CJaguar Animal Health Submits All Required Major Technical Sections of New Animal Drug Application for Canalevia

Jaguar Animal Health, Inc.

("Jaguar" or the "Company"), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, announced today that it has submitted all required major technical sections of its New Animal Drug Application ("NADA") for Canalevia™ to the U.S. Food & Drug Administration's Center for Veterinary Medicine ("CVM") for Phased Review. Canalevia is the Company's proposed Minor-Use Minor-Species ("MUMS") drug candidate for dogs suffering from chemotherapy-induced diarrhea ("CID"). Canalevia is a canine-specific formulation of crofelemer, a novel, first-in-class, anti-secretory active pharmaceutical ingredient that has been isolated and purified from the Croton lechleri tree. Numerous animal and human clinical trials have shown significant beneficial results in the use of crofelemer in the treatment of acute watery diarrhea induced by various infectious pathogens. A human-specific formulation of crofelemer was approved by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The regulatory review process for an animal drug requires the sponsor, the entity assuming responsibility for compliance with applicable regulatory provisions as well as marketing of a new drug, to submit an NADA to the CVM for approval prior to marketing. For companion animals, there are four major technical sections to the NADA that must be filed, including 1.) Target Animal Safety, 2.) Effectiveness 3.) Chemistry, Manufacturing and Controls, and 4.) Environmental Impact. In a Phased Review submission, each technical section can be submitted independently and thus reviewed independently. The Phased Review option speeds the approval process by allowing the CVM to review each section as they are submitted by the sponsor. When all required sections are deemed complete by the CVM, the sponsor files an Administrative NADA for full or conditional approval, which the CVM's Office of New Animal Drug Evaluation has 60 days to review. "The Phased Review was the most appropriate route for Jaguar in order to initiate the earliest review for Canalevia. While certain technical sections were being reviewed, it provided us with ample time to schedule and conduct a pre-submission conference with the CVM prior to finalizing the submission of our CMC section. We look forward to leveraging the approval of crofelemer's Active Pharmaceutical Ingredient with data regarding our plan to utilize the same manufacturers that produce the crofelemer product approved for human use. The complete submission of all major technical sections for the NADA is in line with our expectations when we met with the CVM earlier this summer," commented Lisa Conte, Jaguar's President and CEO. Jaguar received acknowledgement from the CVM that an initial technical section the Company submitted is complete. The Company is pursuing a MUMS approval from the CVM for Canalevia™ for CID in dogs to shorten the timeframe to commercialization. MUMS is an FDA drug designation, similar to the orphan drug designation in humans, which is typically limited to drugs that are used to treat a small number of animals each year. The MUMS designation would allow Jaguar to make Canalevia commercially available by proving the drug is safe and that there is a reasonable expectation of effectiveness prior to collecting all necessary effectiveness data. Jaguar is preparing for the expected commercial launch of Canalevia for CID in the first half of 2016.