M's Science and Eisai Sign Option Agreement for Sigma Agonist SA4503

M's Science Corporation
Eisai Co., Ltd.

M's Science Corporation (Headquarters: Hyogo, President & COO: Akihiko Shimauchi) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that the companies entered into an option agreement for SA4503, a novel sigma agonist which is being developed by M's Science in Europe for the treatment of depression and post-stroke therapy.

Under the terms of the agreement, M's Science will grant Eisai the following rights in exchange for a certain payment: the first review right for evaluating the results of the two Phase Ⅱ studies of the compound currently ongoing in Europe for the above two indications and the first negotiation right regarding the development and marketing of the compound.

“We are very pleased with this collaboration with Eisai, which is the world-leading Japanese pharmaceutical company in central nervous system disease research. I am confident that this agreement facilitates the development of our novel SA4503, and enables us to offer a new treatment for depression and for post-stroke therapy. SA4503 will address significant unmet medical needs in these indications,” said Mr. Akihiko Shimauchi, President and COO of M's Science.

Mr. Haruo Naito, President and CEO of Eisai said “I expect that this strategic alliance with M's Science, which is the Japanese leading biopharmaceutical company, will result in a novel, next generation treatment for brain and nervous system disorders and will enhance one of our focused therapeutic areas- neuroscience.”

[Please refer to the following note for the product information and glossary]


< Glossary >


SA4503 is a novel, small molecule, selective sigma receptor agonist with activity in preclinical models of CNS diseases to enhance neuroregeneration/maturation. Four human Phase I studies including one PET study with SA4503 have been completed in the Netherlands, and the safety profile of this compound in healthy individuals as well as its brain pharmacokinetics, and receptor binding/occupancy have been established. Currently, two Phase Ⅱ studies are being conducted in Europe for the treatment of central nervous system disorders (major depression and post-stroke recovery).

Two Phase Ⅱ Studies in Europe

(1)A randomized, double-blinded, placebo-controlled, parallel, multi-center, 8-week clinical study is currently carried out in four European countries (Finland, Latvia, Estonia, and Lithuania) to evaluate efficacy and safety of SA4503 in moderate to severe major depression patients. Unlike current anti-depressants such as SSRI, SA4503 has the potential to enhance neuroregeneration/maturation and is expected to show efficacy through this novel mode of action. The world market for anti-depression drugs is very large with approximately 2 trillion yen of global sales. Despite the availability of several anti-depression drugs, there remains a significant unmet medical need due to the high incidence of treatment resistant patients.

(2)A double-blinded, placebo-controlled, dose-escalation, multi-center clinical study in stroke patients is currently carried out in three European countries (UK, Spain and Czech) to evaluate safety and efficacy on post-stroke motor dysfunction. Unlike other marketed post-stroke treatment, SA4503 may improve motor dysfunction after stroke even when it is administrated 2~3 days after onset of stroke. It is anticipated that SA4503 could contribute to improve patients' Quality of Life and to reduce the care burden on their families.

About M's Science

M's Science is a privately held biopharmaceutical company. Currently, it is conducting several development projects for its novel compounds which are under evaluation in clinical studies. As one of a few Japanese-based biopharmaceutical companies, M's Science is dedicated to creating new drugs by state-of-the-art research to improve human life. For detail, please visit: http://www.m-sci.com

Company Name: M's Science Corporation
Chairman & CEO: Shiro Mita
President & COO: Akihiko Shimauchi
Business Purpose: Research and development of pharmaceuticals
Foundation: November 9, 2000
Company Capitalization: 2,059,320,000 yen

About Eisai Co., Ltd

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology, including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing affiliates, Eisai actively participates in all aspects of the worldwide healthcare system.