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
- Crowded I/O field still drawing cash
- Orexigen files for bankruptcy, closing chapter on obesity
- SEC goes after Theranos, Holmes
Mergers & analysis
It was all about the neuroscience space this week, led by shifting fortunes for the CGRP inhibitor class. While Novartis AG and Amgen Inc., as well as Eli Lilly Co., all await regulatory decisions on their respective CGRP inhibitors, other players in the migraine space were shaking up the landscape.
Biohaven Pharmaceutical Holding Co. Ltd., which is developing an oral small molecule for acute migraine, improved the terms of its licensing agreement with Bristol-Myers Squibb Co. The biotech picked up the compound in 2016 before its massive IPO, and recently renegotiated the terms of the royalty agreement to improve its own financials.
Meanwhile, Teva Pharmaceutical Industries Ltd. offloaded a group of preclinical CGRP assets, handing them back to discoverer Heptares Therapeutics. Teva has been in close competition with Novartis/Amgen and Lilly on a preventive treatment for migraines, but recently hit a setback due to manufacturing at a third party. Problems at a Celltrion Inc. plant could mean Teva's compound won't make it to the market until 2019.
In a different part of the neuro landscape, Biogen Inc. picked up the rights to Pfizer Inc.'s cast-off schizophrenia drug. The big pharma announced earlier this year it would largely pull out of neuroscience as it tries to beef up its presence in oncology. Biogen, on the other hand, is doubling down on its expertise in the space. As its multiple sclerosis franchise ages and its incredibly high-risk pipeline moves forward, Biogen is trying to add in a few more safe bets.
Elsewhere, Danish pharma H. Lundbeck A/S will pay €100 million upfront to acquire privately held Prexton Therapeutics and add two Parkinson's disease drugs to its pipeline.
Clinically relevant
Regeneron Pharmaceuticals Inc. and Sanofi SA kicked off the week by shaking up the cholesterol space. The partners presented data for their cholesterol drug Praluent (alirocumab) showing it decreases the risk of major cardiovascular events. The data will help it better compete with Amgen's offering, but the market as a whole for these PCSK9 inhibitors has been a bit lackluster. The game-changing news out of this might not be the cardiovascular data, but that Regeneron and Sanofi are willing to lower the price of the expensive drug if payers will ease restrictions for starting Praluent treatment. Game on.
Elsewhere, Alexion Pharmaceuticals Inc., MorphoSys AG, and AbbVie Inc. all presented positive data this week that could allow them to bring filings to the Food and Drug Administration.
Alexion revealed the results from its head-to-head study of its blockbuster rare disease drug Soliris against its follow-on complement inhibitor ALXN1210. The newer compound proved to be non-inferior, but not superior. The results should be enough to gain approval and extend the franchise, but analysts caution it won't allow Alexion to charge a premium price.
MorphoSys, meanwhile, reported updated results for its mid-stage Fc enhanced CD19 antibody MOR208 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The results are strong enough for the German biotech to approach the FDA about gaining accelerated approval for the compound.
AbbVie announced a second positive Phase 3 study for its treatment of uterine fibroids. The drug is already awaiting approval as a treatment for endometriosis and analysts believe the women's health compound could surpass $1 billion in revenues by 2020.
Highly regulated
The FDA had to slap two biotechs with clinical holds this week after safety signals in early trials. First Advaxis revealed the regulatory agency stopped its Phase 1/2 trial after a patient died after receiving a combination of its immunotherapy drug axalimogene filolisbac and AstraZeneca plc's Imfinzi (durvalumab).
Advaxis is still investigating the cause of the patient's death, but at least one analyst is pointing to the British pharma's drug as the problem. It wouldn't be the first time a PD-1/L1 inhibitor caused harm to patients, or was put on clinical hold. While the checkpoint inhibitors are a revolutionary step in the battle against cancer, they are not a perfect solution either.
Solid Biosciences disclosed a full FDA clinical hold after the first patient in its Duchenne muscular dystrophy gene therapy trial needed to be hospitalized. The patient is at home recovering, but Solid's therapy isn't doing as well with the expansion of a partial to a full clinical hold. Some drugs never get their hold removed. Only time, and maybe some good data, are likely to tell if Solid recovers from this.