After having received the approval of the Drug Controller General of India (DCGI), Glenmark

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Pharmaceuticals on Wednesday announced that it is taking Crofelemer, a first-in-class anti-diarrhoeal drug to the next level — phase III study. Post approval from the DCGI, dosing in patients has also commenced.

The 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. The study will be done at leading centres in India and Bangladesh. The total number of patients for this study will be over 700, the company said. “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 and MD, Glenmark Pharmaceuticals.

The phase III study is expected to be completed by December next year. Glenmark Pharmaceuticals has an exclusive licence from Napo Pharmaceuticals to distribute and commercialise Crofelemer in 140 emerging countries (rest of world territories) including India for indications related to HIV, use in acute adult and pediatric diarrhoea.

Although Napo has purported to terminate Glenmark’s licence, Glenmark said it, vehemently denies that Napo has any basis for terminating its licence and is seeking a declaration from an arbitration panel that Napo’s claims of breach are unfounded.

Although Glenmark is confident to pass through the case and continues to work on molecule with a target to launch it within 15-18 months of regulatory filings, experts believe the legal battle may either delay the product launches or the agreement may be terminated by court in a worst case scenario.

Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). It has eight molecules in various stages of clinical development and is primarily focused in the areas of inflammation and pain.