Metsera Signs Manufacturing Deal With Amneal After Phase I Results

Metsera has recently announced a strategic partnership with Amneal Pharmaceuticals to advance the development and supply of its investigational weight loss drug MET-097. This comes shortly after Metsera reported promising early-stage results for MET-097, a long-acting GLP-1 receptor agonist designed to aid in weight loss.

The collaboration between Metsera and Amneal is primarily focused on ensuring a reliable supply of Metsera's next-generation weight loss therapies. Although specific details were limited, it was revealed that Amneal will serve as Metsera’s preferred supplier for their drug products in developed regions such as the U.S. and Europe. Additionally, the agreement grants Amneal the rights to commercialize Metsera's products in various emerging markets across India, Southeast Asia, Africa, and the Middle East.

To support this partnership, Amneal plans to construct two new manufacturing facilities in India. One of these will specialize in peptide synthesis, while the other will handle sterile fill-finish operations. The construction of these plants is anticipated to start later this year, with Amneal committing between $150 million and $200 million over the next four to five years to complete the project.

Beyond supply chain support, Amneal will also assist Metsera in several product development tasks. This includes activities related to formulation, drug substance manufacturing, and drug-device development. According to Metsera’s CEO, Whit Bernard, this collaboration ensures that the company secures high-quality development and commercial-scale capacity for their portfolio of ultra-long-acting injectable and oral nutrient-stimulated hormone (NuSH) analogs. Bernard highlighted Amneal’s unique capabilities and capacity, which are typically not available to biotech firms at an early stage.

Metsera has been experiencing a surge of activity recently. The company emerged from stealth mode in April, backed by $290 million in seed and Series A financing from investors like ARCH Venture Partners, F-Prime Capital, and Newpath Partners. Founded in 2022 by ARCH and Population Health Partners, Metsera aims to make significant strides in the biotech field.

Just last week, Metsera disclosed impressive early-stage data for MET-097. The investigational GLP-1 receptor agonist demonstrated a 7.5% reduction in body weight over 36 days. This outcome either matches or exceeds the effects of other GLP-1 therapies currently available or in clinical trials. Furthermore, patients who received a 1.2-mg dose of MET-097 continued to lose weight, showing a cumulative weight loss of 8.7% four weeks after the final dose. This suggests that MET-097 has a durable effect on weight loss.

Buoyed by these encouraging results, Metsera plans to expedite the development of MET-097. A Phase IIb study is scheduled to commence in the fourth quarter of 2024, with preliminary data expected to be available next year. This accelerated timeline reflects Metsera's confidence in MET-097's potential as a leading weight loss therapy.

By partnering with Amneal Pharmaceuticals, Metsera aims to leverage their extensive manufacturing and development expertise, positioning themselves to bring effective weight loss treatments to a broader market. This collaboration marks a significant step forward in Metsera's mission to develop innovative therapies that address the global challenge of obesity.

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