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    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    Nearly every year, drugmakers ring in the new year with drug price increases in the US. This year too, prices of over 450 prescription medicines increased by an average of around 5 percent at the start of January. This, when high drug prices have been one of the biggest political issues in the US over the last few years. PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed. View US Medicare Part D 2019 Drug Spending (Free Excel Available) Rising healthcare, drug spends in US Over the last several years, we have repeatedly heard political leaders in the US complain about high drug prices. Yet, drug prices and healthcare spends have risen unabated. America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8 trillion, accounting for 17.7 percent of the gross domestic product (GDP). During the year, prescription drug spend increased by 5.7 percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7 percent to US$ 799.4 billion. President Joe Biden recently stressed on the need to cap the prices of essential drugs, and said that the average American pays the highest prices for prescription drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.  Pharma companies, on the other hand, have vehemently argued against any price cuts in the US, saying price cuts would hinder drug research and development for all diseases. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Patented drugs account for 80.3 percent of total Part D spend Medicare is the US federal government’s program that provides health insurance to most people who are 65 years or older. Medicare’s Part D plan provides outpatient drug coverage through private insurance companies that have contracts with the federal government. Eligible people have to choose and enroll in a private prescription drug plan for Part D coverage. Medicare Part B, on the other hand, covers a wide variety of medically necessary outpatient services and some preventative services. Prescription drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent of the total spend for the year. Generic drugs made up for the remaining 19.7 percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8 billion were sold under Part D, accounting for 21 percent of the total spend under the program. View US Medicare Part D 2019 Drug Spending (Free Excel Available)   Eliquis ranks highest on Medicare’s brand drug spend Under Part D, endocrinology and oncology were the two therapeutic areas that generated maximum revenue for pharma companies, driving home sales of over US$ 31.8 billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of around US$ 22.9 billion. Among branded drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018. Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each under the program. Amongst generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the overall dosage units sold also jumped higher by 2.25 billion units to 111.35 billion.  The sales ranking of Part D does bare some similarities with the global ranking of highest selling drugs. In 2020, Humira had retained its position as the highest selling drug in the world, generating sales of US$ 20.4 billion. Both Eliquis and Revlimid had retained their ranking as the third and fourth most selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global sales in 2020. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Medicare’s inability to negotiate prices costs American taxpayers billions of dollars Over the years, drug companies have used Medicare’s inability to negotiate prices under Part D to increase the prices of their drugs significantly and rip off huge profits, a three-year-long US House Oversight Committee investigation has revealed. US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between 2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.   Elsewhere in the world, the same drugmakers are bending over backwards to get into medical insurance programs. For instance, China reported that several international pharma firms, many of them headquartered in the US, slashed the prices of their drugs by up to 94 percent to get into the country’s national medical insurance coverage. In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022 if an expensive Alzheimer’s drug, Aduhelm, is included in the list. In order to ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Our view President Biden's Build Back Better legislation, which the House passed last month, is up for vote in the Senate. The legislation contains provisions that would allow Medicare to negotiate the prices of some expensive drugs, penalize drugmakers who raise prices faster than inflation and cap out-of-pocket costs for insulin at US$ 35 per month. However, chances of the bill being passed in its present form are slim. Even if the Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025. The number would increase over the years, reaching 100 in six years, and hence forth grow by 20 drugs a year. It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.  View US Medicare Part D 2019 Drug Spending (Free Excel Available)    

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    https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data

    #PharmaFlow by PHARMACOMPASS
    06 Jan 2022
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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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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    Biocon now in data integrity net; Chinese money on lookout for generic firms

