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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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Sales Forecast of FDA’s New Drug Approvals of 2017

2017 was a landmark year for the pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both the geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, a strong bounce back from only 22 NMEs approved in 2016. The 46 approvals by the USFDA’s Center for Drug Evaluation and Research (CDER) is the second highest total 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. We also identified eight drugs that got approved in Europe before winning the USFDA nod. This week PharmaCompass shares its compilation of the 46 novel drugs approved in the US, of which 34 (or 74 percent) were small molecules and 12 (or 26 percent) were biologics, which were approved by the USFDA. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! We have also evaluated these new drug therapy approvals with regard to their estimated sales potential. While the sales estimates of a new drug are far from certain, our effort is directed at providing insights into the potential these drugs hold along with attempting to identify emerging market trends. An overview of USFDA’s approvals The USFDA’s CDER focusses extensively on the approval of novel drugs “which are often among the more innovative products in the marketplace, and/or help advance clinical care by providing therapies” that have never before been marketed in the United States. In addition, CDER also looks at new and expanded uses of USFDA-approved drugs. In 2017, the CDER also worked on approving five new biosimilar drugs, which are highly similar to the USFDA- approved therapeutic biological products. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! New formulations or new manufacturers of USFDA-approved products that can provide advantages over original products, such as being able to take the drug on an empty stomach and not with food, were also approved. New dosage forms entered the market that add value to already approved drugs, such as chewable tablets for patients unable to swallow pills and Abilify MyCite (aripiprazole tablets with a sensor). Aripiprazole was first approved by the USFDA in 2002 as a tablet to treat patients with schizophrenia and was marketed under the brand name Abilify. In 2017, Abilify MyCite was approved as a tablet which contains an electronic sensor. Abilify MyCite allows the patient to track whether he or she has taken the medication via a smartphone or the cloud. Patients can also give their caregivers or physicians access to the information through a web-based portal. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! In the list of 2017 approvals, CDER identified 15 of the 46 novel drugs approved in 2017 (33 percent) as first-in-class while 18 drugs (39 percent) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans. Of the 46 novel drugs approved in 2017, 36 (78 percent) were approved in the United States before receiving approval in any other country. The American stars of 2017, by sales revenue Of all the drugs approved by the USFDA, the highest expectations are from Regeneron and Sanofi’s first-in-class monoclonal antibody (mAb) — dupilumab. The (IL)-4 receptor subunit-α antagonist has shown benefits in various kinds of inflammatory and allergic diseases. While the USFDA approved the drug for atopic dermatitis, it is also being developed for asthma, chronic obstructive pulmonary disease (COPD) and other indications. Evaluate Pharma analysts estimate the sales of dupilumab at US$ 4,938 million by 2022. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! Expectations are also high from two other mAb products. Genentech and Roche’s anti-CD20 mAb ocrelizumab for relapsing and primary progressive forms of multiple sclerosis is expected to bring in US$ 4,088 million by 2022 while Pfizer’s avelumab, an anti-PD L1 cancer drug co-developed along with Merck KGaA, which was approved to treat metastatic Merkel cell carcinoma, is expected to achieve peaks sales of US$ 4-6 billion with an estimated US$ 3 billion in annual sales for Pfizer. In late 2015, AstraZeneca partnered with Acerta Pharma to develop a potential best-in-class irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor — acalabrutinib. AstraZeneca acquired 55 percent equity in Acerta for an upfront payment of US$ 2.5 billion and should have completed its payment of an additional US$ 1.5 billion now that the USFDA has approved the cancer drug, which is estimated to have peak sales of US$ 2,500 million. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! Also expected to bring in US$ 2,500 million in sales is Novartis’ treatment for postmenopausal women with a type of advanced breast cancer — ribociclib. While the USFDA approved the drug in March 2017, the EMA approved it in August 2017. The European specials of 2017 While many drugs were approved in the United States before being approved in Europe, PharmaCompass has identified 8 active substances which have not been approved in the US but got EMA approval in 2017. AstraZeneca’s treatment for hyperkalaemia — Lokelma (sodium zirconium cyclosilicate) — got approved by the EMA. However, the FDA did not approve it after the agency raised concerns over the manufacturing of the drug following an inspection of the facility. Lutathera — a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs — got approved by the EMA and its developer Advanced Accelerator Applications (AAA), who in turn got bought over by Novartis for US$ 3.9 billion. The application for Lutathera has been filed with the USFDA. Under the Prescription Drug User Fee Act (PDUFA), the agency is scheduled to make a final approval decision this week (on January 26, 2018). Tivozanib (Fotivda, an oral, once-daily, vascular endothelial growth factor or VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma was also approved in Europe before getting the nod in the US. Our view While the USFDA’s CDER approved the highest number of drugs in two decades, the approvals of the year were done by USFDA’s Center for Biologics Evaluation and Research (CBER) which approved two cell-based gene therapies. Novartis’ Kymriah (tisagenlecleucel), the first-ever gene therapy — known as CAR-T (short for chimeric antigen receptor T-cell) — was approved for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). In its press statement, the USFDA described this as a “historic action”. CAR-T is a type of cancer immunotherapy that harnesses the body’s immune system to fight cancer cells. In this case, the therapy removes a person’s cells, reengineers them and then puts them back in their body to attack cancer cells. In CAR-T therapy, every single dose of the treatment is unique and completely personalized to the patient. The Novartis drug came with a list price of US$ 475,000 for a one-time treatment. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE! Gilead also bet big on the technology and acquired Kite Pharma for US$ 11.9 billion in August. The USFDA also approved Kite’s most advanced CAR-T therapy candidate — axicabtagene ciloleucel (axe-cel). Gilead announced a price significantly lower than the launch price at which Novartis is selling its CAR-T treatment (Kymriah). With Novartis and AstraZeneca getting three therapies approved, Pfizer, Roche, Valeant and the team of Sanofi and Regeneron bagging two each and almost half the drugs approved by the USFDA’s CDER in 2017 expected to generate more than US$ 1 billion in sales, things look promising for innovation in pharmaceuticals and also provide interesting opportunities for generic drug manufacturers. Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!

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25 Jan 2018

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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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Find PharmaFlow Article for Ribociclib

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