The acquisition of Chiltern will add another 4,500 clinical outsourcing workers around the globe to its employee roster. Another CRO that made an acquisition last week was Germany’s Evotec. It bought out its rival Aptuit for US$ 300 million in cash. And the deal will add hundreds of scientists to its organization along with facilities in Basel, Oxford and Verona. Evotec has earned a large number of clients on both sides of the Atlantic. Evotec says most of Aptuit’s 750 employees are scientists. Last year, Aptuit reportedly handled 1,000 projects for some 400 companies. The CRO business has been consolidating for years, with private equity groups leading the way to build up these global organizations. Leading the pack is Thermo Fisher, which had made acquisitions worth US$ 22 billion in the last five years. Three months back, Thermo Fisher Scientific acquired Patheon NV for US$ 5.2 billion while INC Research Holdings merged with private-equity owned CRO — inVentiv Health. FDA to cut nicotine in cigarettes to non-addictive levels   Last week, the US government proposed cutting nicotine in cigarettes to “non-addictive” levels in order to move smokers towards potentially less harmful e-cigarettes. The FDA Commissioner Scott Gottlieb said the agency will study regulating nicotine levels with a view towards the “FDA’s potential to render cigarettes minimally addictive or non-addictive.” “Nicotine itself is not responsible for the cancer, the lung disease and heart disease that kill hundreds of thousands of Americans each year,” Gottlieb said. “It's the other chemical compounds in tobacco and in the smoke created by setting tobacco on fire that directly cause illness and death,” he added.  The FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes. However, after this announcement by Gottlieb, shares of major tobacco firms in the US and UK slumped. Analysts said they expect regulators in Europe to study similar actions on nicotine products. This action shakes up a public health debate on whether e-cigarettes represent a health risk or a potential benefit. NotPetya cyber attack hits Merck’s profits   Merck is the latest in a string of companies that have disclosed that their operations were significantly disrupted by the NotPetya attack, which devastated businesses and government agencies in Ukraine in June and has gradually spread around the globe. According to a Reuters report, Merck said it had been a victim of an international cyber attack in June 2017, due to which the company had to halt production of drugs. As a result, its profits for the rest of the year have been hit. The company, however, said it is yet to know the magnitude of the impact as it is in the process of restoring manufacturing operations. Merck had disclosed the attack last month, but did not disclose the manufacturing shutdown at the time. The company said it was confident that it will be able to maintain a continuous supply of its top-selling and life-saving drugs, such as cancer drug Keytruda, diabetes drug Januvia and hepatitis C drug Zepatier. However, there maybe temporary delays in delivering some other products, which the company did not identify. “Full recovery from the cyber-attack will take some time, but we are making steady progress,” CEO Ken Frazier said. At least four other major US and European firms have also experienced massive outages due to NotPetya.  

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    #Phispers by PHARMACOMPASS
    03 Aug 2017
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    Mylan board survives shareholder meet; Evaluate lowers drug sales growth forecast

    Mylan board survives shareholder meet; Evaluate lowers drug sales growth forecast

    This week, Phispers brings you news on the oversubscription of EU’s online pharmacy Zur Rose, and Amazon’s plans of entering the online pharma business. While shareholders voted against Mylan’s executive pay policy, former Turing CEO Martin Shkreli faced trial. In Canada, supply shortages are likely to play spoiler in the country’s plans to rollout legal recreational marijuana. And Evaluate’s latest World Preview report scaled down its forecasts for worldwide drug sales growth. Zur Rose IPO gets over-subscribed; Amazon may launch its online pharmacy soon   Swiss online pharmacy Zur Rose Group's initial public offering (IPO) is already well oversubscribed. Zur Rose aims to raise up to 230 million Swiss francs (around US$ 240 million) through the share sale to aid its expansion plans in Germany, open new shops and possibly make acquisitions, the company said last week. The company, which was founded by Swiss doctors back in 1993, has been valued at between 780 to 870 million Swiss francs (US$ 813.5 million to US$ 907.4 million). The IPO is expected to be priced in range of 120 francs to 140 francs (US$ 125 to US$ 146) per share. Demand from long-term investors in Germany, Switzerland, Britain and the United States is being cited as the key reason behind the oversubscription of Zur Rose’s IPO. The stock is due to start trading on the SIX Swiss Exchange on July 6. This news should come as music to Amazon’s ears. Amazon is hiring a business lead to figure how the company can break into the multibillion-dollar online pharmacy market. Amazon is learnt to have begun recruitments from the pharmacy space. According to news reports, over the last few years, the Amazon headquarters in Seattle has been discussing whether it should enter the pharmacy business or not. But this year it is ready to get more serious with its plans. Mylan board survives shareholder meet but receives vote against executive pay policy   Last week, we carried news on how rebel investors had upped the ante against Mylan and wanted the drugmaker to remake its board, in wake of the scandal over the high prices of EpiPen. Well, last week, the Mylan shareholders voted against the generic drugmaker's executive pay policy, but re-elected the board at its annual meeting held on June 22. The company did not disclose the vote totals for the directors. In order to vote out the directors, rebel investors needed more than two-thirds of the shares voted, as well as more than half of Mylan’s outstanding shares. New York City Comptroller Scott Stringer, who is one of the chief leaders of this campaign, said failure to disclose the vote totals suggests that the directors of Mylan faced strong opposition. “This company massively hiked prices on life-saving drugs, allegedly overcharged the government for its products, allowed excessive executive pay to go unchecked — all ultimately fundamental failures of board oversight,” Stringer said. BlackRock, Mylan's third-largest shareholder with more than 5 percent of the company's shares, said it had voted against four of the drugmaker’s directors as well as its executive pay. Meanwhile, a Reuters report points that a non-pharmaceutical offering – refined coal – has quietly generated hundreds of millions of dollars in tax credits for Mylan over the last six years, thereby boosting its bottomline. Since 2011, Mylan has bought 99 percent stakes in five companies across the US that own plants which process coal to reduce smog-causing emissions. It then sells the coal at a loss to power plants. This way, it generates credits for itself, that lower Mylan’s tax bill. Supply shortages may delay Canada’s rollout of legal recreational marijuana market   Canada plans to legalize the recreational marijuana market over the next one year. This will make it the first economy to do so. However, the biggest challenge for Canada’s prime minister Justin Trudeau’s legalized pot market is, well, shortage of marijuana. This was revealed by Canada’s minister of finance Charles Sousa. The supply crunch was discussed during a meeting with provincial and federal counterparts last week, Sousa said.  According to an analyst, the Canadian government may use the supply shortage as an excuse to delay rolling out the program. “Ultimately the biggest problem that appears after today’s discussion is one of supply,” Sousa said. According to his ministry officials, the demand is “quite high” for marijuana. “So we want to make certain that, when we do proceed, there is sufficient supply to accommodate the activity because what we’re trying to do is curb the illicit use and organized crime that now exists around it,” Sousa added. Trudeau had unveiled the framework for legalization of marijuana in April this year. Pricing pressure causes worldwide drug sales forecast to fall for first time in 10 years   Across the world, increased scrutiny on the pricing of medicines is beginning to have an impact on drug sales growth. According to Evaluate’s latest World Preview report, consensus forecasts for worldwide drug sales are estimated to hit US$ 1.06 trillion in 2022. However, this is down from the US$ 1.12 trillion that analysts had forecast for the same period last year. It’s the first time in a decade that Evaluate’s forecasts for total drug sales have failed to beat previous year forecasts. However, sales of some of the industry’s top-selling products, such as cancer immunotherapies Keytruda and Opdivo, are expected to help push the sector to its expected trillion dollar sales target. According to this report, despite increasing questions around their pricing, orphan drugs are poised to make up a third of pharma sales by 2022. “The continued political and public scrutiny over pricing of both the industry’s new and old drugs is not going to go away and we are starting to feel the impact now. Market access is becoming harder, as seen by the disappointing sales of the drugs like Repatha, Praluent, and Nucala. And the increasing cost of taking a novel therapy to market, now at US$ 4 billion over the last 10 years puts additional pressure on the productivity of the industry and its longer term sustainability,” Antonio Iervolino, head of forecasting, Evaluate, said. Meanwhile, a Reuters report said the first ever EU antitrust probe into excessive drug pricing is unnerving the European drug industry, with lawyers worried about the reach of market intervention. Last month, the European Commission probed whether Aspen Pharmacare made “unjustified” hikes of up to several hundred percent in the cost of five old cancer drugs. Poster boy of price gouging and America's most hated man Martin Shkreli faces trial   Martin Shkreli, who is often referred to as the “most hated man in America” for raising the price of a life-saving drug by 5,000 percent, is undergoing trial this week for a Ponzi-like scheme at his former hedge fund (MSMB Capital Management) and drug company (Retrophin). Shkreli will face charges of securities fraud in federal court in Brooklyn, New York, more than 18 months after he was arrested in December 2015. Back in 2015, as the CEO of Turing Pharmaceuticals, Shkreli had angered patients and US lawmakers by raising the price of anti-parasitic drug Daraprim from US$ 13.50 a pill to US$ 750. Shkreli has been accused of lying to investors in the hedge fund and siphoning off millions of dollars in assets from biopharmaceutical company Retrophin Inc to repay them. He has pleaded not guilty. The trial will be heard by US District Judge Kiyo Matsumoto in Brooklyn, and is expected to last four to six weeks. Nestle may sell L’Oreal stake, which could lead to share sale of Sanofi   Dan Loeb, activist investor, recently encouraged Nestle SA to sell its stake in L’Oreal. Loeb has amassed a US$ 3.5 billion stake in Nestle SA. This demand by Loeb could lead to the divestment of yet another long-standing investment: L’Oreal’s US$ 11.6 billion (or Euro 10.4 billion) holding in French drugmaker Sanofi. Paris-based cosmetic maker L’Oreal owns about 9.4 percent of Sanofi. For several years now, speculation has been rife that L’Oreal would sell the stock to finance a repurchase of Nestle’s L’Oreal shares.  Nestle had taken the stake in L’Oreal 43 years ago, as the latter had feared nationalization. Back in 1973, L’Oreal had taken control of a French drugmaker named Synthelabo. And in 1999, Synthelabo merged with Sanofi, leaving L’Oreal as a key shareholder. If both these divestments — by Nestle of L’Oreal and by L’Oreal of Sanofi — see the light of the day, they would manifest the growing power of activist investors in Europe. Spokespersons for both L’Oreal and Sanofi declined to comment on a stake sale.  

