Acquisition of development and marketing right of "Dexrazoxane" for the Treatment of Anthracycline Extravasation in Japan

Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; President and CEO: Mutsuo Kanzawa ("Kissei")] announced today that Kissei has entered into the agreement with SpePharm Holding B.V. [Head Office: the Netherlands; CEO: Jean-François Labbé ("SpePharm")] to obtain a development and marketing right of "Dexrazoxane" (the "Agent") for the treatment of anthracycline extravasation in Japan.

Kissei obtains the use patent and the right to use development data, etc. which are owned by SpePharm in Japan under the Agreement, and Kissei will develop the Agent in Japan.

The patient under treating cancer is prone to the state where the intravenously administered anti-cancer agent extravasates outside the blood vessel due to the circulation disorder along with the vulnerable blood vessel caused by chemotherapy. Especially, even if a small quantity of anthracycline, which is one of the anticancer agents, extravasates outside the blood vessel, pain together with rubor and swelling is occurred, and in some cases, necrosis of the skin or the intractable ulcer is occurred in connection with progress of inflammation.
Dexrazoxane is used in Europe and the USA as an only available drug for the treatment of intravenously administered anthracycline extravasation, but it has not been approved in Japan.

The Ministry of Health, Labour and Welfare set up the initiative for "Unapproved New Drugs and New Indications with High Medical Needs" to promote the development of unapproved medications and treatments for indications that are not approved in Japan. This Agent is one of the agents publicly offered for a development company, because it was considered as the agent with high medical needs at the initiative but no appropriate development company to request exist.

Kissei decided to enter into this agreement, because our engagement in the Agent, which is one of the unapproved drugs, is in accordance with its company policy, "Kissei contribute to society through valuable and innovative medicines." Kissei aims at providing the Agent to patients soon by forwarding the development of the Agent promptly.


≪Reference≫
-About SpePharm Holding B.V.-
SpePharm Holding B.V., a Dutch company with its registered office in Amsterdam, is a pan-European specialty pharmaceutical company focused on acquiring, registering and marketing high medical value specialty medicines essentially for the hospital market. Particular areas of therapeutic interest are oncology, critical and supportive care. SpePharm has a commercial presence in the major EU hospital markets, and has partners in markets outside of the EU.
CEO：Jean-François Labbé
URL：http://www.spepharm.com

-About Dexrazoxane-
Dexrazoxane is a catalytic inhibitor of Topoisomerase II, an enzyme found in the cell nucleus. Topoisomerase enzymes are essential for cell growth and proliferation. Anthracyclines bind these enzymes and indicate anticancer effect. Dexrazoxane is supposed to suppress tissue damage caused by anthracyclines extravasation at blood vessel by inhibiting the effect of Topoisomerase II.
Dexrazoxane is marketed as Savene^® by SpePharm in Europe, and as Totect^® by Topotarget in the USA.

-About the initiative of "Unapproved New Drugs and New Indications with High Medical Needs"-
This initiative was set up by the Ministry of Health, Labour and Welfare for the purpose of "helping promote the development of unapproved medications and treatments for unapproved indications by pharmaceutical companies, by means of assessing medical needs for pharmaceutical products or indications that are not approved in Japan despite their use being approved in Europe and the USA, and evaluating whether they are eligible for submission based on evidence already in the public domain, and the necessity of conducting any additional study in order to file an application."