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Our Bureau

Mumbai, Aug. 3

Glenmark Pharmaceuticals Ltd has received regulatory approval from the Drug Controller General of India to initiate Phase II trials for its in-licensed anti-diarrhoeal product Crofelemer. 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, a note from Glenmark said. Glenmark had signed a development and commercialisation alliance with Napo Pharmaceuticals Inc in July 2005. Under the terms of the agreement, Glenmark will be responsible for marketing Crofelemer in over 140 countries, including India, for three indications - AIDS diarrhoea, infectious diarrhoea and paediatric diarrhoea.

Glenmark will provide low-cost and large-scale manufacturing and upon marketing will pay royalties ranging from high single digits to early teens on net sales to Napo. Glenmark is expected to launch the drug in 2008 in the first territory. The company is also working on a development plan for the other indications of AIDS-related diarrhoea and paediatric diarrhoea.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Health

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