Prescribed Reading: No such thing as unicorns
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.
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Mergers & analysis
While mergers and acquisitions continue to be slow this year, companies are still making deals — many in the form of settlements. While financial details weren't really disclosed, the deal this week with the most wide-reaching effects is AbbVie's agreement with Amgen Inc. to stave off biosimilar competition to its uber-blockbuster Humira (adalimumab).
The two companies have been battling it out in court since Amgen garnered approval from the Food and Drug Administration for the copycat biologic, which has delayed the market launch of Amjevita (adalimumab-atto). AbbVie has guaranteed the drug won't enter the market and take market share from Humira until 2023, and has also guaranteed itself a royalty on the sales of the biosimilar — enabling it to offset at least part of the loss.
Yet, if other biosimilars are any indication, this might not actually be a problem for AbbVie. Pfizer recently brought competitor Johnson & Johnson to court over biosimilars. But in this case, Pfizer is suing because it believes that J&J is limiting the uptake of its own biosimilar of J&J's Remicade (infliximab). J&J is laughing all the way to the bank as Remicade continues to pummel the biosimilar competition.
Settlements such as the one between AbbVie and Amgen aren't uncommon; they occur all the time between small molecule drugmakers and generic makers. Just this week, Indivior reached a settlement with Mylan N.V. to keep a generic version of its best-selling opioid-dependence film Suboxone off the market. Generic competition for the drug could cripple the British biotech.
The most recent upset in the Alzheimer's disease field came this week, as Axovant Sciences announced intepiridine failed in the Phase 3 MINDSET study, missing the endpoints in cognition and improvement in daily living activities. While the miss pushed the biotech's stock down 70%, it wasn't entirely unexpected. Alzheimer's disease drug development has been notorious for late-stage failures.
While the industry continues to be hopeful — pushing up the stock of any Alzheimer's disease companies that have even a glimmer of promise — the chances that there is currently a disease-modifying drug already in the pipeline seem slim right now.
But Axovant wasn't the only biotech reeling this week from a trial failure; penny-stock Mateon Therapeutics shuttered its lead program after its drug CA4P failed to show any efficacy in a rare oncology indication. The move has Mateon laying off 60% of its staff and shifting gears to its other pipeline program — a Phase 1 asset that has been in development for than a decade. Mateon's future looks cloudy at best.
Axovant wasn't the only investor disappointment this week. Biotech unicorn Intarcia Therapeutics, Inc. got a rejection letter this week from the Food and Drug Administration for its type 2 diabetes drug-device combo. The company says that the CRL dealt largely with easily-resolvable manufacturing issues, but did not offer a new timeline for resubmitting its application.
Intarcia's drug-device combo uses an already approved GLP-1 antagonist in an implantable device. For this reason, there's a strong likelihood that the drug will eventually get an OK from the FDA. And also for this reason, Intarcia is confident it has a blockbuster on its hands. Yet, other companies have tried new means of administration for drugs and not had that sort of success. Now the market has to wait a little longer to see if unicorns really do exist.
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