Mumbai based Glenmark filed a statement of claim today with the American Arbitration Association against Napo Pharmaceuticals Inc (Napo). In its statement the company is  seeking a declaration that Glenmark’s exclusive rights to develop, commercialise and distribute crofelemer in 140 countries for treatment of diarrhoeal disease includes the exclusive right to distribute through relief agencies in these countries as well.

Glenmark has an exclusive license from Napo to develop, commercialise and distribute crofelemer in 140 countries for specific indications.

Crofelemer is a novel, first-in-class anti-diarrhoeal agent that has a physiological mechanism of action that is different compared to traditional anti-diarrhoeal agents. Besides its potential efficacious role in multiple diarrhoeal indications, Glenmark recognises the importance of relief agency distribution of crofelemer to populations in emerging countries with the most critical need for the product. However, Glenmark believes that contractually it has exclusive legal rights with respect to relief agency distribution in the countries and indications licensed to Glenmark.

Glenmark has the resources, capability and corporate commitment to address relief agency distribution in emerging countries included within Glenmark’s license. The arbitration seeks to confirm Glenmark’s exclusive right to engage in such pursuits and confirm that Napo has no rights to distribute products in Glenmark territories through any channels.

Crofelemer controls diarrhoea with no known drug-drug interactions, minimal systemic adsorption and, unlike current anti-diarrhoeal agents, no serious side effects, and can be used chronically.

Diarrhoea due to infection is widespread throughout developing countries. In 2004, diarrhoeal disease was the third leading cause of death in low-income countries, causing 6.9 per cent of deaths overall.