Prescribed Reading: Gottlieb pushes for efficiency at FDA
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
- Charges come down on ex-Ariad execs
- Coherus cuts staff after rejection
- The CGRP race heats up in migraine
Mergers & analysis
The M&A landscape continues to stagnate, as the sector waits to see if the new administration can bring forward some sort of tax reform. But in the meantime, money is flowing into early development, and biotechs seem to be prepping for a more plentiful time.
Venture firm Atlas Ventures announced earlier this week that it just closed its eleventh fund for $350 million, ready to pour cash into early biotechs. Atlas sees itself as "derisking the story," according to partner Bruce Booth.
Meanwhile, two other biotechs could be setting themselves for a little dealmaking. Exelixis cleared its books of some debt early, cutting its cash on hand, but prepping for a strong commercial performance of its kidney cancer drug.
Sarepta Therapeutics appointed a new CEO that could lead the way for a stronger commercial launch of its Duchenne muscular dystrophy drug. At least one analyst speculated this sets up the company as an acquisition target, but M&A will have to pick up first.
Merck & Co. wowed the industry with positive data from its cardiovascular outcomes study of its cholesteryl ester transfer protein (CETP) inhibitor, anacetrapib. The class has been virtually abandoned by all of the other big pharmas that were in the space, including Eli Lilly & Co., Amgen and Pfizer, amongst others, after several high-profile failures.
Merck was often criticized for continuing with the 30,000-patient CV outcomes study (which definitely had a high price tag) and little chance of succeeding, but Merck defied the odds. The next step isn't so clear though. Merck seems iffy about the data (which it hasn't completely revealed) and said it would consult with experts on whether to file. Even if the data is good, it could be that there is no market for the CETP inhibitor.
Elsewhere, there were several high profile failures this week. Teva Pharmaceuticals partner Xenon announced its second mid-stage failure this year, this time in nerve pain after the shingles virus.
A tiny Australian biotech made headlines this week when it announced its own mid-stage failure in an advanced form of multiple sclerosis. While the success of Innate Immunotherapeutics' drug was always a long shot, backing by several U.S. Congressmen made this a hot stock. With Innate stock crashing down more than 90% at just five cents a share, more than a few Washington noteworthies have taken a hit to their portfolios.
New Food and Drug Administration Commissioner Scott Gottlieb has made promises to streamline the agency and make drug approvals more efficient. In his short time at the top spot, Gottlieb is moving quickly to at least appear that he is living up to promises.
His most recent move was to enact the Orphan Drug Modernization Plan, which will help clear the backlog of 200 pending orphan drug designation requests. This is not a particularly hard designation to get; it merely requires the disease to have a patient population of less than 200,000 in the U.S. and to be a medical need (which there is for virtually every rare disease) — no clinical data required.
While this gives drugmakers a host of tax breaks and discounts, it doesn't necessarily do a lot for speeding approvals.
Also this week, the agency released a list of branded drugs that lack generic competition, along with a policy change that could help bring copycat meds to market faster. Now, a generic can qualify for priority review if the branded drug it references has less than three other approved generics and no blocking patents or exclusivity.
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