Jaguar Health (JAGX) Issued New US Patent

Napo Pharmaceuticals (Napo), a Jaguar Health (NASDAQ: JAGX) (Jaguar) family company, today announced that the United States Patent and Trademark Office on January 2, 2024 issued a new U.S. patent to Napo for methods for treating congenital diarrheal disorders (CDDs) in patients with an inhibitor of chloride-ion transport such as crofelemer, Napo's novel plant-based prescription drug.

"We are very happy that this patent has been issued and believe that it further enhances our intellectual property protection for crofelemer for our core focus on CDD indications," said Lisa Conte, Jaguar's founder, president, and CEO.

Jaguar is supporting investigator-initiated and investigator IND proof-of-concept studies of crofelemer for the rare disease indications of microvillus inclusion disease (MVID) - an ultrarare CDD - and short bowel syndrome (SBS) in the US, European Union, and Middle East/North Africa (MENA) regions, with results expected in 2024. In accordance with the guidelines of specific EU countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for MVID or SBS for these debilitating conditions.

MVID is a catastrophic medical situation for pediatric patients, and there are currently no approved drug treatments.

Some SBS patients are subject to intestinal failure, often requiring parenteral nutrition (PN) from a few to up to 7 days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae from diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms, and these symptoms emerge either early or late, and many times become life-threatening.

Crofelemer has been granted Orphan Drug Designation (ODD) by the FDA and the European Medicines Agency for both MVID and SBS with intestinal failure. The ODD programs in the US and EU qualify sponsors to receive potential incentives to develop therapies for the diagnosis, prevention, or treatment of rare diseases or conditions.

As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 148 patents and approximately 50 patents pending. To date, crofelemer is the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance, which provides an important additional exclusivity advantage due to the inherent practicalities limiting the pathway by which a generic version of the drug could be produced.

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