Eisai acquires manufacturing rights for API from Roche to treat insomnia

Eisai has acquired the rights for manufacturing active pharmaceutical ingredients (API) for Japan from F Hoffman-La Roche for the insomnia treatment / anaesthesia induction agent flunitrazepam.

The transfer of marketing authorisation held by Chugai Pharmaceutical for Rohypnol in the country has also been agreed upon by the three companies.

Under the agreement, Eisai will acquire the rights to manufacture API, as well as intellectual property for flunitrazepam from Chugai and Roche.

Both Chugai and Roche will receive a one-time payment based on the agreement.
"The transfer of the marketing authorisation and transition of activities for Rohypnol from Chugai to Eisai are set to come into force on 1 April this year."

Flunitrazepam has been developed by Roche and is a benzodiazepine-type compound that is indicated for insomnia and preanaethesia treatment in oral tablet form.

It is also indicated for the introduction of general anaesthetic and tranquilizer for local anaesthesia in injectable form.

Eisai and Chugai have formulated the products using flunitrazepam API supplied by Roche for Japan.

The products are marketed under the Silece and Rohypnol brands.

Following the transfer, flunitrazepam manufacturing and marketing as the original drug will be solely conducted by Eisai.

Chugai specialises in prescription pharmaceuticals and is involved in R&D activities in Japan and abroad.