2022-08-09 | NDAQ:JAGX | Press release
New Patent Strengthens Intellectual Property Protection for Company’s Lead Target Indication for Crofelemer
Crofelemer is the subject of the on target study, an ongoing pivotal Phase 3 clinical trial for diarrhea prophylaxis in adult cancer patients receiving targeted therapy
SAN FRANCISCO, Calif./ACCESSWIRE/August 9, 2022/ Jaguar Health, Inc. (NASDAQ: JAGX) today announced that the United States Patent and Trademark Office issued a new U.S. patent on July 19, 2022 to Napo Pharmaceuticals (Napo), the wholly owned subsidiary of the company, for methods of treating diarrhea, as well as pain, abdominal discomfort and other symptoms associated with diarrhea, in patients with a chloride ion transport inhibitor such as the drug product crofelemer from Napoleon.
“We are very pleased that this patent has been issued and believe it further strengthens our intellectual property protection for crofelemer for our primary target indication of Cancer Treatment Related Diarrhea (CTD),” said Lisa Conte, Founder, Chairman and CEO of Jaguar. . “Our drug candidate crofelemer is the subject of on target study, an ongoing pivotal Phase 3 clinical trial for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.
As with all potential tracking indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 147 patents and approximately 37 patents pending. To date, crofelemer is the only oral botanical herbal prescription drug approved under the FDA botanical guidelines, which offers significant additional exclusivity benefit due to the inherent practicalities limiting the route by which a generic version of the drug could be produced.
About Diarrhea Related to Cancer Treatment
A significant proportion of patients undergoing cancer treatment suffer from diarrhea, and diarrhea can lead to dehydration, potential infections and non-adherence to treatment in this population. Newer “targeted cancer therapy” agents, such as anti-epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase (TKI) inhibitors, with or without cyclic chemotherapy agents, may lead to increased electrolyte and fluid content in the intestinal lumen resulting in the passage of loose/watery stools (i.e. diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and can lead to interruptions of cancer treatment or reductions in therapeutic dose, which can impact patient outcomes. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.
Crofelemer is a new oral herbal medicine purified from the sap of the red bark, also called “dragon’s blood”, of the medicinal plant Croton lechleri tree in the Amazon rainforest. Napo Pharmaceuticals has implemented a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity and support for indigenous communities.
About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals and Napo Therapeutics
Jaguar Health is a commercial-stage pharmaceutical company focused on developing new herbal, non-opioid and sustainably-derived prescription medicines for people and animals with gastrointestinal disorders, including chronic diarrhea and debilitating. Jaguar Animal Health is a trading name of Jaguar Health. Jaguar Health’s wholly-owned subsidiary, Napo Pharmaceuticals, focuses on the development and commercialization of proprietary plant-based human gastrointestinal pharmaceuticals from plants responsibly harvested from rainforest areas. Our product candidate, crofelemer, is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics SpA (f/k/a Napo EU SpA), an Italian company established by Jaguar Health in Milan, Italy, in 2021, which focuses on expanding access to crofelemers in Europe.
For more information about Jaguar, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.
Certain statements contained in this press release constitute “forward-looking statements”. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, ” could”, “intend”, “target”, “project”, “consider”, “believe”, “estimate”, “predict”, “potential”, or “continue” or the negative form of these terms or other similar expressions. The forward-looking statements contained in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections regarding future events. These forward-looking statements speak only as of the date of this press 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 periodic reports on form aire 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Except as required by applicable law, Jaguar does not intend to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise. .
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