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Hello, everyone. Damian here with the final act in a pharmaceutical saga, the debate of Vertex Pharmaceuticals’ success, and news on 23andMe’s ongoing transformation.
The need-to-know this morning
- Novo Nordisk said it is increasing the availability of its blockbuster obesity drug Wegovy for new U.S. patients. The Danish drugmaker reported a 31% increase in sales for 2023 and issued better-than-expected guidance for 2024.
- GSK reported fourth quarter and 2023 earnings, and so did Novartis.
Adieu to Aduhelm
Years after a polarizing FDA decision and an ensuing commercial disaster, Biogen is finally parting ways with Aduhelm, its first approved medicine for Alzheimer’s disease.
Neurimmune, the Swiss company that invented Aduhelm, will regain full rights to the intravenous medicine, Biogen said Wednesday. Biogen will also terminate an ongoing clinical trial meant to prove the treatment’s benefits for patients in the early stages of Alzheimer’s.
The company’s decision marks the end of the nearly two-decade Aduhelm saga, which saw a sure-fire blockbuster devolve into a pharmaceutical cautionary tale amid questionable corporate moves, regulatory controversy, and a fateful choice to maximize profits regardless of backlash.
The debate over Vertex’s success in pain
Yesterday we learned that Vertex Pharmaceuticals’ novel pain drug works better than placebo. But can it still become a blockbuster if it can’t beat Vicodin?
As STAT’s Jonathan Wosen reports, analysts and pain experts are picking apart the results of Vertex’s study, in which the company’s drug, VX-548, missed its secondary endpoint of outperforming a combination of acetaminophen and the opioid hydrocodone among patients suffering acute pain after surgery.
To some, that nuance might dampen prescriptions in acute pain, where doctors prize efficacy and the short duration of treatment makes the risk of opioids less pronounced. To others, the advent of a novel, non-addictive pain treatment should be enough to make VX-548 a sought-after product — depending on how much Vertex chooses to charge for it.
23andMe found another drug
23andMe, the storied personal genetics firm, is among the companies that had a very hard 2023 — its shares are down 70% over the past 12 months. This morning it announced some incremental good news: The FDA has signed off on the first clinical trial of a drug called 23ME-01473, the second medicine the company has derived from its DNA database to enter clinical trials. (A third medicine, also in immuno-oncology, is in development with GlaxoSmithKline.)
23andMe says that the new medicine targets ULBP6, a ligand found on the surface of cancer cells, to allow natural killer cells and T-cells, two different types of white blood cells, to target tumors. 23andme said that it hopes to start a Phase 1 clinical trial in advanced solid tumors in the first half of the year.
Drug discovery is a cornerstone of 23andMe’s plans for the future, one in which its DNA testing business seeds a pipeline of therapeutics. The company, which went public at a roughly $3 billion valuation in 2021, has lost about 90% of its value in the intervening years.
Pfizer’s reset year starts with a little profit
The news has been uniformly dour from Pfizer, whose Covid-19 plaudits quickly eroded into disappointment, but the latest downbeat update at least came with a surprise profit.
Pfizer’s earnings, disclosed yesterday, came out to about 10 cents a share, beating Wall Street’s consensus expectation of a 19 cent loss. Pretty much everything else went as expected, which is to say Pfizer made good on its earlier promise to make less money than investors would prefer. The company made no changes to its 2024 projections, which proved shockingly pessimistic when they were disclosed last month.
The question now is just what Wall Street can look forward to. Next month, Pfizer is hosting an R&D for its oncology pipeline, which is shaping up to be a long-form explanation of why the company’s $43 billion purchase of Seagen will pay off in time. Then there’s Pfizer’s foundering future in GLP-1 drugs, on which analysts are expecting an update later this year.
More reads
- Here are the new hotspots for Boston-area biotech, Boston Globe