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Hullo. Lots today on GLP-1s: First we see tirzepatide outperforming semaglutide in a head-to-head study in obesity. Also, compounding pharmacies fire back at Novo Nordisk for its assertion that GLP-1 drugs are too difficult to compound. Also, a Michael Gilman company pivots and more.
Zepbound beat Wegovy head to head for weight loss
Eli Lilly’s drug Zepbound resulted in weight loss that was 47% greater than the weight loss achieved with Wegovy, the rival medicine made by Novo Nordisk, according to a new head-to-head study out this morning. The news likely will not be entirely surprising to the physicians and scientists who closely watch this space: Similar results have been seen when the same drugs — that is, tirzepatide and semaglutide, respectively — are used to treat diabetes.
In the 751-volunteer trial, volunteers receiving Zepbound lost 20.2% of their body weight on average after 72 weeks, compared to 13.7% in those treated with Wegovy. This translated into a 50.3 lbs in the tirzepatide group and 33.1 lbs in the semaglutide group.
Read more.
Arrakis pivots away from cancer
Arrakis Therapeutics, led by biotech veteran Michael Gilman, is transitioning from a focus on cancer to myotonic dystrophy, citing the many challenges it’s faced in developing RNA-intercepting drugs. Arrakis initially tried to target the elusive Myc oncogene, but faced a number of setbacks and technological “cul-de-sacs,” STAT’s Jason Mast writes, delaying progress and prompting layoffs.
Although data were promising and showed that the Arrakis drug could halve Myc expression in mouse tumors, the company’s shelving the program given investor disinterest and the long timeline needed to develop oncology drugs. With myotonic dystrophy, there’s the hope of quicker clinical results and the potential to outperform existing treatments. Arrakis plans on beginning human trials in 2026, and having data in hand before funding is set to run out in 2027.
Read more.
Compounding pharmacies rebut Novo’s FDA petition
Back in October, Novo Nordisk petitioned the FDA to bar compounding pharmacies from copying its weight loss drug semaglutide, citing safety concerns about the purity of these facsimiles. There have been ongoing shortages of GLP-1 drugs, and compounding pharmacies have stepped in to fill in supply gaps; to the chagrin of branded drugmakers, they have ended up with a pronounced market share of their own.
Now, in a lengthy letter, the Alliance for Pharmacy Compounding has now rebutted Novo’s argument, saying that the company’s assertion that compounded versions of the drugs are inferior is “unpersuasive.” The letter says that Novo “disingenuously asserts” that compounded versions are unsafe and unreliable, highlighting patient satisfaction with the products — and says that these drugs have no place on the FDA’s “Demonstrably Difficult to Compound” lists.
Orexo is divesting Deprexis, as it won’t sell
Sweden-based drugmaker Orexo is giving up on Deprexis, its digital app meant to treat depression. The company’s tried to sell it for years to no avail, and now will no longer license the product. Although it’s been a struggle to secure reimbursement for digital therapeutics in the U.S., Orexo’s timing is a bit surprising: Just a few weeks ago, Medicare created a pathway to help pay for some digital mental health treatment, STAT’s Mario Aguilar writes.
“If you look at our balance sheet and our financial situation right now, you will understand that there is a need for us to focus,” CEO Nikolaj Sørenson told STAT. Though the company was one plushly funded, its stock has dropped more than 80% since its peak in 2020. Most of Orexo’s revenue comes from Zubsolv, a drug used to treat opioid addiction.
Read more.
More reads
Coherus, sharpening immuno-oncology franchise, sells another biosimilar for over $500 million, BioPharma Dive
RFK Jr. was paid six figures by his vaccine-challenging group before presidential run, STAT
Ipsen enlists MAITs to take down solid tumors, betting $610M on Biomunex’s novel T-cell engagers, FierceBiotech
Biogen expects steady growth for Alzheimer’s drug Leqembi in near term, Reuters
