|Title||Successful result of Phase Ⅲ clinical trial of GL2701(Tamsulosin/Finasteride Complex) is expected after study completion|
GL PharmTech(CEO, Hun Sik Wang) drew an attention from pharmaceutical industry as the company announced that the company has completed phase Ⅲ clinical trial of GL2701 Tamsulosin 0.2mg/Finasteride 5mg Complex for treating benign prostatic hyperplasia and that the result will be available in the mid of October.
This muliticenter, randomized, double-blindness, parallel, comparative clinical trial aimed to assess the efficacy and safety of GL2701 Cap. vs. monotherapy of Harnal-D Tab® and Proscar Tab® in benign prostatic hyperplasia patients with lower urinary tract symptom. The study was conducted on 359 patients in 14 major hospitals including Gangnam Severance Hospital, Seoul ST. Mary’s Hospital, Seoul Asan Hospital, and Seoul Samsung Hospital for two years, and its study termination was reported to the KFDA on July 20, 2011.
Treatment of benign prostatic hyperplasia using drugs has two goals. One is symptom improvement, and the other is progression prevention. GL2701 Cap, which contains Tamsulosin HCl with a palliative effect and Finasteride with a preventing effect on benign prostatic hyperplasia progression, can satisfy both goals. GL PharmTech expects that this clinical study could validate that combination therapy of the two compounds is more effective than monotherapy. Once GL2701 Complex Cap is released into the market, it is expected to present a new treatment trend of benign prostatic hyperplasia.
The domestic sales revenue of Tamsulosin HCl and Finasteride, components of GL2701, was 71.5 billion won and 51billion won, respectively, in 2010. Due to the large market size exceeding 120 billion won, the result of phase Ⅲ clinical trial of GL2701 Cap, which would be available in mid October, will be interesting.
GL PharmTech announced that the new drug has been already licensed-out for domestic commercialization, and a global licensing agreement has been made for global commercialization.