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Dong-A PharmTech Announces Start of Phase III Trials for Udenafil, Its New Erectile Dysfunction Drug Under Development


11/4/2009 8:01:57 AM

SEOUL, Korea, Nov. 4 /PRNewswire/ -- Dong-A PharmTech Co. Ltd., announced that its U.S. partner, Warner Chilcott plc, has initiated two, phase III trials for udenafil, a new long acting drug under development for erectile dysfunction (ED). Each randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of udenafil, an orally administered selective inhibitor of phosphodiesterase versus placebo. The trials will be conducted in 80 sites in the U.S. and will enroll approximately 1,120 subjects with ED.

Udenafil was approved for marketing by the Korean Food and Drug Administration in November of 2005 and launched commercially in Korea in early 2006 under the trade name Zydena(R). From 2006 to the first half of 2009, over 1,000,000 prescriptions for more than 6 million tablets of Zydena(R) were written for men with erectile dysfunction in Korea.

If approved, udenafil 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), Cialis (Lilly) and Levitra (Bayer/GSK).

About Dong-A PharmTech Co., Ltd.

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.

CONTACT: Mr. Won Geun KIM, General Manager of Dong-A PharmTech Co. Ltd.,
+82 2 560 8008, fax: + 82 2 563 6517, wgkim@donga.co.kr


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