    Biocon now in data integrity net; Chinese money on lookout for generic firms

    This week, Phispers brings you more bad news from India’s Biocon, as Health Canada’s caution notice cites data integrity violations highlighted by its regulatory partner. In the US, the generic industry failed to stall the passage of Maryland’s new price hike law. There is also an analysis of how Chinese firms are looking to buy out generic firms. Meanwhile, Takeda invested more in EU, and FDA launched its Adverse Event Reporting System. Health Canada’s caution notice highlights data integrity violations at Biocon   The news doesn’t seem to be getting any better for India’s Biocon. Last week, Health Canada sent out a caution notice. The notice highlighted that one of Health Canada’s regulatory partners had informed them about data integrity violations and other GMP failings at the same Biocon site in Bengaluru that had been inspected by French health agency ANSM and the US Food and Drug Administration (FDA).   In July this year, PharmaCompass was the first to report on how Biocon’s biosimilar program had suffered a serious setback as an inspection by ANSM in March 2017 of its Bengaluru site had uncovered 35 deficiencies, out of which 11 had been deemed major. However, there was no mention of data-integrity concerns. The inspection was conducted by ANSM on behalf of the European Medicines Agency (EMA) 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). Post the non-compliance report issued by the European regulators, Biocon said in a stock exchange filing that it had withdrawn the dossier for two of these products. 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 had said in the statement. The board of  Biocon also 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. Biocon was also inspected by the FDA this year where discrepancies between the information submitted and the manufacturing process performed at Biocon were uncovered. Biocon had responded by saying that a Form 483 is a standard outcome of any audit and it had responded to all FDA observations.  Since then, things haven’t looked up for the Biocon/Mylan combine. After, they withdrew their applications for the trastuzumab and pegfilgrastim biosimilars from Europe, the FDA extended the target action date for their trastuzumab biosimilar by three months. Unlike other sites, the ANSM inspection report did not specifically raise concerns over data integrity at Biocon. And that’s why, PharmaCompass is of the view that the USFDA might have shared these concerns with Health Canada. Generic industry fails to stall passage of price hike law in Maryland    The generic drug industry in the US took a tough stance against Maryland's new pricing regulations and sought an injunction on passing of the law. However, the industry’s efforts failed to achieve the goal. Generic companies said because they operate nationally, the law could disrupt their operations and impact commerce outside of Maryland. While the court ruled that some of the industry’s arguments have merit, it denied the industry’s request for a preliminary injunction. For now, Maryland’s price hike law has come into effect. Unlike other approaches to regulate drug pricing throughout the country, Maryland’s law focuses specifically on the generic sector. With this new law, Maryland has become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. Takeda vests faith in post-Brexit EU, expands capacity in Ireland   Japanese drugmaker Takeda is making another investment in its manufacturing facilities in the European Union. Takeda’s plans are being seen as a sign of faith in a post-Brexit EU. The company will invest up to US$ 118 million (€100 million) in a new manufacturing plant at its site in Clondalkin near Dublin, Ireland. This investment could add another 100 jobs to its operations in Ireland. The outlay is for a 3,000 square-meter, two-story manufacturing plant next to an existing facility at the Grange Castle business park. A few months back, Takeda had begun construction of a US$ 42.8 million (€40 million) facility at the Grange Castle site to manufacture its newly approved oral multiple myeloma drug Ninlaro.  Other companies have been reluctant to invest in Europe. Leif Johansson, chairman of AstraZeneca, recently said the company will have to pull some manufacturing and research operations out of the UK “if there is not a viable deal for its exit from the EU”. “If something doesn’t happen to take away the current uncertainty it will become a big and important matter for us. Moving manufacturing takes several years,” Johansson said in an interview. FDA launches Adverse Event Reporting System and new search tool   This week, the US FDA launched its Adverse Event Reporting System (FAERS) — a database that contains adverse event (AE) reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the agency.  The FDA also launched a new dashboard to facilitate access to reports of adverse drug reactions. According to The Centre for Biosimilars, FAERS contains 14 million AE  reports submitted by healthcare providers, consumers, manufacturers of drugs and biologics, and other stakeholders. “The database is designed to improve transparency and accessibility to AE data by allowing users to search it more easily,” it says. The database is used as a surveillance tool to help the FDA look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer’s compliance with reporting regulations and responding to outside requests for information. “The FDA is committed to fully informing patients and providers of adverse events reported with medical products, and this enhanced portal now provides patients, doctors, and others with easier access to the data they are interested in,” Scott Gottlieb, FDA Commissioner, said. Chinese money chasing generic firms; Pfizer maybe interested in buying BMS   Chinese money is out to purchase one generic firm after another. Weeks after Chinese pharmaceutical giant Fosun resurrected its deal to acquire India’s Gland Pharma for US$ 1 billion by scaling down the stake it desires to purchase, it is now looking to acquire the manufacturing facilities of another Indian pharma company. It’s new target is Symbiotec Pharma, an active pharmaceutical ingredient (API) maker specializing in steroid-hormone products. This mid-size drugmaker complies with quality standards of the US FDA. Private equity firm Actis holds a 70 percent stake in Symbiotec Pharma, which has been an acquisition target for other drug makers too. Investment bank Rothschild has been mandated to initiate an auction process. But the Chinese money is looking beyond India. According to a Bloomberg report, Shanghai Pharmaceuticals Holding is focusing on a sale of Alvogen’s US business. Alvogen is a generic pharma company, and owners of its US operations (such as private equity owner CVC Capital Partners) are exploring various options. Alvogen’s US operations could be valued at US$ 4 billion. Shanghai Pharma is also bidding for a stake in Arbor Pharmaceuticals as well as Cardinal Health’s Chinese distribution business. Pfizer and BMS: While rumors about Pfizer wanting to buy Bristol-Myers Squibb have been doing the rounds from some months now, a FiercePharma report published this week quoted analysts as saying they believe the American pharma biggie maybe interested in buying BMS. However, Pfizer may postpone pursuing such a big deal until it has “more clarity on corporate tax reform efforts.” Pfizer may also be waiting for “further visibility” on BMS’ Opdivo-Yervoy trial in first-line lung cancer patients, the report says.  US health secy resigns over use of private planes; FDA’s Gottlieb travels commercial   In the US, the Health and Human Services (HHS) Secretary Tom Price resigned last week in the face of multiple investigations into his use of a private charter and military jets to travel around the country. This is being seen as a gross misuse of taxpayers’ money, amounting to nearly US$ 1 million. These trips were between cities where inexpensive commercial flights were also available. Price apologized for his expensive habit, and vowed to cover the cost. In his resignation letter, Price said he regrets the “recent events have created a distraction,” from his work at HHS. According to Endpoints, the FDA said its commissioner Scott Gottlieb “has only traveled via commercial airlines for government travel.” The report adds: “Gottlieb, by the way, does enjoy the occasional treat while traveling”. In fact, Price is not the only one. The US Treasury Secretary Steven Mnuchin has made requests for special travel arrangements using government craft. Meanwhile, the White House has placed new requirements on officials’ air travel plans. Federal agencies were told “all travel on government-owned, rented, leased, or chartered aircraft, except space-­available travel and travel to meet mission requirements ... shall require prior approval from the White House Chief of Staff."

