SEOUL, Korea, Nov. 27 /PRNewswire/ -- Dong-A PharmTech Co., Ltd., announced that it initiated the approval process for Zydena, its new erectile dysfunction drug, in China by filing for import verification. The company is expecting to complete the requirements of the Chinese drug regulatory agency (SFDA) which includes a local clinical study, and receive marketing approval by 2008.
China's pharmaceutical market has expanded dramatically in the past decade, and currently valued at over US$25 billion. It has been reported that as many as 50 per cent of Chinese men aged between 40 and 70 are suffering from erectile dysfunction (ED), similar to other countries. Zydena is expected to participate in a growing prescription ED market by offering a long acting and safe product that will compete with Viagra(R) (Pfizer).
Zydena was launched in Korea in December 2005 and has already captured over 20% (by volume) of the market. This rapid uptake in Korea underscores Zydena's high patient satisfaction (up to 85% on satisfaction scores in clinical studies), excellent efficacy up to 12 hours and a favorable safety profile. In Korea, Zydena competes directly with Viagra(R) (Pfizer), Cialis(R) (Lilly) and Levitra(R) (Bayer).
Dong-A PharmTech has recently completed a 340 patient double-blind, placebo controlled phase 2b dose ranging/confirmation study at 15 urology sites in the USA. The results of this study are expected in December 2006.
Mr. Dong-Hyun Park, President & CEO of Dong-A PharmTech stated, "With the recent filing in China we expect to move rapidly to complete the requirements for approval. We believe that China is a growth market for ED drugs, especially Zydena with its good safety profile and patient preferred long acting efficacy."
About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech Co., Ltd. is an affiliate of Dong-A Pharmaceutical Co. Ltd., the largest drug company in Korea. Dong-A PharmTech is developing Zydena(TM) for non-Korean markets.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.
Dr. Dongjin Yoo
Dong-A PharmTech Co. Ltd,
Tel: +82 2 560 8003,
Fax: +82 2 563 6517,
Dong-A PharmTech Co., Ltd.