Glenmark may launch 'Crofelemer' sooner

Mumbai-based Glenmark Pharmaceuticals today announced new developments that should accelerate the launch of Crofelemer, a novel, drug in development for multiple indications including HIV - associated diarrhea by a consortium of partners including Glenmark, the company said in a filing to the Bombay Stock Exchange.

Following the recent collaboration between Napo Pharmaceuticals and Salix Pharmaceuticals, it is expected that by the first half of 2010, the new drug application (NDA) for HIV-associated diarrhea would be filed in the USA. By that time Glenmark plans to make regulatory submissions in ROW countries ( including North America, Europe, China and Japan) and obtain approvals starting in 2010. Glenmark expects peak sales opportunity of $ 80 million in ROW markets alone.

 

Glenmark and Salix have also entered into a commercial supply agreement for the Crofelemer API. In addition to customary margins on global sup[plies, Glenmark would be entitled to receive royalty on sales in the western markets from Napo.