Clinical Trial for Portal Hypertension Treatment Launched with Dr. Falk of Germany




Zydena® (Udenafil), an erectile dysfunction treatment developed by Dong-A Pharmaceutical (President and
CEO Won-Bae Kim), is set to begin phase II clinical trial in Europe for the treatment of portal hypertension
(PH). The number of PH patients is expected to reach around six million in the US, Europe and Japan by 2010.
There is currently no approved treatment for the condition. If the clinical trials are successful, Zydena7reg will
be hailed as the world’s first PH treatment.




Currently, beta-blockers (a type of adrenergic inhibitor) are used off-label to reduce bleeding, pointing to a
need for a new drug to effectively treat disease-induced chronic varix bleeding.




The phase II trial will be conducted by Germany’s Dr. Falk, Dong-A’s licensing partner. The trial will last for
one year and involve 200 PH patients in Europe.




Dong-Hyun Park, the President of Dong-A Pharmtech, a Dong-A Pharmaceutical's subsidiary in charge of
overseas development, said “Zydena®’s potential as a PH treatment for release to the large and advanced
European market is a very significant step. We hope to develop the drug for further clinical applications,
including prostatic therapy and pulmonary hypertension.”




An official at Dr. Falk said “The partnership with Dong-A to develop Zydena？？ for PH treatment in Europe is
important for Dr. Falk. The successful completion of clinical trials will open up an untapped market for us.”




Zydena® is already a domestic blockbuster, having recorded KRW 10 billion in sales since its launch.
Following completion of US FDA phase II clinical trial, Dong-A Pharmaceutical signed export contracts with 28
countries worth USD 138 million.






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About Dong-A Pharmaceutical

Dong-A is Korea’s leading pharmaceutical company. Based on its corporate philosophy that the greatest value
is life, Dong-A strives to be a responsible corporate citizen that contributes to the health and welfare of
humankind. Over the past 42 years, Dong-A has maintained a reputation as a trustworthy producer of quality
pharmaceutical products, and has risen to become the number one drug company in Korea. It is expanding its
overseas presence on the strength of its new drug and biopharmaceutical products. Dong-A Socio Group
includes Dong-A Otsuka, a beverage company, and Yongma Logis, a 3PL specialized company, and other
subsidiaries.