Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, October 06 2020 - 23:33
AsiaNet
Merck Announces Out-Licensing Agreement for Phase II-ready Anti-ADAMTS5 Nanobody for Osteoarthritis
DARMSTADT, Germany, Oct.. 6, 2020 /PRNewswire-AsiaNet/--

Not intended for UK and US based media

- 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 € 50 million with the potential of 
receiving a further € 400 million related to delivering on certain development 
and commercial milestones



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 € 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 
[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.

M6495 was originally jointly developed by Merck 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 up until the out-licensing 
agreement with Novartis.

Merck in Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant 
R&D and commercial experience in multiple sclerosis (MS). The company's current 
MS portfolio includes two products for the treatment of relapsing MS, with a 
robust pipeline focusing on discovering new therapies that have the potential 
to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of 
those living with MS, by addressing areas of unmet medical needs. 

The company's robust immunology pipeline focuses on discovering new therapies 
that have the potential to modulate key pathogenic mechanisms in chronic 
diseases such as MS and systemic lupus erythematosus.

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About Merck

Merck, a leading science and technology company, operates across healthcare, 
life science and performance materials. Around 57,000 employees work to make a 
positive difference to millions of people's lives every day by creating more 
joyful and sustainable ways to live. From advancing gene editing technologies 
and discovering unique ways to treat the most challenging diseases to enabling 
the intelligence of devices – the company is everywhere. In 2019, Merck 
generated sales of € 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to 
Merck's technological and scientific advances. This is how Merck has thrived 
since its founding in 1668. The founding family remains the majority owner of 
the publicly listed company. Merck holds the global rights to the Merck name 
and brand. The only exceptions are the United States and Canada, where the 
business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma 
in life science, and EMD Performance Materials.

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Source: Merck