Merck Lets Go of Osteoarthritis Drug for €450 Million To Focus on Other Pipelines
By T. Chakraborty, Ph.D.
Osteoarthritis (OA), also known as degenerative joint disease or “wear and tear” disease, is characterized by the disintegration of the cartilage within a joint and changes in the underlying bone structure. These changes usually develop slowly before getting worse with time. OA causes pain, stiffness, swelling, and disrupts daily life by reducing basic functions in a normal human being.
Approximately 32.5 million people in the US alone are living with this debilitating condition. OA has no cure to date, while the symptoms can be treated with a combination of therapies. On October 6th, Merck announced that it is engaged in an out-licensing agreement with Novartis for the development of M6495, their proprietary drug for the potential treatment of OA.
Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck, commented, “With this deal, we have found the right solution for this asset designed to present an innovative mechanism of action for the potential treatment of osteoarthritis, as we prioritize our pipeline to deliver the greatest impact for patients across our internal areas of expertise. This agreement underscores our commitment to ensure this molecule, which has promise in many different types of OA, makes it to patients as quickly as possible.”
As part of the agreement between the two companies, Merck will provide Novartis M6495 for further evaluation in OA patients. Merck is entitled to receive an upfront payment of € 50 million with a further payout of another € 400 million based on pre-discussed commercial milestones and royalties on future net sales. Novartis further added that it would assume full responsibility for the commercialization and developmental aspects of the M6495 program. Previously M6495 was jointly developed by Merck and Ablynx (a Sanofi company) in 2011 under a joint discovery and development agreement. However, the drug was later singularly developed by Merck till it’s licensing agreement with Novartis.
The agreement was primarily based on the success of the two Phase I studies done with M6495. The first study conducted in 54 healthy volunteers evaluated the safety, tolerability, and a significant reduction of ARGS (a neoepitope present in the synovial fluid and serum of OA patients) levels at single doses of M6495. The second study aimed at targeting inhibition of ARGS by dosing M6495 every alternate week in OA patients. The Phase II-ready program which Novartis intends to develop further represents a strong potential for a disease-modifying osteoarthritis drug (DMOAD) coming to the market in the near future. The M6495 is intended to be self-administered via subcutaneous injections that would help maintain the structural integrity of knee joints and alleviate pain.
With this licensing agreement, Merck has made clear of its intentions to focus on other profitable pipelines like oncology. However, the Phase 2 trials of its Sprifermin, a truncated recombinant human FGF-18 protein, and a potential OA treatment, is still ongoing. It would be interesting to see whether it would also do away with Sprifermin in the future.
Editor: Rajaneesh K. Gopinath, Ph.D.
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