Napo Pharmaceuticals, Inc. announced it had applied for a Minor Use in a Major Species (MUMS) designation for crofelemer, for use in chemotherapy induced diarrhea in dogs -- (CID). Crofelemer is also the subject of a pending New Drug Application for use in humans for the indication of chronic diarrhea in people living with HIV/AIDS. A MUMS designation in dogs is limited to a population of 70,000. Based upon existing literature, Napo estimates that there is a patient population of approximately 50,000 dogs in the US. Napo has strong pre-clinical and clinical data to support the mechanistic rationale for the use of crofelemer for CID in dogs based upon previous human studies of over 2,000 patients. Crofelemer is a first-in-class new chemical entity (NCE) that treats watery/secretory diarrhea irrespective of the etiology. The drug normalizes chloride and water flow and transit time of fluids within the lumen of the gut. Crofelemer is a locally acting agent, demonstrating no to minimal systemic adsorption.

Napo Pharmaceuticals, Inc. was informed that the Food and Drug Administration is continuing its review of the new drug application seeking approval of crofelemer for the treatment of chronic diarrhea in people living with HIV/AIDS on anti-retroviral therapy. Salix Pharmaceuticals, Inc. never informed Napo that Salix had filed the NDA for approval of crofelemer as a botanical drug. According to the FDA website, botanical drug products are complex mixtures with a lack of a distinct active ingredient and substantial prior human use as a complex mixture. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products. The FDA has never previously approved an orally acting botanical drug. Crofelemer is a natural product isolated and purified from a tree found in the Amazon Basin, Croton lechleri.

The International Centre for Dispute Resolution ruled in favor of Glenmark Pharmaceuticals Limited on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals, Inc. seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries for treatment of diarrheal diseases includes the exclusive rights to distribute through 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 and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit. 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 pediatric 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.