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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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    29 Apr 2020
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    Dead fish in Hyderabad puts pharma majors under scrutiny; False data uncovered in AstraZeneca’s US$ 4 billion buy

    Dead fish in Hyderabad puts pharma majors under scrutiny; False data uncovered in AstraZeneca’s US$ 4 billion buy

    This week, Phispers has news from across the world. While China is trying to speed up approval of drugs by accepting data from overseas trials, the US achieved record approval of generic drugs last fiscal. In India, pharma companies may face legal action for releasing effluents into a lake in Hyderabad that killed thousands of fish last week. In France, a reformulated thyroid pill from Merck led to severe side effects in patients. And, there was more bad news for Israel’s Teva as its competitors won approvals from regulators in the US and Europe to market cheaper versions of its blockbuster multiple sclerosis drug — Copaxone. Data-integrity uncovered in AstraZeneca’s US$ 4 billion Acerta buy   In February 2016, pharma giant AstraZeneca had invested US$ 4 billion in acquiring 55 percent stake in Acerta Pharma — a biopharmaceutical company based in the Netherlands and the US. The acquisition provided AstraZeneca with a cancer drug under clinical trials — acalabrutinib. An AstraZeneca press release issued at the time of acquisition had said: “Acalabrutinib is a highly selective, irreversible, second generation BTK inhibitor, with approximately 1,000 patients treated to date in clinical studies across the entire development programme.” But the acquisition brought some bad news for AstraZeneca last week, as a story published in Retraction Watch said one of Acerta’s former researchers had falsified early data on acalabrutinib. “The data, published as an abstract in August 2015 in the journal Cancer Research, reported a therapeutic benefit of acalabrutinib in a mouse model of pancreatic cancer,” the report said. The drug is now in human trials. Additional trials published in the New England Journal of Medicine and Blood in 2015 showed acalabrutinib had “promising safety and efficacy profiles in patients” with relapsed chronic lymphocytic leukemia. However, investigation into the data underlying the 2015 abstract revealed some of it was falsified. As a result, the journal retracted on the abstract. Interestingly a few weeks ago, acalabrutinib had won breakthrough therapy status at the US Food and Drug Administration (US FDA) along with an accelerated review plan for its first approval. However, all news was not bad news for AstraZeneca. Its innovative treatment for a type of lung cancer won “breakthrough” designation by the US FDA. The endorsement is for therapy Tagrisso for use in the US by patients with previously-untreated non-small cell lung cancer and a genetic mutation known as EFGR. This paves the way for fast-track approval of the drug. Dead fish in Hyderabad leads to pharma majors being booked for fouling lake water   Pharmaceutical companies in India — such as Hetero Pharma, Aurobindo Pharm, Mylan, SMS Pharma, Vantec and Sriram — that have their manufacturing facilities in Kazipally industrial area and Industrial Development Area (IDA) have been booked under a case for “fouling water of public spring or reservoir”. This happened last week after the Gandigudem lake, which is barely a few meters away from Hyderabad's Outer Ring Road (ORR), reported hundreds of bloated, dead fish washed ashore after it rained heavily. The 266-acre lake is situated near the IDA. The lake has been plagued with pollution for a while now. According to news reports, the Pollution Control Board (PCB) had found traces of chloromethane, a solvent used in the pharma industry, in the samples of the water and dead fish collected from the lake. The diluted traces of the chemical in the lake confirm contamination. Officials said that 230,000 fish had been washed ashore within a span of two days, causing heavy loss to the fishermen dependent on the lake. According to an official, the fish lost was worth US$ 230,038 (Rs 15 million) These companies have been booking under Section 277 (fouling water of public spring or reservoir) and Section 278 (making atmosphere noxious to health) of the Indian Penal Code. A video of a news report on the story can be viewed here. China to accept data from overseas trials in order to speed up drug approvals   China plans to speed up approval of drugs, and will accept data from overseas clinical trials in order to facilitate that. The move could be a boon for international drugmakers as well as for patients who often face lengthy delays for new medicines to reach the market. China has approved just over 100 innovative new drugs in the last 15 years — about a third of the drugs approved in the developed markets. This is the key reason behind the country taking this step to speed up drug approvals. The move also seeks to address high medicine costs, and improve access to healthcare for China’s 1.4 billion population. The Chinese Cabinet will also look into improving the protection of medical intellectual property and boost the number and quality of clinical trial testing centers in China. However, the proposals contained no timeline for implementation. In March this year, China had proposed ways to speed up approvals for imported drugs, including reforming clinical trial requirements. Merck’s French reformulation of most prescribed US drug leads to severe side effects   Popular thyroid drug Levothyroxine reportedly received many complaints of severe side effects from patients in France. The drug works as a stand-in for the hormone thyroxine in patients suffering from hypothyroidism, a condition that affects the body’s metabolism. According to a Reuters report, French police searched German drugmaker Merck KGaA’s plant in Lyon last week as part of a probe into complaints by patients about changes to its thyroid drug Levothyrox. In March this year, Merck had removed lactose from Levothyrox to make it easier to tolerate and replaced it with citric acid and mannitol, a type of sugar alcohol. The new formulation had been requested by the French medicines regulator ANSM in 2012. According to patients, this resulted in severe side effects such as memory loss, hair loss, weight gain and palpitations. Around 3 million people in France, 80 percent of them women, use Levothyrox. According to a Medscape article, levothyroxin is also the most prescribed drug in the US. The prescriptions for Levothyroxine (in the US) stood at 112 million in 2012 and 123 million in 2016. The drug was far ahead of the number two drug on the list (Lisinopril — with 99 million prescriptions in 2012 and 110 million in 2016). Last month, a prosecutor in Marseille had launched a probe into whether Merck had deceived patients with the change in the drug’s formula. Since then, Merck has restored the original drug to the market. Teva fights to hold market share as competitors receive nod for its blockbuster drug   Bad news from Israeli generic drug giant Teva Pharmaceutical Industries doesn’t seem to relent. Last week, Teva was taken unawares when its competitors won approvals from regulators in the US and Europe to market cheaper versions of its flagship Copaxone drug for multiple sclerosis. The launch of the competing products will result in “significant declines” in Teva’s largest product effective this year, Moody’s Investors service said in a note.  On October 3, Mylan said it received approval from the US FDA for the marketing of generic versions of  Teva’s Copaxone (glatiramer acetate) in 40 mg and 20 mg dosages. Mylan said it would start shipping the generic version immediately. According to Bernstein analyst Ronny Gal, Mylan is serving up 25 to 30 percent discounts versus the “prevailing price” on Teva’s Copaxone and Teva is countering it, he added. Analysts had written off Mylan’s long-delayed generic Copaxone until next year. The approval last week surprised analysts and investors. Two days later, Alvogen said it had received an approval from European regulators to market the 40 mg dose of generic Copaxone in Europe. Alvogen has been selling the 20 mg dose of the drug in Europe. These approvals could mean a “downside” to both revenue and profit estimates for 2018, Citi’s Liav Abraham said. Generic drug approvals in US hit all time high; Indian firms corner large chunk   The US FDA approved a record 763 generic drugs in the US fiscal year that ended on September 30, 2017. Amongst these, Indian companies accounted for nearly 40 percent of the approvals, a news report published in the Mint said. The regulator also gave 174 tentative approvals during 2016-17. In comparison, the US FDA had approved 651 generic drugs last year, the latest Activities Report of the Generic Drug Program of the FDA said. Indian companies received a total of 295 product approvals in 2016-17. Amongst them, “the pace of drug approvals was strong for Aurobindo Pharma, Cadila Healthcare and Lupin,” the Mint report added. As per the FDA report, total filings of abbreviated new drug applications (ANDAs) for generic drugs with the US FDA rose to 1,292 in 2016-17 from 852 a year ago. According to analysts, the increasing number of product approvals and filings indicate an increase in competitive intensity in the US, which is a major market for many Indian drug companies. This would also result in more pressure on drug pricing.  

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    12 Oct 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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    Dr. Reddy’s fails EU inspection; Trump disbands business councils after Merck CEO and others quit it over intolerance

    Dr. Reddy’s fails EU inspection; Trump disbands business councils after Merck CEO and others quit it over intolerance

    This week, Phispers brings you the high-pitched drama from President Trump’s American Manufacturing Council, with Merck CEO Ken Frazier leading the pack of CEOs who abandoned it over the Charlottesville unrest, even as J&J’s CEO said he’ll stay on. But then, Trump disbanded the council.   We bring you news on more generic companies in distress due to a drop in their business in the US and compliance problems. Meanwhile, companies like Intas and Aurobindo Pharma from India and Fosun from China are looking for growth via acquisitions. And Softbank has invested US$ 1.1 billion in Roivant. Read on.   Merck CEO’s Trump council resignation over ‘intolerance’ has others follow; council disbanded   The US President Donald Trump’s American Manufacturing Council has been in the news for the last few days. First, Merck CEO Kenneth Frazier resigned from the council, after urging American leaders to reject expressions of ‘hatred, bigotry and group supremacy’ on Twitter. In a statement, Trump had blamed “many sides” for the violence in Charlottesville, Virginia, over the last weekend. A white nationalist rally had turned violent in the city when a car rammed into many people who were protesting peacefully against the demonstration. White supremacists and other hate groups had assembled in the city to protest the removal of a statue of Confederate General Robert E. Lee. Trump has since faced widespread criticism for not specifically denouncing the white supremacists. Following Frazier’s resignation, many CEOs — including Intel Corp’s Brian Krzanich, Under Armour Inc’s Kevin Plank and AFL-CIO chief Richard Trumka — quit Trump’s council over his ‘response to the Charlottesville violence’. Though Frazier said he was taking a stand “against intolerance and extremism”, Trump mocked at him on Twitter, and said he will now “have more time to LOWER RIPOFF DRUG PRICES!” Later, Trump did condemn the hate groups, but it seemed too little to late. Only three weeks back, Trump had called Frazier a “business genius” and a “great, great business leader” and had thanked Merck for investing in American jobs. Frazier is one of the few African-Americans to head a Fortune 500 company. Meanwhile, on Tuesday, Johnson & Johnson’s CEO Alex Gorsky said he isn’t abandoning Trump’s council. In a statement, Gorsky said he’ll stick with the council as a way to express “the values of Our Credo as crucial public policy is discussed and developed.” He said J&J is “an important voice on healthcare.”  However, as the CEO resignations continued to mount, Trump tweeted, “Rather than putting pressure on the business people of the Manufacturing Council & Strategy & Policy Forum, I am ending both. Thank you all!”  Trump made the announcement on Twitter, less than an hour after one of the groups was planning to inform the White House that it would disband, a CNBC report said. Dr. Reddy’s fails EU GMP inspection; can’t export to EU until it clears next inspection   Less than two months after providing positive inspection updates with regard to the status of its manufacturing compliance, Dr. Reddy’s Laboratories (DRL) failed a European cGMP manufacturing inspection last week. The inspection, by the German regulatory authority, at DRL’s FTO 2 finished formulation plant (situated in Hyderabad) uncovered critical deficiencies.  The inspectors concluded that the ‘essential elements of the Pharmaceutical Quality System’ were not effective. Due to this, the plant will not be able to make any further dispatches to the European Union until the next inspection, “to be initiated by an invitation from betapharm,” DRL said in a filing.  Betapharm Arzneimittel GmbH is DRL’s wholly-owned subsidiary in Germany and the Hyderabad plant produces tablets and capsules. Previously, PharmaCompass had observed that the inspection focus of regulators has moved beyond audit trails. In the case of DRL, the inspectors found that out of specification (OOS) results were “systematically invalidated in hundreds of cases”. The integrity of the batch manufacturing/packaging record at the Hyderabad facility was also questioned. The absence of recording “negative events” on the “clean” batch manufacturing records prevented successful investigation into market-complaints. In addition to the integrity of the cleaning being questioned, the design, condition and maintenance of rooms and equipment were also major concerns at DRL. The inspectors found dirty rooms and equipment, along with unsuitable doors and dispensing equipment for manufacturing.    Generics in distress: Sun reports its first loss in 12 years; Mylan cuts forecast   Generic drugmakers have seen their US businesses plummet as the US Food and Drug Administration (USFDA) has stepped up product approvals, ushering in more competition and prompting a steady erosion in prices. As a result, generic drug stocks have been under pressure. Last week, Phispers reported on how Teva Pharmaceutical had reduced its earnings goal. Well, companies like Mylan NV and Sun Pharmaceutical Industries have joined the pack by reporting lackluster quarterly results and cutting guidance. After a gap of 12 years or more, Sun Pharma reported its first quarterly loss last week, after it settled an antitrust case in the US. Sun Pharma paid US$ 148 million (INR 9.5 billion) to plaintiffs including Canadian rival Apotex in July to settle an antitrust lawsuit in the US over sleep-disorder drug modafinil. Sun, which is India’s biggest drugmaker, posted a total loss of US$ 66.3 million (INR 4.25 billion) in the three months ended June 30, 2017. Last week, Mylan also said it is likely to see a decline in its profitability due to delays in the launch of key new drugs and erosion in the prices for generics in the US. Though the FDA is speeding up generics approvals, it’s just not speeding up the ones that Mylan badly needs.  Mylan said it plans to remove copies of big drugs like Copaxone from Teva and Advair from GlaxoSmithKline—from its 2017 guidance, pushing them into 2018. It now expects revenues to hit between US$ 11.5 billion and US$ 12.5 billion for the year, down from a previous range of US$ 12.25 billion to US$ 13.75 billion. Chip Davis, CEO of the Association of Accessible Medicines — a trade group for generic and biosimilar drugs — said some of the (demand-supply) imbalances in the generic marketplace haven’t happened overnight. But the “reality is that the sustainable, robust competitive market is at risk now.” He expects generic drugmakers to continue to feel the pressure, amid declining prices and flat revenues. From June 2016 to June 2017, the number of generic prescriptions is nearly flat, with an increase of only around 1 percent; while revenue is down 12 percent, Davis said. However, one generic company that bucked the trend was Perrigo. It reported US$ 1.24 billion in sales and adjusted earnings of US$ 1.22 per share, topping the consensus for US$ 1.18 billion and 92 cents, respectively. However, this performance too did not come on the back of generics — Perrigo’s generic business declined 13 percent year-on-year. The company performed well due to its consumer business. India’s Intas and Aurobindo, PE player SK Capital and China’s Fosun in acquisition mode   Even during these bad times for generics, some pharma companies are on the prowl. For instance, Ahmedabad-based Intas Pharmaceuticals is on the look out for buying into a larger piece of Israeli-drugmaker Teva’s existing operations in Europe. Last year, it had bought out Teva’s UK and Ireland assets. Intas — with Temasek and Chrys Capital as its investors — is bidding for Teva’s women's health, oncology and pain management divisions in Europe for US$ 1.5 billion. The company has reportedly reached out to several Indian and global banks, such as ICICI, Axis, Citi, Bank of Tokyo Mitsubishi UFJ, HSBC among others, to finalize the financing before putting in a bid by the month-end. If successful, this will be the largest cross-border M&A involving an Indian pharma company.  PharmaCompass has been routinely covering the troubles at Teva, the world’s largest maker of generic drugs. Teva plans to sell off its assets, in order to reduce its US$ 36 billion debt. There is another company that Intas has set its eyes on — Mallinckrodt's US generic business. According to a news report, India’s Aurobindo Pharma and Intas are in the race to buy UK-based Mallinckrodt’s generic drugs business in the US valued at US$ 2 billion. Once complete, this will be the biggest-ever overseas acquisition made by an Indian drug company. The generic business of Mallinckrodt generates sales of around US$ 1 billion. The companies have submitted an initial bid for Mallinckrodt’s generic business, which has been up for sale for the last couple of months. Meanwhile, US specialty drugmaker — Arbor Pharmaceuticals — too is up for grabs. And amongst the bidders for a stake in Arbor are companies like Fosun International Limited’s healthcare business and Shanghai Pharmaceuticals Holding. The two companies are competing to buy a stake of at least 20 to 30 percent, sources said. The holding in the Atlanta-based Arbor could fetch around US$ 600 to US$ 700 million. In the US, SK Capital, a private investment firm focused on specialty materials, chemicals and pharmaceuticals, said it has signed a definitive agreement to acquire Perrigo API, the active pharmaceutical ingredients (API) business of Perrigo Company Plc. The two parties have agreed to enter into a long-term supply agreement for Perrigo API to supply multiple existing commercial and pipeline APIs to Perrigo. The transaction is expected to close during the last quarter of this year. Softbank invests US$ 1.1 billion in Vivek Ramaswamy’s abandoned drug venture —Roivant   Last week, Roivant Sciences announced that Japanese conglomerate — SoftBank Group — is leading a US$ 1.1 billion investment to fund its expansion. SoftBank is the largest private financier in healthcare. Roivant was founded by Vivek Ramaswamy, a 32-year old American entrepreneur who began his career as an investor in the biotechnology sector. Roivant is a holding company with companies like Axovant Sciences and Myovant Sciences under its umbrella, along with private-subsidiaries like Dermavant, Urovant and Enzyyant. According to Endpoints News, SoftBank’s US$ 1.1 billion mega-investment in Roivant won’t likely be its last in biotech. Quoting reports, it says SoftBank group’s global US$ 100 billion equity fund has begun a recruitment campaign for scientists with an eye to backing more companies that use new data technology to identify drugs with solid development potential. Ramaswamy’s business model has relied on therapies that have been taken off the shelves of some big players. Back in December 2014, Ramaswamy had bought an old Alzheimer’s drug that GSK had dropped for US$ 5 million. Six months after purchasing the compound from GSK, and without doing any clinical development, the drug resulted in the biggest biotech IPO ever for Axovant, which got valued at US$ 2 billion. Since then, Ramaswamy has been setting up more companies. Biocon, Mylan suffer another setback as European biosimilar applications are withdrawn   Last month, PharmaCompass broke the story about Biocon’s biosimilar program suffering a serious setback  as a current Good Manufacturing Practices (cGMP) inspection by the French health agency — ANSM — in March 2017 of its drug product site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major. The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine). This week, in a stock exchange filing, Biocon said it has withdrawn the dossier for two of these products. Since the approval of its trastuzumab and pegfilgrastim applications would require a 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 comes two weeks before the FDA is supposed to take a decision on the trastuzumab application. Although Roche’s European patents on Herceptin (trastuzumab) expired in 2014, it is still the third-biggest drug, with 2016 sales of US$ 6.7 billion (CHF 6.8 billion) for the Swiss Group. Until the news of the ANSM inspection surfaced, Mylan and Biocon were expected to be the first to bring a Herceptin biosimilar to market.  

