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April 17, 2014

Announcement of the launch of "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 the launch of "SAVENE® Injectable 500mg" [generic name: dexrazoxane ("the Agent")] for the treatment of tissue damage at anthracycline extravasation sites, today in Japan.

A patient undergoing cancer treatment is prone to be in a state wherein intravenously administered anti-cancer drugs extravasate outside the vein due to vulnerability of the vein and a circulation disorder resulting from other treatments such as chemotherapy. The anti-cancer drug anthracycline, in particular, causes pain, redness, and swelling if it extravasates from the vein even in small amounts and sometimes leads to necrosis of the skin and development of intractable ulcers as the symptoms progress. Consequently, if extravasation of the drug occurs, it is important that appropriate measures are taken as early as possible. Dexrazoxane is the only drug available to treat tissue damage at anthracycline extravasation sites, and it has been approved in more than 30 countries of the West. It is marketed as Savene® in Europe and as Totect® in the USA.

In Japan, a development request was made for the Agent as one of the unapproved new drugs, and the Agent was considered to be one of the drugs with high medical needs and was publicly offered to a development company at a review meeting for "Unapproved New Drugs and New Indications with High Medical Needs" set up by the Ministry of Health, Labour and Welfare. Responding to the public offering, Kissei has developed the Agent, filed for marketing approval with assistance from the Pharmaceutical Development Support Center in January 2013, and gained approval on January 17, 2014.

Kissei has developed the Agent in accordance with the company policy: "Kissei contributes to society through valuable and innovative medicines." Kissei promotes activities to provide information on proper use and will strive to contribute to improvements in the quality of life of many patients or even one person.


〈SAVENE® product reference〉

Brand Name:
SAVENE® Injectable 500mg

Indications:
For the treatment of anthracycline extravasation.

Dosage and Usage:
Usually, the drug should be administered once daily for 3 consecutive days. Day 1: 1000 mg/m2 (body surface area); Day 2: 1000 mg/m2; and Day 3: 500 mg/m2. The dose should be administered as an intravenous infusion over 1-2 hours. The first infusion should be initiated as soon as possible within the first six hours after the extravasation. Treatment on Day 2 and Day 3 should start at the same time as on Day 1. A single dose should not exceed 2000 mg on Day 1 and Day 2 and 1000 mg on Day 3. The dose should be reduced by 50% in patients with moderate or severe renal dysfunction (creatinine clearance values <40 mL/min).

Characteristics:
1. SAVENE® is the first drug for the treatment of anthracycline extravasation to be approved in Japan.
2. SAVENE® inhibits tissue damage at anthracycline extravasation sites.
3. SAVENE® has been approved in 32 countries in the World (January, 2014).

NHI price:
500 mg per vial ¥45,593 (National Health Insurance price entry April 17, 2014)

Manufactured and Distributed by:
KISSEI PHARMACEUTICAL CO., LTD.