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    https://www.pharmacompass.com/radio-compass-blog/biocon-now-in-data-integrity-net-chinese-money-on-lookout-for-generic-firms

    #Phispers by PHARMACOMPASS
    05 Oct 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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    #Phispers by PHARMACOMPASS
    17 Aug 2017
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    Can Biocon-Mylan combine overcome its biosimilar program’s European inspection failure?

    Can Biocon-Mylan combine overcome its biosimilar program’s European inspection failure?

    Last week, 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 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). Following our story, Biocon issued a statement which mentioned that it had received “GMP approval for biologics drug substance facilities” from the French regulator; and that the drug product facility is “to be re-inspected”. This week, PharmaCompass delves deeper into the findings of the French health agency and looks at potentially what this could mean for the future of Biocon’s biosimilar program. Concerns raised by ANSM in March 2017 inspection   In 2006, Biocon established India’s largest integrated biotechnology hub, comprising of an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in a Special Economic Zone (SEZ) near Bengaluru.  In March 2017, the French health agency conducted inspections of three Biocon facilities, two of which were located within the Special Economic Zone in Bommasandra in Bengaluru, and the other in Electronics City, Bengaluru. Biocon received Good Manufacturing Practices (GMP) compliance certificates for one facility located in the SEZ and the other in Electronic City. The inspection certificate reports that the approved SEZ plant performed manufacturing activities for trastuzumab. It also performed activities for pegfilgrastim, restricted to quality control (physico-chemical and microbiological). The Electronics City facility manufactures the active substance used in the pegfilgrastim and insulin glargine biosimilars. In ANSM’s non-compliance report issued to the drug product manufacturing facility (situated in the SEZ in Bommasandra), its concerns relate to the following operations of the biosimilar products: Fulphila® (pegfilgrastim), pre-filled syringe presentation: drug product manufacture and quality control operations; Ogivri® (trastuzumab), vial presentation (freeze-dried product): drug product manufacture and quality control operations; Semglee® (Insulin glargine), cartridge presentation: secondary packaging and drug product quality control. cGMP manufacturing – a stumbling block for biologic drugs    There is no doubt that ANSM’s issuance of GMP compliance certificates to Biocon’s two drug substance facilities for biosimilars is a tremendous achievement.  However, concerns over fill/finish drug product operations have recently delayed US approvals for Pfizer’s biosimilar of Amgen’s drug Epogen (epoetin alfa) as well as Sanofi’s Humira competitor, sarilumab. While Sanofi was able to address the regulator’s concerns in just a few months, Pfizer is facing an uphill battle in its effort to resolve compliance issues at its McPherson, Kansas facility, which it acquired as part of the US$ 17 billion acquisition of Hospira. Unlike other products for which biosimilars have been approved by the US and European regulators, Amgen’s Neulasta (pegfilgrastim), which brought in US$ 4.6 billion in sales last year, has not been an easy product to get approved. Sandoz — Biocon’s competitor for a Neulasta biosimilar — withdrew its European application earlier this year after clinical equivalency concerns coupled with concerns over the lack of a certificate of GMP for the medicine’s manufacturing site emerged. Sandoz’s European withdrawal follows a rejection by the US Food and Drug Administration (FDA) of Sandoz’s application for its proposed Neulasta biosimilar in July 2016, after accepting it for review in November 2015. A little over a month ago, Coherus BioSciences Inc announced that the FDA denied the approval of its Neulasta biosimilar. The FDA requested Coherus for a re-analysis of certain data and asked the drug developer for more manufacturing information, the company said. Other biosimilar makers have encountered problems as well. Hungary’s Gedeon Richter, withdrew its application for a biosimilar of Neulasta after the EMA “was concerned that study results had not shown that (the proposed biosimilar) was handled by the body in the same way as the reference medicine Neulasta.”  In 2014, Apotex was the first to file a proposed biosimilar application for pegfilgrastim in the United States. After that, there has been no news from Apotex, though in a recent May 2017 citizen petition Apotex has asked the FDA to require pegfilgrastim biosimilar applicants to conduct appropriate clinical studies for this complex biologic.  In its petition, Apotex highlighted that Coherus had apparently not conducted the necessary studies and a month later, the FDA denied Coherus’ approval. In 2013, Biocon entered into an exclusive strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin analogs. And, in February 2017, the FDA accepted Mylan/Biocon’s proposed pegfilgrastim biosimilar (MYL-1401H) for review. Based on the User Fee Act, the FDA should take a decision on this application by October 9, 2017. Losing the pole position on trastuzumab   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. A recent QuintilesIMS report, commissioned by the European Commission, shows that in therapy classes where more than one biosimilar has been launched, the first to market biosimilar usually takes the highest biosimilar market share. The report shared examples where the first biosimilar entry captured over 70 percent of the biosimilar market share compared with just 30 to 40 percent for the second entry. A third entrant captured only 5 to 22 percent of the market. While Biocon submitted its application to the European agency in August 2016, Samsung followed with its submission in October 2016, Celltrion in November 2016 and Amgen in March 2017. Any approval delay could lead to a revenue loss of hundreds of millions of dollars. Biocon stock gains on back of meet to discuss Mylan’s trastuzumab filing   Despite everything, there hasn’t been much adverse impact on the Biocon stock due to the news on the French health agency’s inspection. The Biocon stock gained over 13 percent intraday on July 12 as investors turned bullish ahead of the FDA’s Advisory Committee (Adcom) meeting (to be held on July 13) to discuss the trastuzumab filing done by Mylan. According to news reports, investors could monitor the outcome of the Adcom. If the product is approved by the FDA, it will be the first Herceptin biosimilar in the US market. Moreover, the brokerages remained mixed on Biocon’s prospects. According to Moneycontrol, “Biocon could be a beneficiary of the unfolding global biosimilar opportunity.” Our view   Prior to the ANSM inspection, Biocon was inspected by the FDA where discrepancies between the information submitted and the manufacturing process performed at Biocon were uncovered. The company responded in a similar manner by saying that a Form 483 is a standard outcome of any audit and it had responded to all FDA observations.  Now, it remains to be seen how quickly the regulators are convinced with the responses so that Biocon and its exclusive strategic partner Mylan can make a landmark entry into the field of biosimilars. Given all the hurdles in the way to get a biosimilar approved, it remains to be seen whether the Biocon-Mylan combine will create history, or become yet another ‘has been’ in the race for biosimilars.  