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    17 Aug 2017
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    GSK’s overhaul begins under new CEO; Sandoz loses US$ 940 million lawsuit

    GSK’s overhaul begins under new CEO; Sandoz loses US$ 940 million lawsuit

    This week, Phispers brings you news on GSK, whose new CEO is planning a slew of initiatives to make the British drug giant more competitive. This means more challenges for Luke Miels, AstraZeneca CEO Pascal Soriot’s former deputy who is joining GSK as head of pharma division. Soriot, on the other hand, put all rumors to rest in a memo to his staff. In other news, Donald Trump unveiled a glass vial project that will create more jobs in America. And Teva announced job cuts in Israel. While Momenta-Sandoz lost a case to Amphastar.   GSK overhaul begins under new CEO; AZ’s Soriot puts (Teva) rumors to rest in a memo   Pascal Soriot, chief executive of AstraZeneca, put all rumors to rest and told his staff that he expects to work together with them and see the company succeed. A report in the Israeli media earlier this month had said Soriot was in talks to join Teva. Last week, PharmaCompass reported that Soriot had dropped the offer. Though he did not mention Teva, in a memo, Soriot said: “Together, we are poised to achieve something remarkable and that few thought possible…Nothing can break the momentum you have established, and certainly not rumors.” Soriot is reportedly attending the European Society for Medical Oncology (ESMO) annual meeting in Madrid in September, in case AstraZeneca has its clinical data on its new immunotherapy medicine ready to present at the event. Meanwhile, Soriot’s deputy, Luke Miels, is joining GlaxoSmithKline as head of its pharma division. And if news reports are to be believed, employees are going to need courage to work under the Emma Walmsley, the new CEO of the British drug giant. Walmsley is looking for ways to make GSK more competitive. And in order to achieve that, she is pushing some functions and a lot of accountability into GSK’s three divisions. Their leaders will own the successes, as well as any failures. According to news reports, GSK is selling its Horlicks brand in the UK, shutting the Slough plant where the malt drink is made and is abandoning a proposed US$ 457 million (£350 million) biopharmaceutical manufacturing plant in Cumbria.  Walmsley also wants to improve drug research productivity, and wants GSK to have fewer but potentially more lucrative new drug launches in the future. GSK is planning on scrapping more than 30 drug development programs and will focus 80 percent of its R&D budget on the top candidates in four therapeutic areas and potentially exit the rare disease space. Momenta-Sandoz lose case to Amphastar; AbbVie to pay US$ 150m in damages   In the US, Amphastar Pharmaceuticals won a case in a federal court against Momenta Pharmaceuticals Inc and its partner Novartis AG’s Sandoz unit. The two had sought nearly US$ 940 million in damages against Amphastar. Momenta and Sandoz had filed the lawsuit in 2011 after the US Food and Drug Administration (USFDA) had approved Amphastar’s generic version of Sanofi’s blockbuster Lovenox, an anticoagulant used to treat and prevent blood clots. The two companies had accused Amphastar of infringing on a patent held by them, through the production of a generic version of the blood-thinner Lovenox. In a statement, Momenta CEO Craig Wheeler said the company was disappointed and was considering its options, including a potential appeal. “We continue to believe in the importance of investing in innovative techniques for bringing products to market and protecting those innovations from unauthorized use,” he said. Momenta and Sandoz suffered a major setback earlier this year when Pfizer’s fill/finish manufacturing facility in McPherson, Kansas, received a warning letter from the USFDA. The compliance concern had been initially revealed by Momenta in a press statement as the company, in collaboration with Sandoz, is developing a generic version of Teva’s long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Sandoz had tied up with Pfizer as its fill/finish manufacturing partner. Copaxone generated US$ 4.22 billion in sales last year. Meanwhile, a federal jury in Chicago found AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug — AndroGel. The jury ordered AbbVie to pay US$ 150 million in punitive damages. A lawsuit had been filed in 2014 against AbbVie by Jesse Mitchell and his wife. The decision in the Mitchell case is the first in a series of test trials aimed at helping plaintiffs and manufacturers of AndroGel assess the range of damages and define a legal strategy and settlement options for such trials. The jury said AbbVie was not “negligent or strictly liable” for a heart attack Mitchell suffered after taking AndroGel. However, it said AbbVie falsely marketed the drug. And, it did not award Mitchell compensatory damages for his injuries and losses. Trump unveils glass vial project that is likely to create 4,000 jobs in the US   Last week, the US President Donald Trump announced an initiative to manufacture a new kind of glass for injectable drug vials. Corning Inc is making a US$ 500 million investment along with pharma giants Merck and Pfizer to manufacture these vials, which are likely to create nearly 1,000 jobs at facilities in New York and New Jersey and another ‘yet to be announced’ site in southeastern USA. This initiative was part of Trump's ‘Made in America’ week, during which he showcased America-made products. Trump also defended his administration’s ‘America First’ policies. He was joined by the CEOs of Corning, Merck and Pfizer. Trump said the deal could eventually result in a total investment of US$ 4 billion and create around 4,000 jobs. “This initiative will bring a key industry to our shores that for too long has been dominated by foreign countries. We’re moving more and more companies back into the United States,” Trump said. According to Trump, the glass is called Valor Glass and is a “substantial improvement” in quality over existing products. It has superior strength and is more damage-resistant. In Israel, Teva pulls out the job axe; Japan’s Mitsubishi Tanabe buys Neuroderm   Teva Pharmaceutical Industries recently announced that it is beginning negotiation with the labor groups in Israel. It is expected to cut 300 to 350 workers and managers at production sites in Histadrut and Ramat Hovav in the coming months. This move will be yet another step towards Teva’s restructuring and business focus, aimed at bolstering the competitiveness of its sites in Israel. Post this announcement, Histadrut called a work dispute, which will permit employees to strike in 14 days time. Teva currently has 7,000 employees in Israel. Histradrut spokesman Yaniv Levy said: “We will not accept any unilateral measure in which workers are laid off at Teva. We expect the company’s management to act responsibly, and not to involve Teva’s plants in Israel in a series of conflicts that will escalate labor relations.” Meanwhile, Japan's Mitsubishi Tanabe Pharma has agreed to buy Israeli drug maker Neuroderm for US$ 1.1 billion in cash as part of a strategy to grow its business in the US. Mitsubishi Tanabe said it is particularly attracted by Neuroderm’s Parkinson’s disease drug that is in advanced clinical trials in the US and Europe and is likely to be launched in 2019. A minor molecule twist could be the solution to cancer that killed Steve Jobs   Last week, a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs got a nod from the European Medicines Agency (EMA), boosting prospects for its developer — Advanced Accelerator Applications (AAA). The EU drugs regulator said its Committee for Medicinal Products for Human Use (CHMP) had recommended the product — Lutathera (lutetium 177 dotatate). This emerging treatment targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The drug is likely to get a full approval in the coming two months. Stefano Buono, chief executive officer of AAA, said the company was also ready to re-file its application for US marketing approval with the USFDA this month. This French biotech company has described the new drug as a “multi-hundred million” dollar opportunity. Lutathera has the potential to transform AAA’s fortunes. Buono’s AAA, which was spun off from Europe’s physics research centre CERN 15 years ago, had sales from existing diagnostic products of US$ 34.9 million in the first quarter of 2017. Lutathera is unusual in harnessing the same molecule that is already used to diagnose cancer to also deliver treatment. After Celgene, Cardinal Health pulls out of China due to regulatory concerns   After Celgene decided to reduce its footprint in China earlier this month, in order to support only its clinical development and regulatory affairs activities in the country, this week we heard about US drug distributor Cardinal Health putting its China business on the block. As per news reports, state-backed Chinese pharma companies have evinced interest in a deal that may be worth up to US$ 1.5 billion. Shanghai Pharmaceutical, China Resources Pharmaceutical, and Sinopharm are among those evincing interest in buying Cardinal Health, one of China’s largest drug distributors. Ohio-based Cardinal wants to exit the country due to concerns around China's upcoming drug distribution reform, which is likely to slow down its growth. Cardinal has also been diversifying — in April it announced a US$ 6.1 billion deal for Medtronic Plc’s medical supplies units. It has reportedly hired Lazard as an adviser for the China sale and the first round of bidding is due later this week.Meanwhile, Celgene is offloading its Chinese operations to the biopharmaceutical major Beigene. It is also giving Beigene the rights to Abraxane, Revlimid and Vidaza in China. This way, Beigene will assume responsibility for making and selling the approved drugs, along with Celgene’s pipeline prospect CC-122 in China. Celgene had also announced that it would buy a stake in BeiGene to help develop and commercialize the China-based cancer immunotherapy developer's treatment for solid tumor cancers, expanding its position in the field of immuno-oncology. When the deal closes in the third quarter of this year, Beigene will instantly become a commercial-stage biotech.  

