Teva wants in the club. PhRMA, to be exact. Some existing members of PhRMA want the world’s largest generics company to take a long walk off a short pier. Probably something to do with the long, ugly history of patent challenges. AbbVie EVP, Carlos Alban, for one, wrote Teva’s membership would dilute PhRMA’s emphasis on innovation. Teva touts its more than $6 Billion in branded revenue as evidence to the contrary. And here’s another problem for those throwing shade on Teva’s application… PhRMA’s membership already includes companies with substantial interests in generic products (see Novartis / Sandoz, Pfizer / Hospira, and others). We think PhRMA will have a difficult time denying Teva’s application. But we also think the welcome dinner may be poorly attended.
Providing notice of drug price increases sounds reasonable, right? “Not so simple,” say opponents of proposed California drug pricing legislation that calls for a 60-day notice of price increases. Opponents of the bill contend this could hang small pharmacies out to dry as larger pharmacies might be motivated to hoard drugs to avoid the higher prices to come. This could leave areas with fewer hospitals and pharmacies in danger of not being able to obtain drugs for patients with chronic illnesses. The bill could set a precedent in a movement to open up transparency across the health care system. But it could also lead to some nasty unintended consequences. Ugh. Healthcare is hard.
A study published in Cell Chemical Biology suggests the number of drug innovators has decreased to World War II levels. Even though 45 novel drugs were approved by the FDA in 2015—higher than average for the past decade—only 95 companies within the biopharmaceutical space drove those developments. We haven’t seen so few companies since before the 1970s biotech boom. The main reason? Mergers and acquisitions. The study attributes at least some of this effect to companies following Valeant-style acquisition strategies where they acquire a company after the early (see: risky) R&D phase, when they have a novel drug product through proof-of-concept. Come on you innovators! Male pattern baldness isn’t going to cure itself!
Tesaro, a MA based biotech, announced it has successfully reached its Phase III endpoint of progression-free survival (PFS) among all of the 490 patients with recurrent ovarian cancer included in the study. The drug niraparib, a PARP inhibitor, proved effective in a double-blind, placebo controlled, international study among women with the BRCA mutation and for women without the mutation as well as those with HRD-positive and HRD-negative tumors. This is great news for the 239,000 women diagnosed with ovarian cancer each year, especially considering the difficulty in catching this disease in its early stages. All in the form of a single, daily, oral dose. Take that, cancer.
The Drug Industry Association’s largest conference wrapped up this week in Philadelphia. Thousands of pharmaceutical industry professionals gathered to learn from one another on a variety of topics. One theme that seemed to emerge is the growing momentum behind access to real-world data (e.g. claims, pharmacy, EMR). And it is no wonder, with Quintiles and IMS merging, PAREXEL partnering with Optum, LabCorp buying Covance, and PPD partnering with HealthCore, people are starting to ask a lot of questions. Hype? Promise? Value? Pharma has been running outcomes studies for a long time, but now with access to more complete healthcare records, maybe the time is finally right to really make use of these data.