Glenmark Pharmaceuticals has received the DCGI (India) approval to conduct the pivotal study of “Crofelemer” in acute watery diarrhoea patients. Post approval from the DCGI, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel Group, three arm, multi-centre and multinational pivotal study that is being carried out to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe acute watery diarrhoea in adult patients including cholera. This phase III study will be done at leading centres in India and Bangladesh. This study is expected to be completed by the fourth quarter of 2012.

“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,” said Glenn Saldanha, chairman & MD, Glenmark Pharmaceuticals.

Glenmark remains committed to the development of Crofelemer across various diarrhoea indications that it holds exclusive rights. For HIV associated diarrhoea, Glenmark anticipates filings to begin in ROW markets in FY 2012-13 based on the availability of the complete regulatory dossier data.

Glenmark has received approval from DCGI for conduct of study and patient enrolment has been initiated and dosing has commenced. The primary objective is to assess the efficacy of Crofelemer versus Placebo in the treatment of moderate to severe acute watery diarrhoea in adult patients as defined by stool output relative to bodyweight. This has a direct impact on reducing the dehydration which is the major cause of morbidity and mortality in diarrhoeal diseases mainly cholera. The total number of patients for this study will be over 700.

Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals, Inc. to distribute and commercialise Crofelemer in 140 emerging countries (rest of world, or “ROW” territories) including India for indications related to HIV, use in acute adult and paediatric diarrhoea. Crofelemer is a novel, first-in-class anti-diarrhoeal agent that has a physiological and different mechanism of action from traditional anti-diarrhoeal agents. Besides its potential efficacious role in multiple diarrhoeal indications, Crofelemer controls diarrhoea with no drug-drug interactions, minimal systemic adsorption and, unlike current anti-diarrhoeals, no serious side effects.

Although Napo has purported to terminate Glenmark’s license, Glenmark vehemently denies that Napo has any basis for terminating its license and is seeking a declaration from with the American Arbitration Association against Napo Pharmaceuticals' claims of breach are unfounded.