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    27 Jul 2017
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    FDA problems at Pfizer’s US facility continue; China FDA joins ICH

    FDA problems at Pfizer’s US facility continue; China FDA joins ICH

    This week in our compliance round up, we look at the continuing problems at Pfizer’s McPherson unit in the US and China FDA’s entry into the ICH as a regulatory member. Yet again, WHO sources API from a plant in China, where USFDA had raised data integrity concerns. Meanwhile, Aurobindo Pharma’s Unit VII clears FDA inspection with zero observations.   Problems continue at Pfizer’s US facility; its sure-shot biosimilar gets rejected   Earlier this year, Pfizer’s fill/finish manufacturing facility in McPherson, Kansas, received a warning letter from the US Food and Drug Administration (USFDA). The compliance concern was initially revealed in a press release issued by Momenta Pharmaceuticals — a biotechnology company developing a generic version of Teva’s long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Momenta is working in collaboration with Sandoz, which in turn has tied up with Pfizer as its fill/finish manufacturing partner. This week, a month after the FDA staff found that Pfizer’s biosimilar of Amgen’s drug Epogen (epoetin alfa) was nearly identical and an FDA advisory committee followed to recommend approval with a 14-1 vote, the FDA issued a complete response letter (CRL) to Pfizer. The letter cited concerns which had already been raised in the warning letter issued on February 14, 2017, following a routine inspection of the facility. This development continues to be positive news for Teva, as Copaxone generated US$ 4.22 billion in sales last year. Continued compliance concerns at Pfizer indicate that Momenta will still have to wait for its generic to get approved. While previous FDA inspections at the McPherson facility had raised concerns over the assurance of product sterility, no warning letter had ever been issued to this site. In February 2015, Pfizer acquired the McPherson site through its US$ 17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the deal, as the company was issued FDA warning letters in four of the seven continents — Europe, North America, Asia and Australia.  Once again, WHO sources API from Chinese firm where FDA had raised concerns   Three weeks after PharmaCompass shared the differences in assessments of the World Health Organization (WHO) and the USFDA over the observations at a Mylan finished formulation site in India, a similar situation has arisen at an active pharmaceutical ingredient (API) facility in China. 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 cGMP (current good manufacturing practices) for APIs. In the warning letter issued to the firm, the laboratory analysts admitted to 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 the import alert by the USFDA. 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 concluded with “five major deficiencies including data integrity issues and several minor deficiencies”. The WHO went ahead and closed their 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 in the case of Mylan, the WHO approach towards the compliance position has been to focus extensively on product quality.  The WHO has requested manufacturers that use levonorgestrel manufactured by Qinhuangdao Zizhu to take “additional measures such as comprehensive testing upon receipt” to help ensure that the quality of all batches of levonorgestrel is assured. In addition, the WHO has said that procurement agencies may continue to procure FPPs that contain API produced at Qinhuangdao Zizhu Pharmaceutical, until further notice. The WHO-PQT is planning to conduct an on-site inspection of Qinhuangdao Zizhu Pharmaceutical and also plans to work with finished pharmaceutical products manufacturers to identify additional sources for levonorgestrel. China FDA approved as an ICH member   In a major boost to China’s pharmaceutical growth plans, the International Council for Harmonization (ICH) Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member. This decision was taken during a meet in Montreal, Canada, from May 31 to June 1, 2017. While compliance concerns linger over some pharmaceutical factories in the country, China’s acceptance of this membership indicates that the country is prepared to bring its drug manufacturing and testing practices in line with international quality standards. ICH was created in 1990 to bring regulatory authorities and the pharmaceutical industry together in order to discuss scientific and technical aspects of drug registration. Over the last 25 years, ICH has worked on achieving greater global harmonization so that safe and effective drugs are developed and registered in the most resource-efficient manner. In India, Aurobindo’s Unit VII gets zero observations; Lupin founder passes away    Indian pharmaceutical industry lost a veteran this week. Desh Bandhu Gupta, the founder chairman of Lupin and a self-made billionaire, died in Mumbai at the age of 79. Five years back, he had handed over the reins of Lupin to his eldest daughter Vinita Gupta and son Nilesh Gupta. Desh Bandhu Gupta, or DBG as he was known, was a deft businessman who founded Lupin in 1968 with just Rs 5,000 borrowed from his wife. Prior to this, he was the professor of chemistry at the Birla Institute of Technology and Science, Pilani. He went on to become India’s 20th richest person with an estimated net worth of US$ 5.1 billion (according to the 2016 Forbes India Rich List).    While much of the industry abandoned making anti-TB drugs, given the low margins and the government's price controls, Lupin remained consistent as the world’s largest supplier of anti-TB drugs. DBG forged global alliances to develop new medicines to fight tuberculosis.  Meanwhile, another Indian company — Aurobindo Pharma — sailed through a USFDA inspection with zero observation. Aurobindo Pharma’s Unit VII is a formulations manufacturing facility and one of the largest facilities for the company from which has filed the maximum ANDA applications to the FDA. According to a recent company presentation to investors, the company has filed 158 ANDAs (abbreviated new drug application) from this facility, of which 88 drugs received final approvals and 20 drugs have tentative approvals and 50 are currently under review.  

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    29 Jun 2017
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    Does the FDA promote European manufacturers over others? The ice-bucket challenge winner!

    Does the FDA promote European manufacturers over others? The ice-bucket challenge winner!

    This week, Phispers brings you a short analysis on how FDA might be promoting European drugmakers over others. There is also news on how India plans to set up a drug audit office in China to check quality of APIs coming from there. Besides, there is news on lawsuits against J&J, a report on drug spends in the US and updates on new drug trials and approvals.   Does the FDA promote European manufacturers over others?   Does the US regulator have more faith on European manufacturers over those based in India and China? Recent news reports seem to suggest it does. Thomas Cosgrove, the Director of the Office of Manufacturing Quality (OMQ) within US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) spoke at the Food and Drug Law Institute's annual conference last week. Cosgrove directs CDER’s compliance activities with respect to current good manufacturing practice (cGMP) and product quality. In the coverage provided by RAPS, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers.  “If any firm in the supply chain falls down, the supply chain itself can fall down. This is a very real risk," Cosgrove said, noting that the agency can reject applications for drugs over good manufacturing practice (GMP) issues. He further said: “You're pretty confident that those European companies you're dealing with have a strong culture of quality and can perform pretty consistently," But, like in other parts of the world, these companies might not have a deep experience with how the US regulations work or even how to deal with the FDA, and may not have been inspected by the agency before, he added. Cosgrove’s comments come at a time when a compilation by Barbara Unger on FDAZilla.com highlighted that the warning letters issued due to data-integrity concerns to firms in US and Europe (13 total) were more than those issued to firms in India (9) and almost equivalent to firms in China (14). There have also been other examples where inspection data highlights a difference in inspection outcomes for the same facilities. PharmaCompass had recently covered the US and EU’s efforts to utilize each other’s GMP inspections, and how such a dependence maybe problematic. While FDA has stepped up its inspections of foreign drug manufacturers in recent years, there are more than 1,000 foreign drug facilities the agency has never inspected. India to restart inspection of Chinese API manufacturers   India is cracking the whip on quality and will restart inspecting drug manufacturing facilities in China soon, in order to ensure only quality active pharmaceutical ingredients (API) are imported from countries like China. “In the light of the fact that India has faced repeated scrutiny of its manufacturing facilities in the name of quality medicines, the commerce ministry along with other concerned ministries are serious to set up a permanent audit office in China to conduct inspections on a regular basis in China,” G N Singh, Drug Controller General of India, said. The plan to set up a drug audit office in China for inspecting manufacturing units there is not new. It has been in the pipeline for the past three years, as the project is awaiting approval from several ministries in both India and China. India’s health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products. The ice-bucket challenge winner! First new treatment approved by the FDA for ALS in 22 years   Last week, the US FDA approved Radicava (edaravone) — a drug to treat patients with the rare amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease. ALS is a progressive disease that attacks and kills the nerve cells that control voluntary muscles. Eventually, the brain’s ability to start and control voluntary movement is lost, and the patient succumbs to the disease — usually after three to five years from the onset of the symptoms. Around 12,000-15,000 Americans are said to have ALS. Most people with ALS die from respiratory failure. British physicist Stephen Hawking is suffering from ALS. An “ice bucket challenge” conducted in 2014 drew global attention back to ALS. The challenge involved people pouring ice-cold water over each other’s heads, and posting a video on social media, seeking funds for research on the condition. Edaravone is an intravenous drug. The drug is being sold in Japan and South Korea by Mitsubishi Tanabe Pharma Corp. The company is selling the drug at US$ 145,000 per year. In the US, the last drug approved to treat this disease was Riluzole in 1995. However, the drug isn’t a cure for ALS, it only delayed the need for a breathing tube. Six months of treatment with edaravone reportedly reduced the rate of functional decline in patients by about a third. Another bad week for Teva — its new MS drug fails to meet primary endpoint   Teva’s bad days don’t seem to relent. Last week, it’s late-stage trial for laquinimod — considered a successor to the aging flagship multiple sclerosis therapy Copaxone — failed the test on the relapsing-remitting form of the disease. The drug did not meet the primary endpoint, trying to significantly improve the time to disability progression compared to placebo after three months. Teva’s laquinimod was heralded as its brightest pipeline prospect. Investigators are still testing this drug for primary progressive MS and Huntington’s disease. But due to this failure, it’s unlikely that analysts will ascribe much potential value to the drug.  Early last year, Teva (which had partnered with Active Biotech) was forced to suspend use of the highest dose of laquinimod due to cardio side effects. Despite this setback, Teva was hopeful of a win with the lower doses and was preparing for a launch after completing studies this year. Trump administration gets FDA to switch TVs from CNN to Fox News   The Trump administration is ensuring researchers at FDA view the media of its choice. This week, CBS News confirmed an email was sent to researchers at the FDA's Center for Biologics Evaluation and Research to change the channel on internal television screens from CNN to Fox News. CNN and Donald Trump have been feuding for several months now. On May 2, CNN had refused to air an advertisement issued on 100 days of Trump administration, that called mainstream media “fake news” — a term frequently used by the president.  The email from “[White Oak] Digital Display” sent on Wednesday, May 3, was sent to inform the researchers of the “reason for the change from CNN to Fox". White Oak is the name of the FDA’s campus. The email informs employees that the decision came from the Trump administration. “The reason for the change is that a decision from the current administration, administrative officials has requested that all monitors, under our control, on the White Oak Campus, display FOX news,” the email reads. People are paying less for drugs, says IMS Quintiles report While there is widespread outrage in the US over soaring drug prices, a new study by QuintilesIMS Institute shows people are, on an average, actually paying less for their medications than they did a few years ago. QuintilesIMS Institute is a research organization that specializes in healthcare analysis. The report is independent, and did not receive industry funding. While drug prices are on the rise with net prices rising 3.5 percent last year, patients’ out-of-pocket costs for medicines have declined — from US$ 32 per name-brand prescription in 2013 to US$ 28 today, the study said. “The outlook for medicine spending through 2020 is for mid-single digit growth driven by further clusters of innovative treatments, offset by a rising impact from brands facing generic or biosimilar competition,” says a QuintilesIMS report titled ‘Medicines Use and Spending in the U.S. – A Review of 2015 and Outlook to 2020’. However, this isn’t the only report that shows this counterintuitive pattern of declining out-of-pocket costs. A Peterson-Kaiser Health System Tracker report last year found a slight decline in patients' personal spending on prescriptions, even as the overall costs increased. Mixed week for J&J, as it loses talc verdict and wins Xarelto case   Last week was a mixed week for Johnson & Johnson (J&J). On the one hand, the St. Louis jury ordered Johnson & Johnson to pay US$ 110 million to Lois Slemp, a lady who claimed several decades of using talc products caused her ovarian cancer that later spread to her liver. On the other hand, J&J won a bellwether case last week over the alleged risks of its blockbuster drug, Xarelto. The Slemp trial lasted several weeks and had Slemp’s attorneys call upon scientists to testify studies documenting a link between ovarian cancer and talc use. Slemp’s attorneys also presented documents showing that J&J knew about the risks. J&J, however, said it will appeal against the verdict.  A company spokesperson said a previous victory (for J&J) in St. Louis and two in New Jersey “highlight the lack of credible scientific evidence behind plaintiffs’ allegations." In the other case, a US court (the federal jury in New Orleans) cleared Bayer AG and J&J of liability in the first trial emanating from thousands of lawsuits that blamed injuries on the blood thinner Xarelto. “The jury's verdict affirms both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Bayer said in a statement. Rivaroxaban's total 2016 sales were $ 5.392 billion.  

