|
| Monday, 7 September 2020, 08:02 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
TOKYO, Sept 7, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that it will take over by transfer the manufacturing and marketing approval of Parkinson's disease treatment Equfina 50mg TABLETS (safinamide mesilate, "Equfina") in Japan from Meiji Seika Pharma Co., Ltd., effective September 23, 2020.
In Japan, Meiji conducted clinical studies of Equfina and obtained its manufacturing and marketing approval in September 2019. Eisai has exclusively sold Equfina in Japan as a distributor. Based on the license agreement signed between Eisai and Meiji, Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.
Equfina, developed by Meiji in Japan, is a once-daily oral treatment for Parkinson's disease. It is a selective and reversible monoamine oxidase B (MAO-B) inhibitor that helps to maintain the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain (dopaminergic mechanism). In addition, Equfina blocks voltage-dependent sodium ion channels and inhibits glutamate release (non-dopaminergic mechanism). In the clinical studies conducted in Japan for Parkinson's disease patients under treatment with a drug containing levodopa, the extension of levodopa's duration of effect ("on" time) of one hour or more and improvement of motor functions were shown. Improvement effect on the wearing off phenomenon is expected.
Following the completion of the transfer, Eisai will continue to deliver Equfina, a new option for Parkinson's disease treatment in Japan to patients, thereby increasing the amount of time that they can freely engage in activities on their own initiative. Eisai will further contribute to improving the QOL of patients and enabling their families to create a vibrant daily life.
About Equfina (safinamide mesylate "safinamide")
Safinamide is a selective monoamine oxidase B (MAO-B) inhibitor that 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.
Safinamide was discovered and developed by Newron Pharmaceuticals S.p.A. In 2011, Newron entered into a licensing agreement with Meiji, granting Meiji exclusive rights to develop, manufacture and commercialize the drug in Japan and Asia. Eisai has exclusive rights for marketing in Japan, as well as for development and marketing in Asia* based on a licensing agreement signed between Eisai and Meiji. Safinamide mesilate is marketed under the name "Xadago" in 15 countries in Europe, the United States and Australia, and under the name "Onstryv" in Canada.
* South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Myanmar, Singapore, Hong Kong, and Macau
About Parkinson's Disease
Parkinson's disease is a neurodegenerative disease that causes motor impairment such as shaking in the limbs, muscular rigidity and shuffling gait, as well as non-motor impairment such as sensation impairment with pain, insomnia, and autonomic failure. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. According to an estimate by the Japanese Society of Neurology, there are approximately 200,000 patients suffering from Parkinson's disease in Japan.(1) Also, approximately 3 million patients suffer from Parkinson's disease in Asia.(2) The number of patients is increasing due to 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, the duration of effect of a drug containing levodopa ("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 a drug containing levodopa is administered.
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 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 to contribute to the well-being of people worldwide.
For details, please visit its corporate website:
https://www.meiji.com/global/about-us/corporate-profile/meiji-seika-pharma/
(1) Japanese Society of Neurology. Treatment and Management Guideline 2018 for Parkinson's Disease
(2) E Ray Dorsey et al. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the
Global Burden of Disease Study 2016 Lancet Neurol. 2018;17:939-53
(3) Japan Intractable Diseases Information Center: https://www.nanbyou.or.jp/
Contact:
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Topic: Press release summary
Source: Eisai
Sectors: Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2026 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| July 2, 2026 21:45 HKT/SGT |
|
Eisai to Showcase Alzheimer's Disease Portfolio with More Than 50 Presentations at the Alzheimer's Association International Conference(R) 2026 (AAIC(R)) |
| July 2, 2026 21:01 HKT/SGT |
|
UCL and Eisai renew partnership to accelerate treatments for neurodegenerative diseases |
| June 17, 2026 12:28 HKT/SGT |
|
Eisai Announces Strategic Investment Supported by the UK Government's LSIMF |
| May 21, 2026 23:23 HKT/SGT |
|
Eisai Deepens Body of Clinical Evidence for LENVIMA(R) (Lenvatinib) Across Established Indications at ASCO 2026 |
| Apr 21, 2026 19:52 HKT/SGT |
|
Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) |
| Mar 27, 2026 19:14 HKT/SGT |
|
Application Submitted for LENVIMA(R) (lenvatinib) in Japan Seeking Approval of Additional Dosage and Administration for Combination with WELIREG(R) (belzutifan) for Renal Cell Carcinoma that has Progressed After Chemotherapy |
| Mar 27, 2026 17:19 HKT/SGT |
|
Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency |
| Mar 23, 2026 10:19 HKT/SGT |
|
Results from Real-World, Long-Term Treatment Persistence with LEQEMBI(R) (lecanemab-irmb) in the United States Presented at AD/PD(TM) 2026 |
| Mar 19, 2026 09:54 HKT/SGT |
|
Eisai: Regarding Discontinuation of Administration of "Tazverik(R) Tablets 200mg" (tazemetostat hydrobromide) |
| Mar 17, 2026 18:49 HKT/SGT |
|
Eisai Established the Global Capability Centre in Visakhapatnam, India, to Standardize Global IT Infrastructure Operations and Digital Transformation |
| More news >> |
 |
|
|
|