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    29 Jun 2017
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    Investors up ante against Mylan board; More Ipca products banned from the US

    Investors up ante against Mylan board; More Ipca products banned from the US

    This week, Phispers looks at fresh troubles brewing at Mylan, as rebel investors intensify their demand for remaking the board, and a low-cost rival for EpiPen gets FDA nod. Meanwhile, BMS sold off its API plant in Ireland to South Korea’s SK Biotek and Baxter tied up with CRO Dorizoe for speedier development of generic injectables. There is more news on Dr. Reddy’s, Ipca and CROs this week. Read on.  Tough time for Mylan as camp to oust directors grows; Adamis to launch EpiPen rival   The war at Mylan — with rebel investors on one side, and the management on the other side — intensified last week as another proxy firm joined hands with the rebel investors looking to remake the board. Egan-Jones Proxy Services joined ISS, Glass Lewis and a group of rebel shareholders in pushing for the ouster of the board members. Together, they feel Mylan shareholders should vote against the re-election of six directors. Mylan shareholders will meet in Amsterdam on Thursday, June 22, 2017. The investors are not just disturbed over Chairman Robert Coury’s US$ 97 million pay package for 2016, but are also upset that Mylan turned away potential acquirer Teva. And that government investigations over pricing went beyond the EpiPen, and involved its generic drugs as well. However, Mylan’s CEO Heather Bresch shot back by blaming the company’s problems on external pressures, as opposed to internal missteps. Meanwhile, Mylan received another setback last week when Adamis Pharmaceuticals received approval for selling its emergency epinephrine syringes in the US. Adamis’ epinephrine syringes will prove to be a lower cost alternative to Mylan’s widely used EpiPen. Epinephrine treats severe allergic reactions. Adamis is reportedly looking for a marketing partner and would set a price for the product before its launch sometime in the second half of 2017. Its pre-filled epinephrine syringes would be sold under the brand name Symjepi. Trump’s volte-face: Pharma executive order to have positive impact on industry   President Donald Trump has repeatedly spoken about being tough on the drug industry. Yet, his administration is yet to take any measure that lives up to his promise of lowering drug prices. On the contrary, news reports suggest that Trump administration’s plan to lower prescription drug prices may end up being friendly to drug companies. The 'Drug Pricing and Innovation Working Group’, a group of officials from the Trump administration, have been meeting every two weeks to discuss drug pricing. The group is led by Joe Grogan, an associate director at the Office of Management and Budget who worked for Gilead Sciences until March this year. Gilead has been repeatedly criticized for pricing its hepatitis C drugs at US$ 1,000 per pill. To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the US Food and Drug Administration (FDA). According to Kaiser Health News, the policies wouldn't ease the cost of prescription drugs, and might even increase them. The Trump administration is preparing the executive order, which could be signed within weeks. According to another news report, the executive order was originally expected to have a negative impact on the drug industry, but the policies now under consideration would not do so. For instance, the Trump administration is said to be considering direct federal agencies to pursue value-based purchasing contracts for drugs. Another policy under discussion would instruct agencies to pursue trade policies that would strengthen the intellectual property rights of drug companies. The industry too expects a positive impact. Allergan CEO Brent Saunders recently said the executive order on drug pricing could have a positive impact and he believes his company is well-positioned to handle any changes. BMS sells its API plant in Ireland to Korea’s SK Biotek   Bristol-Myers Squibb (BMS) is selling off its API plant in Ireland to South Korea’s SK Biotek. The divestment is in line with BMS’ shift in focus towards biologics manufacturing. SK Biotek is a unit of South Korea’s third largest conglomerate, SK Holdings. The company has been a BMS ingredient supplier for a decade. Though the terms of the deal are not known, it is likely to close in the last quarter of 2017. SK Biotek will continue to manufacture products BMS currently makes at the plant, which includes the API for BMS and Pfizer’s anticoagulant Eliquis.  SK Biotek will use this plant for its contract development and manufacturing business, which is growing at a healthy pace. It plans to add marketing and R&D operations at the site, as well as invest in boosting capacity. “This transaction is an important step to achieve our goal of becoming a leading global CDMO (contract development and marketing organization),” Junku Park, CEO, SK Biotek, said in a statement. Ipca’s products banned from US; Dr. Reddy’s provides positive inspections updates   Of late, Dr. Reddy’s has been providing positive inspection updates. On June 16, the company said it received one US FDA observation for its Srikakulam formulation plant, which the company is addressing. However, the company didn’t disclose the nature of the observation.  Three days prior, on June 13, Dr.Reddy’s had received an Establishment Inspection Report (EIR) for its Miryalaguda plant, indicating closure of the FDA audit. The API plant was inspected by the US regulator in February this year, and had received three Form 483 observations. The Miryalaguda plant was one among the three plants for which the company received FDA’s warning letter in November 2015. The warning letter mentioned deviations in good manufacturing practices (GMPs). Meanwhile, the FDA banned entry of products of Ipca Lab in the US due to non-compliance with manufacturing norms at three of its facilities. All drugs manufactured at facilities in Ratlam, Indore SEZ and Silvassa will be refused admission in the US until the company can demonstrate that products from these sites are in compliance with prescribed norms. The company’s API plant at Ratlam and formulations units at Indore SEZ and Silvassa have been under FDA import alert since 2015 for violation of GMPs. However, few products were exempted from the ban to avoid shortages in the US market. Now, only one API product, chloroquine phosphate manufactured at Ratlam facility, is exempted from the import ban. Baxter in agreement with Dorizoe to speed up development of generic injectables   Global medical products company Baxter International Inc announced it had entered into an agreement with Dorizoe Lifesciences Limited (Dorizoe), a full-service global contract research and development organization headquartered in Ahmedabad (India). The agreement will speed up the development of more than 20 generic injectable products—including anti-infectives, oncolytics and cardiovascular medicines.  “This partnership extends Baxter’s growing pipeline of generic injectables, further strengthening our portfolio with a broad range of high-quality essential medicines,” Robert Felicelli, president, Pharmaceuticals, Baxter, said. Baxter has been in an expansion mode. In December last year, Baxter had announced the acquisition of Claris Injectables Limited (Claris) for US$ 625 million. The acquisition of Claris, which is expected to close in the second half of 2017, will provide Baxter with a portfolio of molecules in anesthesia and analgesics, renal, anti-infectives and critical care. Recently, Baxter also announced a strategic partnership with ScinoPharm Taiwan, a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. The partnership is for developing, manufacturing and commercializing five generic injectables used in cancer treatment, with an option to add up to 15 additional injectable molecules. After AMRI, Parexel International — gets acquired by a PE firm for US$ 4.5 billion   This appears to be a month when private equity firms are continuing to pick up stake in pharma contract research organizations or CROs. On June 6, global asset manager, the Carlyle Group (CG) and GTCR LLC (a private equity firm), acquired Albany Molecular Research (AMRI), a global contract research and manufacturing organization, for about US$ 922 million in cash. And this week, Parexel International Corp, a US drug research services provider, got acquired by Pamplona Capital Management LLP in a US$ 4.5 billion deal. There was pressure from investors, including Starboard Value LP, on Parexel to explore a sale. They argued the company’s profit margins have consistently fallen behind those of its peers. Headquartered near Boston, Massachusetts, Parexel provides a range of services to the pharma industry, such as drug development, regulatory consulting, clinical pharmacology, clinical trials management and reimbursement.  

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    #Phispers by PHARMACOMPASS
    22 Jun 2017
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    After beef, India may ban gelatin capsules; GSK, Gilead’s HIV race heats up

    After beef, India may ban gelatin capsules; GSK, Gilead’s HIV race heats up

    This week in Phispers, we bring you the latest twists in the GSK-Gilead rivalry over HIV drugs. India, which recently banned beef nationwide, plans to now replace gelatin with cellulose-based capsules. A lawsuit in the US says Mylan may have overcharged the government US$ 1.27 billion in the form of rebates on EpiPens. And, there is an update on the opioid crisis. Read on. After beef, India mulls banning animal-based gelatin capsules   As India deals with the aftermath of the controversial cattle trade ban, the Health Ministry is reviewing a proposal to replace gelatin capsules with cellulose-based capsules which are of plant origin and are “safe for use” as compared to animal-based gelatin capsules. Various stakeholders, NGOs and consumers have 21 days to weigh the pros and cons of this proposal and respond. India’s ministry of health and family welfare constituted an expert committee on March 20 this year to address all technical issues pertaining to replacement of gelatin capsules with cellulose-based capsules for encapsulation of drugs. The Indian government's ban on the trade of cattle for slaughter threatens US$ 4 billion in annual beef exports and millions of jobs if the government does not revoke it. Indian meat traders, under the aegis of the Qureshi Action Committee and other trade and industry associations, plan to petition India's Supreme Court to get the government order revoked. As Pfizer hikes price of 91 drugs, Maryland enacts law to curb generic drug price gouging   Last week, we had shared our list of drugs with ‘no patents and no competition’.  While our list provides tremendous opportunities for generic companies in the short-term, we also warned that the FDA’s continued focus on accelerating review of these drugs will require companies to rely on strategies less opportunistic than price gouging, to drive their future business growth. On October 1, 2017 Maryland will become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. The Bill was passed by the Maryland General Assembly on April 20, 2017. On May 26, Maryland Governor Larry Hogan sent a letter to the Speaker of the House stating that he would allow the bill to become law without his signature. The move coincides with Pfizer hiking the price of 91 drugs by an average of 20 percent so far this year in the United States. This includes price hikes for its erectile dysfunction treatment, Viagra, and its pain drug, Lyrica, on June 1. There are two essential provisions of the Maryland Bill. First, it prohibits a generic drug manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.” Second, the Bill authorizes the Maryland Medical Assistance Program (MMAP) to notify the Maryland Attorney General of a price increase when the Wholesale Acquisition Cost (WAC) of a prescription drug increases by at least 50 percent from the WAC within the preceding one-year period. Or, when the price paid by MMAP would increase by at least 50 percent from the WAC within the preceding one year period and the WAC for either a 30-day supply or a full course of treatment exceeds US$ 80. Mylan may have received US$ 1.27 billion more in rebate for EpiPens   In the US, Senate Judiciary Committee Chairman Charles Grassley released a Medicaid investigator's report which highlighted that Mylan’s EpiPen may have received US$ 1.27 billion more from the rebate program from 2006 through 2016 than what the company was entitled to receive. The amount is nearly three times a proposed settlement that the company had announced in October 2016. Earlier, Mylan had said it would return US $465 million to the government as part of settlement negotiations with the Department of Justice (DOJ). Talks with the DOJ continue. Senator Grassley has been involved in a long exchange with Mylan questioning the significant price-hikes which the company had implemented over the years. The EpiPen auto-injector, used to treat allergic reactions, cost US$ 57 a shot when Mylan purchased it in 2007. However, a series of price increases has raised the cost to more than US$ 600 for a pair of EpiPens. Before the price hike controversy hit Mylan, the Epipen generated more than US$ 1 billion in sales and contributed about 40 percent to Mylan’s overall profits. GSK, Gilead’s HIV contest heats up, as GSK goes for priority review   Two of the top 10 fastest growing drugs in 2016 were those used to treat HIV. GlaxoSmithKline’s Triumeq (abacavir, dolutegravir, lamivudine) and Gilead’s Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), both generated a sales growth in excess of US$ 1 billion. For a long time, Gilead dominated the HIV market. But GSK fought back recently. In an effort to stay ahead in the game, GSK used a priority review voucher, for which it paid US$ 130 million, to shave four months off its application approval process. ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc and Shionogi Limited as its shareholders, announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the first HIV maintenance regimen single-tablet, which comprises of only two medicines. The two-drug regimen contains dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland UC). However, don’t count Gilead out. In four late-stage studies, the US company's new drug bictegravir was found to be as effective as GSK's established dolutegravir, which has been the cornerstone of the British group's growing HIV business in recent years. This year, Gilead plans to apply for regulatory approval to sell its combination of bictegravir and emtricitabine/tenofovir alafenamide (FTC/TAF), with a submission in the US in the second quarter and in Europe in the third quarter. If Gilead uses a priority voucher at the US FDA, it could launch in the US market in the first quarter of 2018, industry analysts said. Mallinckrodt explores divestment of its generics business   Mallinckrodt Plc plans to sell off its generic drug unit in a deal that could fetch the company around US$ 2 billion. The move would also help the specialty pharmaceutical maker shift towards higher-margin branded drugs. Mallinckrodt's generics unit has seen its sales plummeting, in part because some of its products include opiate-based pain killers, which have fallen out of favor with doctors due to their addictive potential. The divestment would complete the company’s gradual shift away from its original focus on generic drugs and nuclear imaging towards branded specialty pharmaceuticals, which now make up for bulk of its revenues. Between 2015 and 2016, Mallinckrodt's generic drug sales declined around 18 percent, to just over US$ 1 billion. During the same period, sales of branded specialty drugs increased by around US$ 2.3 billion. The England-based Mallinckrodt has reportedly hired investment bank Credit Suisse Group AG to run a sale process for the unit. Canadian researchers trace the origins of the opioid crisis, as Ohio sues drug makers   Last week, the state of Ohio in the US sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a skyrocketing drug addiction epidemic. Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the US Centers for Disease Control and Prevention. Canadian researchers have traced the origins of the current opioid crisis to a letter published in the New England Journal of Medicine (NEJM) in 1980, which stated that opioids were not addictive. The original letter titled ‘Addiction Rare in Patients Treated with Narcotics’, was just a paragraph long. The lone evidence the letter cited was an anecdote that out of 11,882 hospitalized patients treated with narcotics, only four patients with no history of addiction became addicted. The journal's prestige helped fuel this misguided belief. The letter was cited over 600 times, usually to argue that opioids were not addictive. Last week, the NEJM published an unusual warning for readers about the 1980 letter. The editor's note on the original letter in the NEJM reads, "For reasons of public health, readers should be aware that this letter has been 'heavily and uncritically cited' as evidence that addiction is rare with opioid therapy." The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc".    