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    #Phispers by PHARMACOMPASS
    11 May 2017
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    Pfizer’s US facility receives a warning letter, as Baxter’s cGMP deficiencies result in multi-million dollar legal settlement

    Pfizer’s US facility receives a warning letter, as Baxter’s cGMP deficiencies result in multi-million dollar legal settlement

    Within two months of 2017, we have already seen several pharmaceutical companies come under the regulatory lens and face action. This week, PharmaCompass does a compliance recap, wherein companies like Pfizer saw lapses in their current good manufacturing practices (cGMPs) and companies in India, like Dr. Reddy’s and Cadila Healthcare, who received warning letters in the past, were busy with regulatory re-inspections at the erring sites. Pfizer’s US facility receives a warning letter from the FDA   Pfizer’s fill/finish manufacturing facility in the United States recently received a warning letter from the US Food and Drug Administration (USFDA). This information was revealed in a press release issued by Momenta Pharmaceuticals a biotechnology company developing a generic version of Teva’s long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Momenta’s Glatopa 20 mg/mL product is already available in the US market and is promoted by Sandoz, which in turn has contracted the fill/finish manufacturing operation to Pfizer’s facility in McPherson, Kansas.  In February 2015, Pfizer acquired the McPherson site through its US $17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the deal to buy the drugmaker as the company was issued FDA warning letters on four of the seven continents Europe, North America, Asia and Australia. While previous FDA inspections at the McPherson facility had raised concerns over the assurance of product sterility, no warning letter had ever been issued to this site. This has been the first positive news for Teva this year, after a series of setbacks. Copaxone had generated US $ 4.22 billion in sales last year. And as per Momenta’s press statement, “Glatopa 40 mg ANDA (abbreviated new drug application) remains under regulatory review.” While Momenta says it is working with Sandoz to resolve the matter, it is of the view that “an approval in the first quarter of 2017 is unlikely.”  “Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20 mg (glatiramer acetate injection) product,” Momenta stated in its press release. The Pfizer warning letter will also be welcome news for Mylan as it had recently won a court ruling where four Orange Book-listed patents relating to Copaxone® 40 mg/mL were invalidated based on obviousness. Mylan has “filed a substantially complete ANDA” for a three times per week Glatiramer Acetate Injection 40 mg/mL. Baxter’s cGMP deficiencies result in US$ 18 million settlement   Last month, Baxter International and Baxter Healthcare Corporation settled a type of civil lawsuit that whistleblowers are known to bring. It was settled under the False Claims Act (FCA) case with the Department of Justice (DOJ) for US$ 18 million. The settlement in which there was neither an admission of liability by Baxter nor a concession by the United States that its claims are not well founded was an outcome of the government alleging that Baxter submitted false claims for a drug sold to the Department of Veterans Affairs and Department of Defense, as well as reimbursed by the Medicare and Medicaid programs, because the drug was “adulterated.” A detailed blog written by Stephanie Trunk and Emily M. Leongini highlights that the issue emanated from the “presence of visible mold on HEPA filters installed above the clean rooms” where Baxter manufactured sterile intravenous (IV) solutions. The managers at Baxter prevented the relator and others from removing the moldy filters and from cleaning or sanitizing other associated contaminated surfaces, says the complaint.  This handling of the moldy filters by Baxter allegedly violated numerous cGMP requirements set forth in the FDA regulations. This includes the requirement that a manufacturer establish, and also follow, its own internal standard operating procedures. While the government acknowledged that there was no evidence to suggest that Baxter’s IV solutions had been impacted by the moldy filters, it alleged that the IV solutions violated the FCA because of “Baxter’s failure to comply with cGMP requirements.”  In the past, cGMP violations have had the DOJ collect US$ 750 million from a GSK subsidiary in 2010 and US$ 500 million from Ranbaxy in India in 2013. With an increasing trend of warning letters being issued by the FDA to pharmaceutical manufacturers, it remains to be seen if DOJ will further “highlight the materiality of cGMP compliance to product purchases in support of FCA claims”.  Zydus turns around compliance problems with a zero 483 inspection   Zydus’ Moraiya (Gujarat, India) facility accounted for 60 percent of Cadila’s revenues in the US, its largest market. In an inspection performed by the FDA in September 2014, the investigators found that in 2013, Cadila had failed to adequately review 106 consumer complaints (out of 106 complaints received) and in 2014, up to the date of the inspection, they failed to adequately review another 132 consumer complaints (out of 132 complaints received). While at the time of the inspection, Cadila had already taken the decision to recall products like Warfarin 2 mg (due to oversized tablets), Promethazine 25 mg (due to mixed tablets in the same bottle) and Atenolol 25 mg (due to “thicker appearance”), the inspectors got “no assurance” that the quality system at Cadila was under control and stated that the “deficiency appears to be a pattern of problem” at the Cadila site. Zydus received a warning letter from the FDA in December 2015. Last week, Zydus announced that it did not receive any observations from the USFDA for its formulation facility at Moraiya, which indicates a successful resolution of the compliance at the plant. The company said that the USFDA inspected the plant from February 6 to 15. What’s next at Dr. Reddy’s and Marksans in India?   Marksans Pharma, a company with a questionable compliance track record, saw its manufacturing facility in Goa (India) fail an inspection by the UK drug regulator last year. The inspectors noted critical data integrity violations which included “evidence of destruction of multiple parts of records of prime data”.  In a filing with the Bombay Stock Exchange (BSE), the company announced that its plant in Goa had an inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) from February 14-17, 2017. The inspection was completed without any critical observations, the company informed. It is now awaiting further instruction from the agency in this regard.  In a similar announcement, Dr. Reddy’s informed the bourses that its Miryalaguda facility has been issued a Form 483 by the USFDA with three observations, which the company is addressing. The audit of the company’s API manufacturing plant at Miryalaguda by the USFDA was completed on February 21, 2017.  Back in November 2015, the same facility had received a warning letter after FDA inspectors found partially-filled documents in the garbage. Our view   Over the past years, we have seen compliance concerns being raised time and again at pharmaceutical manufacturing operations. Last week, Sato Pharmaceutical, a company established in 1939 in Japan, received a warning letter from the FDA as it failed to establish an adequate system for monitoring the conditions of its cleanroom environments. Prior to that, FDA’s April 2016 inspection of ACS Dobfar’s operations in Brazil Antibioticos do Brasil (ABL) led to the issuance of a warning letter after the FDA investigators found that the filling zone for sterile injectable product was not sufficiently robust. While data integrity concerns dominated news headlines last year, it seems that aseptic fill/finish may become a leading cause of concern with regulators. It’s clear that manufacturing can no longer be taken for granted as companies of all sizes are suffering economically from their inability to comply with good manufacturing practices.  

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    #Phispers by PHARMACOMPASS
    23 Feb 2017
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    Teva CEO steps down; FDA Warning Letters to firms in Japan, India & China

    Teva CEO steps down; FDA Warning Letters to firms in Japan, India & China

    This week, Phispers highlights more bad news for Israeli drugmaker Teva, along with news on the ‘overwhelming efficacy’ of blood thinner Rivaroxaban over Aspirin, Sanofi’s plans to resubmit its application for Sarilumab, Denmark’s entry into the tug of war for hosting the EMA headquarters and are routine round up of global non-compliance concerns.   Teva CEO steps down, as another bribery probe emerges and discussions of a split start   The chief executive of Teva Pharmaceutical Industries, Erez Vigodman, stepped down after serving for three years. He has been replaced by Chairman Yitzhak Peterburg for the interim period. Teva is the world's biggest maker of generic drugs. In the last five years, he is the third CEO to vacate the position. A sudden change in the company’s leadership came just two months after the resignation of Sigurdur Olafsson, the former head of Teva’s main business unit — generic medicines. Both the executives played an important role in Teva’s US $ 40.5 billion purchase of Actavis Generics last year, touting it as a move that would provide growth. Instead, the acquisition led to more bad news. In a short statement after leaving, Vigodman stated: “I believe that now is the right time for me to step down. It has been a privilege to lead Teva, and I am proud of all we have accomplished. I am confident that the company’s future is bright.” A lot of bad news has already piled up for Teva’s investors since the New Year. This includes the following negative events: The market is criticizing Teva’s acquisition of Actavis (Allergan’s generics division) for US $ 40 billion in cash and shares.   Teva’s acquisition of Mexican company Rimsa proved to be a catastrophe. Rimsa's plants are now shut down.   Apart from the bad decisions over acquisitions, Teva is also involved in two legal wrangles. One was a case of bribery in developing countries, in which Teva agreed to pay US $ 519 million to US authorities after paying bribes to officials in Mexico, Ukraine and Russia to boost sales. Another legal issue involves the investigation of Teva over bribe allegations by Israeli authorities which came up a day after Vigodman stepped down.   A US district court ruling invalidated four patents out of five on its top seller — the multiple sclerosis drug Copaxone. The ruling, issued in late January, may open the door to generic competition (Novartis and Mylan) for thr drug that generates a fifth of Teva’s US $ 20 billion in annual sales.   In the company’s own words: “New products stemming from that asset (Copaxone) would be unexpectedly delayed, while prices of its copycat medicines are likely to remain under pressure in the US, prompting a cut to its 2017 profit forecast.” Following the resignation, at the company's earnings call earlier this week, analysts started asking if Teva would consider a split-up? FDA issues Warning Letters to Indian, Japanese & Chinese firms   Sato Pharmaceutical, a company established in 1939 in Japan, received a warning letter from the FDA as it failed to establish an adequate system for monitoring the conditions of its cleanroom environments. Following the inspection, the firm revised its standard operating procedure related to the “Aseptic Production Area”, however, the FDA found the response to be deficient. FDA inspectors also uncovered that the company had not performed the necessary smoke studies to evaluate air flow characteristics of its open Restricted Access Barrier System (RABS). The company released sterile products manufactured on the aseptic processing line, without studies to demonstrate unidirectional airflow over the exposed sterile product during processing. Although, Sato renovated its RABS to use a closed design and conducted validation studies, the response was found deficient as it does not address the quality of the products which had already been released to the U.S. market using the original open RABS design. An active pharmaceutical ingredient (API) manufacturer in India, Resonance Laboratories Private Limited also received a warning letter from the FDA as the inspectors raised concerns over the facilities water systems and cleaning validation methods. The FDA found that the firm’s response to the inspection observations had failed to perform a retrospective review of CGMP deficiencies on the quality of the products which had already been distributed within the United States. PharmaCompass had shared the news about the compliance troubles at Resonance in November, 2016. The FDA also issued warning letters this week to two Chinese firms who had been placed on its Import Alert list last year. The warning letters sent to Ausmetics Daily Chemicals (Guangzhou) Co., Ltd. and Zhejiang Bangli Medical Products Co., Ltd. showed that the companies failed to sufficiently test the batches of the final product they produced and did not adequately confirm the quality of the incoming active raw materials. Bayer’s Rivaroxaban shows 'overwhelming efficacy' over aspirin   Back in 1897, a young scientist at a Bayer laboratory in Wuppertal, Germany — Dr. Felix Hoffmann — synthesized a chemically pure and stable form of acetylsalicylic acid (ASA), which became the active ingredient in Aspirin™.  Since then, Aspirin has been an important medicine due to its remarkable pain relief, as well as cardiovascular (CV) event prevention properties. The medicine has truly stood the test of time. Last week, Bayer AG and its development partner Janssen Research & Development announced the successful outcome of a large-scale Phase 3 study -- COMPASS, involving 27,402 patients, that assessed the effect of blood thinner Xarelto (rivaroxaban) in preventing major adverse cardiac events (MACE). The trial was scheduled to finish next year but was stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE — which includes cardiovascular death, myocardial infarction and stroke —reached its pre-specified criteria for superiority over aspirin.  The drug could potentially be used on 30 million patients with coronary artery disease (CAD) and peripheral artery disease (PAD), in addition to the roughly 25 million patients it sees in the atrial fibrillation market, says Bayer. Xarelto is currently the only non-vitamin K antagonist oral anticoagulant (NOAC) currently under assessment in this high-risk patient population. The drug is already on the market for reducing the risk of stroke and blood clots. Sanofi fixes problems in French plant, to resubmit application for Sarilumab   In 2014 and 2015, while reviewing new drug applications, the US Food and Drug Administration (FDA) had raised manufacturing questions in only one Complete Response Letter (CRL) sent to the applicant. However, by mid-December, 2016 “an astonishing 40 percent were specifically tied to questions the agency raised about the manufacturing capabilities of a drugmaker or its contractor.” Manufacturing issues derailed sales forecasts through new drug approvals of Sanofi, AstraZeneca, Valeant, Bristol-Myers Squibb, Pfizer and many others. In October 2016, Sanofi received the FDA’s Form 483 for it’s Le Trait facility in France since manufacturing deficiencies were discovered during a routine good manufacturing practice (cGMP) inspection where Sarilumab and Dupilumab are manufactured. This plant is involved in one of the last steps in the manufacturing process of Sarilumab — an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderate to severely active rheumatoid arthritis (RA) which is a combined program of Sanofi and Regeneron. Due to the manufacturing issues, FDA issued a CRL  regarding the Biologics License Applications (BLA) for Sarilumab. Sarilumab is said to become a blockbuster after beating the world’s best-selling drug AbbVie's Humira (adalimumab) in a head-to-head trial. Analysts have previously predicted the drug could bring in more than US $ 1 billion by 2020. In response to the letter received from the FDA, the French company has filed a comprehensive corrective action plan with the FDA and is “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market. In January 2017, Sanofi and its drug development partner Regeneron Pharmaceuticals said they have resolved manufacturing defects at Le Trait facility, which caused the delay for the approval of Sarilumab drug. Sanofi’s CEO Olivier Brandicourt said: “We worked closely with the US FDA to implement a corrective plan and got positive feedback". Assuming the formal inspection will also play out positively, the companies have decided to resubmit their application for Sarilumab by the end of March. Denmark officially bids for relocation of EMA head office   The future location of the European Medicines Agency (EMA) — one of the regulatory jewels of the EU — has been a consistent topic of conversation since the outcome of the Brexit vote.  The intervention of the Japanese government in early September 2016 brought the EMA issue further into the open when a 15-page letter came up where Japanese officials told their counterparts in the UK that if “the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D funds and personnel to Continental Europe.” And now, Denmark is also in the list of countries that are bidding for EMA headquarters’ relocation. Copenhagen’s candidacy launch on February 8 comes in the wake of similar launches by Amsterdam, Milan, Stockholm, Barcelona and Dublin. Only the Czech Republic and Estonia have ruled themselves out, according to the Financial Times. Therefore, we may see a 20-way tug of war amongst cities that want to host the EMA. The Danish Medicines Agency is excited about the Danish government’s decision. Thomas Senderovitz, Director General of the Danish Medicines Agency, said: “The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life science cluster. Major international pharmaceutical companies have a presence in Copenhagen, and we offer a strong administration and unique culture for collaboration between the health sector and universities in Denmark and southern Sweden”. As the news came out, healthcare giant Novo Nordisk backed and supported the decision of the Danish Government. India’s Strides plans to spin off API unit   Just two months after Perrigo agreed to sell its entire shareholding in Perrigo API India to Strides for INR 1000 million (US $14.8 million), Strides announced an organizational restructuring plan. As per the plan, Strides has decided to move away from its business-to-business (B2B) model to a business-to-consumer (B2C) model, which includes de-merging and listing its APIs business, exiting probiotics and capping its investment in the biotech business which was also approved by SeQuent Scientific, which bought into Shasun several years ago. SeQuent also has a veterinary drug business. Strides Shasun plans to rename itself as Strides Pharma. Post restructuring, the new Strides Pharma will comprise its retained formulations business having four US FDA-approved plants in India, Europe and Singapore, and three research and development (R&D) centers. This business will have a front-end presence in the regulated markets of Australia, US and the UK and emerging markets of Africa and India. Last year, Strides Shasun had mentioned they plan to hive off its commodity focused API manufacturing unit as a separate business. Strides — with two API manufacturing facilities, one in India and one in the UK — is a global supplier of painkiller (Ibuprofen), anti-epileptic medication (Gabapentin) and anti-acidity medication (Ranitidine). Strides had said that it would retain API capacities required for captive use while setting up a separate company for manufacturing low-margin APIs such as Ibuprofen, Gabapentin and Ranitidine.  

