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.
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Mergers & analysis
Nick Leschly, CEO of Bluebird bio Inc., suggested at a conference in New York this week that small companies working on rare disease drugs should not depend on their potential drugs as a main source of revenue, but should instead find other ways to bring in sales that allow for them to better serve patients. One suggestion he gave was taking advantage of the Priority Review Voucher (PRV) system to bring in revenue.
BioMarin Pharmaceutical Inc. did just that this week, selling its second PRV to bring in cash. The biotech sold the voucher, which was awarded by the Food and Drug Administration along with the approval of Brineura in April, to an undisclosed recipient for $125 million.
Elsewhere, Biogen is doing some defensive lifecycle management for its best-selling multiple sclerosis drug Tecfidera (dimethyl fumarate). The big biotech inked a deal with Alkermes for its late-stage prodrug version of Tecifdera. The product has shown that it has a slightly better side effect profile and would be a threat to Tecfidera revenues in a couple of years. By hooking up with Alkermes, Biogen is limiting some of its exposure to the blockbuster multiple sclerosis going off patent.
The Medicines Co. has been finding itself in dire straits lately. The specialty pharma is placing all its bets on the PCSK9 inhibitor that it has in development, despite the dismal commercial reception that has been seen for other drugs in this class. (As an aside, Regeneron CEO Len Schleifer admitted at the Forbes Healthcare Summit this week that things with its own PCSK9 inhibitor "didn't go so well.")
In an effort to keep funding the cholesterol-lowering molecule, MedCo. is selling its infectious disease business to Melinta Therapeutics Inc. for $270 million upfront.
Clinically relevant
There's been a lot going on in the ear health space this week. Auris Medical Holding AG is canning a Phase 3 trial ahead of its expected end after another late-stage study of its hearing-loss candidate AML-111 failed to show improvement in patients with severe and sudden deafness. The company is looking into analysis of a subpopulation of the study, and is hoping the FDA will give it a break and let it pursue the smaller patient population.
Auris competitor Otonomy Inc. is also having some problems. The company announced this week that it is restructuring its business and ceasing commercialization efforts for its product Otiprio in an effort to conserve cash to fund its pipeline.
In another sector, Pfizer Inc and its partner Merck KGaA got some negative late-stage results for their checkpoint inhibitor Bavencio (avelumab) in gastric cancer. The PD-L1 inhibitor was a late-comer to the space, and the failure is a setback that will prevent it from competing with market leaders from Merck & Co. and Bristol-Myers Squibb Co., respectively.
Sanofi SA made a rare move this week, asking regulators to limit the use of its dengue vaccine to only patients that have previously been infected with the disease. The request was prompted by the results of a long-term safety study that showed the vaccine would cause a more severe infection in people who had previously never had the disease if they ever got Dengue fever after being vaccinated.
Highly regulated
The Supreme Court heard oral arguments this week in a case that could have far-reaching effects for the pharmaceutical industry. While the case is unrelated to pharma, it has to deal with a procedure that was put in place in 2012 known as inter partes review (IPR) that allows companies to challenge patents.
This process has been in the spotlight in recent months after Allergan announced it had struck a deal with the Saint Regis Mohawk Tribe which had the Native American tribe buying out all of the Orange Book listed patents for Allergan's blockbuster eye drug Restasis and then licensing them back to the company. The tribe is a sovereign nation and therefore immune to the IPR process.
Acorda CEO Ron Cohen pointed out at a conference this week that the IPR process subjects the pharmaceutical industry to a sort of "double jeopardy," allowing generics companies to abuse the system by challenging patents both in court and then through the IPR process. While this was not the intent of the IPR process, generics companies often use the system to get around court rulings that uphold patent rulings for branded pharmaceuticals.
While many pharmaceutical leaders agree the IPR process is unfair, the industry as a whole has tried to distance itself from the deal Allergan struck with the Mohawk Tribe. This week, Regeneron CEO Len Schleifer called the deal "nuts," criticizing Allergan CEO Brent Saunders for further damaging the industry's reputation.