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    #Phispers by PHARMACOMPASS
    13 Jul 2017
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    Biocon

    Biocon's biosimilars program fails European cGMP inspection

    India’s pharma stocks have been taking a beating of late due to compliance-related issues and the pressures on the US market, putting a big question mark on the growth of the country’s pharmaceutical industry in the future. So far, Biocon had been able to weather this storm due to its successful compliance record, and an exclusive strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin analogs, which in turn were expected to bring in a windfall for the company.However, Biocon’s biosimilar program suffered a serious setback as an inspection by the French health agency, ANSM, in March 2017 of its 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).Need for a follow-up GMP inspection The ANSM found major deficiencies in the following areas: Environmental monitoring-training, OOS results management, cleaning validation, process validation, vendors qualification, media fill test, cross-contamination risks, batch manufacturing record, differential pressure alarms’ management in classified areas and access management in SAP for batch certification.The agencies concluded that the European Marketing Authorization Applications of the three biosimilar products currently under assessment should not be approved while the non-compliance report is in effect.The report also mentions that a follow-up GMP inspection is required in order to ensure that all the corrective and preventive action (CAPA) plans have been implemented and finalized by the site and that a robust quality system is in place.Biocon and Mylan have made two submissions to the FDA for their biosimilars of Amgen’s Neulasta (pegfilgrastim) and Roche’s Herceptin (trastuzamab). Now, it remains to be seen if the verdict of the FDA will be any different from that of the European agencies.  

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    08 Jul 2017
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    J&J’s diabetes drug reduces heart risk at the cost of toes; Google’s AI eye doctor initiative

    J&J’s diabetes drug reduces heart risk at the cost of toes; Google’s AI eye doctor initiative