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    16 Feb 2017
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    China shuts plants of major antibiotic producers to fight pollution; more troubles for Teva

    China shuts plants of major antibiotic producers to fight pollution; more troubles for Teva

    This week, Phispers has lots on generics. While the global leader Teva has more troubles at hand, generic players in the US face fresh lawsuits, and Sanofi plans to sell its European generic unit. There is also talk of Novartis buying America’s generic-drugs maker Amneal. In other news, oncologists find problem with clinical trials, and China shuts plants to curb pollution  Teva braces declining sales, lawsuits and closure of its Mexico plant There is more bad news from Israel’s Teva Pharmaceutical Industries. First, its Rimsa plant in Mexico is said to be shut, and a lot of employees have been (reportedly) laid off. As per a news report, it’s difficult to make the Rimsa plant operational anytime soon. Teva had invested US $ 2.3 billion in the facility. There are reports that the company may make a write-down on its investment in Rimsa. In September, the global leader in generics had claimed that the Espinosa brothers, who had controlled Rimsa until its sale to Teva, had deceived the regulatory authorities and patients for years and sold defective and illegal drugs. Teva’s troubles don’t end there. The company is also setting aside US $ 520 million in its bid to settle allegations of paying bribes in Russia, Mexico and Ukraine. In its latest earnings report released Tuesday, Teva noted that “advanced discussions” are under way with the federal courts in the US to resolve the incidents, which took place between 2007 and 2013. Teva has completed 12 acquisitions worth US $ 46 billion in the last four years. Teva’s blockbuster Copaxone, which brings in 19 percent of its overall sales, has lost several patent challenges in the US and is likely to face generic competition early next year, putting more than US $ 4 billion in sales at risk. Even without a generic competitor, sales declined 2.2 percent year-on-year in the third quarter this year.   To control pollution, north China industrial hub curbs drug production If you live in Delhi, and are coping with the hazardous pollution levels, here’s something that will interest you. A wide-ranging ban has been imposed in a northern Chinese industrial hub on production at drug plants, steel mills and other businesses. This is a last-ditch attempt by the government of Shijiazhuang city to meet this year’s pollution control target — to reduce the levels of PM 2.5 (fine particles that pose a risk to human health) by 10 percent. Shijiazhuang is the capital of the northern Hebei province, which reported economic growth of 6.8 percent in the first three quarters of this year. Last week, the government of Shijiazhuang city said for the remaining 45 days of the year, it will curb output at thermal power plants, halt all production at industries such as steel and cement, and limit manufacturing of pharmaceuticals, chemicals and even furniture. In 2014, President Xi Jinping had responded to public outrage over high smog levels. As a result, local officials are trying hard to strike a balance between pollution control and economic growth. Shijiazhuang is home to major active pharmaceutical ingredient (API) producers such as North China Pharmaceutical, CSPC Zhongnuo Pharmaceutical, CSPC Ouyi Pharmaceutical and many others. These companies are critical to the global antibiotic supply chain as they provide the building blocks for antibiotic manufacturing, such as 6-APA and 7-ACA, along with commonly used antibiotics such as Penicillin, Amoxicillin, Amipicillin and Azithromycin.  PharmaCompass has been routinely covering the Chinese bulk drug industry and its impact on the environment. In April this year, PharmaCompass had reported how school children in China were wearing gas masks due to pollution concerns. And prior to that, we had carried an article on how dependent the world has become on bulk drugs from China.  More trouble for generic drug-makers in the US as unions file lawsuits In a fresh salvo at the generic drug industry, a union representing sergeants of the New York Police Department is attempting to hit some companies with civil penalties. The generic industry is already facing charges from a two-year US Justice Department antitrust probe. The union has filed two lawsuits against two groups of drug-makers, which includes Novartis AG’s generic drug unit, Ireland-based Perrigo Co., India’s Wockhardt and Taro Pharmaceutical Industries (Israeli subsidiary of India’s Sun Pharma). The union has alleged that the companies colluded to raise prices of two dermatological creams by as much as 1,000 percent since 2013. Besides this, at least four other unions have filed lawsuits of their own, with two of them adding Actavis Inc., acquired in August by Teva, to the list of defendants. All the unions manage health benefits for their members. The unions say they overpaid for the drugs due to the price collusion. They point to data that the drug-makers took price hikes on certain medicines by nearly the same amounts within months of each other. A lawyer for the New York sergeants’ union said he expects a judge will call a conference in December to decide if the cases can be combined.  Novartis may buy generic drug-maker Amneal for US $ 8 billion Swiss healthcare major Novartis AG is in talks to acquire American generic-drugs maker Amneal Pharmaceuticals. Through this acquisition, Novartis plans to strengthen its Sandoz business. According to Bloomberg, Novartis and Amneal may reach an agreement soon. Amneal makes the antiviral acyclovir (to treat herpes) and gabapentin (for epilepsy and pain). The acquisition could cost Novartis around US $ 8 billion. Amneal is a family-owned business led by co-founders Chintu and Chirag Patel and has operations in North America, Australia, Europe and Asia. Its portfolio of generic treatments includes around 115 approved molecules in the US.  Sanofi to sell off European generic drug unit French drug maker Sanofi confirmed it has decided to sell off its generic drug unit in Europe. The decision will affect two manufacturing plants in the Czech Republic and Romania. Sanofi CEO Olivier Brandicourt recently informed investors that the company has “made a definitive decision to initiate a carve-out process and divest the generics portfolio in Europe.” The move is part of the company’s 2020 strategic roadmap. He, however, did not provide details. Sanofi had acquired Zentiva, a Czech generic business, in 2008 for US $ 2.6 billion. And Sanofi’s generic business is centered around this acquisition. The business is particularly strong in the Czech Republic, Romania and Turkey. On Monday, Zentiva Romania informed the Bucharest Stock Exchange that its majority shareholder Sanofi has decided to sell its Romanian generic drug plant as part of a major divestment plan of its EU generic drugs business. A company spokesperson said the planned scope of the divestment is the generics business “related to Europe,” so it excludes Russia, the Commonwealth of Independent States (CIS) and Turkey. And it includes the two “dedicated manufacturing sites producing and distributing generics for the European market,” one in Prague (Czech Republic), and the other in Bucharest (Romania).  Former Valeant executives arrested for fraud Last week, two former executives of Valeant Pharmaceuticals — Gary Tanner and Andrew Davenport, who had been the CEO of Philidor — were arrested on charges of running a fraud scheme that swindled millions of dollars out of Valeant. The fraud was allegedly conducted with the help of a mail-order pharmacy, that is now defunct. According to Preet Bharara, US Attorney for the Southern District of New York, the arrests were part of an ongoing probe of the scheme. The criminal complaint alleges that Tanner and Davenport conspired to enrich themselves with Valeant funds. The two helped Valeant set up Philidor in early 2013, which was primarily a vehicle to market and distribute Valeant drugs. According to the complaint, Tanner focused on building Philidor’s business, resisted his superiors’ directives to line up other distributors for Valeant’s products and ultimately received a US $10 million kickback from Davenport. The complaint alleges that in 2014, the two orchestrated Valeant’s agreement to buy an option to purchase Philidor, which cost Valeant at least US $ 133 million. More than US $ 40 million of that went to shell companies controlled by Davenport. One such shell company — called ‘End Game LP — gave a kickback of US $10 million to Tanner.  Homeopathy products in the US may carry caveats soon In a report on homeopathic advertising, the Federal Trade Commission (FTC) in the US said that homeopathic drugs should “be held to the same truth-in-advertising standards as other products claiming health benefits.” Only the US Food and Drug Administration (FDA) can prevent homeopathic marketers from selling their products. The FTC has no teeth in the matter. But very soon, homeopathic products could include statements such as ‘there is no scientific evidence backing homeopathic health claims’ and ‘homeopathic claims are based only on theories from the 1700s that are not accepted by modern medical experts.’ However, this may not affect sales of homeopathic products. There are claims that such statements could backfire because homeopaths and those who believe in homoeopathy don’t trust modern medicine. They could also believe that if homeopathy has been around for that long, it must work. This is not the first-time homeopathic medicines would carry caveats. In 1988, the FDA had struck a deal where it agreed that homeopaths could be self-regulating, if they include a disclaimer that their claims haven’t been evaluated by the FDA.  In February this year, PharmaCompass had carried a news nugget on Professor Paul Glasziou, a leading academic in evidence-based medicine at Bond University, who had declared homeopathy as a “therapeutic dead-end” after a systematic review concluded the controversial treatment was no more effective than placebo drugs.   Cancer clinical trials exaggerate benefits of new drugs, say oncologists Two cancer physicians argue that large clinical trials — required for approval of new cancer drugs in the US — often overstate the effectiveness of the treatment in the real world. During cancer clinical trials, some volunteers take the experimental drug, while others receive standard care with existing drugs. The groups are then compared to see if their tumors have shrunk, how long it takes for the tumors to return, and how long do the patients survive. This way, the trial sees whether the experimental drug is safe and effective and can be sold to patients in the US. The process is based on the premise that trials give an accurate indication of safety and efficacy among cancer patients in general, and not only those who are eligible for and selected for the trial. The trouble is, participants in clinical trials are unlike the overall cancer population, point out oncologists Dr. Sham Mailankody of Memorial Sloan Kettering Cancer Center and Dr. Vinay Prasad of the Oregon Health and Science University in JAMA Oncology. They’re younger, healthier, wealthier, better plugged in to the healthcare system, and better educated. According to these oncologists, if cancer patients are similar in age, socio-economic status, have presence of other (similar) illnesses, and other characteristics as those in a clinical trial, they might do as well. But for everyone else, the trial results probably promise more than the drug can deliver.    

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    24 Nov 2016
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    FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution

    FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution

    This week, Phispers brings you news about Wockhardt and how its turnaround plans are going awry. There is also news about Novo Nordisk ending development of an oral form of insulin, data manipulation at Beijing Taiyang, the latest on treatment of high cholesterol and lots more.   Novo ends development of oral insulin, slashes long term growth forecast Novo Nordisk – the world’s biggest maker of insulin – slashed its long-term profit-growth forecast by half due to pressure on prices in its largest market – the US. The company is also ending development of an oral form of insulin, which has long been an unattainable dream for the global pharmaceutical industry. The Danish pharma company will be relying more on in-licensing early stage projects and working with external academic collaborators. Moreover, the company will focus more on diabetes and obesity adjacent conditions such as nonalcoholic steatohepatitis (NASH), cardiovascular disease and chronic kidney disease. In the US, Novo is experiencing payer difficulties that have resulted in disappointing performance of its modern insulins. The profit-growth estimate was trimmed to 5 percent from the 10 percent projected in February this year, as it lost key contracts. The company also saw some products being excluded from insurance-coverage plans as it promised large rebates in the US on 2017 prices. While Novo controls almost half the global market for insulins, the intermediaries who negotiate prices for insured patients in the US are opting for cheaper alternatives. Lower prices and escalating competition from biosimilars have dimmed prospects for Novo, Sanofi and Eli Lilly & Co. These pharma companies have been forced to deepen rebates and discounts.   Systemic data manipulation uncovered at Chinese API manufacturer The FDA has issued a warning letter to Beijing Taiyang Pharmaceutical Industry, a manufacturer of  active pharmaceutical ingredients such as diphenyhydramine hydrochloride, a commonly used ingredient in cold preparations. The warning letter states that FDA investigators “observed systemic data manipulation across the facility.” The investigators documented “unexplained deletions of laboratory test results, discovered that analysts repeated tests until they obtained acceptable results and that the company failed to investigate results that were out-of-specification.” The FDA investigators observed, through a window, a warehouse containing numerous drums bearing the company’s label. “When the investigators requested access to this warehouse, Beijing Taiyang’s staff barred them from entering the warehouse to examine the containers,” the letter adds. The following day, when FDA investigators were given access to the warehouse, they observed that a significant number of drums had been removed and were not available for inspection. The firm also relied on falsified and manipulated test results to support batch release and stability data. The FDA had placed Beijing Taiyang on its import alert list in April of this year.   Wockhardt’s compliance foibles haunt biotech startup Cempra Wockhardt’s ambitious turnaround plans received a serious setback last week when Cempra, a clinical-stage pharmaceutical company focused on developing antibiotics, learnt that the US Food and Drug Administration (FDA) may not allow  it to use an active pharmaceutical ingredient (API) produced by Wockhardt for approval and in the commercial use of its product Solithromycin. Two of Cempra’s products are in advanced clinical development. One of them – Solithromycin – has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP). Its applications for approval have been accepted by the FDA and the EMA. The setback to Cempra was the result of an in-person meeting held with the FDA in late October. The reason for the FDA decision was an import alert placed on a Wockhardt manufacturing facility in August 2016, several months after Cempra’s New Drug Applications (NDA) with Wockhardt had been submitted and accepted for review by the FDA. Cempra began an active dialog with the FDA to determine if the API produced at Wockhardt prior to the import alert was adequate for the NDA. While Cempra plans to provide the FDA with data from API sourced from another supplier, the news is a serious setback for Wockhardt’s ambitious turnaround plans to fix its compliance issues and become an antibiotic research powerhouse.   Sanofi-Regeneron’s potential blockbuster runs into manufacturing problems Last week, Sanofi and Regeneron Pharmaceuticals’ Sarilumab – a product in development for the treatment of moderately to severely active rheumatoid arthritis (RA)—received a setback. The two companies announced that the US FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for Sarilumab. The CRL refers to certain deficiencies identified during a routine good manufacturing practice (GMP) inspection of the Sanofi facility in Le Trait (France) where Sarilumab is filled and finished. Satisfactory resolution of these deficiencies is required before the BLA can be approved. However, Sarilumab performed extremely well in a head-to-head clinical study against AbbVie’s world best-selling drug, Humira. The manufacturing glitch was also the only negative in Sanofi’s better than expected earnings report which was released last week in which Sanofi announced that it would exit its European generics business in the next 12 to 24 months.    Cholesterol woes: Raising HDL can’t save you, and new drugs don’t work. Last year, two new drugs – Rephata and Praluent – that lower cholesterol, came on the market. Back then, analysts had estimated sales of more than US $ 3 billion a year. Working by blocking a protein called PCSK9, the drugs would clear out LDL, or bad cholesterol. While Sanofi and Regeneron launched Praluent, which is said to succeed where the traditional treatment – an inexpensive class of drugs called statins – fails, Amgen launched Rephata with a similar mechanism of action. A year on, doctors are reluctant to write prescriptions until they are sure of the benefits. Similarly, insurers are unwilling to pay for these drugs.  “These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” Geoffrey Porges, a biotech analyst at Leerink, an investment bank specialising in healthcare told STAT News. There was more bad news for patients suffering from high cholesterol. A study published this week has found little evidence that raising HDL, widely known as good cholesterol, protects against heart attacks and strokes. The study was published in the Journal of the American College of Cardiology. The drug industry has repeatedly failed to design a pill that might improve patients’ lives by increasing HDL. A decade ago, Pfizer spent more than US $ 800 million to get the HDL-boosting medication torcetrapib into late-stage trials, only to find that more patients died on the drug than on placebo. Roche was next to fail when its drug, dalcetrapib, came up short in a 16,000-patient trial in 2012. And last year, Eli Lilly shut down a study testing its evacetrapib on 12,000 patients after discovering that the drug had no effect on heart attack and stroke.   Pfizer fined for violating environmental laws in the US For the second time in recent years, Pfizer has been fined by the American authorities for violating the Clean Air Act at a manufacturing plant in Barceloneta, Puerto Rico. Pfizer was fined US $ 190,000 for failing to disclose information about hazardous chemicals that were used at the concerned plant. In early 2014, the Environmental Protection Agency (EPA) had found that Pfizer stored certain substances — in this case, ammonia and methylamine — that exceeded permitted amounts. This triggered a requirement to file a plan, which Pfizer failed to do and had to be fined. The substances were also used without properly being disclosed to the EPA.   Pharmexcil refutes report on drug-resistant bacteria Growing antimicrobial resistance (AMR) is one of the gravest threats to human health. Global deaths because of drug-resistant infections are projected to reach 10 million per year by 2050, with cumulative economic losses of US $100 trillion. A new report by campaigning organisation – Changing Markets – titled ‘Superbugs in the Supply Chain - How pollution from antibiotics factories in India and China is fueling the global rise of drug-resistant infections’ has revealed the presence of drug-resistant bacteria at pharmaceutical manufacturing sites in India. On-the-ground research and analysis of water samples found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai. Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics, the report says. At four of the sites, resistance to three major classes of antibiotics was detected, including antibiotics of ‘last resort’, those used to treat infections that fail to respond to all other medicines. The report says antibiotics manufactured at or near these sites are being exported to United Kingdom’s National Health Service (NHS), French hospitals, and pharma majors including US distribution giant McKesson and French company Sanofi’s generics arm Zentiva.  The report cites Hyderabad-based Aurobindo Pharma as one of the worst offenders. However, Pharmaceuticals Export Promotion Council of India (Pharmexcil), which is part of India’s ministry of commerce, has termed the report as “fabricated” and “backed by vested interests” to malign the Indian pharma industry—the world’s largest producer of antibiotics. Aurobindo Pharma’s wholetime director M Madan Mohan Reddy is the chairman of Pharmexcil.   EMA probes Wanbury Pharma; French agency ANSM warns about fake GMP certificates Mumbai-based drug manufacturer Wanbury Pharma, which is one of the largest exporters of diabetes drug metformin, had been served a show-cause notice by the Maharashtra Food and Drug Administration last week for allegedly re-labelling its drugs that were being exported to Brazil, Mexico, Bangladesh and Pakistan. Wanbury has now come under the lens of the European Medicines Agency (EMA). The EMA is learnt to be investigating the allegations made by the Maharashtra FDA. Meanwhile, the ANSM (French agency for the safety of health products) has been informed of the use of several falsified GMP certificates under its letterhead for import and export activities of active substances. “Because of a recent increase in observed cases, the ANSM reminds stakeholders that the authenticity of GMP certificates should be checked on EudraGMDP Community database,” the ANSM website says.   Teva takes a shot at delaying generic Copaxone by writing to FDA Teva Pharmaceutical has submitted a document to the US FDA explaining the differences between its original multiple sclerosis drug Copaxone and the generic product being marketed by Momenta and Sandoz. In order to enter the market, the generic version of Copaxone requires both FDA approval and legal confirmation that it does not violate Teva's patent. According to analysts, the document is designed to delay the entry of a 40-mg generic version of Copaxone into the market (20mg generic Copaxone is already on the market). The document is also likely to undermine the confidence of FDA officials, leading to considerable delay in approval of the Momenta's generic drug for 40 mg Copaxone. Teva is currently in a court case concerning the patents that protect Copaxone against generic competition (for the 40mg version). However, most analysts believe Teva will lose the case, and that the generic product will be allowed to enter the market in 2017.   Former Valeant CEO and CFO being probed for accounting fraud In the US, an ongoing criminal probe into Valeant Pharmaceuticals is focusing on the extent to which the former chief executive officer – Michael Pearson – and former chief financial officer – Howard Schiller – allegedly hid a relationship with a specialty pharmacy – Philidor Rx Services – from insurers. Pearson was the key driver behind Valeant’s growth, which relied on price-gouging as a growth strategy. Pearson bought older medicines and hiked their prices manifolds to push up profits. Federal prosecutors are reportedly exploring potential charges of accounting fraud in connection with Valeant’s ties with Philidor Rx Services, a Bloomberg news report said. Valeant used its ties with Philidor to steer prescriptions and boost reimbursements for its medicines. For now, the probe is examining actions taken by Pearson and Schiller, though sources say others, such as Philidor executives, may also be charged.      

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    #Phispers by PHARMACOMPASS
    03 Nov 2016
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    GSK uses Apple’s ResearchKit for clinical research; India’s pharma exports drop in Q1

    GSK uses Apple’s ResearchKit for clinical research; India’s pharma exports drop in Q1

    This week, Phispers has lots of interesting pharma news from the across the world, including an analyst’s take on why Pfizer should not split, Elder Pharma’s COO being caught bribing a government official and how Teva’s entry into PhRMA is being resented by other players. And, don’t miss the news on next-generation women who are changing the face of pharma and healthcare in India.  GSK’s uses Apple’s ResearchKit, while Roche and Valeant face problems with clinical trials When it comes to clinical trials, this was certainly a week of action. First, Swiss drug maker Roche reported that a late-stage clinical trial showed its new blood cancer drug – Gazyva – failed to deliver significant improvements over its older Rituxan medicine. And then there was news regarding suicide risks linked to an experimental Valeant Pharmaceuticals drug used to treat psoriasis. The US Food and Drug Administration (FDA) reviewers raised concern over the suicide risk. This news followed similar news about the FDA allowing Juno Therapeutics to resume its clinical trial after the death of three patients.When it comes to clinical trials there was some exciting news from GlaxoSmithKline last week. GSK announced it is taking the next-generation approach to clinical trials by initiating a study on rheumatoid arthritis using Apple’s ResearchKit. This is the first time a drug maker is using the health system for the iPhone to conduct clinical research.GSK intends to record the mobility of 300 participants over three months. The company will also ask these patients to input both physical and emotional symptoms, such as pain and mood. The application created by GSK using ResearchKit comes with a guided wrist exercise that uses the phone’s sensors to record motion. This gives the drug company a standardized measurement across all users. The company will use the results to help design better clinical trials. GSK’s bulk drug plant in UK receives FDA’s warning letter for making contaminated drugs While still on GSK, there was some bad news too for the British drug maker. FDA investigators at GSK’s API manufacturing facility in Worthing, UK, found penicillin in non-penicillin manufacturing areas approximately 69 times in 2012, 72 times in 2013, 30 times in 2014, and 16 times through July 7, 2015.Contamination of non-beta-lactam drugs with beta-lactam drugs (such as penicillin) presents great risks to patient safety, including anaphylaxis and death. There is no safe level of penicillin contamination, as no level has been determined to be tolerable risk.As a follow up to the FDA inspection, GSK had to recall various lots of Bactroban® (mupirocin calcium) products due to potential contamination with penicillin and foreign substances such as glass, paint fragments, and fibers.This is not the first time a facility has had manufacturing compliance issues. In late 2015, a European regulatory body suspended marketing of its drug – Zantac – across Europe for not dealing with a decade-old problem of manufacturing the drug at this facility.  To split or not to split – that may no longer be the question before PfizerThere has been a lot of talk around Pfizer executives indicating that the American pharmaceutical bigwig may be split into different companies in order to bolster shareholder value. This talk gathered momentum three months back, when it scrapped the US $ 160 billion deal to acquire Allergan.However, the idea to split Pfizer was floated five years ago. It was intended to create two different companies – one would produce older drugs, while the other would focus on newer medicines. While a decision on splitting Pfizer is likely to be taken later this year, one Wall Street analyst questioned whether the big drug maker should actually be split. In a note to investors, Sanford Bernstein analyst Tim Anderson suggested a split may not unlock “substantial additional” value for shareholders. Anderson forecasts a value of about US $ 36 a share, which is roughly in line with the current stock price. And unlike in 2011, when growth prospects seemed fuzzy, Pfizer seems to be in a better position today. Competitors resent Teva’s entry into trade associationTeva – the world’s largest generics player – was made a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) last week. The trade association announced it had admitted Teva along with rare-disease manufacturer Alexion and specialty pharma Jazz. AMAG Pharmaceuticals and Horizon Pharma also became full members, transitioning from research associates.However, Teva’s peers are not exactly happy that the Israeli drug maker has joined their exclusive club. For instance, AbbVie argued against letting the copycat giant in. AbbVie claimed that by admitting Teva into PhRMA, the association would dilute its “emphasis on innovation” and spur “internal conflicts” between Teva and companies whose patents it seeks to invalidate.Apart from being a top generics player, Teva is also into branded sales, thanks to multiple sclerosis blockbuster drug Copaxone, and to a lesser extent, the brands it acquired in its Cephalon buyout. Teva had acquired the generics business of Allergan last year for US $ 40.5 billion. As a result, it is selling generic brands in the United States and Europe. In fact, all generic majors – including Dr. Reddy’s, Impax, Mayne, Zydus Cadila, Aurobindo, Intas and Torrent – have queued up to acquire a band of products put on the block by Teva in Europe.  FDA puts four companies that didn’t pay GDUFA fee on import alert. Over the last two years, companies like China’s Jiangsu ZW Pharmaceuticals and Wuxi Kaili Pharmaceutical Company, and India-based Fleming Laboratories and Sharon Bio-Medicine had received warning letters from the FDA for failing to pay the GDUFA (Generic Drug User Fee Amendments) fees.This week, for the first time, the FDA used the authority provided by the Congress to enforce GDUFA’s user fee provisions and placed these firms on import alerts. The FDA added the four companies (mentioned above) to a list of generic drug facilities that are banned from shipping products to the US since they have not paid the GDUFA fee and have failed to meet identification requirements stipulated in the GDUFA of 2012. Next-generation women in Indian pharma and healthcareIndia’s pharmaceutical and healthcare industry has traditionally been a male bastion. This is true of many other countries as well. However, according to a news report published this week, a big change is sweeping across this immensely technical and challenging business landscape. And a new crop of business leaders has emerged in India that is coming up with game-changing ideas. “These women have added tremendous value in shaping these organisations,” says the news report.The story profiled five next-generation women – Namita Thapar (39), CFO of Emcure Pharmaceuticals, Zahabiya Khorakiwala (33), Managing Director of Wockhardt Hospitals, Tara Singh Vachani (29), CEO and Managing Director of Antara Senior Living, Ameera Shah (36), Managing Director of Metropolis Labs and Samina Vaziralli (37), Executive Director of Cipla. Elder Pharma’s COO bribes government official for preventing SFIO probeWhile the next-generation women are busy adding value to their pharma business, another next-generation promoter of a pharma company was indicted for bribing a government official.  Last week, the Central Bureau of Investigation arrested a senior Ministry of Corporate Affairs (MCA) officer – B K Bansal – in Delhi for allegedly taking a bribe of Rs 9 lakh from Anuj Saxena, COO of Elder Pharma, through a middleman for preventing a Serious Frauds Investigation Office (SFIO) investigation pending against the company.Bansal was director general of MCA. At first, Bansal demanded Rs 50 lakh, but later settled for Rs 20 lakh to prevent the investigation. He was caught accepting the second tranche of the payment. Elder Pharma has been going through a crisis recently, after the MCA red-flagged several discrepancies in its finances. The company had only recently sold a major stake in the company.  India’s pharma exports to US, Europe decline by 7 percent in Q1Over the last several months, we have been reading a lot of news regarding compliance issues being faced by Indian pharma companies. Well, all those compliance issues have begun to have a bearing on the financials of Indian pharmaceutical companies. According to figures released by the Pharmaceuticals Export Promotion Council (Pharmexcil), the exports of Indian pharmaceuticals to Europe and the US witnessed a negative growth of 6 to 7 per cent in the April to June quarter this year.Pharmexil will organise an interactive meeting with the joint secretary of the Department of Commerce (DoC) to discuss the reasons behind this decline in exports.Says P V Appaji, director general of Pharmexcil: “Though the Indian pharma exports performed well last year, we have seen a decline in pharma exports, particularly to the US market, in last three months.” 

