November 4, 2024

The need-to-know this morning

Viking Therapeutics reported updated, early-stage study results on its oral obesity drug candidate.
Ascendis Pharma and Novo Nordisk announced a partnership to develop cardiovascular and metabolic drugs that utilize Ascendis' drug-delivery technology.
Neurogene, a developer of gene therapies for rare, neurological diseases, raised $200 million via a PIPE. The deal was priced at a premium to the stock's current price, and comes about a week before the company reports preliminary data on a gene therapy for Rett syndrome.

china

The implications of China's probe into AstraZeneca

AstraZeneca is under scrutiny in China as its top executive there and other personnel are being investigated by authorities. The Chinese market represents about 13% of AstraZeneca's $5.8 billion in revenue, and the country has recently launched a campaign against health care fraud, STAT contributor Brian Yang writes.

Although it remains unclear exactly why Leon Wang, AstraZeneca's executive vice president for international operations, is a subject of any probe, the episode highlights the risks of multinational pharmaceutical companies navigating China's shifting regulatory landscape, where whistleblower protections and anti-corruption efforts are tightening.

Medical meetings

Something big to watch on Tuesday

Oh, not that. This is a biotech newsletter; we're referring to research abstracts that will be posted online for two upcoming medical meetings — held by The Society for the Immunotherapy of Cancer (SITC) and the American Society of Hematology (ASH).

Noteworthy among the SITC abstracts will be results from a randomized Phase 2 study called ARC-10 that is investigating domvanalimab, the anti-TIGIT drug from Arcus Biosciences and Gilead Sciences, in non-small cell lung cancer. The ARC-10 results won't be conclusive — for that, data from an ongoing Phase 3 study will be needed — but anything positive could help reverse negative investor sentiment for the entire TIGIT-targeting drug class.

Over at ASH, there will be many eyeballs on the abstract describing data from the iMMagine-1 study, a pivotal clinical trial of anito-cel, the personalized, BCMA-directed CAR-T therapy for multiple myeloma, being developed under a partnership between Arcellx and Gilead Sciences. Anito-cel has multibillion-dollar sales potential, if it proves to be competitive on efficacy and safer from a neurotoxicity perspective than Carvykti, the currently approved BCMA CAR-T product from Johnson & Johnson and Legend Biotech.

For a preview of the anito-cel data, look here.

GLP-1 drugs

Wegovy shows potential as a treatment for MASH

Novo Nordisk weight loss drug Wegovy has shown potential as a treatment for the fatty liver disease MASH, reducing liver scarring and improving symptoms in a clinical trial. The Phase 3 trial showed that 37% of patients taking Wegovy saw improvement in their fibrosis, with no worsening of their disease. That compared with 23% on placebo.

GLP-1 drugs aren't necessarily meant to replace other treatments for liver disease, STAT's Elaine Chen writes, but could be particularly potent for early-stage MASH. Novo's study is ongoing.

video

How do patent thickets work?

Drug prices tend to drop for brand-name drugs when generics or biosimilars hit the market, making medicines more affordable for patients. But this transition can be extremely slow. Factors like the number patents a branded drug holds and its position on health insurance formularies can delay competition for years.

Humira's a good example: It's protected by many patents, and maker AbbVie was able to delay biosimilars from entering the market for nearly seven years after the initial overlapping patents expired. STAT's fifth video in a series on drug pricing, from STAT's Anna Yeo, explains how these patent thickets work.

Watch here.

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