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June 16, 2011

Approval of Additional Indication, Dosage and Administration of Depakene for suppressing the Onset of Migraine Attacks

Tokyo, Japan, June 16 2011 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that the Ministry of Health, Labour and Welfare (MHLW) approved additional indication, dosage and administration of Depakene (generic name: sodium valproate) for suppressing the onset of migraine attacks in Japan.

Kyowa Hakko Kirin received from MHLW a request dated May 21, 2010 to develop Depakene for suppressing the onset of migraine attacks, based on the results of an investigation by a "Study Group on Unapproved Drugs". At the October 29, 2010 meeting of the Pharmaceutical Affairs and Food Sanitation Council, a preliminary evaluation found no objections to an application for supplemental approval of this indication of Depakene without further clinical studies, and we applied for the approval on November 19, 2010.

Since the launch of Depakene in 1975, it has been widely prescribed to treat epilepsy, and in 2002, an indication was added for the treatment of the manic states of manic disorder and bipolar disorder.
Kyowa Hakko Kirin believes that the latest approval of Depakene, as a new alternative in the treatment of migraines, will contribute to patients and healthcare professionals.

Kyowa Hakko Kirin will be a Japan-based Global Specialty Pharmaceutical Company contributing to human health and well-being worldwide through innovative drug discovery and global commercialization.

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