Transfer of Rights to Insomia Treatment / Anaesthesia Induction Agent Flunitrazepam in Japan

Jan 16, 2017 09:19 JST

Source: Eisai

TOKYO, Jan 16, 2017 - (JCN Newswire) - Eisai Co., Ltd. and Chugai Pharmaceutical Co., Ltd. announced today that Eisai's aquisition 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.

Eisai and Chugai will cooperate to ensure the smooth transfer of API manufacturing rights for flunitrazepam as well as marketing authorization and marketing activities for Rohypnol.

About Rohypnol (flunitrazepam)

(1) Insomnia treatment Rohypnol Tablet 1, Rohypnol Tablet 2
[Indications for use]
Insomnia, preanaesthetic medication

[Dosage and administration]
The usual adult dose is 0.5 mg to 2 mg of flunitrazepam taken once orally before bed or prior to surgery.

The dosage should be increased or decreased appropriately depending on age and symptoms, and should be no more than 1 mg per dose for elderly patients.

(2) Anaesthetic induction agent Rohypnol 2 mg for Injection
[Indications for use]
Introduction of general anaesthetic, tranquilizer for local anaesthesia

[Dosage and administration]
At time of administration, the agent should be diluted with over twice as much solution for injection and should be gently injected (over 1 minute for 1 mg of flunitrazepam) intravenously.

The usual adult dose is 0.02 to 0.03 mg of flunitrazepam per 1 kg of body weight as introduction of general anaesthetic, and 0.01 to 0.03 mg of flunitrazepam per 1 kg of body weight as tranquilizer for local anaesthesia. If necessary, an additional equal or half dose can be administered.

The dosage should be increased or decreased appropriately according to factors including patients' age, sensitivity, overall condition, method of surgery and method of anaesthesia.

About Chugai Pharmaceutical

Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad.

Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.

In Japan, Chugai's research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai's proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.

The consolidated revenue in 2015 of Chugai totaled 498.8 billion yen and the operating income was 90.7 billion yen (IFRS Core basis).

Additional information is available on the internet at http://www.chugai-pharm.co.jp/english

Contact:

Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120

Source: Eisai
Sectors: BioTech

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