TOKYO, Apr 5, 2017 - (JCN Newswire) - Eisai Co., Ltd. and Meiji Seika Pharma Co., Ltd. announced today that they have entered into a license agreement for the commercialization of safinamide (development code: ME2125) for the treatment of Parkinson's disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan.
Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in Asia (seven countries(1)). Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in Japan. Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia. Meiji will manufacture and supply the product of safinamide to Eisai for Japan and Asia. Furthermore, Meiji will receive an upfront payment from Eisai, as well as developmental milestone and sales royalty payments under the agreement.
Parkinson's disease is a neurodegenerative disease which causes motor impairment, including shaking in the limbs, muscular rigidity and brachybasia. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. According to a survey by the Ministry of Health, Labour and Welfare, the number of patients suffering from Parkinson's disease in Japan numbered 163,000 in 2014(2), with the number of patients increasing due to the aging of the population.(3)
Levodopa is widely used to treat Parkinson's disease by replenishing the brain's supply of dopamine. However, as the disease progresses, levodopa's duration of effect ("on" time) decreases, and there are cases of Parkinson's disease symptoms returning before the next dose ("wearing-off" phenomenon). To prevent the "wearing-off" phenomenon, combination therapy with a drug that has a different mechanism of action to levodopa is administered.
Safinamide is a selective monoamine oxidase B (MAO-B) inhibitor, which reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. Additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such, has potential as a new Parkinson's disease treatment which possesses both dopaminergic and non-dopaminergic mechanisms. Global clinical trials of safinamide in combination with levodopa for the treatment of mid- to late-stage Parkinson's disease showed extended "on" time, and an improvement in motor function.(4)
Safinamide was discovered and developed by Newron Pharmaceuticals S.p.A. (Headquarters: Italy, Milan, "Newron"). In 2011, Newron entered into a licensing agreement with Meiji, granting Meiji exclusive rights to development, manufacture and commercialize the drug in Japan and Asia. Safinamide is marketed under the name "Xadago" in eleven countries in Europe, and on March 21, 2017, was approved by the U.S. Food and Drug Administration. In Japan, Meiji is currently conducting Phase II/III trials for safinamide in combination with levodopa.
Through this agreement, Eisai and Meiji will make further contributions to address the diversified needs of, and increase the benefits provided to, Parkinson's disease patients and their families.
About Meiji Seika Pharma
In order to protect and improve people's health and lives, Meiji Seika Pharma, as a "Speciality and Generic Pharmaceuticals Company", runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, as well as generic drugs. Meiji Seika Pharma strives to respond to diversified medical needs and contributes to the well-being of people worldwide. For details, please visit its corporate website: http://www.meiji.com/global/about-us/corporate-profile/meiji-seika-pharma/
(1) South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia, and the Philippines
(2) Patient Survey 2014 (Disease and Injury) by Statistics and Information Department, Minister's Secretariat, Ministry of Health, Labour and Welfare
(3) Japan Intractable Diseases Information Center http://www.nanbyou.or.jp/
(4) Borgohain R et al. Randomized Trial of Safinamide Add-On to Levodopa in Parkinson's Disease With Motor Fluctuations. Mov Disord. 2014 Feb;29(2):229-37
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) 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; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Meiji Seika Pharma Co., Ltd.
Public Relations Department,
Eisai Co., Ltd.
Apr 5, 2017 10:23 HKT/SGT
Eisai (TSE: 4523)
Topic: Press release summary
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