Glenmark plans Phase-II trials of anti-diarrhoea drug

Glenmark Pharmaceuticals has received approval from Drug Controller General of India (DCGI) to initiate Phase-II trials for its in-licensed anti-diarrhoeal product, crofelemer.

According to a release issued by the company to the BSE today, the trial is expected to commence this year, and will involve sixty adult patients suffering from acute diarrhoea in a prospective, randomised, parallel group using a controlled double-blind placebo method. "The trial will be concluded within three months from the start of dosing," the release added.

The company had signed a development and commercialisation alliance with US-based Napo Pharmaceuticals Inc (Napo) in July 2005. "Under the terms of the agreement, the company will be responsible for marketing crofelemer in over 140 countries, including India, for three indications, viz. AIDS diarrhoea, infectious diarrhoea and paediatric diarrhoea. In return, the company will provide low-cost and large-scale manufacturing in FDA-approved manufacturing facilities and upon marketing will pay royalties ranging from high single digits to early teens on net sales to Napo. The company expects to launch the drug in 2008 in the first territory," the release added.

Glenn Saldanha, managing director & CEO of Glenmark, said: "We are happy with the progress that crofelemer is showing. If approved, the drug has the potential to meet a large and unsatisfied need for safe and effective medication for the treatment of diarrhoea."

Napo Pharmaceuticals Inc is based in California, USA with a subsidiary in Mumbai, and recently made its debut in the main market of the London Stock Exchange, the release said.