Approval for sale of Flivas™ (naftopidil) in Korea

May 12, 2011
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma’s licensing partner, Dong-A Pharmaceutical Co., Ltd. (DAP), has obtained approval from the Korea Food and Drug Administration (KFDA) for the sale of Flivas™ (naftopidil) in Korea as an agent for the treatment of benign prostatic hyperplasia (BPH).

Asahi Kasei Pharma and DAP concluded a license agreement in April 2009 granting DAP exclusive rights for the development and sale of Flivas™ in Korea, and DAP filed an application with the KFDA for its approval in March 2010. A National Health Insurance drug price listing for Flivas™ is expected within a year, and DAP will begin its sale accordingly.

BPH is a condition in which an enlarged prostate gland causes urinary symptoms such as discomfort, incontinence, incomplete voiding, and nocturia. Naftopidil is an α1-blocker that suppresses the constriction of smooth muscle in the prostate gland and in the urethra, alleviating the discomfort and other symptoms of BPH.

Flivas™ has played an important role in improving the quality of life for many patients in Japan. As the population ages, Flivas™ will be an increasingly vital therapy for a growing number of patients. The partnership with DAP, which has a wealth of experience in the field of urology, will facilitate the rapid establishment of a major presence of Flivas™ in the vital Korean market.

Corporate profile of Dong-A Pharmaceutical Co., Ltd.

President: Won-Bae Kim
Head office: Seoul, Korea
Paid-in capital: 55.7 billion won (as of Dec. 31, 2010)
Business line: Production and sale of pharmaceuticals
Net sales: 846.8 billion won (year ended Dec. 31, 2010)
Employees: 2,280

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