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Dong-A PharmTech Co., Ltd. Announces Positive Results for Udenafil,,Its New Long Acting Drug For Erectile Dysfunction

icantly (p<0.001) higher compared to 31% in the placebo group. Fifty percent (50%) of the patients in the 150mg group shifted to normal erectile function (EF domain scores >25) after 12 weeks on drug compared to 14% in the placebo group. All three active dose levels were well-tolerated; the most frequently reported adverse events were nasal congestion, flushing and headache and were mostly mild to moderate in intensity. No myalgia, back pain, leg pain or vision disturbances were reported and no serious adverse events related to the drug were reported. Only 4 patients withdrew from the study due to adverse events related to the drug.

Dong-A PharmTech Co., Ltd anticipates that the completion of the phase 2b trial will allow it to proceed with phase 3 clinical trials in the U.S. and Europe.

"We are extremely pleased with the results of this 340 patient phase 2b clinical trial in the U.S. which clearly demonstrated an excellent efficacy and safety profile in erectile dysfunction patients," stated Dong Hyun Park, President and CEO of Dong-A PharmTech. "The completion of this study is a major milestone in the development of udenafil. We plan to aggressively pursue regulatory approval in major markets throughout the world and to replicate in those markets the commercial success already achieved in Korea."

Udenafil was approved by the Korean FDA in November 2005 and launched by Dong-A Pharmaceutical in Korea under the brand name Zydena(R) in late December 2005 as the fourth entrant to the ED market. By the first quarter of 2006, Zydena(R) garnered 21% market share in Korea in terms of tablet volume and effectively expanded the Korean ED market volume by 16% through the introduction of new patients as well as re-entry of former patients. To date, Zydena(R) has maintained its market share, surpassing Levitra(R), and nearly reaching parity with Cialis(R) by sales volume.

Dong-A PharmTech Co., Ltd. has initiated the approval process for udenafil in C
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