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Top drugs and pharmaceutical companies of 2019 by revenues

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

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29 Apr 2020

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Top drugs by sales in 2017: Who sold the blockbuster drugs?

The year 2017 was a landmark year for pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. Sales for most major pharmaceutical companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has generated investor hopes for accelerated dividend growth and share buyback plans. This week, PharmaCompass brings you a compilation of the top drugs of 2017 by sales revenue. Click here to Access All the 2017 Data (Excel version available) for FREE! Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second There wasn’t any upheaval at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant Humira (adalimumab), which is approved to treat psoriasis and rheumatoid arthritis, added almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues. Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The company believes this drug will continue to be a significant cash contributor until 2025 and the US $21 billion sales forecast by 2020 is about US $3 billion higher than its expectation two years ago. In 2016, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) — received approval from the FDA and European authorities. Click here to Access All the 2017 Data (Excel version available) for FREE! Enbrel (etanercept), the longest-used biologic medicine for the treatment of rheumatism around the world, was the second best-selling drug with US $8.262 billion in 2017 sales. The sales of the drug were down from US $9.366 billion in 2016 owing to lower selling prices and increased competition, which in turn hurt demand. Since it was first approved in the United States in 1998, Enbrel has been approved in over 100 countries and the drug is promoted by Amgen, Pfizer and Takeda in different geographies. Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August 2016 for the treatment of patients with rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and other diseases is still not on the market because of a patent-protection challenge from Amgen. Amgen is arguing in the US federal court that its drug has patent protection until 2029. Click here to Access All the 2017 Data (Excel version available) for FREE! Fast-growing drugs: Eylea and Revlimid bring fortunes for Regeneron and Celgene Regeneron’s flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in annual sales last year to record US $8.260 billion in total sales. Eylea net sales grew 11 percent year-on-year in the US and 19 percent year-over-year outside the US. The company believes much of the recent growth in the US was driven by demographic trends with an aging population as well as an overall increase in the prevalence of diabetes. These demographic trends are expected to continue in the coming years, providing an opportunity for continued growth. Eylea sales alone contribute 63 percent to Regeneron’s total sales. Click here to Access All the 2017 Data (Excel version available) for FREE! 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 an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion. Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion. Celgene received a setback this month as the USFDA refused to consider Celgene’s application for ozanimod, an experimental treatment for relapsing multiple sclerosis. The treatment was being seen as a key to the company’s fortunes as Celgene had said ozanimod is worth US $4 billion to US $6 billion a year in peak sales. Click here to Access All the 2017 Data (Excel version available) for FREE! Gilead’s Hepatitis C franchise enters free fall Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the competitive heat as they registered US $9.137 billion in 2017 sales, down from US $14.834 billion the previous year. While reporting 2017 results, Gilead provided guidance for 2018 and said its sales of Hepatitis C drugs could fall further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated US $19.1 billion in sales. One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret at a deep price discount to the competition. AbbVie also claims to have the shortest treatment course at eight weeks, compared with 12 weeks or longer for other treatments. AbbVie reported US $1.274 billion in Hepatitis C drug sales in 2017, down from US $1.522 billion in 2016. Click here to Access All the 2017 Data (Excel version available) for FREE! Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year. The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe) and Vytorin (Ezetimibe and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark Pharmaceuticals entered into an agreement that allowed Glenmark to launch a generic version of Zetia in late 2016. The drugs that had combined sales of US $3.701 billion in 2016 felt the generic heat in 2017 and the sales were US $1.606 billion lower at US $2.095 billion. Click here to Access All the 2017 Data (Excel version available) for FREE! GSK’s Advair, which was expected to encounter generic competition in 2017, continued to breathe easy as the FDA found deficiencies in the applications of Hikma, Mylan and Sandoz. All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017. Top 15 drugs by sales Here is PharmaCompass’ compilation of the best-selling drugs of 2017. 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 2017 data (Excel version available) for FREE! S. No. Company / Companies Product Name Active Ingredient Main Therapeutic Indication 2017 Revenue in Millions (USD) 1 AbbVie Inc., Eisai Humira® Adalimumab Immunology (Organ Transplant, Arthritis etc.) 18,946 2 Amgen, Pfizer Inc., Takeda Enbrel® Etanercept Immunology (Organ Transplant, Arthritis etc.) 8,262 3 Regeneron, Bayer Eylea Aflibercept Ophthalmology 8,260 4 Celgene Revlimid Lenalidomide Oncology 8,187 5 Roche MabThera®/Rituxan® Rituximab Oncology 7,831 6 Johnson & Johnson, Merck, Mitsubishi Tanabe Remicade® Infliximab Autoimmune Disorders 7,784 7 Roche Herceptin® Trastuzumab Oncology 7,435 8 Bristol-Myers Squibb, Pfizer Inc. Eliquis® Apixaban Cardiovascular Diseases 7,395 9 Roche Avastin® Bevacizumab Oncology 7,089 10 Bayer, Johnson & Johnson XareltoTM Rivaroxaban Cardiovascular Diseases 6,590 11 Bristol Myers Squibb, Ono Pharmaceutical Opdivo Nivolumab Oncology 5,815 12 Sanofi Lantus Insulin Glargine Diabetes 5,731 13 Pfizer Inc. Prevnar 13/Prevenar 13 Pneumococcal 7-Valent Conjugate Anti-bacterial 5,601 14 Pfizer Inc., Eisai Lyrica Pregabalin Neurological/Mental Disorders 5,318 15 Amgen, Kyowa Hakko Kirin Neulasta® Pegfilgrastim Blood Disorders 4,553 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 2017 Data (Excel version available) for FREE!