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    #Phispers by PHARMACOMPASS
    21 Jul 2016
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    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    The year 2015 has gone down in history as a record year for mergers and acquisitions in the pharmaceutical and biotech space with deals worth US $ 300 billion being announced. The highlight of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.  Pharma Letter tracked transactions through the year and found the number of deals exceeding US $1 billion at 30 in 2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A deals were announced in 2015 (out of which some are yet to be completed), compared to 137 in 2014.   This week, PharmaCompass brings you a compilation of the top drugs of 2015 by sales revenue and growth. Sofosbuvir – the outright winner of 2015 2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion. The PharmaCompass prediction that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment of infectious diseases like hepatitis and HIV) would become the best-selling drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864 billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira. Humira retained its place as the best-selling drug with US $ 14.012 billion in sales in 2015. However, with sales growth of US $ 11.737 billion in a single year, Harvoni is poised to become the best-selling drug by the end of 2016. Top 20 Drugs by Sales Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2015 data (Excel version available) for FREE!   Product Active Ingredient Main Therapeutic Indication Company 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) AbbVie 12,543 14,012 1,469 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 2,127 13,864 11,737 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen / Pfizer 4,688 8,697 4009 4 Remicade Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson / Merck 6,868 8,355 1487 5 MabThera/Rituxan Rituximab Oncology Roche 5,659 7,115 1,456 6 Lantus Insulin Glargine Diabetes Sanofi 6,978 7,029 51 7 Avastin Bevacizumab Oncology Roche 6,481 6,751 270 8 Herceptin Trastuzumab Oncology Roche 6,338 6,603 265 9 Revlimid Lenalidomide Blood Related Disorders Celgene Corpoartion 4,980 5,801 821 10 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 10,283 5,276 (5,007) 11 Seretide / Advair Salmeterol Respiratory Disorders GlaxoSmithKline 6,005 5,227 (778) 12 Crestor Rosuvastatin Calcium Cardiovascular AstraZeneca 5,512 5,017 (495) 13 Lyrica Pregabalin Neuroscience and Mental Health Pfizer Inc. 5,168 4,839 (329) 14 Neulasta Pegfilgrastim Blood Related Disorders Amgen 4,596 4,715 119 15 Gleevec / Glivec Imatinib Oncology Novartis 4,746 4,658 (88) 16 Xarelto Rivaroxaban Anticoagulants Bayer / Johnson & Johnson 3,369 4,345 976 17 Copaxone Glatiramer Neuroscience and Mental Health Teva 4,237 4,023 (214) 18 Januvia Sitagliptin Diabetes Merck & Co 3,931 3,863 (68) 19 Abilify Aripiprazole Neuroscience and Mental Health Bristol-Myers Squibb/ Otsuka Holdings 6,485 3,804 (2681) 20 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health Biogen 2,909 3,638 729 Click here to access all the 2015 data (Excel version available) for FREE! A year of record FDA approvals 2015 was also the year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information. PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant variation in estimates.  However, in our view, drugs that saw highest sales growth in 2015 are likely to do well this year as well. Top 20 drugs by sales growth (in USD, millions)   Product Active Ingredient Main Therapeutic Indication 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) 2,127 13,864 11,737 2 Viekira Pak Ombitasvir/Paritaprevir/Ritonavir Infectious Diseases (HIV, Hepatitis etc.) 48 1,639 1,591 3 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) 12,543 14,012 1,469 4 Hepatits C Franchise Daclatasvir and Asunaprevir Infectious Diseases (HIV, Hepatitis etc.) 256 1,603 1,347 5 Imbruvica Ibrutinib Chronic lymphocytic leukemia 200 1,443 1,243  6 Cubicin Daptomycin Anti-bacterial 25 1,127 1,102 7 Eliquis Apixaban Anticoagulants 774 1,860 1,086 8 Triumeq Abacavir, Dolutegravir and Lamivudine Infectious Diseases (HIV, Hepatitis etc.) - 1,037 1,037 9 Xarelto Rivaroxaban Anticoagulants 3,369 4,345 976 10 Opdivo Nivolumab Oncology 6 942 936 11 Revlimid Lenalidomide Blood Related Disorders 4,980 5,801 821 12 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health 2,909 3,638 729 13 Xtandi Enzalutamide Oncology 480 1,207 727 14 Ibrance Palbociclib Oncology - 723 723 15 Invokana / Invokamet Canagliflozin Type 2 diabetes 586 1,308 722 16 Victoza Liraglutide Diabetes 2,014 2,704 690 17 Stribild Cobicistat, Elvitegravir, Emtricitabine and Tenofovir Disoproxil Fumarate Infectious Diseases (HIV, Hepatitis etc.) 1,197 1,825 628 18 Levemir Insulin Diabetes 2,133 2,745 612 19 Votrient Pazopanib Oncology 565 565 20 Perjeta Pertuzumab Oncology 927 1459 532   Hepatitis C products, which had three of the four highest sales growths in 2015, clearly show the impact these revolutionary treatments will have on the global healthcare landscape in time to come. Cancer immunotherapy treatments, a new generation of blood thinners and novel diabetes treatments were some of the others which demonstrated stellar growth in 2015. Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they have not been included in the compilation of drugs. Click here to access all the 2015 data (Excel version available) for FREE!   Sign Up, Stay Ahead While some companies like Boehringer and Valeant are yet to release their annual reports. In order to stay informed, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to access all the 2015 data (Excel version available) for FREE!   CORRECTION, April 12, 2016: An earlier version of this compilation did not account for cases where the same drug is sold by multiple companies (e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top 20 Drugs by Sales and Sales Growth has been done.   

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    #PharmaFlow by PHARMACOMPASS
    10 Mar 2016
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    Teva’s third strike at the Japanese generic market, the new favorite of drug makers

    Teva’s third strike at the Japanese generic market, the new favorite of drug makers

    Last fortnight, Japan dominated the pharmaceutical deal making scenario, giving us the much needed respite from compliance-related news coming from the United States week after week.In November-end, Israel’s Teva Pharmaceutical – the world’s largest generic drug maker – established an “unprecedented partnership in Japan” with Japan’s largest pharmaceutical company, Takeda. Teva will have a 51 percent stake in the new company, while Takeda will have 49 percent.Japan is the third largest pharmaceutical market in the world and one of the fastest growing generic markets. Through this partnership, Teva will bring its portfolio of generic drugs to Japan.  Japan government’s increased focus on genericsWith 25 percent of its population over the age of 65 years, and with one of the highest life expectancy in the world of 81.24 years, Japan is an ageing country. As a result, medical costs in Japan were 40 trillion Yen (of US $ 325 billion) in fiscal 2013 alone.The Japanese government has been promoting the use of generics to offset the high price of branded drugs in an effort to sustain the rising cost of its universal healthcare system. The government aims to increase the ratio of generics usage based on volume from the current 50 percent to over 70 percent by mid-2017, and to over 80 percent by March 2021. To achieve this target, the Japanese government plans to price generic drugs at 50 percent of brand-name drugs from April 2016, down from the current 60 percent, in order to encourage wider use of cheaper drugs.Japan’s generic usage at 50 percent is a far cry from that of the United States’, which is the world’s largest pharmaceutical market with a generic usage of almost 85 percent.  Several others also eyeing the Japanese generic marketTeva isn’t the only one interested in Japan. Last year, GlaxoSmithKline bought stake in the Japanese subsidiary of Aspen Pharmacare Holdings in order to boost its commercial operations in the country. Glaxo got a 25 percent stake in the Japanese subsidiary of Aspen in return for transferring distribution rights to some products in Japan. When Aspen launched operations earlier this year, Aspen Japan set a sales targets of around 6 billion yen (US $ 48.2 million) in the first year based on the sales of only five generics. Aspen received permission to sell these generics in Japan from GlaxoSmithKline and US-based Merck. India’s Lupin, which is the only Indian pharma company to have a presence in the Japanese generic market and has made two buyouts in Japan – Tokyo-based I’rom Pharmaceutical in 2011 and Kyowa Pharmaceutical Industry in 2007, earns around 12 percent of its annual revenue from Japan. Last year, Lupin announced plans to build a manufacturing unit in India that would focus only on the Japanese market.More recently, there has been talk of India’s leading generic manufacturer Sun Pharmaceuticals considering to buy out the brand drug portfolio of scandal plagued Novartis in Japan.  Japan has been a tough market to crackBuilding a business in Japan has proved to be a difficult task, even for Teva. Although it made its first foray into the country through a joint venture with Kowa in 2008, followed by a buy-out of Taiyo Pharmaceutical in 2011 (in a deal valuing Japan’s third-largest generics maker at the time at about US $ 1 billion), the financial reports for the past few years show an ongoing decline in Teva’s revenue. While fluctuations in the exchange rate have affected Teva's revenues in Japan, in 2014, Teva's Japan revenue fell 10 percent  in comparison with 2013 (3 percent in local currency). In 2015, Teva reported a steep drop each quarter in revenue in Japan. Teva isn’t the only one that’s seen its Japanese dreams crash. Since the 1950s, domestic firms and multinational corporations (MNCs) across sectors have come together with big schemes and high hopes to pursue joint ventures, co-promotions and other deals. But most alliances have ended in disappointment, with returns to one or both partners falling below expectations. Mistrust for generics and drug lag in JapanIndian drug makers and leading global generic drug producers have several concerns about the Japanese market. Kewal Handa, former managing director of Pfizer Limited (the Indian unit of the America’s largest drug maker) has been quoted as saying: “It’s difficult to get higher launch prices unless the drug is innovative and cost effective. The margins are coming down and prices don’t rule high. The Japanese pharma industry has been self-sufficient with many domestic companies and they prefer their local companies over global companies”.In addition, there is mistrust for generics amid the older generation of Japanese physicians, pharmacists and patients. This mistrust stems not only from a cultural preference for familiar, local products but also from concerns that generic medicines may not undergo the same efficacy and safety tests as innovator products. There are also concerns about the reliability and stability of generic supplies as manufacturers in Japan have frequently withdrawn older products from the market in response to reduced sales and lower reimbursement fees. Moreover, Japan also poses a drug lag for pharma companies. Depending on category, there is a 5-to-10-year delay between approval of a drug in Europe or the US and approval in Japan. For instance, Teva’s blockbuster Copaxone (glatiramer acetate), which is already facing generic competition in the United States, has only recently been approved in Japan. Takeda is, once again, Teva’s partner to help commercialize this multi-billion-dollar drug in Japan. Our viewJapan is changing; and this policy change brought about by the government may actually change the power dynamics among foreign and Japanese drug makers. The recent decision at 234-year old Takeda to appoint a Frenchman as the first non-Japanese to lead the company may be a sign of how things are evolving in Japan. Are you interested in knowing more about the Japanese pharmaceutical market? Read a detailed Credit Suisse report on the sector or check out the Orange Book in Japan to see products that interest you and your company. 

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    #Phispers by PHARMACOMPASS
    10 Dec 2015
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    Tricky balance: Why a change in US drug pricing policy will create a tectonic shift globally

    Tricky balance: Why a change in US drug pricing policy will create a tectonic shift globally

