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“The Phase III trials of Crofelemer will be conducted on over 700 patients at leading medical centres in India and Bangladesh:” Glenmark Pharmaceuticals.
Glenmark Pharmaceuticals said it has received approval from Drug Controller General of India (DCGI) to conduct phase III trials for Crofelemer, aimed at treatment of acute diarrhoea in adults. The company, which is fighting an arbitration case over the drug with Napo Pharmaceuticals Inc, said the Phase III trials of Crofelemer will be conducted on over 700 patients at leading medical centres in India and Bangladesh.
"We are delighted to commence Phase III trials for Crofelemer in adult acute diarrhoea. Adult diarrhoea is a big concern around the world especially in emerging markets and globally millions of patients suffer from diarrhoea every year," chairman and managing director, Glenmark Pharmaceuticals Glenn Saldanha said in a statement.
Phase III trials are randomised controlled multicenter trials on large patient groups (300-3,000 or more depending upon the disease/medical condition studied) and are aimed at a definitive assessment of the effectiveness of the drug.
The company said it has an exclusive license from Napo Pharmaceuticals Inc to distribute and commercialise Crofelemer in 140 emerging countries including India for indications related to HIV, use in acute adult and paediatric diarrhoea.
Napo Pharmaceuticals Inc, however, had recently claimed terminating an agreement signed in July 2005 with Glenmark regarding Crofelemer. Glenmark had countered it by saying, that Napo does not have any basis for terminating its license and "is seeking a declaration from an arbitration panel that Napo's claims of breach are unfounded". In August the company approached the American Arbitration Association over the issue and earlier this month, it asked the panel to issue an interim order directing Napo to comply with the collaboration agreement during the pendency of the arbitration.
Updating about the progress of the trials, Glenmark said post approval from the DCGI, the dosing in patients has also commenced. The primary objective of the study which is likely to be completed by fourth quarter of 2012 is to assess the efficacy of Crofelemer versus placebo in the treatment of moderate to severe acute watery diarrhoea in adult patients, it added.
In the late afternoon, Glenmark Pharmaceuticals was trading at around Rs280.30 per share on the Bombay Stock Exchange, 0.04% up from the previous close.