Glenmark gets DCGI nod for Phase II trials of diarrhoea drug

03 August 2006

Miumbai: Glenmark Pharmaceuticals Ltd will soon start Phase II trials of its new anti-diarrhoeal drug `crofelemer'' following approval from the Drug Controller General of India (DCGI).

The trial is expected to commence this year and will involve 60 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 company has signed a development and commercialisation alliance with Napo Pharmaceuticals Inc for production and marketing of this novel anti-diarrhoeal product, the company said in a statement.

Under the terms of the agreement, Napo will be responsible for marketing crofelemer in over 140 countries, including India, for three indications, viz, AIDS diarrhoea, infectious diarrhoea and paediatric diarrhoea. Napo will provide low-cost and large-scale manufacturing in FDA-approved manufacturing facilities and upon marketing will pay royalties to Glenmak.

Glenmark expects to launch the drug in 2008 in the first territory. It is also working on a development plan for the other indications of AIDS-related diarrhoea and paediatric diarrhoea.

"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," said Glenn Saldanha, managing director and CEO, of Glenmark.