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    #Phispers by PHARMACOMPASS
    08 Jun 2017
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    Sanofi lawsuit highlights Mylan’s unfair trade practices; Fresenius goes on multi-billion dollar spending spree

    Sanofi lawsuit highlights Mylan’s unfair trade practices; Fresenius goes on multi-billion dollar spending spree

    This week, Phispers brings you an update on M&As in the drug and medical equipment industry, along with verdicts of lawsuits against GSK and Mylan. There is also news on Samsung Bioepis’ biosimilar —Renflexis; a directive from the Medical Council of India for doctors to prescribe generics; and news that Marathon may soon wind up. Read on.   M&A update: Fresenius buys Akorn; Becton Dickinson to acquire C R Bard   Fresenius Kabi-Akorn: Fresenius Kabi is buying US-based manufacturer and marketer of prescription and over-the-counter drugs — Akorn — for around US $ 4.3 billion, or US $ 34.00 a share. Kabi will also assume approximately US $ 450 million of Akorn’s debt. The transaction, which is likely to close by early 2018, has the support of Akorn's largest shareholder, who controls approximately 25 percent of its shares. Akorn is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multi-source and branded pharmaceuticals. Sawai to buy Upsher Smith: A leading generics manufacturer in Japan — Sawai Pharmaceutical — and US-based generics manufacturer — Upsher-Smith Laboratories — announced an agreement whereby Sawai will buy the generic pharmaceuticals business of Upsher-Smith, from its parent — Acova for $ 1.05 billion. Upsher-Smith is a privately held drug company, based in Minnesota. It’s owned by the Evenstad family through their company, Acova. It has a diversified product portfolio of over 30 pharmaceutical products. Becton Dickinson to acquire C R Bard: Becton Dickinson and Co, a medical equipment supplier, will acquire C R Bard Inc in a US $24 billion cash-and-stock deal. This way, Becton Dickson will add Bard's devices to its portfolio in the high-growth sectors of oncology and surgery. This is the latest in a string of deals in the medical technology sector. Two years ago, Becton Dickinson had acquired CareFusion Corp for US $ 12 billion. This acquisition will strengthen Becton Dickinson’s position in the markets for catheters, pumps and other items. FDA approves Samsung Bioepis’ biosimilar; Merck to sell it in US   This week, the US Food and Drug Administration (FDA) approved Samsung Bioepis' Renflexis (infliximab-abda) — a biosimilar referencing Remicade (infliximab), across all eligible indications.  In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. The FDA approval comes as a blow to Johnson & Johnson’s top earning drug Remicade, which may finally begin to experience greater competition at lower prices. Samsung Bioepis is a big player in the field of biosimilars. It has arrived in the US market close to a year after the EMA approved it for Europe. While Merck KGaA, the German Merck that specializes in chemical, pharmaceutical and life sciences sectors, sold its biosimilars business to Fresenius Kabi this week, in the US, Merck will be marketing Samsung Bioepis’ Renflexis.  In Germany, Merck KGaA is selling off its entire development pipeline and an experienced team of more than 70 employees located in Aubonne and Vevey (Switzerland) to Fresenius Kabi for Euro 670 million. The product pipeline has a focus on oncology and autoimmune diseases. Confused about the two Mercks? Read: Merck vs Merck: A ‘Mercky’ Tale Doctors in India to prescribe generics; to face action if found violating norms   Last week, Phispers carried news that India’s Prime Minister Narendra Modi indicated his government may bring in a legal framework under which doctors will have to prescribe generic medicines. And soon, the Medical Council of India asked all registered medical practitioners to ensure they prescribe drugs with generic names only. The MCI has asked the medical community to follow its 2016 notification in which it amended the clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mandating the doctors to prescribe medicines by generic names in place of brand names. Therefore, if a patient is complaining of fever, the doctor must prescribe ‘paracetamol’ (the generic name drug), and not Crocin or Dolo (which are brand name drugs). This move will prevent doctors from prescribing brand-name drugs that are costlier. India’s medical regulator has also warned doctors of action against those found violating these regulations. This news comes at a time when price control on stents in India has led to companies withdrawing their innovative products from the market. A stent is a tiny expandable tube shaped mesh to open up narrowed or weakened coronary arteries. It is performed in a cath lab, using a less-invasive procedure known as angioplasty. Last week, Abbott announced it is withdrawing two of its latest coronary stents from India as they were not commercially viable. This includes a bio-absorbable stent that was introduced by the company four years back. In February this year, the National Pharmaceutical Pricing Authority had effected up to 80 percent price cuts on stents under the Drug Price Control Order (DPCO). The price of a bare metal stent was fixed at around US $113 (Rs 7,260) and drug eluting stent (DES) and biodegradable stents at around US $462 (Rs 29,600). After the controversy around DMD drug, Marathon may wind up next month   After creating much hype and controversy around its effort to market a cheap overseas steroid — deflazacort — to the Duchenne muscular dystrophy (DMD) community in the US at a list price of US $ 89,000, Marathon Pharmaceuticals is now quietly planning to shut down its operations. On February 9 this year, Marathon had received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients aged 5 years and older with DMD, a rare genetic disorder that causes progressive muscle deterioration and weakness. Since the drug has been approved outside the US for decades, patients in the US imported the drug from Canada and the UK, where it’s available at a price between US $1,000 or US $2,000 a year. An article published in Endpoints News cites the divestiture of deflazacort to PTC as the main reason why Marathon may not exist past May 1, 2017. When the author of the article contacted Marathon, he received the statement: “With the wind down of our Emflaza business following the close of the PTC transaction on April 20, we will continue to manage the legacy matters of Marathon Pharmaceuticals.” This news comes at a time when PTC, the company that purchased the rights for the drug from Marathon, suffered a  setback as the Washington State Drug Utilization Review Board decided to recommend another medicine for the treatment of the disorder. The board endorsed a policy by the Washington State Health Care Authority, which administers the state Medicaid program, that prednisone is the “lower cost, equally effective alternative” to Emflaza, the drug that PTC bought for around US $140 million last month from Marathon.  Sanofi highlights Mylan’s unfair trade practices in lawsuit    Earlier this week, Sanofi SA sued Mylan NV, accusing it of engaging in illegal conduct to suppress competition to its EpiPen allergy treatment. Mylan’s EpiPen has been at the centre of a public debate on the pricing of drugs.  The lawsuit was filed in Trenton, New Jersey. According to Sanofi, Mylan caused it a loss of hundreds of millions of dollars in sales by erecting barriers that denied American consumers access to and use of a rival product — Sanofi’s Auvi-Q. Auvi-Q had been introduced by the French drugmaker in 2013 to treat anaphylaxis in patients who are at risk of or have a history of the potentially fatal allergic reaction. The company ceased marketing of the product in 2015 following a recall. In a statement, Sanofi sought damages for Mylan's conduct in the market for epinephrine auto-injectors. With the lawsuit filed by Sanofi, Mylan appears to be getting a taste of its own medicine, Back in 2015, in a bold and unusual move, Mylan had sued West Virginia to keep its EpiPens on the state’s “preferred drug list”. The move failed. However, it revealed yet another way in which Mylan can use aggressive marketing and legal tactics to boost profits from EpiPens. Since Mylan acquired rights to EpiPen in 2007, the company raised its price by more than 400 percent. While Sanofi is fighting Mylan in the US, in its home country it has to address regulator’s concerns over Valproate, its treatment against epilepsy and bipolar disorders. According to the French drug regulator, up to 4,100 children in France suffered major malformations in the womb after their mothers took Valproate between 1967 and 2016. Valproate, which is manufactured in France by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development. GSK to pay US $3m in suicide case; Teva introduces competition to Advair   GlaxoSmithKline must fork out US $3 million to a woman who sued the British drug maker because her husband committed suicide after taking a generic equivalent of GSK’s antidepressant — Paxil, a federal court in the US ruled. Back in 2010, Stewart Dolin (a partner at law firm Reed Smith LLP) jumped in front of an ongoing commuter train after taking the generic version of Paxil. The verdict in favor of his wife — Wendy Dolin — was confirmed by GSK. However, the company said it should not be made liable since GSK did not manufacture or market the medicine. The lawsuit had been filed by Wendy Dolin in 2012 against GSK and Mylan — which manufactured the generic version of Paxil. However, a federal judge dismissed Mylan from the lawsuit in 2014. There was more bad news for GSK, as Israeli drugmaker Teva Pharmaceutical Industries launched the first direct competition to GSK’s best-selling Advair (an inhaler with APIs — fluticasone propionate and salmeterol). Teva had won the US regulatory nod to make an inhaler that’s similar to Advair in January this year. However, Teva also launched a generic version of its own inhaler, AirDuo RespiClick. AirDuo is not a true generic of Advair, but contains the same two APIs. However, it delivers a lower dose of salmeterol.  

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    https://www.pharmacompass.com/radio-compass-blog/sanofi-lawsuit-highlights-mylan-s-unfair-trade-practices-fresenius-goes-on-multi-billion-dollar-spending-spree

    #Phispers by PHARMACOMPASS
    27 Apr 2017
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    Could the Ranbaxy whistleblower head the FDA office in India?; Reprieve for GSK as Mylan’s Advair generic gets delayed

    Could the Ranbaxy whistleblower head the FDA office in India?; Reprieve for GSK as Mylan’s Advair generic gets delayed

