May 1, 2023

The need-to-know this morning

Japanese drugmaker Astellas said late Sunday it would acquire eye drug developer Iveric Bio for $5.9 billion, betting on a prospective treatment for a form of vision loss that affects around 1 million people in the U.S.
Sanofi has licensed an experimental Pompe disease therapy from Maze Therapeutics as part of a $150 million cash and equity deal. The therapy, MZE001, is poised to enter a Phase 2 trial this year.
According to a note from RBC analyst Brian Abrahams, Biogen seems to have set a price for its new ALS therapy of $14,230 per dose, amounting to $185,000 the first year of treatment and $171,000 in subsequent years. The therapy, Qalsody, was approved last week for a rare genetic form of ALS.
And in broader business news, regulators on Monday seized First Republic Bank and sold it to JPMorgan Chase Bank. More here from the AP.

Deals

Waksal and Levin: 'the turnaround story of the century'

Sam Waksal is a larger-than-life figure in the biotech universe: He's as known for his blockbuster contributions to drug development as he is for his five-year prison stint for securities fraud. The immunologist has since resurrected his image, and now has "a collaboration that was made in heaven" brewing. Specifically, Waksal is working with Jeremy Levin, a friend and fellow biotech lifer, to develop early-stage treatments for rare brain disorders.

Levin's Ovid Therapeutics will pay $10 million for a stake in Waksal's startup, Graviton. STAT's Damian Garde chatted with the two of them, learning more about their 35-year friendship — plus what they hope to accomplish with their collaboration, and what they've learned from their missteps.

obesity

Wegovy and Ozempic spark weight loss innovation

Obesity management used to be a drug development desert. There were too many ineffective or downright unsafe drugs, and those that made it to the market floundered commercially. That is, until Wegovy and Ozempic. Now, medical weight loss management is in the midst of a renaissance of sorts.

For example, Novartis developed an experimental antibody drug called bimagrumab that caused an average loss of 21% in fat mass and a 4% gain in lean mass in a trial of patients with obesity and diabetes. This ability to build muscle is unprecedented in the weight loss market. The drug's been licensed by a startup called Versanis Bio, helmed by ex-Novartis employees.

Other startups are zeroing in on weight loss as well: "We've seen this incredible resurgence of interest in the space, and it has also happened extremely quickly," said one venture capitalist, who told STAT that recently he's been seeing 10 times more startup pitches related to obesity.

this week

Earnings and approval decisions

Another fun earnings week! Some of the notable players reporting include Vertex Pharmaceuticals, which achieved another approval just last week, and will hold its investor call this afternoon. Analysts are expecting Vertex to perform quite well, particularly now that AbbVie has abandoned its own cystic fibrosis program. The company "has a number of other potential blockbuster pipeline candidates," SVB's David Risinger said. On Tuesday, we'll hear from Pfizer and Sarepta Therapeutics; Moderna and Regeneron will be updating us on Thursday.

Also this week, we'll find out whether GSK's RSV shot, Arexvy, will win FDA approval. At some point this month, regulators will inform Pfizer about their decision for its RSV vaccine, Abrysvo.

equity

Patient advocates have concerns over global access

For a time, the pharma industry's reputation was bolstered in a pandemic glow. That's changing, a new survey shows: In terms of providing equitable patient access to medicines, 52% of the 2,207 patient groups surveyed across the globe thought brand-name drug companies did a "fair" to "poor" job.

"The Covid-19 pandemic revealed the significant inequities that exist in patient access to medicines, not just between countries, but within them as well," said the head of the firm that conducted the survey. That said, the survey did show that 60% of the advocacy groups believed the industry remains innovative, and 65% believe biopharma companies offer products that help people.