| | | |   | Hello, all. Damian here with the latest on an in-demand weight-loss drug, a painful trial success, and the virtues of being a billionaire. | | | Lilly is tightening access to the in-demand Mounjaro A new class of medicines promises dramatic weight loss with fewer side effects than past treatments, but the resulting surge in demand has led to shortages, and now one manufacturer is trying to limit off-label use of its own drug.
As STAT’s Elaine Chen reports, Eli Lilly has altered the discount program for Mounjaro, a treatment approved for Type 2 diabetes but increasingly prescribed off-label for people diagnosed with obesity. In order to use the company’s coupons, which cut the monthly cost of Mounjaro from about $1,000 to $25, patients have to attest to having diabetes, and some pharmacies are checking diagnoses before filling prescriptions.
Lilly’s decision, designed to prevent the shortages that affected similar diabetes treatments, has been vexing to patients with obesity who now face the prospect of paying for Mounjaro out of pocket. “It’s frustrating that I got teased with something that helped other things plus the weight loss, and now I can’t get it,” one patient said.
Read more. | Gossamer’s value-destroying success The good news, for Gossamer Bio, is that its investigational treatment for pulmonary arterial hypertension met its main goal in a mid-stage trial. The bad news is that the actual patient benefit was far below expectations, dimming the drug’s prospects and sending Gossamer’s stock price down by nearly 65%.
As STAT’s Adam Feuerstein reports, Gossamer’s drug, called seralutinib, decreased pressure in the arteries of the lung by 14% relative to placebo and allowed patients to walk 6.5 meters farther over the course of six minutes. But both of those numbers came as a disappointment to analysts, who were looking for a roughly 25% improvement in arterial pressure and six-minute-walk test benefit of 15 to 20 meters.
Gossamer still plans to move seralutinib into a Phase 3 trial, but the drug might have a negligible commercial future. In October, Merck said its competing treatment met its main goal in a Phase 3 study, although detailed data have not yet been disclosed.
Read more. | | | It’s good to be a billionaire Robert Duggan has a lot of money. About $1.8 billion, according to Forbes. And that means Summit Therapeutics, which previously failed to develop treatments for muscular dystrophy and C. difficile, gets to pivot for a third time.
Yesterday, Duggan signed a deal to personally loan the company $500 million in cash, and Summit will pay him interest in the form of stock, adding to the roughly 80% stake in the company he already holds. With the proceeds, Summit will pay $500 million up front to Akeso, a Chinese biotech company, for the rights to a cancer treatment that targets both PD-1, which activates the immune system, and VEGF, a protein found on certain cancer cells.
Rounding out what EP Vantage’s Jacob Plieth called “the craziest biotech deal I've ever seen,” Summit, which had a market value of less than $300 million before the loan, has promised as much as $5 billion more to Akeso if the bispecific antibody reaches certain regulatory and commercial milestones. Just how Summit, which had about $130 million in cash as of last quarter, will foot such a bill remains to be seen. But it helps when there’s a billionaire around. | What’s in store for Sunny Balwani? Weeks after Elizabeth Holmes got sentenced to more than 11 years in federal prison, her former deputy will learn his fate today, facing a potentially harsher punishment for his role in Theranos’ sweeping fraud.
Ramesh “Sunny” Balwani is due before Judge Edward Davila for sentencing on 12 counts of wire fraud and conspiracy. Balwani’s attorneys are asking for probation or home confinement, while prosecutors have requested a 15-year sentence.
Balwani seems likely to serve more time than Holmes. While she was convicted on four counts of fraud related to Theranos’ investors, Balwani’s conviction also includes defrauding patients. Holmes has appealed her sentencing, and Balwani is expected to do the same. | More reads - Karuna Therapeutics replaces its CEO, suggesting takeover unlikely soon, STAT
- Biotech co-founded by Dana-Farber scientists launches with $81m for new approach to drugs, Boston Globe
- ‘This is not a cure’: Consensus begins to emerge on new Alzheimer’s drug, STAT
| Thanks for reading! Until tomorrow,  | | | |
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