Jaguar Animal Health, Elanco Enter Global Collaboration for Development, Co-Promotion of Canalevia

January 31, 2017

Jaguar Animal Health, Inc. and Elanco US Inc., a subsidiary of Eli Lilly and Company, today announced an agreement to license, develop and commercialize Canalevia, a Jaguar drug product candidate under investigation for treatment of acute and chemotherapy-induced diarrhea (CID) in dogs.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, according to Jaguar.

The agreement grants Elanco exclusive global rights to Canalevia, a product whose active pharmaceutical ingredient is sustainably isolated and purified from the Croton lechleri tree, for use in companion animals. Jaguar and Elanco will collaborate on the global development of the product and on its commercialization in the U.S.

“Elanco continues to seek innovative solutions for our customers and the animals they care for,” said Aaron Schacht, vice president of Elanco Research and Development. “We look forward to collaborating with Jaguar to bring this potential new, exciting solution to veterinarians around the world.”

Under the terms of the Agreement, Jaguar will receive an upfront payment of $1.5 million and additional payments upon achievement of certain development, regulatory and sales milestones in an aggregate amount of up to $61 million payable throughout the term of the agreement; product development expense reimbursement, and royalty payments on global sales. The agreement specifies that Jaguar will supply the licensed products to Elanco, and that the parties will agree to set a minimum sales requirement that Elanco must meet to maintain exclusivity.

Elanco will also reimburse Jaguar for Canalevia-related expenses, including reimbursement for Canalevia-related expenses in Q4 2016, certain development and regulatory expenses related to Jaguar’s planned target animal safety study and the completion of Jaguar’s field study of Canalevia for acute diarrhea in dogs.

“We are very happy to have entered into this strategic collaboration with Elanco as they extend their commitment to novel, first-in-class products for companion animals,” commented Lisa Conte, Jaguar’s president and CEO. “Elanco is a recognized leader in animal health with great commercial reach. We believe this agreement will significantly expand market awareness regarding the novel, anti-secretory mechanism of action of crofelemer and its potential to serve as a new method of treating diarrheal diseases. We anticipate that commercialization of Canalevia will expand our range of first-in-class gastrointestinal products beyond production animals, horses and foals to companion animals in need around the world, and we believe that the collaboration with Elanco will provide broad access to key markets globally.”

Jaguar has retained the commercial responsibility for the CID indication of Canalevia in dogs, which has received MUMS designation from the FDA and which the company expects will be the first indication available commercially in the next year. Jaguar has established a foundation of direct educational and promotional capabilities for novel anti-secretory agents through its non-prescription product line for production animals.

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