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
- PhRMA rejiggers its membership criteria.
- Senate confirms Scott Gottlieb as FDA Commissioner.
- Sanofi pledges to lower price increases.
Mergers & analysis
Dealmaking continues to be weak, but Pfizer struck an interesting early-stage deal that had the industry buzzing this week. The big pharma tapped gene tinkering company Sangamo Therapeutics to collaborate on a hemophilia A gene therapy. The drug is currently pre-clinical but should be entering the clinic shortly. This move further validates Pfizer's faith in gene therapies, despite the first generation of gene therapies failing to live up to their promise several years ago.
What is further intriguing about the deal is that Pfizer did not tap its current partner on the hemophilia B gene therapy. Pfizer has been developing another therapy for the smaller patient population with Spark Therapeutics. The collaboration has allowed Spark to move its own in-house programs forward, and the gene therapy is currently awaiting regulatory approval. Spark has garnered particular interest because everyone is waiting with bated breath to see how the biotech will price the therapy that only has to be administered once.
This was a big week in the immuno-oncology space; some companies managed to gain a leg up while others had major setbacks. Let's start with the setback — Roche announced earlier this week that its checkpoint inhibitor Tecentriq (atezolizumab) failed in a late-stage study in second-line bladder cancer patients. This is a big deal because the Food and Drug Administration gave the drug a greenlight in both second-line and first-line bladder cancer —both on an accelerated basis, meaning that the approvals were just conditional and based on mid-stage studies. Roche was responsible for conducting more studies that reaffirmed the safety and efficacy. This study did exactly the opposite.
But it's not just a problem for Roche; several other checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo (nivolumab) and Pfizer's Bavencio (avelumab), have accelerated approvals in second-line bladder cancer. This might have the FDA rethinking how quickly it is approving these drugs and what it really knows about how well they work.
That said, AstraZeneca could be planning to seek accelerated approval for its checkpoint inhibitor in non-small cell lung cancer (NSCLC) after the British pharma announced positive results for Imfinzi (durvalumab) in lung cancer this morning.
Elsewhere, Eli Lilly & Co. announced positive results for its chronic migraine treatment galcanezumab, part of the closely watched CGRP inhibitor class. The company plans to seek approval for the drug in the second half of this year. This puts it only slightly ahead of competitors in the space, including Amgen and Novartis, Teva Pharmaceuticals and Alder.
Even as accelerated approvals for checkpoint inhibitors are coming under fire, the FDA hasn't changed its stance on the approval route just yet. The agency approved a combination of Merck & Co.'s Keytruda (pembrolizumab) in combination with chemotherapy in NSCLC, further cementing Merck's lead in the space.
But Keytruda isn't the only blockbuster that the FDA is bolstering with its regulatory action. The agency rejected a second copy of GlaxoSmithKline's Advair, this time from Hikma Pharmaceuticals. The British pharma cautioned that an entrance of a generic this year would cut into sales of the ultra-blockbuster asthma drug, making earnings expectations for the company virtually flat. New CEO Emma Walmsley will likely now be able to celebrate strong earnings during her first year on the job.
On the other side of the pond, the European Medicines Agency was touting its achievements in 2016 ahead of having to move its headquarters from the U.K., once the Brexit is finalized. In 2016, the EMA recommended marketing authorization for 81 drugs, including 27 drugs that are completely new to Europe.