Jaguar Health announced its wholly-owned subsidiary, Napo Pharmaceuticals, has entered into a Termination, Asset Transfer and Transition Agreement with India-based Glenmark Pharmaceuticals. Glenmark is Napo’s primary manufacturer of crofelemer, the active pharmaceutical ingredient (API) in Mytesi, Jaguar’s and Napo’s FDA-approved human prescription drug product. The Agreement returns to Napo certain rights which Napo licensed to Glenmark in 2005 related to the development and commercialization of crofelemer for certain specified human indications in India and 140 other countries largely in developing regions. As a result of the execution of the Agreement, Jaguar, through Napo, now controls commercial rights for Mytesi for all indications, territories and patient populations globally, and also holds commercial rights to the existing regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe, and Botswana.
Mytesi is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar and Napo are pursuing a follow-on indication for Mytesi in chemotherapy-induced diarrhea (CID), an important supportive care indication for patients undergoing primary or adjuvant chemotherapy for cancer treatment. Mytesi is also in development for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome (SBS); for irritable bowel syndrome (IBS) (Mytesi has demonstrated benefit to IBS-D patients in published Phase 2 studies); for supportive care for inflammatory bowel disease (IBD); and as a second-generation anti-secretory agent for use in cholera patients. Mytesi has received orphan-drug designation for SBS.
Pursuant to Napo’s settlement with Salix Pharmaceuticals, Inc. in May 2016, Napo has held global commercial rights to Mytesi for certain proposed follow-on indications, including CID, IBS and IBD.
Crofelemer, which was developed by members of Jaguar’s management team while working at Napo, is isolated and purified from the Croton lechleri tree, which is sustainably harvested by Jaguar. Crofelemer is also the API in Canalevia, Jaguar’s prescription drug product candidate for treatment of various types of diarrhea in dogs. As previously announced, Jaguar signed a four-year manufacturing and supply agreement with Glenmark in September 2015 for the manufacture of crofelemer.
“We highly value our relationship with Glenmark, given their expertise and long-term experience in the cGMP-compliant manufacturing of crofelemer. Although the transfer of rights covered by the Agreement for the specified emerging economies has for some time been agreed to in principle between Jaguar and Glenmark—as part of our joint negotiations on the global manufacturing and supply of crofelemer—we are very pleased about the signing of this new Agreement,” Lisa Conte, Jaguar's president and CEO, said. “As a result of the execution of the Agreement, Jaguar is now free to design and implement a truly global strategy to bring Mytesi to approval for potentially millions of patients for our proposed follow-on indications, and for the corresponding opportunities for financial return that we expect will result for our various stakeholders.”
Glenmark manufactures crofelemer for Jaguar and Napo at its facilities located in Ankleshwar, India, and in Aurangabad, India.