Amneal and Metsera Form Strategic Alliance To Develop Next-Gen Obesity and Metabolic Disease Treatments

Amneal Pharmaceuticals, Inc., a global pharmaceutical company, and Metsera, Inc., an emerging clinical-stage biopharmaceutical company, collaborate to develop new therapies for obesity and metabolic diseases. They announced an agreement to join forces to streamline the development and supply of a pipeline of new weight loss drugs globally.

Metsera is advancing next-generation therapies targeting obesity and metabolic diseases, including ultra-long-acting injectable and oral nutrient-stimulated hormone (NuSH) analogues. With a library of over 20,000 NuSH peptide analogues and peptide/antibody conjugates, Metsera aims to meet the growing needs of the dynamic global landscape of obesity and diabetes through various modalities.

Recently, Metsera reported promising results from a Phase 1 clinical trial for its glucagon-like peptide-1 (GLP-1) receptor agonist, MET-097. This randomised, placebo-controlled, double-masked trial demonstrated that MET-097 led to significant and sustained weight loss. It is anticipated that MET-097 will be the first drug produced through the collaboration between Amneal and Metsera.

Amneal brings global solid product development and manufacturing capabilities, including in-house active pharmaceutical ingredient (API) production and sterile fill-finish processes, which enhance Metsera’s offerings. With extensive expertise in complex pharmaceutical manufacturing, Amneal has a trend of quality and innovation at scale, having developed and distributed over 280 pharmaceutical products.

With its ability to develop science-driven products, high-quality and cost-effective manufacturing, and easy scalability, Amneal is well-positioned to make a compelling foray into the expanding global obesity market. Under the deal, Amneal would be a more favourable supplier of developed markets to Metsera, which include the United States and Europe. Amneal also gets the license to market certain Metsera products in some emerging markets, including India and other Southeast Asian countries, Africa, and the Middle East.

Amneal would also receive a license for the marketing of Metsera's products in some emerging markets, including India and countries in Southeast Asia, Africa, and the Middle East. Amneal would establish two new greenfield manufacturing sites in India. One will be dedicated to peptide synthesis, and the other will be for sterile fill-finish manufacturing. Construction of this new site will be started at the end of this year. 

Total investment in this facility is estimated to be $150 million-$200 million over four to five years, with actual contributions made by Metsera, besides government incentives. Amneal will also collaborate with Metsera on several product development activities, including drug substance manufacturing, formulation, and drug device development.

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, stated, “GLP-1s and other breakthrough obesity therapies have significant and wide-ranging health benefits for patients. Amneal is deeply committed to providing access to high-quality, affordable, essential medicines, including those in new categories. Through this strategic collaboration, we can extend our mission to a new portfolio of injectable and oral weight loss therapies. We are excited to work with Metsera and apply Anneal's deep expertise in complex pharmaceutical manufacturing to bring these programs to market,”

“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 analogues. Collaborating with Amneal brings dedicated access to unique capabilities and capacity not typically available to biotech firms at an early stage. These comprise access to Amneal’s drug substance manufacturing, product formulation and drug-device development capabilities, including its in-house API and sterile fill-finish, through established and new state-of-the-art facilities,” said Whit Bernard, Chief Executive Officer of Metsera.