Novartis Acquires Global Rights to Merck's Investigational Osteoarthritis Drug M6495 for €450 Million

On the morning of October 7, EY Health learned that Merck announced a collaboration with Novartis, licensing the global development rights for its investigational new drug for osteoarthritis (OA), M6495, to Novartis. In return, Merck will receive an upfront payment of €50 million, along with up to €400 million in milestone payments and sales royalties.

It is reported that approximately 237 million people worldwide suffer from symptomatic and activity-limiting osteoarthritis, which ranks as the third leading cause of disability globally. In the final stages of the disease, total knee replacement is typically required. Statistics indicate that osteoarthritis is likely the primary indication for total hip and knee arthroplasty in the United States; however, the U.S. Food and Drug Administration (FDA) has not yet approved any pharmacological agents for the prevention or slowing of disease progression.

M6495 is a single-domain antibody targeting the metalloproteinase ADAMTS5, designed for patient self-administration via subcutaneous injection to maintain knee joint structural integrity and alleviate pain. M6495 is currently in Phase II clinical trials for the treatment of osteoarthritis.

M6495 has previously completed two Phase I clinical studies. One study in healthy subjects demonstrated that M6495 had a favorable safety and tolerability profile and significantly reduced ARGS levels in subjects; the other study aimed to explore the efficacy and safety of M6495 in reducing ARGS levels in patients with osteoarthritis.

In fact, M6495 was initially co-developed by Merck and Ablynx (later acquired by Sanofi in 2018) in 2011 as part of a joint discovery and development agreement. The asset was subsequently developed exclusively by Merck until the aforementioned out-licensing agreement with Novartis was reached.

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