Merck Serono and Ono Pharmaceutical Form Collaborations to Develop Oral Multiple Sclerosis Drug and Cancer Immunotherapy

GENEVA, October 4, 2011 -

- Merck Serono to collaborate with Ono for the development and commercialization of ONO-4641, an oral investigational sphingosine-1-phosphate (S1P) receptor modulator, in Phase II in multiple sclerosis

- The companies will also collaborate in Japan on the development and marketing of Stimuvax, Merck Serono’s investigational cancer immunotherapycurrently in Phase III clinical development

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the signature of two separate agreements with Ono Pharmaceutical Co., Ltd., 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. “We also believe that Ono will bring a wealth of experience in developing innovative therapies and understanding regulatory requirements in Japan.”

“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,” said Gyo Sagara, Ono’s President and Representative Director. “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.”

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 (about € 14 million) 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 Co., Ltd., 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 Inc., Seattle, Washington, USA.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Stimuvax

Merck Serono is investigating the use of Stimuvax^® (BLP25 liposome vaccine) in the treatment of NSCLC. Merck KGaA obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA. Stimuvax is being developed in Europe by Merck Serono. In the United States and Canada, Stimuvax is being developed by EMD Serono, an affiliate of Merck.

The START study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,500 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS).

The INSPIRE study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enrol approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

About Ono Pharmaceutical

Ono Pharmaceutical Co., Ltd. is a R&D-oriented pharmaceutical company specializing in creating innovative medicines in specific areas and is headquartered in Osaka, Japan.  

For more information about Ono, visit the company’s website at www.ono.co.jp.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta™, tesamorelin), as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merckgroup.com

Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève, Suisse, Media relations, Tel: +41-22-414-36-00