Jaguar Health Completes Filing of New Animal Drug Application for Conditional Approval of Canalevia-CA1 (Crofelemer) to Treat Chemotherapy-Induced Diarrhea in Dogs, Clearing Way for December 2021 Launch

Canalevia ™ -CA1 is the first and only oral prescription herbal drug candidate for CID in dogs
Jaguar launches awareness-raising competition in honor of International Jaguar Day; click here enter

SAN FRANCISCO, CA / ACCESSWIRE / November 2, 2021 / Jaguar Health, Inc. (NASDAQ: JAGX) announced today that the filing of the New Animal Drug Application (NADA) has been completed to obtain conditional approval from the US Food and Drug Administration for the commercialization of Canalevia ™ -CA1 (Crofelemer – sustained-release tablets). , Jaguar’s oral prescription herbal drug candidate for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

“All of the required major and minor technical sections of our conditional approval application for Canalevia for CID in dogs have been deemed ‘completed’ by the CVM, and filing the NADA is an administrative activity that will lead to marketing approval 60 days later so we plan the commercialization of Canalevia-CA1 for CID in dogs in late December 2021, “said Michael Guy, DVM, MS, Ph.D., Jaguar’s vice president of preclinical and non-clinical studies.

According to the National Cancer Institute, which is part of the National Institutes of Health, about 6 million new cancer diagnoses are made in dogs each year in the U.S. B. In humans, which means that about 40% of dogs treated are due to chemotherapy due to Diarrhea can be reduced, changed, or canceled – which can affect the full benefits of the chemotherapy drug.

Chemotherapy is becoming the most widespread oncological treatment method in veterinary medicine. In addition, tyrosine kinase inhibitors (TKIs), the most widely used and widely used targeted chemotherapy with significant rates of diarrhea, are widely adopted by small animal practitioners.

There are currently no FDA approved drugs for the symptomatic treatment of CID in dogs.

The story goes on

“Treatment for CID is important in affecting the outcome of a dog’s cancer treatment by allowing them to maintain a therapeutic dose, and to aid patient comfort and the dog’s ability to be in control of what is at home What matters – the carpet, couches, and the general living environment, “said Lisa Conte, president and chief executive officer of Jaguar and parents of two Jack Russell terriers. “This has been a year of pandemic dogs, with dog ownership increasing in the US. They are important members of the family.”

In addition to the CID in dogs, Jaguar plans to apply for conditional approval of the CVM to market Canalevia for the treatment of exercise-induced diarrhea (EID) in dogs in 2022.

Canalevia-CA1 is being marketed as a prescription drug by the company’s Jaguar Animal Health division. Crofelemer, the active ingredient in Canalevia-CA1, comes from the Croton lechleri ​​tree, which is harvested responsibly and sustainably in South America.

Jaguar is launching an awareness-raising competition in honor of International Jaguar Day

In honor of International Jaguar Day (November 29, 2021), we have dedicated this sixth awareness competition in our series to the jaguars. These majestic animals have long played a central role in the ecology, cosmology and shamanic traditions of several indigenous peoples in Central and South America, as described in a wonderful book, An Indomitable Beast, by one of the world’s preeminent jaguars and great cat protectors and scientists, Dr. Alan Rabinowitz (@DrRabinowitz). Dr. Rabinowitz, may he rest in peace, died in 2018. One edition of An Indomitable Beast is the award for this competition.

The winner will be selected at random from the pool of contestants who correctly answer all or most of the questions on the multiple choice form. Entries must be received by November 26, 2021 at 9:00 a.m. Eastern Time. No fee is required to enter the competition. Additional competition conditions apply. click here for participation and for the conditions of participation of the competition.

Stay tuned to the Jaguar Health Community page on Instagram (https://www.instagram.com/jaguarhealthcommunity/) to see the contest winner’s name, the answers to the contest questions, and more about future contests to experience.

About Jaguar Health, Inc., Napo Pharmaceuticals, Inc., and Napo EU SpA

Jaguar Health, Inc. is a commercial-stage pharmaceutical company focused on the development of novel, herbal, non-opioid, and sustainably-derived prescription drugs for humans and animals with gastrointestinal conditions, particularly chronic debilitating diarrhea. Our wholly owned subsidiary Napo Pharmaceuticals, Inc. focuses on the development and marketing of proprietary herbal medicines for the human gastrointestinal tract from plants responsibly harvested from rainforest areas. Napo EU SpA, the Italian subsidiary largely owned by Napo Pharmaceuticals, is focused on expanding Crofelemer’s access in Europe.

More information about Jaguar can be found at https://jaguar.health. For more information on Napo Pharmaceuticals, please visit www.napopharma.com. For more information on Napo EU, please visit www.napoeu.com.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements”. These include statements regarding the expectation that Canalevia will be available conditionally for CID by the end of December 2021 and for EID in 2022 for dogs. In some cases, you may refer to forward-looking statements by using words such as “may”, “will,” “should”, “expect”, “plan”, “aim”, “anticipate”, “could”, “intend”, “aim” , “Project”, “rethink”, “believe”, “estimate”, “predict”, “potentially” or “continue” or deny these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Jaguar has based 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 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. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Except as required by law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances, or otherwise.

CONTACT:
Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health

Jaguar JAGX

SOURCE: Jaguar Health, Inc.

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