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29 Mar 2018

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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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05 Oct 2017

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Axovant’s hyped Alzheimer’s drug fails trial as Pfizer emulates Axovant; Amneal and Impax in merger talks

This week in Phispers, we bring you news about intepirdine, Axovant’s experimental drug for Alzheimer’s disease, on which both patients and investors had vested much faith. The drug failed primary endpoints. Meanwhile, Pfizer is emulating the Axovant strategy as it split four of its clinical-stage orphan drugs into a new company. There was more bad news for Biocon-Mylan, as Amgen filed a patent infringement case against Mylan in the US. Novartis’ new CEO says it will reduce the development cost of drugs by relying on data science. And, there is news on NASH drugs and on merger talks between Amneal and Impax Labs. Axovant disappoints investors; its Alzheimer’s drug fails primary endpoints After two years of brouhaha by investors, Axovant’s experimental drug intepirdine, as a treatment for mild to moderate Alzheimer’s disease, turned out to be a damp squib. The experimental drug did not meet its co-primary efficacy endpoints, a press release issued by Axovant said. The medicine turned out to be no different from 99 percent of medicines tested against Alzheimer’s. Investors had poured millions of dollars into Axovant. According to an estimate compiled by Bloomberg, intepirdine was expected to generate more than US$ 2 billion in sales for Axovant by 2023. But that was not to be. At 24 weeks, patients treated with 35 mg of intepirdine did not improve on either of two surveys — the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) — compared to patients treated with placebo. Back in 2015, Axovant — a company founded by Vivek Ramaswamy — had bought intepirdine from GlaxoSmithKline for US$ 5 million and launched Axovant’s US$ 315 million IPO around the drug. That’s when PharmaCompass had raised the question — has 29 year-old Ramaswamy shown GlaxoSmithKline that it made a billion dollar mistake by selling of its old Alzheimer drug to him? In April this year, Ramaswamy stepped down as CEO of Axovant by appointing former chief executive of Medivation, David Hung, in his place. Medivation got sold to Pfizer for US$ 14.3 billion last year. Last month, Ramaswamy’s Roivant (Axovant’s biggest shareholder) raised US$ 1.1 billion from big investors lead by Softbank’s Vision Fund. Roivant also raised millions of dollars from hedge funds like Viking Global Investors. These investments diluted the stakes of Ramaswamy and other initial investors in Roivant. But Ramaswamy is laughing all the way to the bank. Through divestments, he has secured a war chest for Roivant, which has been spinning out new companies with names ending with ‘vant’ — such as Axovant (neurology), Myovant (women's health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Pfizer emulates Axovant; Ibrance maybe a US$ 5 billion drug next year Even as Axovant’s intepirdine failed to meet primary endpoints, the American pharmaceutical behemoth Pfizer seems to have taken a leaf out of its strategy book. Pfizer’s R&D strategy executive Lara Sullivan gained the company’s support to split four of its clinical-stage orphans into a new company called SpringWorks Therapeutics. And much like Axovant, Pfizer too is starting out with a mega-round of US$ 103 million in venture capital funding. SpringWorks is getting considerable financial support from Pfizer and funds like Bain Capital Life Sciences, Bain Capital Double Impact, Orbimed and LifeArc. Pfizer has spent US$ 24 billion over the past three years on R&D, the third highest R&D spend amongst pharma companies. Along with drug-focused acquisitions, Pfizer has spent US$ 43 billion in the same period. Ibrance to brighten up Pfizer’s fortunes: Meanwhile, Pfizer’s breast cancer drug Ibrance now competes with Novartis’ Kisqali. It will also compete with Lilly’s forthcoming drug abemaciclib. Though side effects are an issue for all the three drugs, Ibrance is expected to brighten up Pfizer’s fortunes. According to Morgan Stanley, Ibrance could bring in sales of US$ 939 million in the third quarter and US$ 1 billion in the fourth quarter, leading to US$ 3.5 billion in sales for 2017. And in 2018, Ibrance could fetch US$ 4.85 billion in sales. Novartis vows to slash drug development costs, while FDA terms system ‘broken’ The time and cost of taking a medicine from discovery to market has for long been seen as a drag on the pharmaceutical industry’s performance. The process has been estimated to take up to 14 years and cost at least US$ 2.5 billion. Last week, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the clinical trials system is “broken” and there needs to be new ways to collect and utilize patient data. She was speaking at a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine. This week, the incoming chief executive of Novartis, Vas Narasimhan, has vowed to slash drug development costs, and save up to 25 per cent on multibillion-dollar clinical trials as part of a “productivity revolution” at