January 17, 2014

New Drug Application Approval for "SAVENE® Injectable 500mg" for the Treatment of Anthracycline Extravasation in Japan

Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; President and CEO: Mutsuo Kanzawa ("Kissei")] announced today that a new drug application for "SAVENE® Injectable 500mg" (the "Agent", generic name: dexrazoxane ) for the treatment of tissue damage at anthracycline extravasation sites has been approved by the Ministry of Health, Labour and Welfare in Japan.

The Agent is one of the agents publicly offered for a development company, because it was considered to be an agent with high medical needs at a review meeting for "Unapproved New Drugs and New Indications with High Medical Needs" that was set up by the Ministry of Health, Labour and Welfare. Responding to the public offering, Kissei undertook to develop the Agent, with assistance from the Pharmaceutical Development Support Center. In January 2013, Kissei filed a new drug application for the Agent, and the application was approved today.

A patient undergoing cancer treatment is prone to the state where the intravenously administered anti-cancer agent extravasates outside the vein due to a circulation disorder and vulnerability of the vein resulting from chemotherapy. A combination of treatments have been used for anthracycline extravasation, including suction of the extravasated fluid, drug treatment with adrenocorticosteroids, application of a cold compress and a hot compress, surgical intervention, etc. Most of these treatments or measures lack strong supporting evidence, and no drugs that have shown efficacy or effects on extravasation are currently available in Japan. However, as of now, November 2013, dexrazoxane has been approved in 32 Western countries for the treatment of anthracycline extravasation.
Kissei has developed the Agent because our work on the Agent, which is an unapproved drug, is in accordance with the company policy, "Kissei contributes to society through valuable and innovative medicines." By obtaining approval to launch the Agent, Kissei aims to resolve the unapproved status of the Agent and expects it to become a new treatment option for medical personnel and patients.


-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 Norgine B.V. in Europe, and as Totect® by Biocodex USA, 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 in Japan 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."