Prescribed Reading: Rough start for pharma, but optimism abounds
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
- Celgene highlights pipeline progress.
- Sanofi sues Mylan over missed Auvi-Q opportunity.
- Q&A with ASLAN CEO Carl Firth about the Asia market.
Mergers & analysis
First quarter earnings kicked into high gear this week for pharma, with more than a half dozen companies reporting financials on Thursday alone. As Johnson & Johnson's earnings report foretold last week, this was a bumpy start to the year for many big pharmas, but the tone of virtually all of the investor calls was one of optimistism and expectation for growth going forward.
Amgen reported Enbrel earnings that were down 15%, AstraZeneca continued to feel the brunt of generic competition to its once-blockbuster Crestor, Biogen highlighted the upcoming threat to its multiple sclerosis franchise from Roche's recently approved Ocrevus, and Roche is keenly feeling the threat to its top three earners from biosimilars.
Yet, amidst all the turmoil, there were a few shining moments this week. AbbVie talked candidly about the surplus of cash its has — about $8.2 billion —from the continually impressive sales of Humira, giving it the flexibility to do business development any way it wants, even as its pipeline barrels forward. Bristol-Myers Squibb shocked everyone when it reversed itself on previous comments about its position in lung cancer. Opdivo continues to have more than $1 billion in sales a quarter and will grow in 2017.
Elsewhere, Sarepta CEO Ed Kaye announced during a first quarter earnings call that he will step down from the company in September. Kaye was long-time chief medical officer at the biotech and stepped into the lead role in 2015 amidst a swirl of controversy and problems. He successfully navigated the company to a Food and Drug Administration approval (albeit, one that has been hotly debated).
Kaye's departure fuels speculation that Sarepta is now a potential takeout target. Wait and see.
The Medicines Co. and partner Alnylam Pharmaceuticals announced Wednesday that they will be starting their cardiovascular outcomes trial for their PCSK9 synthesis inhibitor, as well as an ambitious 3,000-patient Phase 3 program. The drug is a closely watched follow-on to the major flops that Sanofi/Regeneron and Amgen, respectively, began marketing in the last couple of years.
Both Praluent and Repatha continue to struggle and have widely missed the uber-blockbuster projections that were once predicted for them. The problem for The Medicines Co. just may be that it is currently making an extremely large investment in a drug that doesn't have any commercial potential. For MedCo and Alnylam, the biggest hurdle may not be the data, but building a non-existent market.
Scott Gottlieb moved one step closer to becoming the Food and Drug Commissioner this week when the Senate's Health, Education, Labor and Pensions Committee voted in favor of his appointment in a 14 to 9 vote that was largely split down party lines.
Gottlieb has, for the most part, been seen as the best possible candidate for the post of all the names that were thrown around. Any opposition that has come up has been due to his potential conflicts of interest due to his years as a consultant to the pharma industry — he has essentially made millions of dollars off the companies he will now be tasked with regulating.
The nominee has acknowledged those conflicts and offered to recuse himself for the first year from any decisions that involve 20 specific companies for which he's done work. While it's an imperfect solution, Gottlieb's next step will be a vote on the Senate floor. Expect opposition to continue raising concerns, but expect Gottlieb to move into the role by mid-May.
Also this week, the FDA approved BioMarin's ultra-rare disease treatment for Batten's disease, Brineura (cerliponase alfa). The company priced it at $702,000 — a price that will drop down to $486,000 after rebates, discounts and contracts with payers. While ultra rare disease drugs have long gotten a pass on high price tags, recent backlash suggests that is changing. It will be interesting to see if BioMarin can overcome this; sales will tell.
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