Obesity Startup Metsera Inks Manufacturing Pact With Amneal on Heels of Phase I Readout

3D illustration of tow GLP-1 therapy autoinjectors

iStock, aprott

A week after it released positive early-stage data, Metsera has partnered with Amneal Pharmaceuticals in an effort to secure the development and supply of its investigational weight loss therapy MET-097.

Metsera on Tuesday announced a supply-focused partnership with Amneal Pharmaceuticals for its pipeline of next-generation weight loss therapies, including an injectable GLP-1 receptor agonist.

Details of the deal were scant but the companies said that Amneal will be Metsera’s “preferred supply partner” for its drug products in developed markets, including the U.S. and Europe. As part of the agreement, Amneal will also have the license to commercialize Metsera’s products in different emerging markets, including India and various countries in Southeast Asia, Africa and the Middle East.

To help support Metsera, Amneal plans to build two new manufacturing plants in India. One facility will be dedicated to peptide synthesis, while the other will be for sterile fill-finish operations. Amneal will set aside a net of $150 million to $200 million over the next four to five years for this construction project, which the company expects to begin later this year.

In addition to supply support, Amneal will ahelp Metsera with some product development activities, including formulation, drug substance manufacturing and drug-device development.

“With this collaboration, we have secured high-quality development and commercial scale capacity for our broad portfolio of ultra-long-acting injectable and oral NuSH [nutrient stimulated hormone] analogs,” Metsera CEO Whit Bernard said in a statement. Amneal brings to the table its “unique capabilities and capacity not typically available to biotech firms at an early stage,” Bernard noted.

It’s been a whirlwind of recent activity for Metsera. The biotech emerged from stealth in April, with $290 million in seed and Series A financing with backing from ARCH Venture Partners, F-Prime Capital and Newpath Partners. Metsera was founded in 2022 by ARCH and Population Health Partners.

Last week, Metsera unveiled impressive early-stage data for MET-097, its investigational long-acting GLP-1 injectable drug, touting a 7.5% drop in body weight at 36 days. This magnitude of effect, according to the startup, either matches or surpasses that of other commercially available or clinical-stage GLP-1 therapies. Four weeks after the last dose, patients treated with a 1.2-mg dose of MET-097 saw cumulative weight loss of 8.7%, pointing to the candidate’s durable effect.

Encouraged by these findings, Metsera intends to accelerate MET-097’s development with a Phase IIb study set to start in the fourth quarter of 2024. Early data from this study is expected next year.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
MORE ON THIS TOPIC