    This week in Phispers, we bring you news on J&J’s Invokana, a drug that reduces heart risk while increasing the risk of amputation of toes. There is news from Google, which is tying up with India’s Aravind Eye Care System for its artificial intelligence eye doctor initiative. And WHO takes a step towards reducing antibiotic resistance by grouping antibiotics into ‘Access’, ‘Watch’ and ‘Reserve’.  Manufacturing errors trigger drug recalls by Lupin and Dr. Reddy’s in the US   Earlier this month, we carried an article on the end of India’s pharma honeymoon. News this week from Lupin and Cipla added another dimension to the problem as manufacturing errors triggered drug recalls in the United States. Lupin voluntarily recalled a lot of its birth control pills — Mibelas 24 Fe — in the US. A market complaint indicated a packaging error, making the lot number and expiration date no longer visible. This product is an oral contraceptive for women. As a result of the packaging error, the FDA says the first four days of the birth control packet have four non-hormonal placebo tablets as opposed to the active tablets. This may place the user at risk for contraceptive failure and unintended pregnancy. Similarly, Dr. Reddy’s had to recall hundreds of thousands of cartons of a popular acne medicine — Zenatane — manufactured by Cipla’s plant in Pune. According to FDA enforcement reports, Dr. Reddy’s is recalling 190 lots, consisting of 778,279 cartons of its Zenatane brand isotretinoin capsules, in four dose sizes. The voluntary Class II recall was initiated in late May after the products failed dissolution testing. During this period of turmoil, the Indian company which is generating a lot of positive press is Cadila Healthcare. Cadila’s US division Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has received final FDA approval to market Nystatin Topical Powder, an anti-fungal antibiotic used to treat skin infections caused by yeast. There is more good news from Zydus Cadila. After years of patent battles, the FDA has approved Zydus Cadila’s generic version of Shire’s ulcerative colitis drug Lialda. This came as a rude shock to Shire investors who had believed the US$ 800 million drug was safe for a few more years. However, there is a chance that instead of a flood of generics, the Zydus' generic may be the only competition for Lialda for sometime. Zydus Cadilla has indicated that its version will have a six-month exclusivity. J&J’s diabetes drug saves heart at the cost of toes; Sanofi’s insulin slashes hypoglycemia risks for seniors   Would you like to sacrifice your toes to save yourself from a heart attack? Well, a diabetes drug made by Johnson & Johnson (J&J), does just that. The drug — Invokana — decreases the risk of heart attacks and strokes, while increasing the risk of amputation, particularly of toes. According to the results of the 10,142-patient study, funded by J&J, for every three heart attacks, strokes, or cardiovascular deaths prevented by Invokana, there were two amputations, 71 percent of them of toes or the lower foot. While this is a setback to J&J, its rivals — Eli Lilly and Boehringer Ingelheim — who make a similar drug called Jardiance, may be cheering the findings of this study, performed on sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs prevent the kidney from absorbing sugar from the blood. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” Harlan Krumholz of Yale University said. Another study examining an at-risk population of seniors who had switched to basal insulin found Sanofi’s Toujeo to outdo its peers at cutting the risk of hypoglycemia in older patients. During a six-month follow-up, the study found that amongst the ‘at-risk’ seniors, those taking Toujeo were 57 percent less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s predecessor, Lantus. Google ties up with Indian hospital chain for artificial intelligence eye doctor initiative   Google will soon begin work on a grand experiment that would use machines to widen access of healthcare. If successful, this initiative will protect millions of diabetes patients from an eye disease that leads to blindness. Last year, researchers at Google had said they had trained image recognition algorithms to detect signs of diabetic retinopathy roughly as accurately as human experts. Left untreated, diabetic retinopathy causes blindness. The software examines photos of a patient’s retina to spot tiny aneurisms that would help detect early stages of the disease. Google is working with the Aravind Eye Care System in India, a network of eye hospitals, in order to integrate this technology. “This kind of blindness is completely preventable, but because people can’t get screened, half suffer vision loss before they’re detected,” Lily Peng, a product manager with the Google Brain AI research group, said. “One of the promises of this technology is being able to make healthcare more accessible.” There are more than 400 million people worldwide with diabetes, including 70 million in India. FDA tells Endo to pull out its opioid pain medication, as Gottlieb attacks addiction   Last week, the US FDA asked drugmaker Endo Pharmaceuticals to remove its powerful opioid pain medication — Opana ER — from the market, due to “the public health consequences of abuse”. “We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” he added. Opioid overdoses killed 33,000 Americans in 2015, with half of those involving a prescription opioid. Opana ER, which is oxymorphone hydrochloride, is used to manage severe pain. The FDA approved it for this use in 2006. The drug is about twice as powerful as OxyContin, another often abused opioid. In 2012, Endo reformulated the drug to make it more resistant to physical and chemical tampering. While the drug met the standards for approval, FDA says Endo never showed that the reformulation would reduce abuse. Amgen loses bid to delay Novartis’ biosimilar; FDA rejects Coherus’ biosimilar for Neulasta    Amgen lost a case in the Supreme Court of the United States that sought to delay biosimilars of its rivals. Amgen had argued that its biosimilar rivals should be forced to delay their 180-day marketing notices until the FDA had made up its mind on the marketing application. However, on Monday, the Supreme Court took a decision by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.” This has proven to be a clear win for Sandoz — the generic unit of Novartis that is fielding an array of copycat biologics. The group is launching a copy of Amgen’s Neupogen. And in the process, Sandoz has unleashed a fresh wave of biosimilars hitting the US market. However, Amgen won somewhere else — the FDA rejected Coherus Biosciences’ application for a biosimilar of Amgen’s blockbuster Neulasta (a drug that fights infections in cancer patients). This action effectively delays any rival until 2018, at the earliest. The FDA's response comes as Amgen gears up for biosimilar competition for Neulasta, which generated about US$ 4.6 billion in sales last year. The FDA requested Coherus for a re-analysis of certain data and asked the drug developer for more manufacturing information. WHO updates list of essential medicines; groups antibiotics into three categories   Last week, the World Health Organization (WHO) released its Essential Medicines List (EML), with a new advice on which antibiotics to use for common infections and which to preserve for serious circumstances. Amongst the additions to the WHO Model list of essential medicines for 2017 are medicines for HIV, hepatitis C, tuberculosis and leukaemia. The EML is used by many countries to increase access to medicines. The updated list has added 30 drugs for adults and 25 for children, and specifies new uses for 9 already-listed products. In all, it contains 433 drugs deemed essential to address the most important public health needs. This time, WHO has grouped antibiotics into three categories – ACCESS, WATCH and RESERVE – with recommendations on when each category should be used.  Initially, the new categories apply only to antibiotics used to treat 21 of the most common general infections. If found useful, it could be broadened in future versions of the EML to apply to drugs to treat other infections. Antibiotics in the ACCESS group must be available at all times as treatments for a wide range of common infections. It includes drugs like amoxicillin, an antibiotic used to treat infections such as pneumonia. The WATCH group includes antibiotics that are recommended as first- or second-choice treatments for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of urinary tract infection) and upper respiratory tract infections (such as bacterial sinusitis and bacterial bronchitis), should be dramatically reduced to avoid further development of resistance. The third group, RESERVE, includes antibiotics that should be considered as last resorts, such as colistin and some cephalosporins. These must be used only in the most severe circumstances when all other alternatives have failed.  

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    #Phispers by PHARMACOMPASS
    15 Jun 2017
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    Top drugs by sales in 2016: Who sold the blockbuster drugs?

    Top drugs by sales in 2016: Who sold the blockbuster drugs?