    This week, Phispers brings you news on how GSK’s new CEO Emma Walmsley’s term began with a short-term reprieve from the generic threat to its blockbuster drug Advair. There is also news on FDA’s nod to Roche’s multiple sclerosis drug; a new bill in the US that seeks to lower drug prices; a US federal court order that directs Novartis to hand over documents of ‘sham’ doctor events; and how the drug industry in the US is finding FDA’s proposed quality metrics a bitter pill to swallow. Read on.   Could the Ranbaxy whistleblower head the FDA office in India?   There are indications the Ranbaxy whistleblower — Dinesh Thakur — could emerge as a strong contender to head the US Food and Drug Administration’s (US FDA) office in India.  Recently, the US President Donald Trump nominated Scott Gottlieb as the commissioner of the US FDA. Besides being a prominent physician, Gottlieb is also assistant professor at New York University School of Medicine and a resident fellow specializing in health policy at the American Enterprise Institute (AEI). A recent blog published by the AEI, written by Roger Bate (a health scholar at AEI) states: “Other than whistleblower accounts and one French investigation, all quality infractions perpetuated by India’s drug industry have been unearthed by the US FDA. So it is worrisome that a few well-informed local experts and media are privately suggesting that the local US FDA office in India has recently become heavily influenced by the domestic drug industry.” According to Bate, the only way to resolve this matter is by putting “someone beyond repute” in the top FDA job in India. “I can think of only one uniquely qualified person – Dinesh Thakur. Mr Thakur runs a firm, Medassure, that assists companies improve quality controls. But he is best known for being the Ranbaxy whistleblower, who brought that company to account for its fraudulent production of substandard medicine, which led to seven felony counts in a US court and US $ 500 million in fines and penalties in 2013,” Bate added. “For those who would break the rules he is the one person they would not want in charge of the US FDA Indian office, and for that reason Scott Gottlieb should ask him to do it and staff it with folks he trusts,” he said in the blog post. Watch this space to know if Gottlieb pays heed to Bate’s advise. India’s Indoco Remedies receives FDA’s warning letter   Last week, Indoco Remedies said it got a warning letter from the US FDA for two of its facilities in Goa. According to a news report, the US FDA wasn’t fully convinced with the drug company’s response to its earlier observations.  The US FDA had inspected Indoco’s manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016. In the Form 483, the FDA had issued six observations. None of the observations pertained to breaches of data integrity or data falsification, Indoco said in a stock exchange filing. The company’s Plant II manufactures ophthalmic and injectables, while Plant III makes tablets. Another news report states that, the US FDA has said Indoco did not investigate batch failures properly; the quality control unit lacked authority to reject or approve all drugs and did not fully follow procedures; no procedures were established and followed to prevent microbial contamination and equipment systems and facilities were not appropriate. “We as a company are fully committed in resolving the issue and will respond at the earliest,” Indoco said in the statement. Reprieve for GSK as Mylan’s Advair generic gets delayed   Emma Walmsley took over as the new CEO of GlaxoSmithKline on April 1. Her term began with a short-term reprieve to the British pharma giant from the threat of generic Advair, as there was a delay in the approval for Mylan’s copy of this blockbuster lung inhaler. Mylan received a complete response letter (CRL) from the US FDA, which served a blow to the company. Mylan executives were confident they would get a thumbs up from the FDA. GSK said it had noted Mylan’s CRL announcement. The possible introduction of generic Advair in the US this year was “an event we have anticipated and planned for,” GSK said. While it’s unclear how long Mylan will have to wait to get its version of Advair on the market, Mylan could refile within two months and get an FDA response as early as July 2017. There is also news that the launch may get delayed by two years if the issues and concerns raised by the FDA run deeper. If generics do arrive by mid-2017, GSK has forecast Advair’s US sales to be around US $ 1.24 billion (1 billion pounds), down from US $ 2.28 billion (1.83 billion pounds) in 2016. Meanwhile, Mylan received another setback last week. On Friday, Mylan announced its manufacturing partner for EpiPen devices had expanded the recall of EpiPens to the US and other markets. During the previous week, Mylan had said it had recalled about 81,000 EpiPen devices in countries outside the US, following reports of the EpiPen failing to work in emergencies. The recall was first announced for Europe, Japan and Asia. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen. The recall does not include Mylan’s generic EpiPens, the FDA said. Novartis ordered to hand over documents pertaining to ‘sham’ doctor events   A judge in the US has ordered Novartis to hand over documents on 79,236 educational events the company says it held with doctors. Novartis has been trying to avoid furbishing those documents. Federal prosecutors claim those events were shams. Instead, the prosecutors have termed these as “kickbacks”. The US government has alleged that Novartis invited the same doctors to speaker events several times. The company treated these doctors to lavish dinners and gatherings, in return for prescribing more Novartis medications. The complaint states that Novartis used these sham events to provide doctors with remuneration in the form of honoraria, dinner at high-end restaurants, and entertainment. Roche gets nod for its multiple sclerosis drug that could be a game changer   Last week, Regeneron and Sanofi bagged an FDA nod for Dupixent, a landmark new eczema therapy, and Roche received the nod for ocrelizumab, a drug that promises to change the multiple sclerosis (MS) drug market. Ocrelizumab — which will be sold as Ocrevus — can be prescribed to treat most multiple sclerosis patients, including relapsing/remitting and primary progressive patients. This characteristic of Ocrevus could find favor with clinicians who focus on the disease, thereby changing the rules of the game. Roche has priced this drug at US $ 65,000 a year, a 25 percent discount to Rebif, a disease modifying drug (DMD) used to treat relapsing forms of multiple sclerosis (MS). “According to the NMSS (National Multiple Sclerosis Society), MS medicines on average cost almost four times more today than they did 12 years ago,” notes a spokesperson for Roche. In fact, Rebif costs about US $ 86,000. “We feel that the industry needs to start to reverse this trend,” the spokesperson added. EvaluatePharma has pegged consensus forecasts of revenue for 2022 at US $ 4 billion for this therapy. Dupixent is expected to land about a billion dollars behind Ocrevus. Industry attempts to delay FDA’s proposed quality metrics program   The pharmaceutical industry is not finding the US FDA’s proposed quality metrics program palatable. Some months back, the FDA had revised its draft guidance in response to industry concerns. A consortium of industry groups — comprising the Association for Accessible Medicines (AAM, formerly GPhA), the Pharmaceutical Research and Manufacturers of America (PhRMA), International Society for Pharmaceutical Engineering (ISPE), Bulk Pharmaceuticals Task Force (BPTF) and the Pharma and Biopharma Outsourcing Association (PBOA) — have now asked the FDA to halt its plans to move the program forward. The consortium has submitted its comments to the revised draft guidance along with the Biotechnology Innovation Organization (BIO). Several major pharmaceutical companies, including Allergan, Baxter, Celgene, Gilead, Sanofi and Teva, have also voiced their concerns. “After careful consideration and analysis with our member companies, PhRMA believes additional dialogue between FDA and industry and subsequent resolution of several fundamental issues are necessary before the FDA seeks to advance a quality metrics submission program,” said a PhRMA statement. Both BIO and AAM have concurred. PhRMA and AAM say the burden of the program (as described in the revised draft guidance) would outweigh its potential benefits. Democrats introduce bill to reduce drug prices in the US   With the Republicans failing to repeal and replace the Affordable Care Act (or Obamacare) in the US last month, Democrats stepped in last week with some proposals of their own. Several of the proposals in this drug pricing bill — known as Improving Access to Affordable Prescription Drugs Act — are expected to reshape the pharmaceutical industry. Led by Senator Al Franken, a coalition of Democrats and independent Senator Bernie Sanders, the bill would require drug companies to publicly report development, manufacturing and marketing costs; allow Medicare to negotiate drug prices; tax drugmakers who implement big price hikes; and mandate more reporting by patient assistance groups who receive pharma funds. It would also pave the way for importing cheaper (and safe) medicines from Canada, end the direct-to-consumer advertising tax deduction, outlaw pay-for-delay arrangements that keep generic drugs off the market, and create incentives to bolster generic drug competition. Besides, it would set aside US $10 billion over 10 years for the National Institutes of Health (NIH) to establish a Center for Clinical Research that would take federally funded research into the clinic. The center would conduct all phases of testing. Additionally, the bill calls for a cap on patients’ out-of-pocket expenses, a measure drug companies might like because it would require payers to cover more drug spending. However, the bill is likely to face opposition due to its transformative nature. Meanwhile, Health and Human Services Secretary Tom Price said he is working with President Trump on their own drug pricing bill. And Democrat Rep. Elijah Cummings reportedly said that Trump has called him three times to follow up on their conversation at the White House earlier this month. According to Cummings, Trump is not just talking about letting Medicare negotiate drug prices. He is talking about importing cheaper drugs from other countries.  

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    06 Apr 2017
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    Seven of your facilities are out of compliance, FDA tells Wockhardt; Mylan’s EpiPen sales crash

    Seven of your facilities are out of compliance, FDA tells Wockhardt; Mylan’s EpiPen sales crash

    In Phispers this week, there is news on how alternatives to Mylan’s EpiPen have eaten into its US sales. Warning letters posted by the FDA revealed that it considers seven of Wockhardt’s sites out of compliance and there is more trouble in the works for the former Ranbaxy promoters. And, Novartis faces punitive action in South Korea. Read on.   Mylan’s EpiPen sees drastic drop in market share in Jan-Feb 2017   Last year, Mylan was in the news for hiking the price of EpiPen by 500 percent. At that time, there were no generic avatars of the life-saving anti-allergy medicine available in the US market. But now, the scenario has changed. Data from athenahealth network shows that prescriptions for alternatives of Mylan’s EpiPen have “quadrupled since the beginning of 2017”. More than 60,000 prescriptions for epinephrine auto-injectors, written for 50,000 patients by more than 1,400 healthcare providers in the US, were evaluated by researchers at athenahealth between January 2016 and February 2017. The share of alternatives to EpiPen have significantly increased in the last two months, as opposed to the end of 2016. “At the end of 2016, EpiPen alternatives made up only 5.3 percent of prescriptions for epinephrine auto-injectors. By the last full week of February, that figure had grown to 28.9 percent,” athenahealth said. The key reason for this sudden and significant shift is the lower price tags of the EpiPen alternatives. Most of these alternatives are priced at a fraction of the cost of Mylan’s EpiPen. Moreover, insurers could also be affecting the prescription patterns. In January this year, health insurance company Cigna began to cover only generic options to EpiPen. Seven of your facilities are out of compliance, FDA tells Wockhardt   This week, US FDA posted the warning letter issued to Wockhardt's US-based Morton Grove facility. The concerns raised by the investigators ranged from Wockhardt's “investigations into out-of-specification (OOS) test results” that were found to be neither thorough, nor timely, nor based on scientific rationales” to the “original results” that were “invalidated without scientific justification under the protocol and only re-test results were reported as part of batch release decisions.”  Of serious concern is the fact that in the warning letter the FDA has said: "At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with cGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs. In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist.” Second FDA warning letter to Megafine over "calibration records in trash”   Megafine Pharma received its second FDA warning letter in less than a year for its facility which manufactures active pharmaceutical ingredient (API) intermediates. The Megafine plant in Vapi (Gujarat) was inspected last September and once again data integrity was the primary cause of concern raised by the FDA. The facility was “issuing analysts with blank controlled document forms that had already been approved and signed”. Moreover, FDA investigators found torn, partially complete Quality Assurance-signed calibration records in the trash and saw QA staff shredding documents without reason. In another observation, "analysts reprocessed data up to 12 times, and only included the final result in the report for review by Quality Assurance. Your Deputy Manager, Quality Control stated that it is common practice to ‘play with parameters’ to get the proper integration." FDA investigators also noticed that the interior surfaces of the drug manufacturing equipment were not as clean as required. Megafine's API plant in Lakhmapur, Nashik, was placed on FDA's Import Alert list in 2015. Ghosts of Ranbaxy continue to haunt Singh brothers   Former promoters of Ranbaxy — Malvinder and Shivinder Singh — were directed by the Delhi High Court to seek its permission before selling any of their unencumbered assets. This puts in jeopardy reported plans of the brothers to sell their stakes in companies like Fortis Healthcare and Religare, although the court hasn’t passed an outright injunction against such an exercise. The Singh brothers have also been directed to furnish details of all unencumbered assets in order to ascertain that they have enough funds to cover an arbitration payment of more than US$ 3.74 billion (Rs 250 billion) granted to Daiichi Sankyo by a Singapore tribunal last year. The brothers have been engaged in a legal battle with Daiichi Sankyo, which bought out Ranbaxy in 2008 for US$ 4.1billion. Daiichi had accused the Singh brothers of misrepresenting the problems facing Ranbaxy when it acquired the firm. In 2014, Daiichi sold Ranbaxy to Sun Pharma. Investors demand cut in new GSK CEO’s prospective pay package   A number of investors in Britain’s largest drug company — GlaxoSmithKline (GSK) — are reportedly putting pressure on its board to reduce a proposed multi-million pound pay deal for its new CEO, Emma Walmsley. They want Walmsley’s package to be sufficiently lower than the one awarded to her predecessor — Sir Andrew Witty — who is slated to retire later this month. His base salary is US$ 1.34 million (£1.1million) a year, while Walmsley’s proposed base salary is US$ 1.22 million (£1 million) a year, said news reports. Some shareholders don’t think her proposed pay package fits Walmsley’s work experience. She is set to become Big Pharma’s first female CEO. But her resume is heavily tilted towards consumer products. Till recently, she was heading GSK’s consumer health joint venture. And prior to 2010 (a year when she joined GSK), she spent 17 years at cosmetics company — L’Oreal. GSK is in “active consultations with shareholders” and is “acutely aware of the need for a balanced and responsible approach to remuneration,” a spokesperson said. Children with AIDS write to India’s PM about Cipla’s Lopinavir   When the Indian government failed to clear its dues, Cipla — the only manufacturer of Lopinavir syrup (a child-friendly HIV drug) — stopped production of the drug. As a result, children living with HIV (CLHIV) have written to Prime Minister Narendra Modi for help. The letter dated March 4 is signed by 637 children ranging from ages three to 19. “The pharmaceutical company Cipla has in various forums cited delay in payments by the national program for the HIV medicines by several years and even non-payment of its dues in many cases. Profits on child doses of HIV medicines are small and delayed payments are having a chilling effect on the ability of the National AIDS Control Organization (NACO) to convince the company to participate in the bids it invited annually,” the letter said. Cipla is the dominant player in the Indian market across the HIV segment. Even though the Indian government has failed to pay Cipla for consignments it had sent back in 2014, the company has not stopped participating in government tenders. The Health Ministry, on the other hand, says it has instructed State AIDS Control Societies (SACS) to purchase the drug from local markets. “An emergency tender has been placed but we have instructed SACS and state governments to purchase from local markets,” Arun Panda, Additional Secretary, Health Ministry, said. Novartis faces drug ban in South Korea over bribe issue   Novartis is due to face additional punitive measures from the health ministry of South Korea later this month for allegedly providing illegal bribes to local doctors in exchange for prescribing its drugs. Last week, the Korean Ministry of Health and Welfare said it is reviewing its own administrative actions against Novartis Korea, which could take the form of a fine or a lifting of insurance benefits on drugs sold by the company in South Korea. Novartis is headquartered in Basel, Switzerland. Last week, the Korean Ministry of Food and Drug Safety had slapped Novartis Korea with a fine of US$ 174,937 (200 million won) and a three-month sales ban on 12 drugs, including variations of the company’s flagship dementia drug Exelon. According to the ministry, this 200 million-won fine is equivalent to a three-month ban on 30 drugs, including Novartis’ top-selling diabetes drug — Galvus. Korea’s punitive measures against Novartis Korea have come a year after Seoul prosecutors began a probe into a massive bribery scam that involved the company’s executives and employees. In August last year, six former and current Novartis employees in South Korea were indicted over illegal practices to boost sales of the company's drugs. Samsung Bioepis wins high-stakes case against AbbVie’s Humira   There is more news from South Korea. The Seoul-headquartered Samsung Bioepis, a biopharmaceutical company, won a high-stakes court case last week against US drug firm AbbVie for a biosimilar of the world's best-selling drug — Humira. Samsung is keen to sell a version of this arthritis treatment in Europe sometime early next year. The biosimilar version of Humira is pending approval by the European Medicines Agency (EMA). This ruling of the England and Wales High Court Chancery Division of the Patents Court, while determining that the two patents covering AbbVie’s Humira are invalid, also said that AbbVie's indications pertaining to rheumatoid arthritis, psoriasis and psoriatic arthritis were unpatentable. The other claimant in this case is Tokyo-based Fujifilm Kyowa Biologics. In 2015, Humira displaced Pfizer’s anti-cholesterol drug Lipitor by crossing US$ 14 billion in sales.    

