July 26, 2011
Kyowa Hakko Kirin Submitted New Drug Application in Japan for KW-6500
(Apomorphine Hydrochloride Hydrate)
Tokyo, Japan, July 26, 2011 ---Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-6500 (Apomorphine hydrochloride hydrate) under development for the treatment of hypanakinesia from Parkinson's disease-related motor complications. KW-6500 was also granted an orphan drug designation in March of 2011.
Domestic clinical trial results confirm that KW-6500 is useful for quickly improving symptoms of hypanakinesia for which conventional drug treatment is not adequately effective. We submitted this application with the concept that KW-6500 is a new drug treatment alternative that can contribute to improving life quality, by reducing the suffering from hypanakinesia caused by Parkinson's disease.
In February of 2006, Kyowa Hakko Kirin contracted Britannia Pharmaceuticals Limited, a UK pharmaceutical company, for the licensing rights to exclusively develop and market KW-6500 in Japan and part of Asia. It has been approved in 20 countries overseas including the US, the UK, France, and Germany.
Kyowa Hakko Kirin believes that KW-6500 is a new alternative for Parkinson's disease treatment that will lead to improved symptoms for patients.