Prescribed Reading: Consolidation, clinical holds and landmark results
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
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- Spotlight on the evolving pharma salesforce
- Judge denies industry pushback on Nevada law
Mergers & analysis
Teva Pharmaceutical Industries Ltd. kept the deal ball rolling this week as the company attempts anything it can to monetize assets and bring down debt. After selling off the copper intrauterine device Paragard last week for over $1 billion, the company made two more deals this week — worth a combined $1.4 billion — to sell off the remainder of its women's health biz.
The beleaguered Israeli company has finally picked up a new CEO and is trying to pay down its $35 billion debt, while moving back it its generics base. This turnaround story is still in the first chapter, but it's definitely off to a compelling start.
Elsewhere, consolidation continued in the contract research, development and manufacturing sector, with Catalent picking up Cook Pharmica for $950 million. While one of the smaller deals in the space, it is just the latest.
In a special twist, UltraGenyx has put its hat in the ring for Dimension Therapeutics. Regenxbio announced a deal with Dimension earlier this summer, but UltraGenyx is swooping in with a better offer. UltraGenyx is offering $5.50 per share, while Regenxbio's offer was worth $3.41 per share. Both companies are trying to snag Dimension's rare disease gene therapy pipeline.
Alnylam pleased shareholders this week, producing results in a Phase 3 study that finally validated its RNA interference (RNAi) technology. The company has been around for more than a decade and has had a number of setbacks. If it can get patisiran to succeed, it would be the first RNAi drug to be approved.
A Phase 3 success for AbbVie and Roche's Venclexta could expand the market for the leukemia drug. Venclexta (venetoclax) could be a complementary drug to AbbVie's blockbuster Imbruvica, which it picked up in its $21 billion acquisition of Pharmacyclics. AbbVie's shift to oncology could help it buffer losses of the blockbuster rheumatoid arthritis drug Humira as it faces biosimilar competition.
Meanwhile, industry lobbying group PhRMA is trying to highlight progress being made in the Alzheimer's disease development pipeline. Yet, a recent report showed that there were only 87 medicines in development. While it sounds like a lot, the track record for these drugs is dismal. The report shows that only four drugs have been approved between 1998 and 2014, while more than 123 drugs have failed during that time.
The Food and Drug Administration continued its mass clinical hold, this time halting trials of Roche's Tecentriq. The agency has been shutting down trials of PD-1/L1 inhibitors being tested in combination with immunomodulating drugs in blood cancers after multiple patient deaths in several of Merck & Co.'s Keytruda (pembrolizumab) trials.
While the FDA is just being cautious, the continued clinical holds raise some major concerns about the future of the class of drugs — a class that at least a few big pharmas have been depending on.
The FDA took some positive action for GlaxoSmithKline, approving its triple combo inhaler for chronic lung disease. The approval signals one of the first big wins for new CEO Emma Walmsley and her massive restructuring plan, as well as a follow-on to the company's blockbuster Advair, which has been facing the threat of generic competition.
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