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    09 Mar 2017
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    Pharma industry unveils new campaign to repair reputation, Did Takeda pay a heavy price for its $ 5.2 billion buy of Ariad?

    Pharma industry unveils new campaign to repair reputation, Did Takeda pay a heavy price for its $ 5.2 billion buy of Ariad?

    This week, Phispers brings you news on Mylan’s EpiPen rival Auvi-Q, which is due for launch this year. We analyse Takeda’s US $ 5.2 billion acquisition of Ariad, and also bring you news on Sun Pharma’s consolidation plan, a big patent battle between Bristol-Myers and Merck and a multimillion dollar advertising blitzkrieg launched by the pharma industry to boost its image. And there is lots more. Read on. Pharma industry unveils new campaign to counter price hike fracas The pharmaceutical industry – which has been under caustic public criticism for unrealistic price increases – is rolling out a multimillion-dollar ad campaign to repair its reputation and defend the value its drugs provide. The campaign was unveiled by the Pharmaceutical Research and Manufacturers of America (PhRMA) recently. PhRMA officials said they would spend tens of millions of dollars every year for the next four to five years. This way they hope to rehabilitate the industry’s image, that has been tarred by episodes of price-gouging. The campaign will emphasize how biopharmaceutical companies develop breakthrough medications that save lives and can be the answer to the problem of rising healthcare costs. “Less hoodie, more lab coats” is how PhRMA President and CEO Stephen Ubl described the advertising campaign in a press briefing.    Did Takeda pay a heavy price to buy Ariad? On January 9, Takeda made a US $ 5.2 billion acquisition of Ariad Pharmaceuticals. Takeda valued Ariad — a Cambridge-headquartered cancer firm — at US $ 24 per share. This marks a 75 percent premium over Ariad’s previous closing stock price. Here’s how the deal, which analysts find overpriced, got sealed. On December 9, Takeda offered to buy Ariad for US $ 20 per share. But Ariad’s CEO Paris Panayiotopoulos rejected Takeda’s offer, citing it had been undervalued. On December 22, Takeda decided to up the offer to US $22 per share. But even that was rejected. On December 24, Takeda’s CEO Christophe Weber called Panayiotopoulos and made Takeda’s “best and final” offer — at US $24 per share. Ariad decided to move forward with the deal. It had not received a formal offer from three other potential suitors. On January 8, the two companies agreed to the acquisition. In October last year, Ariad had come under criticism from Senator Bernie Sanders for increasing the list price of its blood-cancer drug Iclusig four times in 2016. Takeda seems to be making a big bet on Ariad’s top pipeline asset — the lung-cancer drug brigatinib. However, brigatinib is a late entrant in the field and faces tough competition from companies like Roche and Novartis. Moreover, Pfizer has a third-generation version of a similar drug in its pipeline. Therefore, a fight for market share may considerably limit brigatinib’s potential. And the US $ 5.2 billion price may eventually prove to be a heavy price for Takeda.     Sun Pharma to sell Ohm Labs to reduce manufacturing footprint in US  Sun Pharmaceutical plans to sell its Ohm Labs manufacturing site based in New Jersey as part of a larger consolidation plan for its manufacturing units. The US site came into Sun’s fold through the acquisition of Ranbaxy in 2015, and is expected to fetch roughly US $ 100 million. Sun has a total of 33 formulations and 14 active pharmaceutical ingredient (API) sites. Last year, as a part of its manufacturing consolidation in the US, Sun had announced the sale of two facilities located in Philadelphia (Pennsylvania) and Aurora (Illinois) to Frontida Biopharm. Subsequently, the Philadelphia site received an FDA warning letter, for an inspection that took place in June-July last year. Bristol-Myers and Ono settle patent dispute with Merck over Keytruda Two weeks back, Phispers had predicted that this year may well be the year of big patent battles between pharmaceutical giants. This week, there is more on patent disputes — Bristol-Myers Squibb and Ono Pharmaceuticals have agreed to set aside their patent dispute with Merck over the PD-1 (short for programed cell-death protein-1) checkpoint drug – Keytruda – in exchange for US $ 625 million in cash and a 6.5 percent royalty on sales for the next six years. Even though Bristol-Myers Squibb may keep losing to Keytruda on key franchise initiatives, it can now get a share in Merck’s good fortunes. Bristol-Myers has experienced a series of painful setbacks on the checkpoint front. On January 20, Bristol-Myers issued a late release which said it is abandoning any plans for an accelerated approval of a combination of  Opdivo and Yervoy for lung cancer, conceding the early lead for frontline use to Merck and Keytruda. Mylan’s EpiPen competitor to be reintroduced in the US market An EpiPen rival Auvi-Q is set to return to the market free of charge for millions of consumers who have commercial insurance. But the list price for Auvi-Q, and the starting point for insurance companies, will be much higher — at US $ 4,500  — which is 7.5 times the list price drugmaker Mylan charges for EpiPen. A single prescription for EpiPen (in a two-injector pack) comes at a list price of US $ 608. In 2015, Sanofi had voluntarily recalled all its Auvi-Q injections in the US due to inaccurate doses. This gave Mylan a virtual monopoly in the field of epinephrine injection. In 2016, Kaleo was given back the rights to reintroduce its epinephrine auto-injector in the US market. Kaleo intends to reintroduce Auvi-Q in the first half of this year. Mylan faced serious criticism after media reports pointed how the company had raised the price of EpiPen by more than 500 percent since 2007. Public outcry forced Mylan to develop a generic version of EpiPen priced at US $ 300 for a two-pack. The generic EpiPen hits the market just weeks after Kaleo would reintroduce Auvi-Q. GSK poaches AstraZeneca’s Miels to head its pharma business GlaxoSmithKline's Abbas Hussain, who is president of global pharmaceuticals, is leaving the company. And GSK has announced that AstraZeneca’s current executive vice president of European operations, Luke Miels, will replace Hussain. Miels will take the responsibility for a portfolio of medicines and vaccines with annual sales of more than US $ 18.8 billion (£15 billion) and operations in over 100 markets. Earlier, Hussain was being viewed as a potential contender to take over from GSK's CEO Andrew Witty, who steps down at the end of March this year. However, in September last year, GSK announced that Emma Walmsley, head of the company's consumer healthcare division, will succeed Witty. While commenting on Hussain's departure Witty said: “Succession processes are challenging for everyone involved and, unfortunately, it is rare that all of those involved stay in the company.” Mallinckrodt coughs up US $ 100 million in penalty to settle FTC charges Drugmaker Mallinckrodt has agreed to pay US $ 100 million to settle Federal Trade Commission (FTC) charges that the company and its Questcor division violated antitrust laws after Questcor purchased rights to a drug that “threatened its monopoly in the US market” for its own drugs. The FTC complaint claims that while benefiting from its monopoly in the highly-expensive Achthar drugs — that are used to treat spasms in infants and as a drug of last resort in other serious conditions — Questcor illegally acquired the US rights to develop a competing drug — Synacthen Depot — from Novartis, in 2014. In 2001, Questcor had acquired the rights to Acthar and overtime raised the price of a vial from US $ 40 to more than US $ 34,000, the FTC said. Simultaneously, it monopolized the market by purchasing the rights to a similar drug, Synacthen, which was being sold by Novartis in Europe and Canada at a fraction of the price. Eli Lilly buys back migraine drug out-licensed to CoLucid Eli Lilly has said it will buy out CoLucid Pharmaceuticals for US $ 960 million in cash, and bring back to its fold lasmiditan — the late-stage acute migraine pill candidate Lilly had out-licensed to CoLucid in 2005. This announcement comes as a shot in the arm for Lilly, which is struggling from the recent setback to its experimental Alzheimer’s treatment, solanezumab. In November 2016, there was news that the drug failed in a large clinical trial. Lasmiditan was discovered by Lilly and licensed out to CoLucid in 2005. CoLucid's lasmiditan has already succeeded in a late-stage trial for acute migraine relief. Lilly said in a statement that the acquisition will “enhance its existing portfolio in pain management for migraine.” According to Migraine Research Foundation, about 40 million Americans suffer from migraines, and the disease costs America around US $ 36 billion annually in terms of healthcare costs and loss in productivity. “We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of phase 3 development and potential commercialization,” CoLucid’s CEO Thomas Mathers said.    

