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Glenmark to launch anti-diarrhoea drug

Glenmark Pharmaceuticals is preparing to launch novel anti-diarrhoea drug Crofelemer following successful phase III trials
Glenmark Pharmaceuticals has announced it is preparing to launch novel anti-diarrhoea drug Crofelemer following successful phase III trials.

The ADVENT trial demonstrated the safety and efficacy of Crofelemer in the treatment of chronic diarrhoea in people living with HIV/AIDS who were also undergoing anti-retroviral therapy.

The trial was conducted under a 'fast track' designation given by the US Food and Drug Administration – a process to support and accelerate the development of drugs to treat serious diseases and fill an unmet medical need.

"The results from these pivotal phase III studies for Crofelemer in the treatment of HIV-associated diarrhoea are very encouraging for Glenmark as they will accelerate our goal to provide patients access to this drug across multiple diarrhoea conditions," said Glenn Saldanha, CEO and managing director, Glenmark. "We are encouraged by these results as we could now prepare for the launch of Crofelemer and this will be our first novel product."

India-based Glenmark has exclusive licence to market the drug in 140 countries, excluding the US, Europe, Japan and China where its partners, Napo Pharmaceuticals and Salix Pharmaceuticals have rights to the treatment. 

Territories where Glenmark will develop and commercialise the drug include areas with high HIV prevalence including India, with 2.5 million estimated to be affected, and South Africa, with 9 million estimated to be affected.

HIV patients in these countries manage diarrhoea on a chronic basis, with current treatments affecting anti-retroviral regimens.

Crofelemer is developed to act locally in the gastrointestinal tract without reacting to other drugs, and having no serious side-effects.

Glenmark has said it expects approval of the drug in India in 2012.

9th November 2010

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