Eisai Co., Ltd.,a leading global research and development-based pharmaceutical company, and Chugai Pharmaceutical Co., Ltd. (Chugai) announced that Eisai’s acquisition of the rights for manufacturing active pharmaceutical ingredients (API) for Japan from F. Hoffman-La Roche Ltd. for the insomnia treatment/anaesthesia induction agent flunitrazepam (Eisai product name: Silece, Chugai product name: Rohypnol) as well as the marketing authorization held by Chugai for Rohypnol in Japan has been agreed upon by the three companies, and this contract has come into effect.
Under this agreement, Eisai acquires the rights to manufacture 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 to Eisai are scheduled to take effect on April 1, 2017.
Developed by Roche, flunitrazepam is a benzodiazepine-type compound that is indicated for insomnia and preanaethesia treatment in oral tablet form, and for the introduction of general anaesthetic and tranquilizer for local anaesthesia in injectable form. For Japan, Eisai and Chugai have formulated the products using flunitrazepam API supplied by Roche and marketed under the brands Silece and Rohypnol, respectively. With this transfer, manufacturing and marketing of flunitrazepam as the original drug will be solely conducted by Eisai.
