SEOUL, Korea, March 28 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that it has completed a 340 patient phase 2b “at-home” clinical study for udenafil, its new long acting (12 hour half-life) oral phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in the U.S. was a randomized, double-blind, placebo controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. Following a 4-week non-drug baseline period, 340 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 50mg, udenafil 100mg or udenafil 150mg. The drug treatment period was 12 weeks with evaluations every 4 weeks. The primary efficacy endpoints were the change in the International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit; mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3, respectively. The study had several secondary efficacy measurements including changes in scores from the other IIEF domains, scores from the remaining SEP questions, changes from baseline in the Patient Self-Assessment Questionnaire (PSAE) and the mean Global Assessment Score (GAQ).
All primary efficacy endpoints were statistically significant compared to placebo. The mean vaginal penetration success rates were 72% (50mg), 88% (100mg) and 82% (150mg) and significantly (p<0.001) higher compared to the 60% observed in the placebo group. The mean intercourse completion rates were 53% (50mg), 66% (100mg) and 69% (150mg) and significantly (p<0.001) higher compared to the 38% observed in the placebo group. Patients reporting improved erections after the 12-week course of therapy were 58% (50mg), 80% (100mg) and 73% (150mg) and significantly (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® in late December 2005 as the fourth entrant to the ED market. By the first quarter of 2006, Zydena® 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® has maintained its market share, surpassing Levitra®, and nearly reaching parity with Cialis® by sales volume.
Dong-A PharmTech Co., Ltd. has initiated the approval process for udenafil in China by filing for import verification. The company is expecting to complete the requirements of the Chinese drug regulatory agency (SFDA), which include a local clinical study, and receive marketing approval in China by 2008.
China’s pharmaceutical market has expanded dramatically in the past decade, and is currently valued at over US$25 billion. It has been reported that as many as 50 percent of Chinese men aged between 40 and 70 are suffering from ED, comparable to other countries. 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/Schering-Plough).
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.
Contact: Mr. Chan Won OH General Manager, International Product Development Team 252, Yongdu-Dong, Dongdaemun-Ku Seoul 130-078, Korea Tel: +82 2 920 8220 Fax: +82 2 925 4026 Email: ocw@donga.co.kr
Source: Dong-A PharmTech Co., Ltd.