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    #Phispers by PHARMACOMPASS
    26 Jan 2017
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    Trump’s comments on drug prices sink pharma stocks; Teva lowers guidance by $ 1 billion

    Trump’s comments on drug prices sink pharma stocks; Teva lowers guidance by $ 1 billion

    The New Year began with the JP Morgan Healthcare Conference— the drug industry’s annual investor meet — where industry leaders were busy announcing deals, until Donald Trump accused the industry of “getting away with murder”. His comments sent shockwaves within the industry as pharma and biotech stocks tanked. In the first Phispers of 2017, we also bring you a compilation of the likely patent conflicts this year. And, there is news on Aurobindo Pharma’s acquisition, Teva's revised guidance for 2017, lowering of growth prospects for Mylan, fresh bribery charges against Novartis and more.   Trump promises aggressive federal bidding process to slash drug prices   Donald Trump, America’s president-elect dropped a bombshell in his first news conference held Wednesday, accusing the pharmaceutical industry of “getting away with murder”. He said he would bring down drug prices, as well as government spending on drugs by changing the way the country bids for drugs. During the event held at Trump Tower in New York, Trump said: “Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly.” The country’s federal law forbids the government from negotiating drug prices with drug companies in order to lower the price of drugs for seniors using Medicare. Trump, however, did not announce how he will address the issue of high drug prices. In the past though, he has called for ending the policy. His comment came in the midst of the JP Morgan Healthcare Conference, a major annual investor meeting taking place in San Francisco, and knocked down the stocks of biotech and pharmaceutical companies by around 2 percent. “If anybody is walking away from this conference thinking ‘business as usual,’ I think that’s a mistake,” Heather Bresch, chief executive of Mylan Pharmaceuticals said at the JP Morgan meet. “The pricing model has got to change. It’s not incremental change; I don’t think that’s what this country needs. I think it’s truly rethinking the business model,” she added. Mylan was under scrutiny recently for repeated list price increases on its lifesaving allergy drug EpiPen. RECOMMENDED READ: Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend   Teva lowers guidance, Mylan expected to lose US $ 800 million in 2018   Israeli drugmaker Teva revised the predictions it made in July 2016, about its financial expectations for 2017. And these are considerably below its previous expectations. For instance, it laid out a revenue forecast of US $ 23.8 billion to US $ 24.5 billion for 2017, well below the US $ 25.2 billion to US $ 26.2 billion guidance it had previously estimated. Teva now expects its earnings per share (EPS) to be between US $ 4.90 and US $ 5.30 — another big drop from its July guidance of US $ 6.00 to US $ 6.50. Several industry observers had expected this downward revision. “I think it’s pretty clear that management’s prior expectations for 2017 were very inflated,” Umer Raffat, an Evercore ISI analyst, said.  Meanwhile, Teva began the new year by forking out over US $ 520 million in order to resolve a bribery lawsuit in the US filed by its shareholders. It pertained to its operations in Russia, Ukraine and Mexico.   The year gone by was a turbulent one for Teva. For instance, its US $ 2.3 billion acquisition of Rimsa (short for Representaciones e Investigaciones Médicas, SA de CV), a leading pharmaceutical manufacturing and distribution company in Mexico, went the Ranbaxy way, with the former owners filing a legal complaint against Teva. The complaint mentioned that Teva is suffering from “buyer’s remorse” and is trying to undo the transaction “by any desperate measure” after destroying the Rimsa companies with firings and manufacturing shutdowns. It’s not just Teva which is set to see a downtrend. Mylan's EpiPen — which hogged the headlines last year for its price hikes — is projected to face substantial decline, until 2018, say analysts. EpiPen is all set to face competition from Kaleo’s Auvi-Q (another epinephrine injection), which is due for launch in the first half of 2017, Ronny Gal of Bernstein Research said. EpiPen (excluding the generic version) will bring in only US $ 300 million in 2018 for Mylan, down from its US $ 1.1 billion estimate for 2016, Bernstein Research said.   Aurobindo to acquire Portugal’s Generis Farmaceutica   The New Year began with a bang for India’s Aurobindo Pharma. The company said it has inked a pact to acquire Portugal’s Generis Farmaceutica SA from Magnum Capital Partners for a consideration of US $ 143 million (or €135 million). In a statement, Aurobindo Pharma said the binding agreement has been inked through Aurobindo’s wholly-owned subsidiary — Agile Pharma BV Netherlands. Generis produces and sells pharmaceutical products in Portugal.  The combined entity will benefit from a robust pipeline covering all major molecules coming off patent in the next five years, V Muralidharan, Senior Vice President of European Operations at Aurobindo Pharma, said. “The acquisition of Generis, by leveraging its strong portfolio and unrivalled brand recognition will allow us to establish ourselves as the top generics player in the Portuguese market,” he added.  The deal, however, is conditional, and depends on obtaining necessary approvals from Portuguese authorities. The acquisition deal includes Generis’ manufacturing facility in Amadora (Portugal) with a capacity to produce 1.2 billion tablets/capsules/sachets annually.   Patent battles between the Big Pharma could dominate 2017   This year may well be the year of big patent battles between pharmaceutical giants. It began with a ruling on a patent infringement case involving partners Sanofi-Regeneron and Amgen. A US federal judge ordered French pharmaceutical giant Sanofi and partner Regeneron to stop selling their latest cholesterol treatment — Praluent — due to patent infringement. After the court order, the stocks of Regeneron and Sanofi got hammered. Sanofi and Regeneron plan to immediately appeal that decision. According to the ruling, Sanofi and Regeneron had infringed biotech giant Amgen’s patents for a rival cholesterol fighting drug — Repatha. Both Praluent and Repatha are the only approved ‘PCSK9 inhibiting’ therapies known to considerably reduce bad cholesterol levels in patients during clinical trials. Both won FDA approval in 2015 and both are expensive — priced at US $ 14,000 per year. Sanofi is also in a battle with Novo Nordisk. In the last week of December, there was news that Sanofi filed a lawsuit in the US accusing Novo Nordisk of making the false claim that Sanofi’s insulin drugs would no longer be available for many US patients. According to Sanofi, Novo made that claim in order to promote its own competing drug. The complaint seeks an order forcing Novo to pay damages and withdraw marketing materials for its drug Tresiba. Both Sanofi and Novo have been tied in a regulatory race for their basal insulin/GLP-1 combo diabetes products. But Sanofi is already ahead in the race, as last week it rolled out Soliqua, a combination of (insulin) Lantus and GLP-1 drug Adlyxin, at a list price of US $ 127 for a 300-unit pen. Novo’s Xultophy—which received regulatory approval on November 21—won’t be in the market until early May. And then there is the battle between Merck and Gilead. The latter ended the year on a sour note after a federal jury in the US ordered Gilead to pay US $ 2.5 billion in royalties to Merck in an ongoing dispute. The legal battle between Merck and Gilead centres around Gilead's flagship hepatitis C cures — Sovaldi and Harvoni. Both these drugs gained disrepute for their lofty prices. Yet they dominated the hepatitis C drug market (before they ran into trouble with insurers and benefits managers who demanded better deals). Lastly, there is a significant patent battle brewing in experimental biopharma technology in the form of a spat between the University of California and the University of Vienna on one side and the Broad Institute of MIT and Harvard University on the other. The battle centers around CRISPR-Cas9 — an early-stage gene-editing platform that significantly simplifies the process of slicing and dicing problematic genetic material. It is being tested as a treatment option for cancer, sickle cell, and a host of other diseases.    The dispute is around who owns the patent right to CRISPR. While University of California at Berkeley professor Jennifer Doudna and the University of Vienna’s Emannuelle Charpentier were first to announce their discoveries, MIT's Feng Zhang actually won the patent after going through an expedited process.    After Korea, US and China, Novartis faces bribery charges in Greece   In the last one year, Swiss drugmaker Novartis has faced three sets of bribery charges. The fourth one came in the New Year, with Greek officials announcing they are investigating Novartis for bribery in the wake of local media reports raising questions about the company. Greek corruption prosecutors raided the Athens offices of Novartis last week, as part of the probe over bribery allegations. Greek authorities have reportedly interviewed scores of sources. In March 2016, Novartis paid US $ 25 million to settle a US Securities and Exchange Commission (SEC) case that claimed the Swiss drug maker paid bribes to health professionals in China to increase sales during 2009 and 2013.    While the US case got settled, Novartis has been accused by a whistleblower in Turkey of paying bribes through a consulting firm to secure business advantages. In August 2016, PharmaCompass had reported that six former and current Novartis executives at its unit in South Korea allegedly paid more than US $ 2 million to doctors in return for prescribing its medicines. Among those indicted was the former CEO of Novartis’ Korea unit. Twitter bans Martin Shkreli for making unwanted advances at journalist   In September 2015, Martin Shkreli, the former CEO of Turing Pharmaceuticals, had received widespread flak for raising the price of anti-parasitic drug Daraprim by a factor of 56. Since the Daraprim episode, Shkreli has also been indicted on unrelated fraud charges. Well, Shkreli is back in news. And once again for all the wrong reasons. A few days back, he was temporarily kicked off Twitter and its live-streaming platform — Periscope — for making unwanted advances toward Lauren Duca, the weekend editor of Teen Vogue. In a tweet to Twitter’s CEO Jack Dorsey, Duca said: “How is this allowed?” She included two screenshots of Shkreli's Twitter profile page. Apparently, Shkreli manipulated a photograph of Duca with her husband, wherein he had put his face in place of Duca’s husband. Duca also posted another screenshot wherein Shkreli had put up a montage of Duca’s photos as his Twitter background image, with the text: “For better or worse, till death do us part, I love you with every single beat of my heart.” Moreover, Shkreli’s Twitter bio said that he had a “small crush” on Duca. “Hope she doesn't find out,” it said. According to the Twitter spokesperson, Twitter’s rules prohibit “targeted harassment”. Oncology deals: Takeda acquires Ariad; Daiichi ties up with Kite; Ipsen with Merrimack   The JP Morgan conference saw some major deals being announced in the field of oncology. Japan’s Takeda Pharmaceutical Company and Massachusetts-headquartered Ariad Pharmaceuticals recently entered into a definitive agreement under which Takeda will acquire all outstanding shares in Ariad for US $24 per share in cash, in a deal valued at US $ 5.2 billion. Ariad Pharmaceuticals is a cancer-focused drugmaker. The agreement has been unanimously approved by the boards of directors of both companies. It is likely to close by the end of February this year, subject to required regulatory approvals and other conditions.   Kite Pharma — a California-based, clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products — has entered into a deal with Daiichi Sankyo of Japan.  Kite Pharma will enter the Japanese market, along with Daiichi, which has lined up US $ 250 million deal. Kite Pharma’s new drug application for the pioneering CAR-T drug —KTE-C19 — is in the final weeks of being completed and shipped to regulators in search of an accelerated approval. CAR-T (short for chimeric antigen receptors-T cell) is a therapy for cancer, using a technique called adoptive cell transfer. The T cells, which can recognize and kill cancer cells, are reintroduced into the patient.  Under the deal, Kite will be taking US $ 50 million upfront and US $ 200 million in milestones for the deal, while Daiichi Sankyo is reserving another US $ 200 million in additional milestones for each new drug candidate that Kite takes to the FDA over the next three years.   Meanwhile, French pharmaceutical company Ipsen has entered into a US $ 1 billion deal to acquire oncology assets from Massachusetts-headquartered Merrimack Pharmaceuticals, including the pancreatic cancer drug Onivyde. The deal is broken down into two steps, involving an upfront fee of US $ 575 million, to be followed by a potential US $450 million that would depend on approvals for Onivyde in the US. With this deal, Merrimack is likely to pay off US $ 195 million in debts, return US $ 200 million to stockholders and make a further payment of US $ 450 million to shareholders. Merrimack would also plough US $ 125 million into the development of three experimental cancer drugs.    

