January 30, 2013

New Drug Application submitted for "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 a new drug application for "Dexrazoxane" (the "Agent") for the treatment of tissue damage at anthracycline extravasation has been filed with the Ministry of Health, Labour and Welfare in Japan.

In September 2011, Kissei entered into the agreement with SpePharm Holding B.V. [Head Office: the Netherlands] to obtain a development and marketing right of the Agent in Japan, and has developed it.

Dexrazoxane is used in Europe and the USA as an only available drug for the treatment of tissue damage at intravenously administered anthracycline extravasation, but it has not been approved in Japan. The 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 of "Unapproved New Drugs and New Indications with High Medical Needs", the Ministry of Health, Labour and Welfare set up, but no appropriate development company to request exist.

Kissei has developed the Agent, 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." By approval and launch the Agent, Kissei aims that the unapproved situation of the Agent will be resolved, and that it is provided to patients soon.


-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 SpePharmAG in Europe, and as Totect® by Apricus Biosciences, 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."