NEW DRUG APPLICATION APPROVAL IN JAPAN FOR SAVENE® INJECTABLE 500MG FOR THE TREATMENT OF ANTHRACYCLINE EXTRAVASATION

NEW DRUG APPLICATION APPROVAL IN JAPAN FOR SAVENE^® INJECTABLE 500MG FOR THE TREATMENT OF ANTHRACYCLINE EXTRAVASATION

London, 20 January 2014: Norgine B.V. and its Japanese partner, Kissei Pharmaceutical Co., Ltd. have announced that the Ministry of Health, Labour and Welfare in Japan approved the new drug application for SAVENE^®(dexrazoxane) injectable 500mg for the treatment of anthracycline extravasation.

Norgine B.V., has both license and supply agreements with Kissei to develop and commercialise SAVENE^® (dexrazoxane) injectable 500mg in Japan.

In Japan, Kissei developed SAVENE^® to help meet the clinical need of those cancer patients affected by anthracycline extravasation. Anthracycline extravasation refers to the inadvertent infiltration of chemotherapy into the subcutaneous or sub dermal tissues surrounding the intravenous or intra-arterial administration site. Management and treatment of anthracycline extravasation should be initiated as soon as possible to minimise potential tissue damage and ensure best possible treatment outcomes for patients.

Paul Pay, VP Corporate and Business Development at Norgine said: “Anthracycline extravasation is a distressing complication of cancer treatment and we are pleased that Kissei has obtained manufacturing and marketing approval by the regulatory authorities in Japan.”

-Ends-

Notes to editors

About dexrazoxane

SAVENE^®(dexrazoxane) has two major mechanisms of action:

Chelation of iron
Inhibition of DNA topoisomerase II.

Dexrazoxane binds to iron and prevents the formation of free radicals, which are considered to play a major role in the development of extravasation-induced tissue necrosis. In addition, dexrazoxane binds to DNA topoisomerase II at a different step in the catalytic cycle than anthracyclines and locks the enzyme in a form that is no longer affected by the anthracyclines.

About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s net product sales were c€67 million and the company employs over 1,000 people.

Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology, critical and supportive care.

Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.

Media contacts

Isabelle Jouin, Norgine Corporate Communications, +44 (0)1895453643, ijouin@norgine.com

Rachelle Michaels, Norgine Corporate Communications, +44 (0)1895453607, rmichaels@norgine.com

NORGINE and the sail logo are trademarks of the Norgine group of companies

PR2014Jan16.01

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