Warner Chilcott initiates phase III trial of erectile dysfunction drug udenafil

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.

Mr. Dong Hyun Park, President & CEO of Dong-A PharmTech, commented that, "We are extremely pleased to be entering the last phase of our udenafil development program in the United States with our partner Warner Chilcott. We are aiming to complete the remaining clinical trials for the udenafil erectile dysfunction program in the U.S. and European Union as well as most other major markets within 2 years. In addition, based on recent positive meetings with the USFDA, we anticipate initiating Phase 2b clinical trials which will evaluate the safety and efficacy of udenafil for benign prostatic hyperplasia (BPH) and pulmonary arterial hypertension (PAH)".

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®. From 2006 to the first half of 2009, over 1,000,000 prescriptions for more than 6 million tablets of Zydena® were written for men with erectile dysfunction in Korea.

Zydena was also approved for marketing by the Russian Food and Drug Administration in July of 2008 and launched commercially in Russia in March 2009 under the trade name Zydena®.

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® (Pfizer), Cialis (Lilly) and Levitra (Bayer/GSK).