the company. Quoting analysts, Narasimhan said between 10 and 25 per cent of trial costs could be reduced if digital technology were used to carry them out more efficiently. The Swiss drug major has 200 drug development projects under way and is running 500 trials. Therefore, digital technology “will have a big effect if we can do it at scale,” he added. Narasimhan plans to partner with, or acquire, artificial intelligence and data analytics companies, to supplement Novartis’s strong but “scattered” data science capability. After Pfizer, Takeda may soon exit Brazil; seeks suitors for Multilab Not long ago, Brazil was one of the hottest emerging markets for drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that has dampened drug demand. In July this year, Pfizer relinquished its 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro — for a paltry 1 Brazilian Real (or US$ 0.30) to the heirs of the company. Pfizer had acquired the stake for US$ 240 million back in 2010. And this month, it looks like Japan's largest pharmaceutical company Takeda is following Pfizer’s footsteps and is going to dispose off its 2012 acquisition of Multilab laboratory (which it had acquired for Brazilian Real 500 million or US$ 158 million). According to news reports, Takeda may recover only a fifth of its original investment (of Brazilian Real 100 million or US$ 31.57 million). Takeda is expected to receive proposals for Multilab from mutual funds and domestic companies with similar business interests. FDA issues warning on Ocaliva (obeticholic acid) use; Allergan’s NASH drug also stumbles The US FDA issued a warning as 19 patients died after taking Intercept’s liver disease drug Ocaliva. The company responded by saying the dosing administered was incorrect. In most cases, the exact cause of death wasn’t known. But seven of the patients who died were taking Ocaliva more frequently than recommended, the FDA said. Earlier this month, Intercept had warned doctors that Ocaliva can cause injuries, organ failure, or death if it’s not used exactly as intended in patients with primary biliary cholangitis, a relatively rare liver condition for which the drug was approved last year. The company says it is working with the FDA on revised labeling aimed at more clearly indicating the recommended dosing regimen for all patients. Intercept is in the final stages of testing Ocaliva for nonalcoholic steatohepatitis, or NASH, a silent disease in which the liver gets inflamed and damaged due to a buildup of fat. Dozens of pharma companies including Gilead Sciences, Allergan and Intercept Pharmaceuticals are trying to develop a treatment for the disease. Over the last two years, at least six deals valued at US$ 3.52 billion or more have taken place involving drugs that target various aspects of NASH. Meanwhile, Allergan’s Cenicriviroc (CVC) showed mixed results in a Phase 2b clinical trial. CVC is facing trials for the treatment of liver fibrosis in adult NASH patients. The trial involved a two-year study. According to Seeking Pharma, 20 percent of patients in the placebo arm during year one who crossed over to receive CVC during year two achieved the combined endpoint of reduction in fibrosis by at least one stage and no worsening of NASH compared to 13 percent for those who continued on placebo. However, “there was no difference between CVC and placebo in patients who remained on treatment for two years as determined by the composite endpoint,” it added. Another setback for Biocon/Mylan, as Amgen files patent infringement case in US News doesn’t seem to be getting better for the Biocon/Mylan combine. First, they withdrew their applications for the trastuzumab and pegfilgrastim biosimilars from Europe. And then, the FDA extended the target action date for their trastuzumab biosimilar. Now, the duo will be facing Amgen in court to defend themselves in a patent infringement case. Last week, Amgen filed a complaint for patent infringement under the Biologics Price Competition Innovation Act (BPCIA) against Mylan, which is developing a biosimilar of its drug Neulasta (pegfilgrastim). Approval delays, spiraling compliance costs and now litigation expenses won’t help the profitability of Mylan-Biocon’s endeavors. In Europe, competition is already moving ahead as the EMA’s Committee for Medicinal Products for Human Use recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant. This is the fourth patent litigation under the BPCIA regarding a proposed biosimilar of Neulasta, none of which are yet FDA-approved. Amneal in merger talks with Impax Laboratories Analysts have been predicting a consolidation in the world of generics. According to reports, Impax is in merger talks with generics competitor Amneal Pharmaceuticals. The deal would value Impax at US$ 2 billion or more. According to FiercePharma, the talks could result in a deal next month. Impax is headed by Paul Bisaro (who quit Allergan to join Impax in March this year). He has considerable experience in M&As. Last year, Bisaro sold off part of Allergan’s business to Teva Pharmaceuticals in a US$ 40.5 billion deal. And last month, Shanghai Fosun Pharmaceutical picked up a 5.2 percent stake in Impax. Amneal, on the other hand, is owned by Chintu and Chirag Patel.