    The year 2016 finished with a whimper insofar as mergers and acquisitions (M&As) were concerned. The preceding year — 2015 — had gone down in history as a record year for M&As in the pharmaceutical and biotech space, when deals worth US $300 billion were announced. While drug companies were not as active on the M&A front, the product sales growth in 2016 continued to stay extremely robust and the order of the top ranked drugs changed little from the previous year. This week, PharmaCompass brings you a compilation of the top drugs of 2016 by sales revenue. Click here to Access All the 2016 Data (Excel version available) for FREE!   The top-sellers   Abbvie’s Humira (adalimumab) continued to remain the best-selling drug in the world and added another US $2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year also saw the US Food and Drug Administration (FDA) approve Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to Access All the 2016 Data (Excel version available) for FREE! Gilead’s Harvoni (ledipasvir and sofosbuvir), with record sales of US $13.864 billion in 2015, had a slightly muted performance in 2016 as sales fell to US $9.081 billion (a drop of US $4.783 billion). Gilead failed to maintain its initial rate of new prescriptions, and competition from Merck and AbbVie forced it to offer major discounts to health insurers.  While Gilead executives still believe there is lots of growth left in the hepatitis C market, this year Gilead will continue to face headwinds as Merck's new combination pill — Zepatier — entered the market with a list price at US $54,600 for a 12-week regimen, well below the US $94,500 for Harvoni. Biological drugs, Enbrel (etanercept), Remicade (infliximab) and MabThera (rituximab), held onto their positions of 2015, although their combined sales increased a little over US $300 million. This means that for yet another year, the four best-selling drugs in the world are from biological origin. Celgene’s Revlimid (lenalidomide) — a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US $5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to the company's total sales of US $11.229 billion. With almost identical sales of US $6.7 billion, Roche’s cancer treatments Herceptin and Avastin were also into the top 10 best selling drugs in 2016, making Roche have the most number of products, three of which made it to the list. Click here to Access All the 2016 Data (Excel version available) for FREE! Facing onslaught of generics, biosimilars   Against the backdrop of questions being raised about insulin pricing and possible collusion in the United States, Sanofi saw its insulin treatment Lantus (insulin glargine) drop from number six on the 2015 list to number 9 in 2016 as sales fell by US $717 million to a little over US $6 billion. Sanofi’s competitors in the diabetes space — Novo Nordisk and Eli Lilly — also registered a drop in their insulin sales.  In addition to the pricing pressure, Sanofi will continue to contend with Lilly and Boehringer Ingelheim’s FDA approved biosimilar of insulin glargine — Basaglar — which was approved in December 2015. Click here to Access All the 2016 Data (Excel version available) for FREE! Basaglar is biologically similar to Sanofi’s Lantus and was announced at a price 15 percent lower than that of Lantus. GSK’s Advair, which is preparing for generic competition in 2017, saw its sales drop 5 percent in British Pounds to £3,485. However, the dollar value was significantly lower in view of the fall in the Pound’s value after Brexit.  AstraZeneca’s Crestor (rosuvastatin calcium), Otsuka’s Abilify (aripiprazole) and Novartis’ Gleevec (imatinib) all saw their sales crash in 2016 as a result of generic onslaught. The three drugs together witnessed a combined sales drop of US $5.7 billion. Top 20 drugs by sales   Here is PharmaCompass’ compilation of the best-selling drugs of 2016. 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 2016 data (Excel version available) for FREE!   S. No Product Active Ingredient Main Therapeutic Indication Company 2016 Revenue in Millions (USD) 2015 Revenue in Millions (USD) Sales Difference in Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) Abbvie 16,078 14,012 2,066 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead 9,081 13,864 (4,783) 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen/Pfizer Inc. 8875 8697 178 4 Remicade  Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson/Merck & Co 8,234 8,355 (121) 5 MabThera/Rituxan Rituximab  Oncology Roche 7227 6974.55 252 6 Revlimid Lenalidomide Oncology Celgene 6,974 5,801 1,173 7 Avastin Bevacizumab Oncology Roche 6,715 6,617 98 8 Herceptin Trastuzumab Oncology Roche 6,714 6,473 242 9 Lantus Insulin Glargine Diabetes Sanofi 6,057 6,773 (717) 10 Prevnar/Prevenar 13 Pneumococcal 13-Valent Conjugate Anti-bacterial Pfizer Inc. 5,718 6,246 (528) 11 Xarelto Rivaroxaban Cardiovascular Diseases Bayer/Johnson & Johnson 5,392 4,255 1,137 12 Eylea Aflibercept Ophthalmology Regeneron Pharmaceuticals, Inc./Bayer 5,046 3,978 1,068 13 Lyrica Pregabalin Neurological/Mental Disorders Pfizer Inc. 4,966 4,839 127 14 Neulasta Pegfilgrastim Blood Disorders Amgen 4,648 4,715 (67) 15 Seretide/Advair Salmeterol Respiratory Disorders GlaxoSmithKline 4,252 4,491 (239) 16 Copaxone Glatiramer Neurological/Mental Disorders Teva 4,223 4,023 200 17 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead 4,001 5,276 (1,275) 18 Tecfidera Dimethyl Fumarate Neurological/Mental Disorders Biogen 3,968 3,638 330 19 Januvia Sitagliptin  Diabetes Merck & Co 3,908 3,864 44 20 Opdivo Nivolumab Oncology Bristol-Myers Squibb 3,774 942 2,832   Blockbusters in the making   With almost US $5 billion in sales, a 14 percent growth over the previous year, Pfizer’s Lyrica enjoyed its last year before generic competition enters the market as Generics (UK) Limited (Mylan) and Actavis Group PTC ehf won a patent challenge in the United Kingdom. Lyrica generics are expected in the United States in late 2018. Click here to Access All the 2016 Data (Excel version available) for FREE! As Abbvie’s Humira begins to face competition from Amgen, Abbvie’s US $21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), which generated total 2016 sales of US $3.083 billion — an increase of US $1.64 billion over the previous year.  Anticoagulants, Xarelto (rivaroxaban), Eliquis (apixaban), Pradaxa (dabigatran) all registered significant positive growth with a combined increase of almost US $ 2.75 billion. Gilead and GSK’s combination HIV treatments — Genvoya and Triumeq — also reported sales increase of over a billion dollars each. Sign up, stay ahead   In order to stay informed, and receive industry updates along with our data compilations, 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 2016 Data (Excel version available) for FREE!  

