News
10.1.2024
Acceleration of Metsera’s Business
Acceleration of Metsera’s Business
Thanks to our recent generation of highly competitive and exciting data, we are accelerating the growth of our organization to support the rapid development of potentially leading medicines for overweight, obesity, and associated diseases. To support this growth, Metsera has promoted Whit Bernard to Chief Executive Officer while Clive Meanwell will become Executive Chairman.
Whit has been instrumental in the ideation, business processes, key strategies, and action plans of Metsera from day one. Whit’s vision, fundamental understanding of the market opportunities, exceptional leadership, and unrelenting focus on execution, makes him the ideal Chief Executive as Metsera enters the next exciting phase of accelerated growth. Whit’s promotion was approved by the Metsera board of directors on Friday, September 27th.
Clive will continue as Chairman and General Partner of PHP – which remains a strong partner in the rapid emergence of Metsera as a leading company in a highly competitive landscape.
Whit and Clive will continue to work closely together on Metsera’s ideas, unique business processes, key strategies, programs, and projects, also connecting externally with a range of stakeholders and partners. Our commitment to Metsera’s purpose to reduce the physical, emotional, and economic burdens of obesity—thereby creating value for all stakeholders – is stronger than ever.
10.1.2024
Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases
Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases
Amneal to construct state-of-the-art manufacturing facilities and utilize existing manufacturing network to ensure supply of Metsera’s portfolio of novel injectable and oral development programs, including GLP-1 and amylin receptor agonists
Agreement provides Amneal with a new high-growth vector to drive long-term value creation
Metsera gains high-quality, efficient, large-scale manufacturing capabilities for its portfolio to enable rapid product development and anticipated commercial launches
October 1, 2024
BRIDGEWATER, N.J. and NEW YORK -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, and Metsera, Inc. (“Metsera”), 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.
- 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 and $200 million 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.”
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.metsera.com.
About Amneal
Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for
obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin,
non-incretin and combination therapies with potential best-in-class profiles to address multiple
therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape.
Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised $290
million in financing from leading healthcare investors and is based in New York City. For more
information, please visit us at www.metsera.com and follow us on LinkedIn.
Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Contact:
Amneal Contact
Anthony DiMeo
VP, Investor Relations
[email protected]
Metsera Contact
Dan Budwick
1AB
[email protected]
9.24.2024
Metsera Reports Highly Competitive Results from Ongoing Trial of Novel, Potential OnceMonthly Injectable GLP-1 Receptor Agonist MET-097
Metsera Reports Highly Competitive Results from Ongoing Trial of Novel, Potential OnceMonthly Injectable GLP-1 Receptor Agonist MET-097
Results include 7.5% reduction in body weight from baseline at day 36
Weight loss continued to at least 4 weeks after last dose administered
MET-097, incorporating Metsera’s HALO™ platform technology, achieved 380-hour half-life
Potential for monthly dosing and dosing regimens without titration
Metsera launching Phase 2b trials in Q4 2024, with data anticipated in first half of 2025
NEW YORK, September 24, 2024 – Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced positive topline results from the Phase 1 clinical trial of MET-097, an ultra longacting injectable, fully-biased GLP-1 receptor agonist. In this study, MET-097 achieved significant and durable weight loss, supporting a potential once-monthly dosing regimen.
“We are excited about these positive results, which position MET-097 as an ultra-long acting, potent, yet well tolerated GLP-1 drug candidate,” said Steve Marso, M.D., chief medical officer of Metsera. “We are encouraged by both the safety profile and initial efficacy, in which MET-097 achieved weight loss matching, or potentially exceeding, currently available and investigational next-generation GLP-1 and GLP-1 combination drugs. Importantly, these data suggest the possibility for no titration and once monthly dosing, which may result in a more convenient, more scalable, and better tolerated way to administer GLP-1 medicines.”
The randomized, placebo-controlled, double-blind Phase 1 trial was designed to evaluate the tolerability, pharmacokinetics, pharmacodynamics and efficacy of subcutaneous MET-097 in 125 healthy, non-diabetic, overweight or obese adult participants. MET-097 was evaluated at single doses from 0.16 mg to 1.6 mg and weekly doses from 0.2 mg to 1.2 mg, given five times without titration.
- Observed dose-linear pharmacokinetics with a half-life of 380 hours, consistent from subject-to-subject, based on the ultra-long clearance conferred by HALO™, Metsera’s proprietary, novel peptide lipidation platform technology. This translates to a 2-3 fold longer half-life than currently available and investigational nutrient-stimulated hormone (NuSH) products.
- Gastrointestinal adverse events were dose-related, mostly mild, and transient. Occurrence of these events was consistent with marketed and clinical-stage NuSH compounds. No severe treatment-related adverse events were observed, and there were no treatment-related study drug discontinuations.
- Change in body weight from baseline was dose-dependent, and at 1.2 mg was 7.5% at day 36 (one week after the final dose), consistent with or better than marketed and clinical-stage GLP-1 / GIP compounds.