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    12 Jan 2017
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    India steps up efforts to improve drug quality; Allergan vows to limit price hikes

    India steps up efforts to improve drug quality; Allergan vows to limit price hikes

    This week, Phispers has two news items that demonstrate Indian government’s keenness to improve drug quality and reduce bribing of doctors by drug companies. There is more news on Mylan’s EpiPen and Novo Nordisk’s combination drug for diabetes. Read on. Indian government takes steps to improve drug quality standardsThe Indian government is firm on improving the quality standards in the pharmaceutical industry. As a first step, it is working on enhancing the skills of the workforce employed in the industry. Through a notice issued last week by the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, the government has made it “imperative that all personnel employed in pharmaceutical manufacturing units undergo certification programs developed by the Life Science Skill Sector Development Council”. With effect from January 1, 2018, no person shall be employed in any pharmaceutical manufacturing unit unless the person has obtained a formal diploma or degree in the relevant area, the notice said.Meanwhile, the CDSCO is planning to recruit 500 drug inspectors in the coming year in order to double its manpower by the end of 2017. The organization has already recruited 147 drug inspectors, who will enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP) In EpiPen aftermath, Allergan CEO promises to limit price hikesIn the wake of Mylan’s EpiPen fiasco, Allergan’s CEO Brent Saunders has committed to rebuilding its “social contract” with patients by promising to avoid price gouging and limiting price hikes on brand-name medicines.In a blog posted on the company website this week, Saunders said Allergan would not raise prices more than once a year. And that any price hike will be limited to single-digit percentage increases.Saunders also said the company will avoid “major” price hikes without any corresponding increases in costs as products near patent-expiration. Condemning price gouging, Saunders said: “Recently, the actions of these outliers have shifted attention away from the increasingly vibrant medical innovation ecosystem focused on finding new medicines, improving outcomes for patients and, by doing so, lowering the overall cost of disease.”  Mylan now under antitrust investigation over marketing of EpiPens to schools  It seems more trouble awaits Mylan Pharmaceuticals over the EpiPen price increase. Mylan is now being investigated by the New York attorney general for potential antitrust violations involving the marketing of these allergy auto-injectors to schools. The attorney general’s office began looking into this matter last week and has issued subpoenas to Mylan for information about its policy of offering discounted EpiPens to schools on the condition that these schools would not purchase competitive products.Since 2004, the price of EpiPens has been increased by 450 percent, after adjusting for inflation. A two-pack now sells for more than US $ 600. Mylan has announced several steps to reduce the cost of EpiPen, including introducing a generic version. But it continues to face political flak.According to an analyst at Sanford C. Bernstein & Co, Mylan’s financial incentive plans are to be blamed for its EpiPen price hike. In 2014, Mylan announced it would reward some 100 employees and executives for not only hitting, but exceeding aggressive profit targets. The company’s top five executives could earn as much as US $ 82 million through the price increases.According to another news report, Mylan has increased its branded ad spending on the EpiPen by 357 percent over five years. During the same time, it hiked the price of EpiPen by 179 percent. FDA puts off decision on Novo’s combination diabetes drug The competition between Sanofi and Novo Nordisk over FDA approval for their combination diabetes drugs is getting interesting. Two weeks after the FDA put off approval of Sanofi’s insulin-plus-GLP-1 combo, the FDA has put off a decision on Novo Nordisk’s combination drug too. The FDA will now review Novo’s drug in December. The drug – which is a marriage of Tresiba and Victoza – has already been approved in the EU as Xultophy. Sanofi’s LixiLan is a combination of Lixisenatide and Lantus.Both Xultophy and LixiLan have prospects of becoming blockbuster drugs, with a US $ 6 billion market potential between them. Both companies are counting on these drugs to increase sales, since their diabetes products are being subject to increased competition and pricing pressure. However, a decision on Sanofi’s combination drug is expected to be taken before Novo’s Xultophy. This news has come at nearly the same time as news about its long-time CEO, Rebien Sorensen, stepping down. From January, Sorensen will be succeeded by Lars Fruergaard Jorgensen, currently executive vice president and head of corporate development. India plans penal provisions to deter drug companies from bribing doctors The Indian government plans to deter pharmaceutical companies from bribing doctors with freebies by replacing the voluntary code, brought into place in January 2015, with a strong mandatory code that has penal provisions.The voluntary code was to expire in June 2015. But it has been given four extensions, even though it wasn’t deterring drug companies from giving freebies to doctors. According to a report published in The Economic Times, the chemicals and fertilizers ministry is reworking on the toothless voluntary code to come out with a mandatory one, with penal provisions. The ministry has sought legal opinion on the new code, which will be applicable to both pharmaceutical and medical devices companies. Gilead urged to drop legal action against generic Sovaldi in UkraineIn June, Gilead Sciences had filed a claim against a Ukrainian drug wholesaler, the Ukrainian Drug Regulation Authority, and the Ministry of Health, alleging several of its patents prevent generic drug makers from marketing a version of its Hepatitis C drug – Sovaldi – for the next few years.This week, International humanitarian-aid non-governmental organization – Doctors Without Borders – has urged Gilead Sciences to drop the case that prevents Pharco Pharmaceuticals – a generic drug maker – from selling a copycat version of Gilead’s Sovaldi in Ukraine.If Gilead wins the case, generic versions of Sovaldi will not be available in Ukraine. According to the World Health Organization, more than 1.3 million people are believed to be infected with Hepatitis C in Ukraine.In a letter, dated September 5, the organization has urged Gilead to “reconsider its business strategy in high-burden, middle-income countries, especially Ukraine,” since its strategies “threaten sustainable access to Hepatitis C treatment in a number of countries” where the advocacy group treats patients. A hearing in this case is scheduled for September 12.In March 2015, a US $ 10 version of Sovaldi was made available in Bangladesh by Incepta Pharmaceuticals. Sovaldi sells for US $1 ,000 a pill in the US. FDA’s letters to Pan Drugs and Zhejiang Hisoar explain reasons behind import alerts India’s Pan Drugs had two of its facilities placed on FDA’s import alert list last year. Recently, the FDA posted the warning letter issued to Pan Drugs on its website. The letter explains why the finished formulations unit failed an inspection.For instance, Pan Drugs’ quality unit allowed the use of adulterated API ‘dated May 25–31, 2015’ which was manufactured at Pan Drugs’ Nandesari facility. The Nandesari facility was placed on FDA import alert on May 5, 2015, for egregious cGMP deviations. “Your firm used this API for the manufacture of drugs which were then shipped to the US market from October 7 to November 23, 2015,” the warning letter said.Additionally, the quality unit of Pan Drugs approved certificates of analysis for several API as well as finished products, prior to conducting all quality control and release testing. The production manager “falsified the documents,” the warning letter said.In the case of Hisoar, whose facility was also placed on import alert, FDA investigators discovered that the facility lacked basic laboratory controls to prevent changes to its electronically-stored data and paper records. “When you encountered suspect and out-of-specification (OOS) results, you retested samples until you obtained desirable results,” the warning letter said. 

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    08 Sep 2016
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    Mylan’s EpiPen price hike defense; India throws out plans of a bulk drug policy

    Mylan’s EpiPen price hike defense; India throws out plans of a bulk drug policy

    This week, Phispers takes you through the EpiPen price hike controversy, and the Indian government’s decision not to adopt a bulk drug policy. There is more news pertaining to Teva’s divestitures, GSK’s new drug for HIV treatment and drug recalls by Cadila, Teva and Sagent. A setback to Indian pharma as minister says govt against bulk drug policy Earlier this year PharmaCompass had highlighted the ‘inconvenient truth about Chinese drug manufacturing’ – that a serious imbalance exists in the global supply chain with regard to its dependence on China.  India had declared 2015 as the Year of the API, under the ‘Make in India ‘programme. A Cabinet note for a bulk drug policy, based on the recommendations of the Katoch committee, had been floated earlier this year. Such a policy would have helped the Indian pharmaceutical sector turn into a US $ 200-billion industry by 2030, and shifted global dependence away from China.However, the plan suffered a setback as the chemical and fertiliser minister Ananth Kumar announced this week that the government was against a bulk drug policy. Instead, states will have to come up with “bulk drug parks” which will help boost manufacturing of bulk drugs.This news comes at a time when a Bloomberg analysis concluded that China drug sales grow despite safety concerns at home. Around 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw those that were false or incomplete. “Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials,” the Bloomberg report said.Currently, India is dependent on China for APIs. More than 75 per cent of India’s bulk drug imports come from China. And there is concern over quality. Mylan CEO blames system for EpiPen price hike, announces launch of generic versionLast week, Mylan made headlines as its 400 percent price increase of EpiPen auto-injector came under scrutiny. The furor continued, even as the Mylan CEO Heather Bresch tried her best to justify the price hikes in an interview, which generated more negative publicity. In the interview, Bresch blamed the healthcare system for the price hike. According to her, the price of US $ 608 for the life-saving EpiPen reflects a system where there are “four or five hands that the product touches and companies that it goes through before it ever gets to that patient at the counter.” This week, Mylan tried to suppress the furor by announcing it would launch an authorized generic version of EpiPen for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks, will have a list price of US $ 300. This is still significantly higher than the price of the auto-injector prior to Mylan’s acquisition of the EpiPen in 2007. In Canada, the twin pack costs US $ 200, in France it is around US $ 100.In the interview, Bresch acknowledged that the high retail price in the US was used to subsidize the price of EpiPens in Europe, where they sold at just US $ 100 or US $ 150.Bresch went onto say: “Congress and the leaders of this country need to quit putting their toe in this topic and really fix this — we have an outdated system.”After the interview, pharma bad boy Martin Shkreli defended the price increase while some Americans turned to Canada for cheaper EpiPens. And Senators questioned if the FDA was to blame for the high drug prices. Meanwhile, analysts said the authorized generic version of EpiPen may actually make more money for Mylan!  Aurobindo, Intas in race to buyout UK and Irish portfolios of TevaLast week, two Indian drug makers – Aurobindo Pharma and Intas Pharmaceuticals – emerged as the final contenders to buyout the UK and Irish portfolios of Teva. These portfolios of the Israeli generics behemoth have been put up for sale to comply with the European anti-trust regulations.Both Aurobindo and Intas put up binding offers of around US $ 1 billion, along with firm financing commitments, The Economic Times reported. Last year, Teva had acquired Allergan Plc’s generic business for US $ 40.5 billion. Teva is selling assets as part of a broader divestiture process to comply with the anti-trust regulations for this acquisition.In order to comply with these regulations, Teva has already sold 80 products in the US to drug makers like Dr Reddy’s, Sagent, Cipla, Zydus Cadila, Aurobindo, Impax and Perrigo.  Glaxo plans to shake up HIV treatment with new drugGlaxoSmithKline plans to capsize the decade-old strategy for treating HIV. Executives at GSK are hoping that the company’s latest HIV pill is powerful enough to suppress the virus, with the help of just one more drug. The drug – Dolutegravir – belongs to a class of HIV drugs known as integrase inhibitors that rapidly reduces the level of virus in the blood. It has already been approved for use as part of traditional triple therapy and hasn’t reported cases of the virus developing resistance to dolutegravir in patients who are new to the treatment.Since the mid-1990s, the treatment of HIV – a virus that causes AIDS – hasn’t changed much. In the mid-1990s, a new class of antiretroviral drugs were introduced. One drug from the new class, along with two other drugs from an earlier class, hindered the virus from developing resistance. This three-drug regimen has been the standard approach for treating HIV for the last two decades.Dolutegravir, according to GSK CEO Andrew Witty, would be the game changer because taking fewer drugs will lead to fewer side effects.GSK’s majority-owned HIV business – ViiV Healthcare – is undergoing the long process of proving the efficacy of the Dolutegravir. Pfizer and Japan’s Shionogi & Co hold minority shares in ViiV Healthcare. Japanese wholesaler arrested for illegally selling drugs to Chinese touristsHidenobu Zaima, president of Tokyo-based drug wholesaler – Biken Pharmacy, was arrested along with four others, on the suspicion of illegally selling large quantities of prescription drugs to Chinese tourists and violating the Pharmaceutical and Medical Device Law.Zaima is believed to have sold about 291,000 products to a Chinese broker for US $ 147,000 between September 2015 and May 2016. Chinese tourists often buy prescription and over-the-counter products in other countries, such as Japan and Hong Kong, where they can be cheaper. They also believe that drugs bought in these countries would be of better quality. Teva, Cadila and Sagent recall drugsThis was a week of drug recalls in the US. Teva issued a recall of antibiotics for the second time this year. This time the recall pertained to amoxicillin manufactured at a plant in Canada. The company is recalling 53,000 bottles of the drug manufactured by Teva Canada Limited in Toronto.Earlier this year, Teva had recalled amikacin sulfate manufactured at its facility in Hungary due to the potential for the presence of glass particulate. Meanwhile, India’s Cadila Healthcare recalled 26 batches (or 223,776 bottles) of an antidepressant -- venlafaxine HCL ER capsules – as well as nine lots for which the company did not specify the bottle count. These drugs were manufactured at the company’s plant in Ahmedabad. The drugs failed dissolution specifications when retained samples were tested. Venlafaxine is used to treat major depressive disorder, anxiety and panic disorder.Similarly, Sagent Pharmaceuticals recalled one lot of oxacillin for injection manufactured by India-based Astral SteriTech. The action was taken after a customer complained that small, dark particulate matter was found in the solution after it was reconstituted. The foreign matter found in the vials was identified as iron oxide.  

