Amneal Pharmaceuticals, Inc, a global pharmaceutical company, and Metsera, Inc. , a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced that they have entered into a collaboration agreement to enable the efficient development and large-scale supply of a portfolio of new weight loss medicines globally.
The collaboration positions Amneal and Metsera to deliver weight loss and metabolic disease medicines at scale. Among other compelling aspects of the collaboration, it is important to know that:
• Metsera is advancing a portfolio of next-generation therapies for obesity and metabolic diseases, including ultra-long acting injectable and oral nutrient stimulated hormone (NuSH) analogs and combinations designed with best-in-class profiles. With a library of over 20,000 NuSH peptide analogs and peptide/antibody conjugates, Metsera aims to address the increasing demand and future needs of the highly dynamic global obesity and diabetes landscape across a broad range of modalities.
• Metsera recently announced highly competitive results from the Phase 1 clinical trial of its glucagon-like peptide-1 (GLP-1) receptor agonist injectable, MET-097. The randomized, placebo-controlled, double-blind Phase 1 trial demonstrated that MET-097 achieved significant and durable weight loss. MET-097 is expected to be the first drug manufactured under Amneal and Metsera’s collaboration.
• Amneal has leading global product development and manufacturing capabilities , including in-house API and sterile fill-finish manufacturing, which complement Metsera’s offerings. Amneal has deep expertise in complex pharmaceutical manufacturing and a strong track record of delivering quality and innovation at scale, which includes developing, manufacturing and distributing a diverse portfolio of over 280 pharmaceutical products.
• Amneal is expediting its entry into the rapidly growing global obesity market while leveraging its core competencies: science-driven product development, high-quality and cost-effective manufacturing, and the ability to rapidly scale-up and execute.
Under the terms of the agreement, Amneal will serve as Metsera’s preferred supply partner for developed markets, including the United States and Europe. Amneal will also be granted a license to commercialize Metsera’s products in select emerging markets, including India and certain countries in Southeast Asia, Africa and the Middle East.
Amneal will construct two new greenfield manufacturing facilities in India, one for peptide synthesis and one for sterile fill-finish manufacturing. The new site, which will house both facilities, is expected to break ground later this year, with a total net cost to Amneal of between 150 million USD and 200 million USD over the next four to five years, net of contributions from Metsera and government incentives. Additionally, Amneal will support Metsera with certain product development activities, including drug substance manufacturing, product formulation and drug-device development.
“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 and essential medicines, including those in new categories. Through this strategic collaboration, we have the opportunity to extend our mission to a new portfolio of injectable and oral weight loss therapies. We are excited to work with Metsera and apply Amneal’s deep expertise in complex pharmaceutical manufacturing to bring these programs to market,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.
Whit Bernard, Chief Executive Officer of Metsera, said, “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 analogs. 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 both established and new state-of-the-art facilities.”
