Amylyx names chief commercial officer as GLP-1 receptor antagonist launch plans start ramping up

Amylyx Pharmaceuticals has named Dan Monahan as chief commercial officer, positioning an exec who led the U.S. commercialization of Rexulti to oversee the planned launch of a GLP-1 receptor antagonist.

Monahan joined Amylyx one year ago as general manager and head of U.S. commercial markets. Before joining Amylyx, Monahan spent almost three years at Otsuka, where he led the U.S. commercialization of central nervous system products such as Rexulti and Abilify Maintena. Monahan also held roles at Sanofi and Novartis, where he worked on the commercialization of Cosentyx, earlier in his career.

Amylyx has tasked Monahan with leading its commercialization strategy, starting with the GLP-1 receptor antagonist avexitide. As an antagonist, avexitide blocks the GLP-1 receptor. Better known GLP-1 agonists such as Eli Lilly’s tirzepatide and Novo Nordisk’s semaglutide activate the receptor.

GLP-1 antagonism could counter low blood sugar, leading Amylyx to identify the molecule as a potential treatment for post-bariatric hypoglycemia (PBH). About 8% of people who undergo bariatric surgery to lose weight develop PBH, leading to debilitating events linked to a lack of glucose in the brain.

Amylyx is preparing to start a phase 3 trial of avexitide in PBH in the first quarter of 2025. Data from the 75-patient trial are due next year. With pivotal data on the horizon, Amylyx is working toward “ensuring launch readiness for the avexitide program,” Joshua Cohen and Justin Klee, co-CEOs of the biotech, said in a statement.

If approved, avexitide will enter a post-bariatric surgery market that is being reshaped by the explosive growth of GLP-1 receptor agonists. The number of patients undergoing metabolic bariatric surgery fell 25.6% between the last six months of 2022 and the last six months of 2023, according to a study of claims data in the U.S. Yet, Amylyx continues to see an opportunity for its candidate in PBH.

“Bariatric surgery is not going away,” Klee said at an Evercore event last month. “We see it as kind of differentiated in a way from the GLP-1s. Most people who want to lose 20, 30, 40 pounds never would have done bariatric surgery in the first place. It's the people who wanted to lose 100 pounds, 100-plus pounds who really focused on bariatric surgery and I think still are.”

The existing PBH patient population, which Amylyx puts at about 160,000, is the initial opportunity for avexitide. Monahan now sits at the head of a commercial team that will work to get avexitide to those patients, assuming the molecule is approved.