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    #Phispers by PHARMACOMPASS
    01 Sep 2016
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    Sanofi’s rough week; Quality snags at Pfizer; FDA warns against commonly used drug

    Sanofi’s rough week; Quality snags at Pfizer; FDA warns against commonly used drug

    This week, Phispers delves into Pfizer’s acquisition of Medivation and its impact on Sanofi. There is also news on antipsychotic drug Abilify, besides snippets on a lawsuit against Valeant, Mylan’s price hikes and more quality snags that were unveiled at Pfizer’s plant near Chennai. Read on.    Rough week for Sanofi as FDA delays its diabetes drugs, while Pfizer walks away with Medivation Pfizer agreed to pay US $14 billion in cash for Medivation in a deal that adds the prostate cancer drug Xtandi to its product portfolio. Medivation was one of the few independent companies with a cancer treatment that is selling well. Xtandi currently generates about US $ 2 billion a year in annual sales. The acquisition has come as a setback for French drug maker Sanofi that spent five months pursuing Medivation. At one point, Sanofi even attempted to replace Medivation’s board and force a deal.  There was another setback for Sanofi, as it saw the launch of its diabetes combination medicine get delayed until November this year. Sanofi spent US $ 245 million on a priority review voucher to beat Danish drug maker Novo Nordisk to market with a diabetes drug that pairs its best-selling medicine Lantus (a basal insulin) with lixisenatide. However, the FDA’s fast-track review pushed out the launch of the combination till at least November.  The FDA asked Sanofi for more data on the dual-drug delivery pen – a device that triggered debate during an FDA advisory panel review in May this year. The FDA decision on Novo’s product is due next month. With this unexpected delay, Novo could get more than a two months’ head start over Sanofi.    FDA warns against the use of antipsychotic drug Abilify In the US, patients taking the antipsychotic drug Abilify have reported uncontrollable urges to gamble, binge eat, shop, and have sex, according to the FDA. The regulator issued a warning this week on the drug, which is one of the top-selling prescription medications in the United States. Other serious side effects of the drug include a higher chance of developing diabetes and hyperglycemia, and increased risk of suicide among patients under the age of 24. Also known as aripiprazole, the drug is used to treat schizophrenia, and can be used in combination with other drugs to treat depression. In the US, 1.6 million patients received Abilify prescriptions last year. The warning comes amid pending class-action lawsuits against the manufacturer of Abilify – Otsuka America Pharmaceutical. The class-action suits allege the company didn’t properly warn patients about the possibility of impulse-control issues.  However, these problems are rare. In the 13 years since the drug was approved, there have been only 167 reports of patients experiencing significant impulse-control problems, according to the FDA.   Counterfeit pills may have killed the late singer Prince A little over a year ago, the Drug Supply Chain Security Act (or Drug Quality and Security Act) became effective in the United States. The law was introduced to secure the supply chain of medicines and restrict counterfeit drugs – an industry estimated to be bigger than Pfizer and GSK put together. It seems that regulatory agencies still have a lot of work to do in this area. A mis-labelled bottle of pills found in the home of the late singer Prince contained the powerful painkiller fentanyl, a synthetic opioid 50 times more powerful than heroin. Prince died on April 21 this year. According to sources close to the investigation, the pills were found in a bottle of Aleve, an over-the-counter medication sold in the US that contains the painkiller naproxen. Two dozen pills, found in one bottle, were falsely labelled as ‘Watson 385’ – an identifier for a mix of acetaminophen (paracetamol) and hydrocodone.   Valeant mired in trouble with a lawsuit and faltering sales of female sexual dysfunction drug According to a lawsuit filed last week, Valeant Pharmaceuticals refilled patient prescriptions without their permission and directed them to buy expensive drugs in order to boost sales. The lawsuit provides insight into how a mail-order pharmacy – Philidor Rx Services – assisted Valeant in directing prescriptions to its brand-name medicines over cheaper generic versions.  Meanwhile, Valeant hired Paul Herendeen as its new chief financial officer, luring the executive away from Zoetis, the animal health products maker. While Valeant is busy battling challenges on various fronts, its US $ 1 billion acquisition of Sprout Pharmaceuticals of Addyi – the first medicine to combat female sexual dysfunction – is turning out of be a bust, as it has reported meagre sales.   Pfizer’s plant in Chennai faces more compliance issues Earlier this month, Pfizer had to halt production at a plant near Chennai in India, after a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) joint inspection highlighted quality concerns. The other regulators in the PIC/S inspection were the Medicines and Healthcare products Regulatory Agency of the UK (MHRA), the United States Food and Drug Administration (USFDA), Therapeutic Goods Administration of Australia (TGA) and Health Canada. Three years ago, the plant was first cited with an FDA warning letter. Last year, when Pfizer acquired the plant from Hospira, it was well aware of the quality issues. But Pfizer was probably not aware of the extent of troubles that awaited it. Last week, a GMP non-compliance report posted by European Medicines Agency (EMA) listed that an inspection by the MHRA uncovered a variety of critical issues, raising doubts on whether the injectable products coming out of the facility are sterile or not. MHRA inspectors found that employees were using aseptic processes that could allow for microbial contamination. Pfizer’s investigations into issues were not getting to root causes of problems, they said. All of the plant’s shortcomings were linked to employees who lacked the “scientific knowledge” to know what to do. The MHRA withdrew the plant’s GMP certificate and has halted imports to the European Union of six injected antibiotics until the problems get addressed.   Mylan’s outrageous drug price hikes for EpiPen come under scrutiny The EpiPen auto-injector, which reverses life-threatening allergic reactions, is under scrutiny. In 2015, the drug had generated US $ 1.2 billion in sales for Mylan. The EpiPen has been around since 1977, but Mylan acquired the auto-injector in 2007. The EpiPen precisely calibrates the dosage of epinephrine. The patient now pays about 400 percent more for this advantage to receive a dollar’s worth of the life-saving drug. EpiPens were sold for about US $ 57 when Mylan acquired it. Today, it is being sold at US $ 500 or more in the US. Meanwhile, Senator Amy Klobuchar (District Minnesota) has asked the US Federal Trade Commission and the Senate Judiciary Committee to investigate price hikes undertaken by Mylan. Klobuchar is the ranking member of Senate Judiciary Antitrust Subcommittee. And Senator Richard Blumenthal (District Connecticut) wrote to the company for data about assistance programs for  patients and first responders. He also demanded that Mylan lower its price. Last year, Mylan raised the price on EpiPen — its biggest-selling product — twice by 15 percent (each time). Due to lack of competition, the price hikes were easy.   Korea’s Celltrion ships first batch of biosimilar Remicade to US Last week, a day after winning a lawsuit in the US, Korean pharmaceutical firm Celltrion shipped the first batch of its biosimilar medicine -- Remsima – to the country. The lawsuit was on the sale of Remsima – an autoimmune disorder drug – in the US, the world’s largest pharmaceutical market. Celltrion said that the move will accelerate the US launch of Remsima, a biosimilar version of Janssen's Remicade. Remsima has been on sale in Europe since 2013. Pfizer will take charge of sales of Remsima in the US. The drug will soon be available to patients in the US suffering from rheumatoid arthritis and ulcerative colitis under the brand name of Inflectra. Remicaid’s sales were in excess of US $ 8 billion in 2015.  Celltrion CEO Kim Hyoung-ki has projected that the company will earn more than US $ 1.7 billion in the US market next year, assuming a double-digit market share.   Four healthcare CEOs on the world’s top 20 severance packages list Even though the Pfizer-Allergan US $ 160 billion merger did not go through, Allergan CEO’s Brent Saunders has little to complain. In a recent Bloomberg compilation, his severance package of US $ 140 million ranks in the top 20 of all S&P 500 CEOs. Joining him in the top 20 are other CEOs of healthcare companies such as McKesson (with a severance package of US $ 198 million), Aetna (US $ 91 million) and Regeneron (US $ 90 million). McKesson Corporation is an American company distributing pharmaceuticals at a retail sale level and providing health information technology, medical supplies, and care management tools. Aetna is an American managed health care company, which sells traditional and consumer directed health care insurance plans and related services, such as medical, pharmaceutical, dental, behavioral health, long-term care, and disability plans. Regeneron is a US-based biotechnology company with four FDA approved products and over US $ 4 billion in revenues in 2015.   

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    https://www.pharmacompass.com/radio-compass-blog/sanofi-s-rough-week-quality-snags-at-pfizer-fda-warns-against-commonly-used-drug

    #Phispers by PHARMACOMPASS
    25 Aug 2016
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    Why Mylan thinks Teva`s shares are “toilet paper”?

    Why Mylan thinks Teva`s shares are “toilet paper”?

    In case you haven’t had time to follow the Mylan-Teva, Perrigo-Mylan saga of the past few weeks, we compiled a quick set of facts for your speed read needs: Table: Perrigo & Mylan versus Mylan & Teva:   Perrigo Mylan Teva Fast Fact World’s largest manufacturer of OTC healthcare products for the store brand market Holds the number one ranking in the U.S. generics prescription market in terms of sales Teva is the world’s largest generic medicines producer Annual Revenues (2014) $4.06 billion $7.72 billion $20.27 billion Size of their generics business $927.1 million $6.46 billion $9.8 billion Top products Tysbari®  Epi-Pen®   Copaxone®  (royalty share: 18% up to $2 billion in sales) ($1 billion) ($4.24 billion) 2013 Acquisitions DEC-2013: Elan Pharmaceuticals FEB-2013: Agila Specialties     $9.5 billion $1.75 billion     (Tax inversion)     2014 Acquisitions NOV-2014: Omega Pharma $4.5 billion JUL-2014: Abbott’s non-US generics business $5.3 billion (tax inversion)       SEPT-2014: Arixtra® rights       $300 million   2015 Acquisitions   FEB-2015: Famy Care MAR-2015: Auspex     $800 million $3.2 billion  April 2015 Perrigo & Mylan Mylan & Teva   Perrigo has rejected 3 takeover offers from Mylan. They first valued Perrigo at just under $29 billion, the next at $33 billion and the last one at $35.6 billion. Mylan rejected Teva’s unsolicited $40 billion bid for Mylan, 50% in cash and 50% in stock. Teva valued Mylan at $82/share.   If Mylan’s takeover of Perrigo fails, there is a high possibility that Teva, in its quest for growth, will eventually acquire Mylan. However, the highlight of this month long saga, has been the over 3,000 word letter Mylan’s Executive Chairman wrote when rejecting the Teva deal (Mylan internally refers to Teva stock as “toilet paper”).  Mylan’s Board answered that financially, Teva’s offer, does not even come close to qualify as a proposal worth pursuing (starting point of discussion - excess of $100 per share). Other concerns were also cited such as: Mylan having a substantial business in India, while Teva has a limited presence, and has been disparaging about India’s products and culture. In addition, should the deal come through, the massive overlapping positions would create significant antitrust concerns. On the other hand, here are some comments from the response of Mylan. Take your pick on what you think hurt the most: * “Mylan would give Teva severe indigestion”. * We believe Teva shares to be “low-quality and high-risk currency”. * Teva is offering Mylan shareholders to “take stock of a poorly performing troubled company in a combination that lacks industrial logic and is a terrible cultural fit”. * There is “persistent turnover and turmoil amongst the Teva leadership and Board”, “strategic confusion” and Teva’s under performance is “directly attributed to its “dysfunctional” culture”.  * The Board was described “like a Nuthouse” and ran the only CEO with pharmaceutical experience out of town within 18 months of being on the job  * “Do not wish to make Teva’s problems Mylan’s problems”  

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    https://www.pharmacompass.com/radio-compass-blog/why-mylan-thinks-teva-s-shares-are-toilet-paper

    #Phispers by PHARMACOMPASS
    30 Apr 2015
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