March 31, 2023

podcast

What happened to the market for monkeys?

Are some drugs too cheap? And why are biotech stocks still in the tank? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

We explain how biotech is affected by a bizarre situation involving smuggled monkeys, international intrigue, and a criminal investigation. We also discuss what leads to generic drug shortages, whether every major pharmaceutical firm needs a weight loss drug, and what it means when a drug company cancels a conference appearance.

Listen here.

redemption

Price hike penalties rolled back for seven drugs

Medicare a few weeks back announced that 27 drugs would face penalties for hiking prices faster than inflation. Now, the agency is saying that seven drugs on that list are off the hook, Rachel Cohrs reports. The drugs that are taken off the list are made by Stemline, Shionogi, Acrotech Biopharma, Kite Pharma (which is owned by Gilead), Kamada, and Bausch + Lomb.

Medicare officials said that the cutback on the list happened because the agency made some recalculations after considering public feedback. As STAT reported earlier this month, Pfizer had the most drugs on the list of any manufacturer, with five.

fungus among us
CDC warns of deadly fungus, so GSK buys an anti-fungal

GSK is buying an FDA-approved antifungal drug, Brexafemme, from New Jersey-based Scynexis for $90 million. It's propitious timing, given the CDC's recent warning about an emerging strain of the Candida auris fungus that's drug-resistant. Antifungals — well, antimicrobial drugs in general — tend to largely be ignored by the biopharma investment community, which makes this deal noteworthy.

Brexafemme, or ibrexafungerp, got the regulatory green light in 2021 to treat vulvovaginal candidiasis, but the drug has a broad spectrum of activity against existing and emerging resistant strains of fungi, GSK said. It's part of a class of drugs called enfumafungins, which Scynexis is still investigating. As part of this deal, GSK has first negotiation rights to any other assets derived from enfumafungins.

strategy
Making the most of academia-industry partnerships

Academicians churn out all kinds of new medical technologies and novel drug targets — but their partnerships with industry still often fail. Deerfield Management's Dave Greenwald opines that biopharma companies should consider three important things before partnering with academia. First, there needs to be agreement on intellectual property — academics are often less cautious about maintaining secrecy, while companies have to focus on "preserving first-mover advantage."

Second, academia and biopharma need to play to their strengths. While academic groups might do well at identifying targets, industry is far superior at doing the preclinical legwork needed for toxicity studies and the like. And thirdly, logistics matter. There should be regular meetings to discuss progress, and to keep the research and the expectations as transparent as possible.

generics

Supreme Court asked to review skinny labeling

The U.S. solicitor general is asking the Supreme Court to examine the "skinny label" controversy for medicines — saying that this process threatens the availability of generic drugs. Skinny labeling is a tactic where generic drug makers seek regulatory approval for a specific use, but not for all the indications a patented drug might be approved for. This helps generic drug companies avoid lawsuits claiming patent infringement.

But in 2020, a legal battle between Teva Pharmaceuticals and GSK culminated in the former paying $234 million in damages — because it purportedly encouraged doctors to prescribe its generic version of a heart drug instead of GSK's brand-name drug. GSK had asserted that Teva "induced" infringement of one of its patents. This decision sparked concerns that "skinny labeling" would rob consumers of access to generic drugs — and the solicitor general seems to think that argument holds water.