Glenmark's new diarrhoea drug in final-stage trials

Glenmark Pharmaceutical’s attempts to become the first Indian company to develop a new drug may succeed by next year, as its candidate for the anti-diarrhoea associated with HIV, named Crofelemer, has moved into the final stage of clinical trials.

The first stage of the final, Phase III, trial for the treatment of chronic diarrhoea in people living with HIV/AIDS on antiretroviral therapies has been completed. The next phase will begin soon in the US by the co-developers, Napo Pharmaceuticals and Salix Pharmaceuticals, Glenmark said in a press release today.

“With Crofelemer progressing to the final stage of Phase III trials, we will accelerate the manufacturing scale-up and are planning for its commercial launch. Based on the current progress, we anticipate the launch of Crofelemer in India within 2010,” said Glenn Saldanha, managing director and chief executive.

The drug, which has a fast-track approval status from the US Food and Drug Administration (FDA), is a potential first-in-class innovative drug, with a peak sales opportunity of $80 million in the rest of the world’s markets (other than the US and Europe) in HIV-related diarrhoea alone, in addition to potential sales in adult acute infectious diarrhoea.

Glenmark has Crofelemer rights for diarrhoea indications in 140 countries. Glenmark and Salix have a commercial supply agreement for the active pharmaceutical ingredient (API) of the drug. In addition to margins on global supplies, Glenmark will receive royalty on sales in the western markets from Napo.

Share prices of Glenmark rose 2.13 per cent on the Bombay Stock Exchange (BSE) today, to close at Rs 258.50.

Source : www.business-standard.com