Glenmark develops API for Napo''s phase III diarrhoea drug trials by US

Mumbai: Glenmark Pharmaceuticals Ltd has developed crofelemer active pharmaceutical ingredient (API) for use in a phase III trials by Napo Pharmaceuticals Inc (Napo) in the US for chronic diarrhoea in persons living with HIV / AIDS. The company is manufacturing this API at a dedicated unit at its US FDA approved facility in Ankleshwar.

"We see this as an important product for India and Glenmark''s licensed territories," said Glenn Saldanha, managing director and CEO of the company, "Many diarrhoea diseases are resistant to antibiotics; crofelemer''s mechanism of action treats the symptom of dehydration regardless of cause. Furthermore, a strong safety database, including over 1,200 patients to date will help us target successful registration and launch of crofelemer by 2008-09."

The company signed a development and commercialisation alliance with Napo in July 2005. As per the agreement, Glenmark will be responsible for marketing crofelemer in over 140 countries, including India, for three indications - AIDS diarrhoea, acute infectious diarrhoea and pediatric diarrhoea. In return the company will provide low-cost and large-scale FDA-approved manufacturing facilities and upon marketing will pay royalties on net sales to Napo. Glenmark recently received approval from the Drug Controller General of India (DGCI) to initiate a phase II trial for acute infectious diarrhoea. The company is also working on a development plan for the other indications of AIDS related diarrhoea and paediatric diarrhoea.

Napo Pharmaceuticals Inc is focused on developing and commercialising proprietary pharmaceuticals for the global marketplace, in collaboration with local partners, in order to address major global unmet medical needs in developed and developing countries. The company is based in California, US with a subsidiary in Mumbai and recently made its debut in the main market of the London Stock Exchange.