Business

Glenmark Pharmaceuticals Ltd has announced new developments that will accelerate the launch of Crofelemer – a novel drug in the development for multiple indications including HIV-associated diarrhoea by a consortium of partners including Glenmark. 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 diarrhoea would be filed in the US.

By that time, Glenmark plans to make regulatory submissions in ROW (developing economies) markets excluding North America, Europe, China&Japan and obtain approvals starting in 2010. Glenmark expects peak sales opportunity of $ 80 million in ROW markets alone in HIV-related diarrhoea indication in addition to potential sales in adult acute infectious diarrhoea in 140 countries around the world. Glenmark and Salix have also entered into a commercial supply agreement for the Crofelemer API.

Glenn Saldanha, managing director&CEO, Glenmark Pharmaceuticals, stated, “This is an exciting development for Glenmark. We are optimistic about the opportunity that Crofelemer presents. The recent collaboration agreement for the US market, the fast track status for the molecule granted by the US-FDA and the burgeoning issue of HIV-associated diarrhea provides a huge opportunity for our organisation.”