Glenmark Pharmaceuticals has won the arbitration claim against Napo Pharmaceuticals, Inc., regarding exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries.
The International Centre for Dispute Resolution (ICDR) ruled in favour of Glenmark. Crofelemer for the treatment of diarrhoeal diseases includes the exclusive rights to distribute though relief agencies in these countries and an injunction prohibiting Napo from sharing confidential information concerning the manufacture of Crofelemer.
The ICDR ruled that Glenmark's exclusive rights to commercialise and distribute Crofelemer include the exclusive right to distribute Crofelemer through relief agencies into the 140 countries that comprise the Glenmark territory. The ICDR also ruled that Glenmark has two years from the time Crofelemer is approved in India (on an indication by indication basis) to file for regulatory approval in the 140 countries in its territory. Finally, the ICDR found that Napo breached the Collaboration Agreement by disclosing confidential information concerning the manufacture of Crofelemer to Aptuit Laurus (Aptuit) and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit.
Glenn Saldanha, chairman & MD, said, "We are delighted that the arbitrators have reaffirmed Glenmark's rights to commercialise Crofelemer through relief agencies. Diarrhoea is a big concern around the world, especially in emerging markets and globally millions of patients suffer from diarrhoea every year. This ruling will allow Glenmark to further its commitment to working with relief agencies to distribute Crofelemer to affected populations. We also are pleased that the arbitrators have prevented Napo from sharing confidential information concerning the manufacture of Crofelemer with our competitors and other third parties."
Napo also had filed a claim in the same proceeding seeking a ruling that Glenmark had materially breached the Collaboration Agreement between the parties by failing to, among other things, commercialise Crofelemer in all 140 countries in its territory and to manufacture a paediatric formulation for Crofelemer. In its ruling today, the ICDR rejected Napo's material breach claim, finding that Glenmark has complied with all of its obligations under the Collaboration Agreement.
The ruling today is an Interim Award addressing the issues presently before the ICDR. Certain other issues between the parties have been deferred to a second phase.
Glenmark 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.