March 30, 2012
Announcement regarding Marketing Authorization Approval in Japan of Apokyn® Subcutaneous Injection 30 mg (Apomorphine Hydrochloride Hydrate) for Treatment of Parkinson's Disease
Tokyo, Japan, March 30, 2012 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announces that it has received marketing authorization approval for Apokyn® Subcutaneous Injection 30 mg (Apomorphine Hydrochloride Hydrate, hereafter "Apokyn®") for treatment of Parkinson's disease. Apokyn® has received an orphan drug designation in Japan in March 2011. Patients may inject themselves with Apokyn® using a special injector.
A new drug application was submitted in July 2011 following studies that demonstrated that Apokyn® is useful in promptly improving "off" episodes in patients with motor complications who responded inadequately to conventional therapies.
Apomorphine preparations have received approval for the treatment of Parkinson's disease in more than 20 countries, including the U.S., U.K., France, and Germany. Kyowa Hakko Kirin obtained exclusive development and marketing rights in Japan and part of Asia in a license agreement with Britannia Pharmaceuticals of the U.K. signed in February 2006.
Kyowa Hakko Kirin believes that Apokyn® provides a new treatment option that is potentially useful in the treatment of Parkinson's disease.