politics
FDA regulator's unusual post prompts speculation around motive
In a highly unusual move yesterday, the FDA's top drug regulator, George Tidmarsh, used his personal LinkedIn page to raise questions about the safety of voclosporin, a rather obscure drug the FDA approved in 2021 to treat patients with lupus nephritis. The maker of the drug, Canada-based Aurinia Pharmaceuticals, saw its stock price sink 16% on the post, which Tidmarsh has now deleted.
Biotech investors began speculating whether Tidmarsh was trying to exact revenge on a prominent investor who he has a personal connection with.
They noted that Aurinia's largest shareholder, Kevin Tang, had previously served as chairman of La Jolla Pharmaceuticals when Tidmarsh was CEO. Tidmarsh left the company unexpectedly after its only approved drug flopped commercially and another key drug in its pipeline failed a clinical trial. In a press release issued at that time, Tang, speaking for La Jolla, said Tidmarsh had left the company to "pursue other interests."
Read more from STAT's Adam Feuerstein.
obesity
Metsera shows promising data, but questions remain on monthly dosing
Metsera, a biotech that is developing obesity treatments and that Pfizer is set to acquire, released some new data yesterday showing that its GLP-1 candidate was highly effective in a mid-stage trial.
In the study, which tested 28 weekly doses of the drug, called MET-097i, patients on the highest dose experienced placebo-adjusted weight loss of 14%.
That's competitive weight loss compared with the drugs on the market, but the selling point of Metsera's drugs is supposed to be that they can be dosed monthly. The company has another ongoing Phase 2 trial that will test monthly dosing, but it's not yet completed.
The tolerability of the drug is not entirely clear from the company's announcement. In the trial testing weekly doses, patients experience placebo-adjusted rates of nausea ranging from 4% to 23%, and rates of vomiting ranging from 4% to 15%. The company did not disclose absolute rates of side effects, but said that only 3% of participants discontinued.
financing
Novo's parent company has a keen interest in gout
From my colleague Allison DeAngelis: Novo Holdings is homing in on gout, and it's leaning on the team behind one of the last major pushes into the arthritic condition.
Novo, along with SR One and Catalys Pacific, co-led a $205 million investment in Crystalys Therapeutics, a new startup developing a gout drug licensed from a Japanese drug company. The drug, dotinurad, is a URAT inhibitor that is already on the market in Japan and China.
Novo Nordisk's parent company got the ball rolling more than two years ago, when it called up James MacKay, who led Ardea Biosciences after its acquisition by AstraZeneca. Ardea pursued one of the last major R&D pushes into the inflammatory condition, but the pharma company sold off the drug in 2016.
"James has been proselytizing to Roman [Camarda] and I about gout for years," Kenneth Harrison, senior venture partner at Novo Holdings. (Camarda is a prinicipal at Novo Holdings.) Gout is a common condition, affecting millions of Americans. But Harrison, MacKay, and other investors say there are gaps in addressing the build-up of uric acid that causes gout. "It seems the market, from our diligence, thinks that gout is a solved problem…. But it's anything but solved."
Crystalys is already enrolling patients in two Phase 3 trials of dotinurad. The series A funding will fuel the company through those tests. After that, the team will assess next steps — MacKay is prepared to take the startup through commercialization, but acknowledges it would be a good "bolt-on" acquisition for any pharma company that already has a rheumatology focus.
policy
Trump's MFN deadline came and went
If you were scrolling down this newsletter waiting for me to get to any news on President Trump's "most-favored nations" policy — well, there's not really much to report.
Yesterday was the deadline for major pharma companies to meet Trump's demands related to his plan for lowering U.S. drug prices in line with what other countries pay.
There were a few press releases. The lobbying group PhRMA said it will launch a new website in January that will connect patients to direct-to-consumer offerings in which they can directly buy treatments from pharma companies without going through insurance. Meanwhile, AbbVie said it will launch its ovarian cancer drug Elahere in the U.K. at a list price equal to the U.S. list price. And Novartis said it would start selling Cosentyx, its treatment for inflammatory conditions, directly to patients.
These are similar to announcements that other pharma companies have been making in the past few weeks, but as STAT reported, it's not clear if these kinds of moves will be enough to satisfy the president. No companies have announced yet that they've reached agreement with Trump on meeting his demands to lower prices offered to government and commercial payers in the U.S.
The administration also has not said anything publicly on whether and how it plans to enforce its demands.
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