Eisai Acquires Manufacturing Rights to Insomnia Drug API

Eisai, Chugai Pharmaceutical, and Roche have agreed that Eisai will acquire the manufacturing rights in Japan for the active pharmaceutical ingredient (API) for the insomnia treatment and anesthesia induction agent, flunitrazepam, which is marketed by Eisai under the brand name Silece and by Chugai under the brand name Rohypnol. The agreement also includes Eisai’s acquisition of the marketing authorization held by Chugai for Rohypnol in Japan.

Under the agreement, Eisai acquires the rights to manufacture the API as well as intellectual property for flunitrazepam in Japan from Chugai and Roche. Chugai and Roche are entitled to receive a one-time payment based on this agreement. The transfer of the marketing authorization as well as the transition of marketing activities for Rohypnol from Chugai are scheduled to take effect on April 1, 2017.

Developed by Roche, flunitrazepam is a benzodiazepine-type compound that is indicated for insomnia and pre-anesthesia treatment in oral tablet form. It is also indicated for introducing general anesthetic and tranquilizer for local anesthesia in injectable form. For Japan, Eisai and Chugai have formulated the products using the flunitrazepam API supplied by Roche. With this transfer, manufacturing, and marketing of flunitrazepam as the original drug will be solely conducted by Eisai.

Source: Eisai

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