- Cumulative weight loss at the 1.2mg dose was 8.1% at day 57, four weeks after the final dose, suggesting durable pharmacodynamic effect consistent with the observed 380 hour half-life.
“The Phase 1 data show that our proprietary HALO™ technology platform clearly confers ultralong product half-life in people, validating the science underlying the Metsera discovery strategy. Based on these strong results, we believe we can produce a series of NuSH analogs with halflives between 2-3-fold longer than the current marketed and investigational peptide NuSH analogs, and on par with antibody conjugated NuSH analogs,” said Brian Hubbard, Ph.D., chief scientific officer of Metsera.
Metsera plans to initiate a Phase 2b trial of MET-097 in Q4 2024, with data anticipated in the first half of 2025.
About Metsera
Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for
obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin,
non-incretin and combination therapies with potential best-in-class profiles to address multiple
therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape.
Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised $290
million in financing from leading healthcare investors and is based in New York City. For more
information, please visit us at www.metsera.com and follow us on LinkedIn.
Contact:
Media:
Dan Budwick
1AB
[email protected]
investors:
Matt Clawson
1AB
[email protected]
4.18.2024
Metsera Launches to Lead the Next Generation of Medicines for Obesity and Metabolic Diseases
Metsera Launches to Lead the Next Generation of Medicines for Obesity and Metabolic Diseases
Advancing a broad portfolio designed to accelerate innovation and shape the future of treatment for weight loss, obesity-related conditions and metabolic diseases
Clinical-stage pipeline includes oral and injectable incretin, non-incretin and combination therapies designed with best-in-class profiles to address multiple targets and meet the future needs of a rapidly evolving weight loss treatment landscape
Founded by Population Health Partners and ARCH Venture Partners; $290 million in financing raised from a syndicate of leading healthcare investors
NEW YORK, April 18, 2024 – Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, announced its launch today. Founded by Population Health Partners and ARCH Venture Partners and led by former executives of The Medicines Company, Metsera is rapidly advancing a broad portfolio of oral and injectable incretin, nonincretin and combination therapies designed with best-in-class profiles to address multiple targets and meet the future needs of a rapidly evolving weight loss treatment landscape.
“Metsera was purpose-built over the last two years to get ahead of the innovation curve in one of the largest and fastest growing markets in the history of biopharma,” said Clive Meanwell, chief executive officer of Metsera. “We have assembled a portfolio of long-acting injectable and oral agents to address multiple next-generation weight loss goals. With a proven team of world experts across multiple company functions, leading healthcare investors and proprietary health technology tools, we are wellpositioned to rapidly advance our clinical stage pipeline and create value for patients, health systems and investors.”
Metsera has raised $290 million in financing led by ARCH Venture Partners with participation from other leading healthcare investors including F-Prime Capital, GV, Mubadala Capital, Newpath Partners, SoftBank Vision Fund 2 and other undisclosed investors.
“We are in the early days of an incredibly exciting new era of innovation in weight loss and obesity associated diseases,” said Kristina Burow, Metsera board member and managing director of ARCH Venture Partners. “Metsera’s portfolio is focused beyond the current generation of market leaders to address the full spectrum of future weight loss therapeutic needs, including effective weight maintenance, preserving muscle, less-frequent dosing, and better efficacy, tolerability and patient access.”
Metsera’s portfolio of next-generation injectable and oral development programs is sourced from the company’s proprietary library of over 20,000 gut hormone peptides and peptide/antibody conjugates. Development programs include parallel strategies and are focused on multiple next-generation targets and combinations. These include:
- GLP-1 portfolio: led by an injectable, fully-biased GLP-1 receptor agonist in Phase 1 clinical trials with a potential class-leading duration of effect
- A dual amylin/calcitonin receptor agonist (DACRA) engineered for class-leading duration of effect which is being combined with the GLP-1 receptor agonist
- A unimolecular GGG (GLP-1, GIP, Glucagon) engineered for class-leading duration of effect and combination with DACRA
- An oral peptide delivery platform, including two IND-ready candidates with potential best-inclass bioavailability and multiple first-in-class oral follow-on candidates
- A range of other early-stage programs and delivery modalities
“Metsera’s portfolio is designed to unlock new treatment strategies through scalable, sustainable and personalized interventions for weight loss, weight maintenance and disease prevention,” said Sir Stephen R. Bloom, FMedSci, FRS, senior vice president of research and development at Metsera and head of drug development, metabolism, digestion and reproduction at Imperial College London. “Through optimized combinations of injectable and oral peptides, we aim to establish a cycle of continuous and responsive innovation to address a growing worldwide obesity crisis.”
About Metsera
Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for
obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin,
non-incretin and combination therapies with potential best-in-class profiles to address multiple
therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape.
Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised $290
million in financing from leading healthcare investors and is based in New York City. For more
information, please visit us at www.metsera.com and follow us on LinkedIn.
Contact:
Media and Investors:
Dan Budwick
1AB
[email protected]