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Dong-A PharmTech Co., Ltd. Announces Portal Hypertension Clinical Trial With Udenafil
Date:2/25/2008

hat NASH will become the leading cause of chronic liver disease in the next decade yielding 3-5 million patients in developed countries with fibrosis, cirrhosis and portal hypertension.

Currently, there are no approved pharmacological treatments available for portal hypertension, although off-label use of beta-blockers (i.e., propranolol, nadolol, timolol) has exhibited some reduction of bleeding. Beta-blocker therapy, however, is often contraindicated in portal hypertension patients (reported as high as 47% in one clinical trial) and is often not well tolerated leading to discontinuation of therapy (15%), and does not often meet treatment objectives of reducing portal vein pressure sufficiently in as many as 70% of patients treated. An effective long term treatment for life threatening variceal bleeding is thus needed.

Udenafil was approved for the treatment of erectile dysfunction in Korea under the brand name Zydena(R) in late December 2005 and has gained high patient acceptance among ED patients, garnering a market share of approximately 24% by volume during the third quarter of 2007. Udenafil is entering phase 3 clinical development in the USA for erectile dysfunction

Dong Hyun Park, President and CEO of Dong-A PharmTech, stated, "We are pleased to be working with Dr. Falk Pharma on evaluating the potential of our new long acting phosphodiesterase inhibitor, udenafil for treating portal hypertension. Dong-A PharmTech is continuing its development of udenafil for erectile dysfunction in the USA and will develop udenafil for other indications such as benign prostatic hyperplasia and pulmonary hypertension."

Ms. Ursula Falk, Managing Director of Dr. Falk Pharma commented, "Our partnership with Dong-A PharmTech for the development of udenafil for portal hypertension in Europe is extremely important for our company. Successful completion of this study will establish the effectiveness of udenafil as a potential new therapy for the greatly
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SOURCE Dong-A PharmTech Co., Ltd.
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