Jaguar Health Filing for Second Indication of Exercise-Induced Diarrhea in Dogs Under MUMS for Crofelemer
Company's Legacy Animal Health Business Supports Focus on Human Health Benefits
SAN FRANCISCO, CA / ACCESSWIRE / September 18, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") issued the following updates today regarding the Company's September 11, 2019 pre-submission conference with the U.S. Food & Drug Administration's Center for Veterinary Medicine (CVM) regarding Jaguar's plans to evaluate crofelemer for exercise-induced diarrhea (EID) in dogs.
"Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, and while the episodes of diarrhea may not be life-threatening, they are nevertheless significant if the goal is peak physical performance. Thus, there is a considerable need in the world of working dogs for products that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance," commented Dr. Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, a veterinary physiologist and board-certified specialist in veterinary internal medicine and veterinary sports medicine at Oklahoma State University, where he conducts research on animal exercise physiology and performance.
To expedite the submission and application process for the EID indication, Jaguar will be leveraging use of the same major technical sections for EID that have been or will be submitted in support of the Company's application for crofelemer delayed-release tablets (CanaleviaTM) for the indication of chemotherapy-induced diarrhea (CID) in dogs. Jaguar now has two separate indications for Canalevia (crofelemer) being considered for Conditional Approval by the CVM.
Jaguar participants in the meeting, which was with representatives from CVM's Office of New Animal Drug Evaluation (ONADE) and the Office of Minor Use/Minor Species (OMUMS), included Michael Guy, DVM, MS, PhD, Jaguar's vice president and clinical veterinarian, David Sesin, PhD, Jaguar's chief manufacturing officer, and Gina Franklin, the Company's vice president of clinical operations.
"We had a very collaborative discussion with the CVM September 11th," Dr. Guy commented. "With regard to Jaguar's application for the proposed EID indication, the CVM agreed in principle to accept and review the same Chemistry, Manufacturing and Controls (CMC), Safety, and Environmental technical sections that will be considered for the CID application, and a separate meeting will be held between Jaguar and the CVM to discuss results from clinical studies that may be used for a decision on Reasonable expectation of effectiveness (RxE) for the proposed EID indication."
EID is a common problem among working dogs, such as sled dogs and military dogs, when subjected to periods of intense, long-duration off-leash exercise.
Crofelemer, the active pharmaceutical ingredient being tested, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that a separate meeting will be held between Jaguar and the CVM to discuss results from clinical studies that may be used for a decision on Reasonable expectation of effectiveness (RxE) for the proposed EID indication. 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.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.