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Canalevia would be the first and only FDA-approved herbal medicine for dogs suffering from diarrhea while on chemotherapy
Canalevia will be available through the fourth quarter of 2021, subject to conditional approval
SAN FRANCISCO, CA / ACCESSWIRE / May 18, 2021 / Jaguar Health, Inc. (NASDAQ: JAGX) (“Jaguar” or the “Company”) today released updates to the company’s development program for its oral herbal drug candidate Canalevia ™ (Crofelemer- Sustained-release tablets) used to treat chemotherapy-induced diarrhea (CID) in dogs and exercise-induced diarrhea (EID) in dogs. There is currently no FDA approved prescription product for the treatment of this type of debilitating diarrhea in dogs.
“We are excited to report our progress at Canalevia, which has the potential to help thousands of dogs suffering from diarrhea from chemotherapy,” said Michael Guy, DVM, Ph.D., Jaguar’s vice president, preclinical and non-clinical Studies. “With feedback from the FDA Center for Veterinary Medicine (CVM), we have completed submitting updated versions of the required minor and major technical sections of Jaguar’s conditional approval application for Canalevia for CID under The Minor Use and Minor Species (MUMS). Animal Health Act of 2004. We anticipate regulatory approval and commercialization of Canalevia under conditional approval for CID in the fourth quarter of 2021. “
“Managing this type of debilitating diarrhea in dogs undergoing cancer treatment is a comfort issue for dogs. In addition, managing diarrhea can help dogs better tolerate their chemotherapy and improve the home and living environment for dog owners,” said Lisa Conte, president of Jaguar and chief executive officer and parent of two Jack Russell terriers. “We are excited to report our progress on this unique drug and believe that Canalevia will be an important treatment option for veterinary teams and dog owners once it is approved.”
The company is also in the process of completing the EID submission package for regulatory approval and marketing in the same timeframe. Working dogs, including search and rescue dogs, military dogs, and sled dogs, often suffer from diarrhea if they exercise extensively on a leash for long periods of time.
“Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, which can affect peak physical performance,” said Dr. Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, Veterinary Physiologist and Board-Certified Specialist in Veterinary Internal Medicine and Veterinary Sports Medicine at Oklahoma State University, where he conducts research on the physiology and performance of animal exercise. “There is a significant need in the working dog world for a safe and effective drug that can reduce the frequency and severity of exercise-induced diarrhea without compromising performance.”
According to current estimates, more than 230,000 dogs in the United States receive chemotherapy for various types of cancer each year, and approximately one in four (more than 50,000 dogs) has diarrhea as a side effect of treatment. Jaguar estimates that 5,000 to 15,000 dogs in the United States suffer from EID annually.
Jaguar’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., currently markets one form of crofelemer, Mytesi®, the only non-opioid oral herbal medicine approved by the FDA for the treatment of non-infectious diarrhea in adult patients with HIV / AIDS antiretroviral therapy. Crofelemer, derived from the Croton lechleri tree, is harvested responsibly and sustainably in South America. Napo is pursuing the development of Mytesi for the treatment of cancer therapeutic diarrhea in humans.
As previously announced, Jaguar has received the Minor Use / Minor Species (MUMS) designation for CID in dogs for Canalevia. Jaguar will also apply for MUMS labeling for Canalevia by the end of May 2021 to treat EID in dogs. In order to obtain conditional approval of a MUMS drug, a company must provide chemistry, manufacturing and controls (CMC), environmental impact and target animal safety data identical to those required for a new veterinary medicinal product application (NADA), as well as data which indicate a reasonable value expectation of effectiveness (RxE). After submitting and reviewing the application, the FDA may issue Conditional Approval (CA-1) through the CVM. This approval allows the product to be marketed while the sponsor continues to collect the essential evidence of efficacy required for full NADA approval. A sponsor who receives approval or conditional approval for a drug labeled by MUMS will then receive seven years of marketing exclusivity.
The MUMS designation is based on the orphan drug designation for the development of human drugs and offers possible financial incentives to promote MUMS drug development, e.g. B. the availability of grants to cover the cost of developing the MUMS drug and an extended period of exclusive commercialization. The purpose of the MUMS Act is to promote the development and availability of veterinary medicines intended as minor use in one major species (defined as dogs, cats, cattle, horses, chickens, turkeys and pigs) for the treatment of diseases that Geographical areas occur rarely or to a limited extent and promote the development and availability of veterinary medicinal products for use in smaller species (defined as all animals other than humans that do not belong to the seven main species).
About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
Jaguar Health, Inc. is a commercial-stage pharmaceutical company focused on the development of novel, herbal, non-opioid, sustainable prescription drugs for humans and animals with gastrointestinal conditions, particularly chronic debilitating diarrhea. Our wholly owned subsidiary Napo Pharmaceuticals, Inc. is focused on the development and commercialization of proprietary herbal human gastrointestinal medicines made from plants responsibly harvested from rainforest areas. Our Mytesi® (Crofelemer) product is approved by the U.S. FDA for the symptomatic relief of non-infectious diarrhea in adults with HIV / AIDS receiving antiretroviral therapy and is the only oral, herbal, prescription drug approved under FDA Botanical Guidance.
More information about Jaguar can be found at https://jaguar.health. More information about Napo can be found at www.napopharma.com.
Mytesi (Crofelemer) is an anti-diarrhea drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV / AIDS receiving antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious causes of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies may not receive appropriate therapy and their disease may worsen. In clinical trials, the most common side effects, which were more common than placebo, were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), gas (3.1%) and increased bilirubin (3.1%)).
For full prescribing information, go to Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug that is extracted and purified from the red bark sap of the medicinal Croton Lechleri tree in the Amazon rainforest. Napo has set up a sustainable harvesting program for Crofelemer to ensure high levels of quality and ecological integrity.
Certain statements in this press release constitute “forward-looking statements”. These include statements relating to the belief that Canalevia has the potential to help thousands of dogs suffering from diarrhea from chemotherapy. The belief that diarrhea management in dogs undergoing cancer treatment can help dogs better tolerate their chemotherapy and improve the home and living environment for dog owners. the belief that Canalevia will be a key treatment option for veterinary medicine teams and dog owners once approved, and the expectation that Canalevia could be available under conditional approval for CID and EID in the fourth quarter of 2021. In some cases you can identify yourself forwards – statements such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, “could”, “intend”, ” aim, “project,” “” consider, “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. The forward-looking statements in this version are only predictions. Jaguar has relied upon these forward-looking statements largely on its current expectations and projections of future events. These forward-looking statements speak only as of the date of this publication and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified, some of which are beyond Jaguar’s control and some of the factors that could affect our actual results are set out in the periodic reports on Formul ar 10-K and Form 10-Q, which we file with the Securities and Exchange Commission. Except as required by law, Jaguar does not plan to publicly update or revise the forward-looking statements contained herein as a result of new information, future events, changed circumstances, or otherwise.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.
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