GHP October 2015

ghp October 2015 | 5 Jaguar Animal Health Signs Crofelemer Formulation Development and Manufacturing Contract with Patheon Jaguar Animal Health, Inc., an animal health company focused on developing and commercializing first-in- class gastrointestinal products for companion and pro- duction animals, announced today that it has signed a crofelemer formulation development and manufacturing contract with Patheon, a leading global provider of drug development and delivery solutions to the global phar- maceutical and biopharma industries. Crofelemer is an active pharmaceutical ingredient (API) in Canalevia™, Jaguar’s prescription drug product candidate for the treatment of various forms of acute diarrhea in dogs. Under the terms of the contract, Patheon will provide enteric-coated crofelemer tablets for Jaguar for use in animals. The tablets will be used in Jaguar’s pivotal efficacy trial for Canalevia™, scheduled to begin in the fourth quarter of this year. Jaguar expects to use safety and effectiveness data from this trial in support of the initiation of the filing of a new animal drug appli- cation (NADA) with the FDA for Canalevia™ in 2016 for the indication of acute diarrhea in dogs. A Jaguar proof-of-concept study completed earlier this year provided statistically significant results indicating that Canalevia™ is superior to a placebo for the treatment of acute diarrhea in dogs. Crofelemer is isolated and purified from the Croton lechleri tree, which is sustainably harvested by Jaguar. Jaguar is also developing formulations of Canalevia™ for cats and horses. Patheon is the manufacturer of Fulyzaq®1, a human-specific, enteric-coated formulation of crofelemer that was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Members of Jaguar’s management team developed crofelemer while working at Napo Pharmaceuticals, Inc. (Napo), where the drug was initially developed. In 2014 Jaguar entered into a license agreement with Napo which, among other things, assigned to Jaguar Napo’s rights of reference to the information included in the FDA-approved human new drug application of crofelemer to support Jaguar’s regulatory submissions for global veterinary purposes. As Jaguar announced this past August, it has submit- ted to the FDA all required major technical sections towards a conditional NADA for Canalevia™ for dogs suffering from chemotherapy-induced diarrhea (CID), a minor use in a major species (MUMS). MUMS is an FDA drug designation, similar to the orphan drug designation in humans, which is typically limited to the use of a drug to treat disease that occurs infrequently or in a small number of animals. FDA encourages sponsors to seek MUMS designation and conditional approval of qualifying drugs to address unmet medical needs in the veterinary industry. Jaguar is preparing for the expected commercial launch of Canalevia™ for CID in the first half of 2016. “Our contract with Patheon is a key component of our carefully-crafted formulation and manufacturing Contract secured in preparation for pivotal trial and expected launch of Jaguar’s prescription drug candidate, Canalevia. plan for Canalevia™,” stated Lisa Conte, Jaguar’s president and CEO. “The Chemistry, Manufacturing and Controls section of our NADA for Canalevia™ for CID leverages the fact that we will be utilizing the same cGMP-compliant manufacturers that produce the crofelemer product approved for human use, and we plan to take the same approach with our Canale- via™ NADA for acute canine diarrhea. This plan was discussed during our meeting with the FDA’s Center for Veterinary Medicine earlier this year.” The Company announced last month that it recently signed a manufacturing and supply agreement with a leading, India-based pharmaceutical company, and Jaguar intends to use this firm as its primary manufac- turer of the crofelemer API for animal health use.