Prescribed Reading: An uptick in year-end M&A
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
- Incyte pays $280M in bispecifics deal with Merus
- Teva pays out for bribery charges
- And ophthalmology is grabbing a lot of attention
Mergers & analysis
Companies are getting in some last-minute deal making before 2016 finally comes to a much anticipated close. While overall M&A was a bit slow this year, a few companies have been taking advantage of some healthy market conditions to increase their pipelines through bolt-on acquisitions.
Allergan conducted its twelfth deal of the year this week, buying regenerative medicines company LifeCell for $2.9 billion – a deal that will complement is medical aesthetics business.
Meanwhile, Novartis got in a few year-end deals, that helped shuffle around its portfolio a bit more. The pharma giant is picking up Texas-based Encore Vision in an effort to bolster its flailing eycare business Alcon and is offloading three COPD drugs to Sunovion Pharmaceuticals. It also announced earlier in the week that it would pay $50 million upfront to gain access to an experimental drug for nonalcoholic steatohepatitis (NASH) being developed by small-cap biotech Conatus Pharmaceuticals, and finished the week by selling off another drug to Sunovion Pharma — this time from its oncology portfolio.
Pharmas have spent the year reprioritizing their internal assets and ridding their portfolios of any compounds that don't fit the new mold.
Alexion reported a failure for its high-priced rare disease drug Soliris on Wednesday evening, hoping to sneak in the bad news. While the results of the PROTECT trial won't have a big impact on the company, it’s another blemish on Alexion's already very tarnished exterior.
Roche, on the other hand, announced positive results for two of its drugs: a Phase 3 trial in hemophilia A and Phase 3 data for its multiple sclerosis drug Ocrevus, which were published in the New England Journal of Medicine.
Biotech Acadia grabbed attention with its Phase 2 results for Nuplazid in Alzheimer's disease psychosis. While the company is claiming a win and moving ahead into late-stage trials for the indication, investors were skeptical and pointed to the poor data regarding duration of response.
The U.S. Food and Drug Administration continued its ongoing new draft guidance for generic drugmakers that gives them drug-specific bioequivalence recommendations, releasing the latest batch of 31 recommendations. The process has been ongoing since 2010.
The agency also pushed out the PDUFA date for Roche's much-lauded MS drug Ocrevus (ocrelizumab), shifting the approvable date from Dec. 28 to March 28 due to issues with the manufacturing process. This is the sixth time this year that the FDA has delayed an approval for manufacturing purposes, with all of the others resulting in Complete Response Letters for the respective companies.
The regulatory agency has only issued 12 CRLs in 2016, making manufacturing a difficult and problematic issue for the industry this year. In fact, the FDA has issued double the number of manufacturing-related warning letters in 2016 – 40, versus 20 in 2015.
Off the bench
Oncoceutics announced earlier this week that it will expand a trial it is conducting with Massachusetts General Hospital and the Dana Farber Cancer Institute that is supported by a National Cancer Institute grant. The trial has already enrolled 17 patients with glioblastoma and seen promising results, therefore expanding to another 36 patients.
Meanwhile, MaxCyte has inked a collaboration with Washington University in St. Louis to develop immuno-oncology drugs using MaxCyte's cell engineering platform for CAR-based therapies.
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