SEOUL, South Korea, Feb. 25 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that its European licensee, Dr. Falk Pharma, has initiated a 200 patient, phase 2 proof of concept clinical study to investigate the use of udenafil, a long acting phosphodiesterase type 5 inhibitor, for portal hypertension, an unmet medical need. The multi-center, European study is designed to investigate the safety and efficacy of udenafil in a study population of patients with portal hypertension resulting from liver disease.
Udenafil represents a potential new pharmacotherapy in the growing and underserved portal hypertension market which is projected to be 6 million people (US, EU and Japan) by 2010. Portal hypertension is the build-up of pressure in the portal vein (the vein carrying blood from the spleen and digestive tract to the liver). A major complication related to portal hypertension is variceal bleeding, where increased pressure causes veins in the esophagus to rupture and bleed. These episodes are fatal in 30% of patients and reoccurring in 70% of survivors
The most common cause of portal hypertension is cirrhosis of the liver due to alcohol abuse or hepatitis. Cirrhosis from chronic liver disease ranks among the top 15 causes of death worldwide and is expected to increase over the next 20 years due to the prevalence of hepatitis C and hepatitis B, and an increase in non-alcoholic fatty liver disease in development countries.
An estimated 170 million people are infected with hepatitis C and 350 million with hepatitis B globally. It is estimated that up to 25% of those who are chronically infected with hepatitis will develop portal hypertension due to cirrhosis.
The epidemic of obesity in developed countries will lead to a greater incidence of non-alcoholic fatty liver disease (NAFLD), Type II diabetes and high cholesterol which can progress to non-alcoholic steatohepatitis (NASH) and lead to fibrosis and cirrhosis. It is expected that 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 underserved portal hypertension market.”
About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech is a late-stage pharmaceutical company incorporated in Korea, focused on the development and commercialization of udenafil worldwide excluding Korea.
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.
ocw@donga.co.kr
CONTACT: Mr. Chan Won OH, Director, International Product Development Team
of Dong-A PharmTech Co., Ltd., +82 2 920 8220, fax, +82 2 925 4026,
ocw@donga.co.kr
