News Release Details

NP-500 is the Active Pharmaceutical Ingredient in Jaguar’s Drug Product Candidates to Treat Diseases Related to Insulin-resistance in Dogs, Horses & Cats

SAN FRANCISCO--(BUSINESS WIRE)--Oct. 26, 2015-- Jaguar Animal Health, Inc. (NASDAQ: JAGX) (“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 the U.S. Patent and Trademark Office (USPTO) has issued Notices of Allowance in two pending patent applications, licensed exclusively by the Company for veterinary use, covering NP-500 and its use. NP-500 is the active pharmaceutical ingredient (API) in Jaguar’s drug product candidates to treat and manage diseases related to insulin-resistance, such as obesity-related metabolic dysfunction in dogs and cats, diabetes mellitus, and potentially equine laminitis.

NP-500 is derived from a plant found in North America and has been through Phase 2 human clinical testing by third parties. Its novel mechanism of action has been shown in animal models to increase insulin sensitivity, reduce blood glucose levels, reduce serum free fatty acids and triglycerides, and even provide a potential benefit for blood pressure. In traditional medicine, the plant was brewed as a tea and used for the treatment of Type II diabetes and other various human illnesses. In March 2014, the Company filed an investigational new animal drug application (INAD) for NP-500 for metabolic syndrome in horses and an INAD for NP-500 for diabetes mellitus in cats, and in September 2014 Jaguar filed an INAD for NP-500 for obesity-related metabolic dysfunction in dogs.

The two NP-500 pending patent applications were submitted to the USPTO by Napo Pharmaceuticals, Inc. (Napo) in April 2011. Per the terms of a license agreement between Jaguar and Napo, Jaguar has an exclusive license to these and other specified Napo intellectual property for all veterinary treatment uses and indications for all species of animals except humans.

According to a 2013 national survey of veterinarians, approximately 17% of dogs in the U.S. are obese. Studies show that obesity is more common in elderly dogs, as well as in neutered dogs. Obesity-related metabolic dysfunction manifests in altered lipid profiles, insulin resistance, and mild hypertension, which could decrease a dog's lifespan. Currently, there are no FDA-approved products for the treatment of metabolic syndrome or insulin resistance in dogs.

In cats, the prevalence of obesity-related diabetes is high. In horses, insulin resistance is associated with an equine metabolic syndrome characterized by obesity, regional adiposity, and hypertriglyceridemia. It is also known to be a risk factor for laminitis. Various studies report the prevalence of insulin resistance as 10% in horses and 28% in ponies. There are also currently no FDA-approved products for the treatment of metabolic syndrome in horses or ponies.

“We remain committed to leveraging our broad intellectual property portfolio and robust pipeline of products that have extensive safety and disease model testing in both animals and man to identify opportunities to develop species-specific, first-in-class products for markets that can be readily accessed and have treatment gaps,” explained Lisa Conte, Jaguar’s president and CEO. “Insulin resistance and the clinical manifestations of such are a significant problems in dogs, horses and cats, and we plan to initiate clinical studies for NP-500 in 2016 and beyond.”

About Jaguar Animal Health, Inc.

Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Canalevia^™ is Jaguar’s lead prescription drug product candidate for the treatment of various forms of diarrhea in dogs. Neonorm^™ Calf is the Company’s lead non-prescription product. Canalevia^™ is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm^™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia^™ and Neonorm^™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has filed nine investigational new animal drug applications, or INADs, with the FDA and intends to develop species-specific formulations of Neonorm^™ in six additional target species, and formulations of Canalevia^™ for cats, horses and dogs.

For more information, please visit www.jaguaranimalhealth.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the potential use of NP-500 to treat and manage equine laminitis, Jaguar’s intention to initiate clinical studies for NP-500 beginning in 2016, and the Company’s plan to develop species-specific formulations of Neonorm^™ in six additional target species and formulations of Canalevia^™ for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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Source: Jaguar Animal Health, Inc.

KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com