With early phase 1 data now out in the wild, metabolic disease outfit Metsera is wasting no time locking down supplies of its GLP-1 and amylin receptor agonist candidates.
Metsera is teaming up with New Jersey-based generics and specialty drug maker Amneal Pharmaceuticals, which will now serve as the biotech’s “preferred supply partner” for developed markets including the U.S. and Europe.
As part of the deal, Amneal will receive a license to market Metsera’s products in select emerging markets like India and certain Southeast Asian countries should Metsera’s drugs eventually win approval, the companies said in a joint press release.
Further, Amneal will build out two new manufacturing facilities in India—one for peptide synthesis and one for fill-finish manufacturing—at a single new site where the company plans to invest between $150 million and $200 million over the next four to five years.
Amneal said it plans to break ground at the new site “later this year.”
Beyond the commercial realm, Amneal is also slated to chip in on Metsera’s development activities such as drug substance manufacturing, formulation and drug-device development, the partners said.
The deal is expected to both bolster Metsera’s development capabilities and offer commercial-scale capacity for the future. The scope of the supply deal is noteworthy given how early Metsera is in its development journey.
Metsera debuted in April with $290 million as part of a growing wave of biotechs looking to spearhead the next generation of obesity and metabolic disease medicines. As of late September, the Population Health- and Arch Venture-founded company had raised a total of $322 million.
Last week, Metsera unveiled partial phase 1 data for its GLP-1 receptor agonist prospect MET-097, which the company linked to “significant and durable” weight loss in a study of 125 nondiabetic adults who are overweight or obese.
Metsera tested its candidate at multiple doses, with a 7.5% reduction in weight versus baseline observed at Day 36 for patients in the 1.2-mg/weekly group.
Metsera has touted the potential for its GLP-1 medicine to be given just once a month, which would offer a convenience edge over Novo Nordisk’s marketed GLP-1 Wegovy or Eli Lilly’s Zepbound, which are dosed weekly.
Beyond MET-097, Metsera’s preclinical pipeline includes a dual amylin/calcitonin receptor agonist designed to be paired with the company’s GLP-1 candidate. The biotech is also working on a unimolecular GGG (GLP-1, GIP, glucagon) drug.
Meanwhile, Metsera is handing the reins over to Whit Bernard, who previously served as the biotech's operating chief and as a managing partner at Population Health Ventures. Bernard is taking up the CEO post from Clive Meanwell, M.D., who founded and led The Medicines Company.