Merck KGaA, Darmstadt, Germany, Announces Out-Licensing Agreement for Phase II-ready Anti-ADAMTS5 Nanobody for Osteoarthritis

• Merck KGaA, Darmstadt, Germany, out-licenses promising clinical-stage program to Novartis
• Anti-ADAMTS5 Nanobody^® program is Phase II-ready with novel MoA which could protect against cartilage damage and reduce joint pain
• Merck KGaA, Darmstadt, Germany, receives upfront payment of € 50 million with the potential of receiving a further € 400 million related to delivering on certain development and commercial milestones

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that it has entered into an out-licensing agreement with Novartis, for the development of M6495, an anti-ADAMTS5 Nanobody^® for the potential treatment of osteoarthritis (OA).

The Phase II-ready program represents potential for a disease modifying osteoarthritis drug (DMOAD). M6495 is being developed with the aim to be self-administered via subcutaneous injections to maintain structural integrity of knee joint and reduce pain.

“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,” says Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “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, Merck KGaA, Darmstadt, Germany, will out-license to Novartis the Phase II-ready asset M6495 for further evaluation in OA patients. Merck KGaA, Darmstadt, Germany, will receive an upfront payment of € 50 million with the potential of receiving a further € 400 million related to delivering on certain development and commercial milestones and royalties on future net sales. Novartis will assume full responsibility for the development and commercialization of the M6495 program.

Two Phase I studies were completed with M6495: one study in healthy volunteers demonstrated M6495 safety and tolerability and a meaningful reduction of ARGS (a neoepitope from cleaved aggrecan, found in the synovial fluid and serum of OA patients) levels at single doses (n=54); one study targets inhibition of ARGS with dosing every other week in OA patients. Novartis will continue to characterize M6495 in future studies with the goal of bringing it to market for osteoarthritis patients.

M6495 was originally jointly developed by Merck KGaA, Darmstadt, Germany, and Ablynx (now Ablynx, a Sanofi company) as part of a joint discovery and development agreement in 2011; the asset was later solely developed by Merck KGaA, Darmstadt, Germany, up until the out-licensing agreement with Novartis.