    American hedge fund manager and co-founder of Turing Pharmaceuticals Matrin Shekreli’s decision to increase the price of an old, off-patent, AIDS treatment from US $ 13.60 per tablet to US $ 750 overnight, has created a media outrage. While New York Times covered the price increase, Hillary Clinton’s tweet accusing drug companies of “price gouging” sent biotech stocks tumbling. All this  happened two weeks after Presidential candidate Bernie Sanders introduced legislation in the Senate to crack down, on what he believes, are "skyrocketing" increases in prescription drug prices.  In a recent poll, nearly three-quarters of Americans polled that “the cost of prescription drugs is unreasonable”. They have a valid point, as data provided by the International Federation of Health Plans on drug prices across countries in 2013 showed remarkable variations in the price of the same drugs (refer table below). The prices in the US were significantly higher than those in other developed countries.   Table: Drugs are the costliest in the US     Annual Sales Drug prices in different countries (in US $)   Innovator 2014, US $ million United States Canada Netherlands Spain England Switzerland Enbrel Amgen 8,707 2,225 1,646 1,509 1,386 1,117 1,017 Gleevec Novartis 4,746 6,214 1,141 3,321 3,348 2,697 3,633 Humira AbbVie 11,844 2,246 1,950 1,498 1,498 1,102 881 Copaxone Teva 4,788 3,903 Not Available 1,190 1,191 862 1,357 Gilenya Novartis 2,477 5,473 2,541 2,428 2,287 2,299 2,499 Celebrex Pfizer 2,699 225 51 112 164 112 138 Cymbalta Eli Lilly 1,615 194 110 52 71 46 76 Nexium Astra Zeneca 7,681 215 Not Available 23 58 42 60   Serial price increasing Shekreli Shekreli’s price increase of Daraprim from US $ 13.50 to US $ 750 isn’t his first attempt at trying to develop a business strategy by buying old neglected drugs and turning them into high-priced ‘specialty’ drugs.  Prior to becoming CEO of Turing Pharmaceuticals, Shekreli was heading Retrophin, which bought the marketing rights for a drug called Thiola from a small company in Texas called Mission Pharmacal. Retrophin increased the price of Thiola from US $ 1.50 per pill to over US $ 30 per pill in a fashion similar to what was done in the case of Daraprim. In fact, when Retrophin bought the drug, the company had stated that its first move would be to raise the price.   Drug price increases, the new normal Shekreli isn’t the only one who’s jacking up prices. Horizon Pharma PLC upped the price of Vimovo pain tablets after buying the rights from AstraZeneca in late-2013. On January 1, 2014, the first day it started selling Vimovo, Horizon raised the list price for 60 tablets to US $ 959.04 – a 597 percent increase. Horizon raised the price again on January 1, 2015 to US $ 1,678.32 for the tablets. However, Canada’s Valeant Pharmaceuticals wins the price-increase race. The CEO of Valeant, who said he “has a duty towards his shareholders”, is taking his responsibility so seriously that 80 percent of the additional sourcing costs experienced by the Cleveland Clinic is attributed to Valeant’s price increases.   The price of Mephyton (a drug that helps blood clot better), a Valeant drug, has increased from US $ 9.37 per tablet to US $ 58.76 – an eight-fold increase since July 2014. A diuretic – Edecrin – is now available at US $ 4,600 a vial, nine times higher than the May 2014 price of about US $ 470.  Products like Glumetza, rights to which Valeant obtained through the acquisition of Salix Pharmaceuticals, have undergone a monthly price increase from US $ 519.92 to US $ 4,643. Two other drugs that Valeant acquired earlier this year – Isuprel  and Nitropress – also made headlines when their prices were increased by 525 percent and 212 percent respectively. The focus on drug pricing has now even got traditional big pharma’s pricing policy under review. Pfizer’s price increase on 133 drugs, Merck’s price increase on 38 drugs or Sanofi and NovoNordisk’s  in-tandem insulin price increases  since 2009, are all making headlines.   The importance of the US market Price disparity between the United States and other markets is something that has existed for several years. In fact, most of the proposals made by politicians, which include negotiating power for Medicare (America’s national social health insurance program), are not new.  Pfizer’s CEO, Ian Read, for one sees no “real future” in the new measures. Even “President Obama wanted to give such powers to Medicare, but couldn't push the change through Congress…even when they controlled both houses of parliament recently,” he said. However, the impact of a change in the US policy could create a tectonic shift in the pharmaceutical industry. After all, North America (United States and Canada) contributes more than 40 percent to the global pharmaceutical industry. And patented drugs contribute 71 percent to the overall US spend on medicines. This implies that almost 30 percent of the global pharmaceutical revenues come from patented drugs sold in the United States. On the other hand, the patented drugs are only 14 percent of the prescriptions in the US, which represent a tiny percentage of global prescriptions. Any change in policy that would reduce pricing power in the United States would be felt – directly or indirectly – by the other prescriptions dispensed across the world.   Table: Region and leading country spending US $ billion 2012 2008-2012 CAGR 2017 2013-2017 CAGR Global 965.4 5.40% 1,170-1,200 3-6% Developed 621.6 2.90% 650-680 1–4% U.S 328.2 3.00% 350-380 1–4% EU5 148.7 2.40% 140-170 0–3% France 36.7 0.30% 30-40 (-2)–1% Germany 42.1 3.80% 41-51 1-4% Italy 26.2 2.90% 23-33 0-3% Spain 19.9 1.70% 13-23 (-4)-(-1)% UK 23.9 3.40% 20-30 1-4% Japan 111.3 3.00% 90-120 2-5% Canada 22 3.10% 20–30 1-4% South Korea 11.3 6.30% 10-20 3-6% Pharmerging 223.9 15.00% 370-400 10-13% China 81.7 22.30% 160–190 14-17% Tier 2 59.6 15.60% 90–110 10-13% Brazil 28.5 14.60% 38-48 11-14% Russia 17.1 17.70% 23-33 8-11% India 14 15.10% 22-32 11-14% Tier 3 82.6 9.40% 100-130 5-8% Rest of World 120 4.70% 125-155 2-5% Source: IMS Market Prognosis, September 2013   Our view With Europe slowing, a shift in the US policy would make emerging markets, especially Asia, the biggest priority for the pharmaceutical industry. Not only is the growth rate expected to be significantly higher in “pharmerging” countries (another term for developing countries where the use of pharmaceuticals is growing rapidly, such as China, Brazil, India, Russia and 17 other nations including Mexico, Turkey and Poland), but the patient population is also substantially more than the developed world. The big question is: What will happen first – price control in the US or an all-out wager to develop sales in the ‘pharmerging’ regions?   

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    #Phispers by PHARMACOMPASS
    08 Oct 2015
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    Teva and Otsuka’s Multi-Billion dollar plan when blockbusters turn Generic: Deuterium Chemistry

    Teva and Otsuka’s Multi-Billion dollar plan when blockbusters turn Generic: Deuterium Chemistry

    Two blockbusters, Otsuka’s Abilify® (aripiprazole) and Teva’s Copaxone® (glatiramer acetate), with combined sales of more than $10 billion in 2014 are going to face severe generic competition this year. Interestingly, both companies have turned to a new technology platform, which uses deuterium chemistry analogs of old, off-patent drugs to secure their future profits.  A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine or SD-809. This improved version breaks down more slowly in the body, allowing physicians to give it less often and at lower doses. The worth was established, when Teva paid $3.5 billion for the company Auspex, which developed SD-809.   SD-809 is expected to be approved in 2016 for the potential treatment of chorea (abnormal involuntary writhing movements), associated with central nervous system disorders like Huntington’s disease, tardive dyskinesia, and Tourette syndrome. Now, while this may have sounded like complex chemistry, you’ll be surprised by the simplicity of the concept.   What is this deuterium that replaced the hydrogen? Deuterium is a non-radioactive, stable and naturally occurring hydrogen isotope. The atomic mass of hydrogen is approximately 1.0 atomic mass unit (AMU), while that of deuterium is approximately 2.0 AMU. We all have 1-2g of deuterium in our bodies.   Why does a deuterium swap make a difference? Replacing some hydrogen atoms with deuterium does not change the shape or electronic structure of the molecule, but it can make a big difference in how it behaves. The reason: chemical bonds formed with deuterium are generally stronger and longer-lasting than those with hydrogen. Stronger bonds allow for small molecule drugs to resist to metabolic enzymes in the body that break down weaker hydrogen bonds. The result: the drug is broken down slower in the body, stays longer and hence is not required in high doses or as often. In addition, the deuterated drug is more stable in the presence of other drugs, resulting in reduced drug-drug interactions.   What did Teva & Otsuka buy? Teva: In addition to Auspex’s lead compound, SD-809, Teva also procured other pipeline candidates, which include deuterated versions of levodopa for Parkinson’s disease and pirfenidone for idiopathic pulmonary fibrosis.  As Roche purchased InterMune® $8.3 billion last year needs to get changed to “As Roche purchase Intermune for $8.3 billion last year” Otsuka’s $3.5 billion acquisition of Avanir Pharmaceuticals involved a pipeline of products, which are combinations of common, cough syrup ingredient, dextromethorphan with an old-heart drug, quinidine.    The promise of deuterated dextromethorphan for Alzheimer’s disease (Avanir compound AVR-786) was a key driver for Otsuka to purchase Avanir. The challenges and opportunities It can be difficult and not always clear to figure out where exactly to swap the deuterium for maximum effect. Legally, a deuterated compound is only considered a new drug if there is sufficient difference in the “active moiety” structure because initially the FDA had considered tetrabenzaine and deutetrabenzaine (SD-809) to be the same drug!  However, deuterium chemistry, while simple, requires specialization, which serves as an opportunity for chemical companies to consider developing.  With almost $7 billion in acquisitions in under 6 months, deuterium chemistry does deserve attention.  

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    #Phispers by PHARMACOMPASS
    21 May 2015
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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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    #Phispers by PHARMACOMPASS
    30 Apr 2015
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    Who has the biggest one? Sales of the top pharma products by revenue.

    Who has the biggest one? Sales of the top pharma products by revenue.

    We always knew math was fuzzy, but never imagined addition could get so complicated.  A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best selling products along with the top therapy areas. The list, based on data published by IMS Health, caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical companies.  As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics. Which pharmaceutical company is the largest? Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.  Should divisions like diagnostics, animal health, vaccines, consumer health be counted when determining the size of a pharmaceutical company? FiercePharma, in their analysis, used the total revenue of all divisions of the organizations to determine the largest organization; in their case it is Johnson & Johnson. IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest company. As currency exchange rate fluctuations have their own, big role, in determining the size of organizations, we believed it would be best to share the revenues, as presented, so that you can draw your own conclusions. Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)  Big Pharma IMS Rank IMS Sales (US $Mn) Fierce Pharma Rank Fierce Pharma Sales (US $Mn) Group Sales based on the Annual Report (Currency as reported, Mn)    Novartis 1 51,307 2 57,996 USD 57,996 Pfizer 2 44,929 4 49,605 USD 49,605 Sanofi 3 40,037 5 43,070 Euro 33,770 Roche 4 37,607 3 49,866 CHF 49,866 Merck & Co 5 36,550 6 42,237 USD 42,237 Johnson & Johnson 6 36,422 1 74,331 USD 74,331 AstraZeneca 7 33,313 8 26,095 USD 26,095 Glaxo SmithKline 8 31,470 7 37,960 GBP 23,006 Teva 9 26,001 11 20,272 USD 20,272 Gilead Sciences 10 23,673 10 24,474 USD 24,890 Amgen 11 20,473 12 20,063 USD 20,063 Lilly 12 19,909 14 19,615 USD 19,615 AbbVie 13 19,049 13 19,960 USD 19,960 Bayer 14 18,347 9 25,470 Euro 42,239 Bristol-Myers Squibb Not in Top 20 15 15,879 USD 15,879 NB: Mn is million Click here to access and download all the 2014 data (Excel version available) for FREE! Since each group has multiple divisions, we further split the sales for you to brainstorm: Table 2/ Sales comparison of the different divisions of top pharmaceutical companies in 2014 (Annual Reports in Mn)  Big Pharma Pharma Division Vaccine Division Generics Consumer Health Other Divisions Medical Devices/ Diagnostics Division Animal Health Division Divestures/ Other adjustments Novartis USD 31,791   Sandoz USD 9,562   Alcon USD 10,827     USD 5,816 Pfizer USD 45,708     USD 3,446 USD 451       Sanofi Euro 22,578 Euro 3,974 Euro 1,805 Euro 3,337     Euro 2,076   Roche CHF 38,969         CHF 10,897     Merck & Co USD 30,740 USD 5,302     USD 6,195       Johnson & Johnson USD 32,313     USD 14,496   USD 27,522     AstraZeneca USD 26,095               Glaxo SmithKline GBP 18,670     GBP 4,336         Teva USD 10,458   USD 9,814           Gilead Sciences USD 24,474             USD 416 Amgen USD 19,327       USD 736       Lilly USD 16,481       USD 788   USD 2,346   AbbVie USD 19,960               Bayer Euro 12,052     Euro 7,923       Euro 22,264 Bristol-Myers Squibb USD 15,879               Click here to access and download all the 2014 data (Excel version available) for FREE! Not sure that it adds any extra clarity on what should define a global pharmaceutical company… Since the various divisions make companies complicated to assess, what about product sales? The good news is that we have a winner!  Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason. Unfortunately, things stopped making sense the moment we reached the number-two product on the IMS list. Lantus®, Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.   So unless the Euro/Dollar exchange rate moves back towards the 1.5 range, there seems to be a serious difference in the way the product sales are calculated by companies and by IMS.    Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications! Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports) Products IMS Rank IMS Sales (US $Mn) Annual Reports Sales (US $Mn) Pharma Compass Rank Big Pharma Currency Annual Reports Sales in Mn Marketing Partner Marketing Partner Annual Report Sales (US $Mn) Humira® 1 11,844 12,543 1 Abbvie USD 12,543     Lantus® 2 10,331 7,676 5 Sanofi Euro 6,344     Sovaldi® 3 9,375 10,283 2 Gilead Sciences USD 10,283     Abilify® 4 9,285 7,556 6 Bristol Myers-Squibb USD 2,020 Otsuka 5,536 Enbrel®   5 8,707 8,538 4 Amgen USD 4,688 Pfizer 3,850 Seretide® 6 8,652 6,589 8 GSK GBP 4,229     Crestor® 7 8,473 5,512 11 AstraZeneca USD 5,512     Remicade®   8 8,097 9,880 3 Johnson & Johnson USD 6,868 Merck & Co. 2,372 Mitsubishi Tanabe 640 Nexium® 9 7,681 3,655 19 AstraZeneca USD 3,655     Mabthera®   10 6,552 6,936 7 Roche CHF 5,603 Roche 1,305 Avastin®   11 6,070 6,449 9 Roche CHF 6,417     Lyrica® 12 6,002 5,168 12 Pfizer USD 5,168     Herceptin®   13 5,564 6,306 10 Roche CHF 6,275     Spiriva® 14 5,483 3,917 17 Boehringer Euro 3,237     Januvia® 15 4,991 3,931 16 Merck & Co. USD 3,931     Copaxone® 16 4,788 4,237 14 Teva USD 4,237     Novorapid® 17 4,718 2,835 20 Novo Nordisk DKK 17,449     Neulasta® 18 4,627 4,596 13 Amgen USD 4,596     Symbicort® 19 4,535 3,801 18 AstraZeneca USD 3,801     Lucentis®   20 4,437 4,152 15 Novartis USD 2,441 Roche 1,711 Click here to access and download all the 2014 data (Excel version available) for FREE! It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view. Our take: With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing upon and others, which may not be worthwhile to pursue. While the assessment of pharmaceutical sales is far more complicated than what we had originally imaged, the focus of Big Pharma on small molecules is on Hepatitis C drugs (Sofosbuvir,­ Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments. Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports) Products Big Pharma Sales (US $Mn) 2013 Sales (US $Mn) 2014 Growth (%) Ibrutinib Pharmacyclics, Inc (now AbbVie) 14 492 3414% Dasatinib Bristol-Myers Squibb 1280 1493 17% Trametinib GSK 10 68 580% Nilotinib Novartis 1266 1529 21% Ruxolitinib Novartis 163 279 71% Ceritinib Novartis Not launched 31   Sunitinib Maleate Pfizer 1204 1174 -2% Crizotinib Pfizer 282 438 55% Axitinib Pfizer 319 410 29% Tofacitinib Citrate Pfizer 114 308 170% Click here to access and download all the 2014 data (Excel version available) for FREE! However, Big Pharma is now all about biologics. IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.  The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis). Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!  

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    https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue

    #PharmaFlow by PHARMACOMPASS
    23 Apr 2015
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