Safinamide to be made available in Asia for Parkinson's


Meiji Seika and Eisai enter into a collaboration for the development and commercialisation of safinamide in Parkinson’s disease for Japan and Asia

Eisai and Meiji Seika Pharma have entered into a license agreement for the commercialisation 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 - more specifically: South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia and the Philippines.

Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorisation 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.

Parkinson's today

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, with the number of patients increasing due to the ageing of the population.

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 decreases and there are cases of Parkinson’s disease symptoms returning before the next dose.

The treatment

To prevent this “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. As such, it 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 duration of effect and an improvement in motor function.

Newron Pharmaceuticals

Safinamide was discovered and developed by Newron Pharmaceuticals, a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain.

In 2011, Newron entered into a licensing agreement with Meiji, granting Meiji exclusive rights to development, manufacture and commercialise the drug in Japan and Asia.

Safinamide is marketed under the name “Xadago” in eleven countries in Europe, and was approved by the US Food and Drug Administration in March.

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In Japan, Meiji is currently conducting Phase II/III trials for safinamide in combination with levodopa.