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    #PharmaFlow by PHARMACOMPASS
    19 Apr 2017
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    Trump’s comments on drug prices sink pharma stocks; Teva lowers guidance by $ 1 billion

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

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

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    #Phispers by PHARMACOMPASS
    12 Jan 2017
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    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017.   Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).  The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed.   Top Ten Drugs by Cost, 2014 [Most expensive for Medicare]    Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13     $1,224,835 $94,218 Elaprase 100     $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60     $2,901,115 $48,352 Naglazyme 129     $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15     $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.  Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember.   View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!    

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    #PharmaFlow by PHARMACOMPASS
    05 Jan 2017
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    US probe crashes Indian pharma stocks; Sanofi, Novartis, GSK do not effectively disclose clinical trial data

    US probe crashes Indian pharma stocks; Sanofi, Novartis, GSK do not effectively disclose clinical trial data

    As India deals with new currency notes and the US elects Donald Trump as its new President, Phispers brings you the latest pharma news from both these countries. Probe into price collusion in the US resulted in pharma stocks tumbling in India. There is also news on a likely breakthrough in the treatment of diabetes, the latest on the vaccine scandal in China, compliance news from across the globe and more.   Drug firms in US face probe into price collusion; feel the pressure in pricing Last week, Senator Bernie Sanders asked the US Department of Justice and the Federal Trade Commission to investigate three insulin makers for price collusion. Citing 13 instances since 2009, he said the prices of Lantus (Sanofi’s blockbuster diabetes medication) and Levemir (Lantus' direct competitor, made by Novo Nordisk), “have gone up in tandem in the US”. And from 2014 to 2015, the price of both medications “went up by 29.9 percent”. Sanders’ letter also cites that Eli Lilly and other companies have been fined in Mexico for colluding on insulin pricing.   The letter has been sent at a time when Andy Slavitt, the acting administrator for the Centers for Medicare & Medicaid Services (CMS), condemned drug makers for cost increases.  Total prescription drug spending in 2015 was about US $ 457 billion, or 16.7 percent of healthcare spending. Based on recent trends, Slavitt said CMS is estimating average annual increases of 6.7 percent until 2025. However, drug makers are already feeling the pricing pressure. GlaxoSmithKline CEO Andrew Witty said the company has seen a 2 percent dip in net prices in the US this year, and expects further reductions driven by payer and hospital consolidation. In addition, new data-driven flexible pricing schemes being offered by Swiss drug-maker Roche and other drug companies are replacing the current “pay-per-pill” approach. These mechanisms are more popular in cancer treatment. Roche has introduced flexible pricing for cancer drugs in about a dozen European countries, including Italy, Belgium, Hungary, Switzerland and Austria.   Indian pharma stocks crash due to price collusion probes in the US The probes in the US are impacting share prices of Indian pharmaceutical companies, which together comprise the second-biggest suppliers of generic medicines to the US. The share prices of Indian pharma dipped amid mounting concerns about potential pressures on drug prices in the US, after news of a Justice Department probe. Prosecutors in the US are investigating generic pharmaceutical companies for suspected price collusion. Among the drug makers to have received subpoenas are companies like Mylan, Teva Pharmaceutical Industries, Actavis (which Teva bought from Allergan Plc in August), Lannett Co, Impax Laboratories, Covis Pharma Holdings Sarl, Sun Pharmaceutical Industries, Mayne Pharma Group, Endo International’s subsidiary Par Pharmaceutical Holdings and Taro Pharmaceutical Industries.    More arrests in Chinese vaccine scandal case In a crackdown on the black market sale of vaccines, China’s eastern province of Shandong saw 27 additional arrests, taking the total number of people arrested to 324. Nearly US $ 90 million worth of illegal vaccines are estimated to being sold in dozens of provinces across China. A mother-daughter duo — Pang Hongwei, a former pharmacist at a hospital in Shandong and her 21-year-old daughter — were caught peddling 25 kinds of unrefrigerated vaccines, which could have compromised inoculations and resulted in paralysis and even death. Probes found 300 illegal distributors aiding Pang across 24 provinces and regions. The drug regulator in Shandong said it would work with police forces and the health ministry to inspect vaccine stocks to ascertain where US $ 88 million worth of vaccines had ended up. The case – involving vaccines against meningitis, rabies and other illnesses – underlines the challenge being faced by China to regulate its fragmented supply chain. Fake vaccines scandals have been a public-health menace in other countries as well. For instance, it was learnt that substandard products had been distributed across Indonesia since 2003. As a result, the Indonesian government will reinoculate children aged 10 and below.  A diabetes breakthrough? Insulin resistance reversed by removal of proteinA team of investigators led by researchers from the University of California School of Medicine reportedly reversed diabetic insulin resistance and glucose intolerance in mouse models of obesity and diabetes by removing the protein – galectin-3 (Gal3).When you bind Gal3 to insulin receptors on cells, the protein prevents the insulin from attaching to the receptors, resulting in cellular insulin resistance. The researcher showed that by genetically removing Gal3 or using pharmaceutical inhibitors to target it, insulin sensitivity and glucose tolerance could be returned to normal, even among older mice. However, obesity remained unchanged. “This study puts Gal3 on the map for insulin resistance and diabetes in mouse model,” said senior author of the study. “Our findings suggest that Gal3 inhibition in people could be an effective anti-diabetic approach,” the author added.  