Agreements

Date: 2017-04-05

Type of information: Licensing agreement

Compound: safinamide

Company: Newron Pharmaceuticals (Italy) Meiji Seika Pharma (Japan) Eisai (Japan)

Therapeutic area: Neurodegenerative diseases - CNS diseases

Type agreement: R&D - research - development - licensing - commercialisation

Action mechanism:

Monoamine oxidase inhibitor/sodium channel blocker. 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.
Safinamide was discovered and developed by Newron Pharmaceuticals. The drug is marketed under the name “Xadago®” in eleven countries in Europe, and on March 21, 2017, was approved by the FDA. In Japan, Meiji is currently conducting Phase II/III trials for safinamide in combination with levodopa.

Disease: Parkinson's disease

Details:

• On February 16, 2012, Newron Pharmaceuticals has finalized a definitive license agreement with Meiji Seika Pharma covering the research, development, manufacturing, and marketing of safinamide in Japan and key Asian territories.
The transaction follows a binding agreement on principal terms and conditions as announced on January 5, 2012, and will become effective upon the return of the global rights to safinamide from Merck Serono, the division for biopharmaceuticals of German company Merck KGaA, to Newron by April 17, 2012.
• On January 5, 2012, Newron Pharmaceuticals has agreed with Meiji Seika Pharma on the principal terms and conditions of a license transaction covering the research, development, manufacturing, and marketing of safinamide in Japan and key Asian territories.

Financial terms:

Under the agreement, Newron has received an up front payment of €5m. Other financial terms of the agreement are not disclosed.

Latest news:

• On April 5, 2017, Newron Pharmaceuticals announced that its partner Meiji Seika Pharma has entered into a collaboration with Eisai. The two Japanese groups have concluded a license agreement for the commercialization of safinamide for the treatment of Parkinson’s disease in Japan and Asia. Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in Asia (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 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.