Merck Announces Out-Licensing Agreement for Phase II-ready Anti-ADAMTS5 Nanobody for Osteoarthritis

Darmstadt, Germany (ots/PRNewswire) - - Merck 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 receives upfront payment of EUR 50 million with the potential of
receiving a further EUR 400 million related to delivering on certain development
and commercial milestones

Not intended for UK and US based media

Merck, 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. "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 will out-license to Novartis the Phase II-ready
asset M6495 for further evaluation in OA patients. Merck will receive an upfront
payment of EUR 50 million with the potential of receiving a further EUR 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
(https://clinicaltrials.gov/ct2/show/NCT03224702) 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
(https://clinicaltrials.gov/ct2/show/NCT03583346) 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.