Sanofi, Novartis, GSK do not effectively disclose clinical trial data, finds online tool A new online tool was launched last week by AllTrials, a consortium of researchers and medical journals that has been pushing the pharmaceutical industry to do a better job of disclosing clinical trial data. This is an important, though a contentious issue because without access to such data, independent researchers are unable to verify results that can lead to improved treatments, better healthcare, and lower costs. For instance, the tracker found that Sanofi had the largest number of missing trial results – there are 285 missing results from 435 eligible trials, which meant the company has not shared 65 percent of its findings. Among other transgressors is Novartis, which did not disclose results for 201 studies, or nearly 38 percent of 534 eligible trials. And GlaxoSmithKline failed to release findings for 183 trials, or almost 23 percent of 809 eligible studies.  Compliance news: Valeant, Resonance Labs in trouble; Mylan settles dispute with Strides FDA’s warning letter for Valeant: There is fresh trouble for Valeant Pharmaceuticals, which has been dealing with several problems, including a government probe into its accounting and pricing practices. The US Food and Drug Administration (FDA) has sent a warning letter to Valeant for its manufacturing problems that reflect an inability to integrate some of the products that have come into its fold through acquisitions. The letter describes how a Valeant production plant in Rochester (New York), which mostly makes products for the Bausch + Lomb division, experienced various problems with the OraPharma ONSET Mixing Pen — a compounding and dispensing device used for mixing two solutions together. “Organizational structure has not assured that acquired products are adequately integrated into your quality management system,” the letter said. Valeant acquired OraPharma in 2012. Compliance trouble for Resonance Labs: Indian API manufacturer Resonance Labs is in compliance trouble as Health Canada has placed it on its Inspection Tracker, based on information obtained from a regulatory partner regarding general GMP observations. Usually alerts from Health Canada are followed by either a warning letter from the FDA or a Non-Compliance Report from the European authorities. Mylan and Agila settle dispute over pending payments: Mylan NV’s US $ 1.6 billion cash acquisition of Agila Specialties (a developer, manufacturer and marketer of high-quality generic injectable products) in 2013 from India’s Strides Arcolab had run into compliance problems. Within a year of acquiring Agila, Mylan had received a notice from the FDA regarding violations of GMPs. But last week, Mylan settled its two-year old dispute over pending payments with Strides. Mylan received US $ 170 million as final settlement. Lupin receives EIR from FDA for Goa plant: In June we had asked how long it would take for Lupin to address FDA’s concerns pertaining to its Goa facility. And we were positively surprised this week when Lupin announced a successful closure of the inspection. Lupin received the Establishment Inspection Report (EIR) from the US health regulator for its Goa plant leading to closure of all outstanding inspections of the facility. Old Ranbaxy facility being inspected by FDA: Next up is Sun Pharmaceuticals, as the US FDA commenced its scheduled inspection of the Mohali manufacturing site of Ranbaxy. Sun had acquired Ranbaxy two years back as part of a US $ 4 billion deal with Japanese drug maker Daiichi Sankyo. As per news reports, the inspection started on November 7, and may continue for a week.   GSK sues Pfizer, as both companies announce plant closures Last week, both GlaxoSmithKline and Pfizer made announcements regarding shutting down manufacturing plants. GSK Consumer Healthcare announced it will close its manufacturing facility in Ermington (Australia) in 2020. And US drugs behemoth Pfizer said it will close two manufacturing sites in the UK by 2020, resulting in 370 job losses. The Park Royal site in London, which Pfizer inherited when it acquired Hospira in September this year, will shut down by May 2017. The site takes liquid medicines and puts them into dosed vials, which are then sold to hospitals. The global cold chain packaging and distribution site in Portsmouth will shut by the end of 2020. The Pfizer spokesperson said the decision has nothing to do with Brexit. The global packaging site will be consolidated in Puurs (Belgium), “where there are better production capabilities to support the product pipeline”, the spokesman added. Meanwhile, British drug giant, GSK has filed a patent infringement lawsuit against Pfizer over allegedly copying its popular meningococcal group B vaccine – Bexsero. The drug competes with Pfizer’s Trumenba. Meningococcal disease is a potentially fatal bacterial infection of the bloodstream, brain and the spinal cord lining. GSK’s Bexsero is currently the only vaccine against the disease that is available in most markets. And the legal step taken by GSK represents its desire to protect the drug’s powerful market share.  Biotech startup Cempra’s woes continue Last week, Wockhardt’s ambitious turnaround plans received a serious setback when Cempra — a clinical-stage pharma company focused on developing antibiotics — learnt that the US 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. A regulatory panel of experts on November 4 narrowly recommended that Solithromycin — an antibiotic from Cempra being projected as an answer to the menace of antibiotic resistance — should be approved for use. The 7-to-6 votes in favour of Solithromycin suggests that there is an unmet need for new treatments that outweigh the safety concerns surrounding the product. The Wall Street had forecasted Solithromycin to be a blockbuster. Little wonder then that the investors were rattled last week and the stock plunged 58 percent after the US FDA disclosed its review.     

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    10 Nov 2016
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    India steps up efforts to improve drug quality; Allergan vows to limit price hikes

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

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

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    08 Sep 2016
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    Sanofi’s rough week; Quality snags at Pfizer; FDA warns against commonly used drug

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

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

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    #Phispers by PHARMACOMPASS
    25 Aug 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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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    10 Mar 2016
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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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