|Title||KFDA approves PhaseⅠclinical trial of Tamsulosin 0.4mg|
GL PharmTech drew an attention from pharmaceutical industry as the company announced that it initiated the development of high-dose IMD(incrementally modified drug) for Harnal-D(Tamsulosin), which was developed by Astellas Pharma for treating benign prostatic hyperplasia with a market value of 50 billion won.
In particular, as no high-dose Harnal-D is currently available in the domestic market, the IMD is expected to be competitive once developed.
GL PharmTech(CEO, Hun Sik Wang, Yu Jin Choi) announced that PhaseⅠclinical trial of high-dose Harnal-D(Tamsulosin) 0.4mg has been approved by the KFDA.
Tamsulosin 0.4mg GLARS, which was approved for clinical trial, is not a product with a dose that simply doubles that of the conventional brand, Harnal-D 0.2mg (Astellas Pharma), but a product with novel biological profiles.
GL PharmTech emphasized that the IMD was designed to improve nocturia while reducing concurrent diseases of benign prostatic hyperplasia.
The conventional Harnal-D has disadvantages of varying blood concentration depending on diet, and particularly high occurrence rate of orthostatic hypotension, an adverse event that occurs upon medication before diet. To improve the aforementioned disadvantages, new IMD development focuses on the complete removal of dietary influence.
"As GLARS technology, a new DDS technology, was introduced to maintain drug absorption in the large intestine as well, the shortening of efficacy maintenance, which is caused by low late phase concentration, a disadvantage of the conventional CR (Controlled-release) IMD compared to the conventional IR (Immediate-release) drug, is expected to be completely solved" Mr. Hun Sik Wang, CEO of GL PharmTech, commented.
"Currently Phase Ⅲ clinical trial of Tamsulosin/Finasteride Complex has being conducted in 14 clinical study centers, and the new IMD is expected to be released into the market together with the commercialization of Tamsulosin/Finasteride Complex" Mr. Wang said.
In particular, as the clinical trial of high-dose IMD for Harnal-D has been initiated, other domestic pharmaceutical companies will have to take an action to cope with the development of high-dose IMD for Harnal-D due to continuous demand of high-dose Harnal-D from hospitals, and the expectation of high revenue creation.
Domestic market for Tamsulosin, which accounts for the highest proportion of drugs for benign prostatic hyperplasia, shows an annual growth rate of 19%. This year market size is expected to reach approximately 78 billion won, of which Harnal-D account for approximately 47 billion won.