Merck Serono has signed two separate agreements with Ono Pharmaceutical, Osaka, Japan to strengthen its multiple sclerosis and cancer franchises.

The first agreement grants Merck worldwide exclusive license rights for the development and commercialization of ONO-4641 outside of Japan, Korea and Taiwan. ONO-4641 is a novel oral compound currently in phase II of development that was originally discovered and developed by Ono for the potential treatment of multiple sclerosis. 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 tumor antigen MUC-1 that is in development in phase III for patients suffering from non-small cell lung cancer.

"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," said Dr. Stefan Oschmann, president of Merck Serono.

Under the terms of the agreement for ONO-4641, Merck Serono will acquire worldwide exclusive rights, excluding Japan, Korea and Taiwan, to develop and commercialize ONO-4641. Ono will receive 1.5 billion Japanese Yen as an upfront payment and could receive additional payments based on the achievement of certain development, regulatory and commercial milestones for ONO-4641. No further financial terms are disclosed. ONO-4641 is a sphingosine-1-phosphate (S1P) receptor agonist, and the multi-national phase II study, DreaMS (drug research evaluation for multiple sclerosis) is on-going in patients with relapsing-remitting multiple sclerosis.

Under the terms of the separate agreement for Stimuvax, Ono will receive a co-development and co-marketing license for Stimuvax in Japan and Merck Serono will receive an upfront payment of € 5 million. No further financial terms are disclosed. A phase II study for Stimuvax (EMR63325-009) is being conducted by Merck Serono, a Japanese subsidiary of Merck, for the treatment of non-small cell lung cancer in Japan; phase III studies are in progress outside Japan. Merck obtained the exclusive worldwide licensing rights from Oncothyreon, Seattle, Washington, USA.