Glenmark Pharmaceutical's Crofelemer enters phase-3 clinical trials

MUMBAI: Glenmark Pharmaceuticals, a mid-sized pharma company, on Monday said its Crofelemer, a novel drug in development for multiple indications including HIV-associated diarrhea, has entered phase-3 clinical trials. This makes it one of the first Indian companies to have reached such a stage.

Phase 3 is typically considered to be the last stage of clinical trials, as under this, the drug is tested on a large universe of people that includes healthy people and patients as well. The first two phases are on healthy people and patients each respectively.

Shares of Glenmark rose 0.7% to Rs 301 in intra day trading on the BSE on Monday, after the announcement.

In the statement, Glenmark said it has crofelemer rights for diarrhea indication in about 140 countries.

Glenmark also plans to make regulatory submissions in rest-of-the-world markets (that excludes North America, Europe, China and Japan) and obtain approvals starting in 2010. Glenmark expects peak sales opportunity of $80 million in ROW markets alone in HIV-related diarrhea indications, the statement added.