Merck and Ono Sign Collaborations for Multiple Sclerosis and Cancer

Merck KGaA has announced that they have signed two agreements for collaboration of their Merck Serono division with Ono Pharmaceutical Co. Ltd., headquartered in Osaka, Japan, to strengthen their multiple sclerosis and cancer franchises.

The initial agreement grants Merck Serono exclusive license rights for the development and commercialization of ONO-4641 outside of Japan, Korea and Taiwan.  ONO-4641 is a novel oral sphingosine-1-phosphate (S1P) receptor modulator, currently in Phase II of development that was originally designed for the potential treatment of multiple sclerosis.

Under the terms of the partnership Ono will receive 1.5 billion Japanese Yen (about €14 million) as an upfront payment, plus additional payments depending upon certain development, regulatory and commercial milestones for ONO-4641.

The second license agreement provides Ono with co-development and co-marketing rights of Stimuvax in Japan. Stimuvax is an investigational therapeutic cancer immunotherapy designed to stimulate the body’s immune system to target cancer cells that express the tumour antigen MUC-1.  The drug is currently in Phase II study for the treatment of non-small cell lung cancer in Japan, and Phase III studies are in progress outside Japan.

Under the terms of the agreement for Stimuvax, Merck Serono will receive an upfront payment of €5 million. Merck obtained the exclusive worldwide licensing rights for Stimuvax from Oncothyreon Inc., which is in development in Phase III for patients suffering from non-small cell lung cancer.

Stefan Oschmann, Executive Board Member of Merck and responsible for the Merck Serono division, commented that “Merck Serono is committed to building on our leadership franchise in multiple sclerosis and we are excited about adding a potential oral treatment, ONO-4641, to our pipeline.”  He added “we also believe that Ono will bring a wealth of experience in developing innovative therapies and understanding regulatory requirements in Japan.”

Gyo Sagara, Ono’s President and Representative Director, stated that “we are very glad to partner with Merck Serono for the development and marketing of ONO-4641, given Merck Serono’s commitment to developing treatments for people living with multiple sclerosis.”  “Moreover, we are delighted to collaborate in Japan on Stimuvax and together with Merck Serono to offer a potential future medicine for people suffering from non-small cell lung cancer.”

Merck currently sells the MS blockbuster Rebif (interferon beta-1a) and last month signed a licensing deal for Peptimmune’s PI-2301, a second-generation peptide copolymer.  However it has abandoned its own MS pill cladribine after regulators on both sides of the Atlantic rejected the drug.


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