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28 Sep 2017

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

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

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24 Aug 2017

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

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

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17 Aug 2017

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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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13 Jul 2017

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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

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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15 Jun 2017

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US introduces bills to let FDA recall unsafe drugs, allow drug imports from Canada

In Phispers this week, we bring you news on two new bills in the US that seek to bring in cheaper medicines from Canada, and allow FDA to recall unsafe drugs. We also bring you the real reason why Sanofi, even after offering US$ 30 billion, could not bag Actelion. And, there is news on gene-editing technology CRISPR and Mylan and Biocon’s application for Pegfilgrastim, a proposed biosimilar. Read on. US introduces bill to allow FDA to recall unsafe drugs In the United States, Republican Rosa DeLauro introduced a new bill last week that will allow the US Food and Drug Administration (FDA) to do what many assume it already can require pharmaceutical or over-the-counter drug (OTC) companies to stop marketing unsafe products. The law will also cover homeopathic products. The bill, once passed, will be known as the Recall Unsafe Drugs Act. Once enacted, this law will give FDA mandatory recall authority over drugs and homeopathic products. “Most people would be shocked to learn that while the FDA has the authority to order a recall of medical devices and biologic products, such as vaccines and blood products, the agency cannot order recalls of prescription and over-the-counter medications,” DeLauro said. This loophole is problematic, as some companies can refuse FDA’s calls to remove their pharmaceutical products from the market because they are unsafe. New bill in US pushes for drug imports from Canada, while industry resists it The Trump administration appears committed to providing cheaper medicines. A new bill the Safe and Affordable Drugs from Canada Act would require the FDA to set up a “personal importation program” to allow individuals to import 90-day supplies of their medicines from Canadian pharmacies. The bill has been drafted by Senators Amy Klobuchar, Chuck Grassley and John McCain. However, the pharmaceutical industry is pushing back. In a statement to FiercePharma, the Pharmaceutical Research and Manufacturers of America (PhRMA) pointed to a Drug Enforcement Administration report last year that mentioned to how counterfeit fentanyl from China made its way to the US through Canada and Mexico, worsening the current opioid crisis. Imports “would exacerbate these threats,” a PhRMA spokesperson said. Imported drugs wouldn’t “be subject to the US FDA’s robust safety requirements, and there would be no way to trace the country of origin for the imported products. Even Canada has said it does not and would not be able to guarantee that US citizens would receive products that are safe, effective and of high quality,” the spokesperson added. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.” A fortnight back, PharmaCompass carried a news on Marathon Pharmaceuticals, which received FDA approval for Emflaza (deflazacort) to treat rare genetic disorder Duchenne muscular dystrophy (DMD). The drug carries a list price of US$ 89,000 for a year’s supply, when patients in the US are importing it from Canada and the UK for around US$ 1,000 to US$ 2,000. Prospectus highlights Sanofi’s struggles in J&J’s US$ 30 billion acquisition of Actelion Sanofi made headlines recently, not for the acquisitions it made, but for the one it wasn’t able to close. Late last year, the French pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion, which had started back in January 2016. The Actelion-J&J deal prospectus offers insights into why Sanofi (identified as Company A) failed in its US$ 30 billion acquisition even though it would have delivered “approximately equivalent value to Actelion’s shareholders”. According to