Jaguar Animal Health, Inc., an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals and high value horses, announced yesterday that it has submitted a formal request to the U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) for a determination about whether or not Canalevia qualifies as a “minor use,” per the requirements of The Minor Use and Minor Species Animal Health Act (MUMS Act), for the indication of exercise-induced diarrhea (EID) in dogs. EID is a distinct physiological manifestation that has been recorded in dogs, humans and horses. EID may occur before, during or after sustained physical exertion.
The MUMS Act became effective in 2004. The purpose of the Act is to encourage development and availability of animal drugs intended to be used in a major species (defined as dogs, cats, cattle, horses, chickens, turkeys and pigs) to treat diseases which occur infrequently or in limited geographic areas and to encourage development and availability of animal drugs for use in minor species (defined as all animals other than humans that are not one of the major species). MUMS designation is modeled on the orphan drug designation for human drug development and offers possible financial incentives to encourage MUMS drug development, such as the availability of grants to help with the cost of developing the MUMS drug.
Canalevia, Jaguar’s lead drug product candidate, under investigation for various types of diarrhea in dogs, is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree, which is sustainably harvested. Numerous animal and human clinical trials have shown significant beneficial results in the use of crofelemer in the treatment of secretory diarrhea.
Jaguar has already received MUMS designation for Canalevia for use in dogs with Chemotherapy-Induced Diarrhea (CID), which the company expects will be the first indication available commercially in the next year.
“If we are successful in obtaining MUMS designation for Canalevia for use in dogs with EID, it is our hope that this could lead to access to Canalevia, under conditional approval, for dogs for this indication also within a year,” said Lisa Conte, Jaguar’s president and CEO.
“EID is a common problem among working dogs, such as sled dogs and military dogs, when subjected to periods of intense, long-duration exercise off-leash. Several mammalian species that physically train and run in competitive events can push themselves to extreme physical demands,” said Dr. Michael Guy, DVM, MS, PhD, vice president and clinical veterinarian of Jaguar. “At this highest level of physical exertion, secretory diarrhea is a common result, and the diarrhea can be debilitating enough to require medical attention and removal from competition or training. Diarrhea can have serious consequences for the canine athlete due to their high capacity for metabolic heat generation and reliance on evaporative cooling to dissipate that heat.”
FDA established, and periodically reassesses, a specific “small number of animals” for each of the seven major animal species to be used in determining whether any particular intended use in a major species qualifies as a minor use. For dogs, this number is currently 70,000. Jaguar believes that Canalevia will qualify for MUMS designation for EID because, in the company’s estimate, the total number of dogs in the United States affected by EID on an annual basis is less than 70,000. If CVM decides that the indication of Canalevia for EID is an acceptable minor use, then Jaguar will be eligible to apply for MUMS designation for this indication.
To obtain conditional approval of a MUMS drug, Jaguar must submit CMC (Chemistry, Manufacturing and Controls) and safety data similar to that required for an NADA (New Animal Drug Application), as well as data suggesting a reasonable expectation of effectiveness. After the submission and review of the application, the FDA through the CVM can grant a conditional approval (CA-1). This approval allows for commercialization of the product while the sponsor continues to collect the substantial evidence of effectiveness required for a full NADA approval. The sponsor of a designated MUMS drug has up to five years to demonstrate substantial evidence of effectiveness. A sponsor that gains approval or conditional approval for a MUMS designated drug receives seven years of marketing exclusivity.
With conditional approval under MUMS designation for Canalevia™ for use in dogs with EID, Jaguar would be required to initiate a pivotal field study in the five years following such conditional approval to generate the data required for full NADA approval.
Canalevia is the subject of a recently forged collaboration with Elanco US Inc. Jaguar and Elanco US Inc. will collaborate on the global development of Canalevia for treatment of acute diarrhea in dogs, as well as on co-promotion and commercialization of Canalevia for the canine acute diarrhea indication in the U.S. Jaguar has retained commercial responsibility for the CID and EID indications of Canalevia in dogs.