the deal prospectus, even though Sanofi had bid a higher indicative price, the board of directors of Actelion perceived ‘significant uncertainty’ posed by a potential transaction with Sanofi. The uncertainty was created when, “Sanofi indicated that it would only be willing to proceed with a transaction on the basis of a price lower than its previously communicated offer price and on different terms”. While the deliberations have been on since January 2016, last month the board of Actelion felt “J&J’s proposal offered significantly greater transaction certainty because the transaction documentation was nearly final and because J&J had already completed the required due diligence”. Sarepta sells priority review voucher to Gilead for US$ 125 million Sarepta Therapeutics has sold its priority review voucher (PRV) to Gilead for US$ 125 million. The voucher is awarded under the rare pediatric PRV program. It speeds up the US FDA approval process for any future drug or biologic from 10 months to six months. For Gilead, this is the third PRV it has purchased. Last year, it bought PaxVax’s PRV for about US$ 200 million and in 2014 it bought Knight Therapeutics’ PRV for US$ 125 million. The voucher was awarded to Sarepta after it won FDA approval for its DMD drug Exondys 51 (eteplirsen) in September 2016. Sarepta’s pricing is a far-cry from the most expensive PRV ever sold by United Therapeutics to AbbVie for US$ 350 million in August 2015. It will be interesting to see what Marathon Pharmaceuticals who also received the most recently awarded PRV for its DMD drug Emflaza (deflazacort) uses their voucher for after an “outrageous” pricing controversy paused the sales of their product. With the passage of the 21st Century Cures law, the number of PRVs on the market is likely to increase. This legislation reauthorizes the rare pediatric PRV program until October 2020. Broad Institute to keep valuable patents on gene-editing technology — CRISPR A biological and genomic research center affiliated with MIT and Harvard known as the Broad Institute will keep valuable patents on a revolutionary gene-editing technology known as CRISPR. A US patent agency Patent Trial and Appeal Board in Alexandria, Virginia rejected a claim by a rival team associated with the University of California at Berkeley and University of Vienna in Austria that they invented the technology first. CRISPR is a biotechnology innovation that makes it easier for scientists to edit DNA in living cells. It works as a type of molecular scissors that can trim away unwanted pieces of genetic material, and replace them with new ones. The patent rights for Broad Institute could be worth billions of dollars, as the technology could revolutionize treatment of genetic diseases, crop engineering and other areas. In 2012, a research team led by Berkeley’s Jennifer Doudna and Vienna’s Emmanuelle Charpentier was first to apply for a CRISPR patent. Months later, a team at Broad Institute, led by MIT’s Feng Zhang, applied for a patent by opting for a fast-track review process. It obtained a CRISPR patent in 2014, and has since obtained additional patents. Meanwhile, Berkeley is not the least bit happy with the ruling and may appeal. USFDA accepts Mylan and Biocon’s second biosimilar application of Amgen’s Neulasta Last week, Mylan and Biocon announced that the US FDA has accepted Mylan’s Biologics License Application (BLA) for Pegfilgrastim, a proposed biosimilar. This product is a biosimilar version of Amgen Inc’s branded drug Neulasta, which is used to reduce the chance of infection due to low white blood cell count and incidence of fever in patients treated with chemotherapy in certain types of cancer. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. Pegfilgrastim is one of the six biologic products co-developed by the companies. The FDA goal date set under the Biosimilar User Fee Act is October 9, 2017. The two companies have already filed biosimilar pegfilgrastim with regulators in Europe, Australia and Canada. Mylan President Rajiv Malik commented: “We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.”

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23 Feb 2017

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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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10 Mar 2016

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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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