Issuance of New European Patent Bolsters IP Protection for Jaguar Health in the Treatment of Congenital Diarrheal Disorders (CDDs)

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced that its subsidiary, Napo Pharmaceuticals, has been granted a new European patent for treating diarrhea associated with congenital diarrheal disorders (CDDs) using crofelemer, a plant-based drug. This patent strengthens Jaguar's intellectual property protection for its core rare disease target indication, particularly for microvillus inclusion disease (MVID), an ultrarare CDD.

The company is supporting investigator-initiated proof-of-concept studies for crofelemer in treating short bowel syndrome (SBS) and MVID across the US, EU, and Middle East/North Africa regions. Results are expected by the end of 2024 and throughout 2025. Jaguar now holds approximately 200 patents issued and pending, with crofelemer being the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance.

Positive

• New European patent issued for treating congenital diarrheal disorders (CDDs) with crofelemer
• Strengthened intellectual property protection for core rare disease target indication
• Ongoing proof-of-concept studies for short bowel syndrome (SBS) and microvillus inclusion disease (MVID)
• Approximately 200 patents issued and pending
• Crofelemer is the only FDA-approved oral plant-based prescription medicine under Botanical Guidance

Negative

• None.

Insights

Intellectual Property Lawyer

The issuance of a new European patent for Jaguar Health's crofelemer in treating congenital diarrheal disorders (CDDs) is a significant development in the company's intellectual property strategy. With approximately 200 patents issued and pending, Jaguar is building a robust IP portfolio, which is important in the pharmaceutical industry.

The new patent specifically covers methods of preventing, ameliorating and treating diarrhea associated with CDDs using proanthocyanidin polymer compositions like crofelemer. This patent strengthens Jaguar's position in the rare disease market, particularly for microvillus inclusion disease (MVID), an ultrarare CDD.

From a legal perspective, this patent issuance offers several advantages:

• Extended market exclusivity in Europe for crofelemer in treating CDDs
• Potential deterrent for competitors considering entering this specific therapeutic area
• Enhanced value proposition for potential partnerships or licensing agreements

Moreover, crofelemer's status as the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance provides an additional layer of exclusivity. This unique position makes it challenging for generic versions to enter the market, further solidifying Jaguar's competitive advantage.

While this patent strengthens Jaguar's position, investors should note that the value of this IP will ultimately depend on the success of ongoing clinical studies and market adoption of crofelemer for these rare disease indications.

Rare Disease Specialist

The new European patent for Jaguar Health's crofelemer in treating congenital diarrheal disorders (CDDs) is a promising development in the rare disease space. CDDs, particularly microvillus inclusion disease (MVID), represent a significant unmet medical need with no currently approved drug treatments.

MVID is characterized by severe infantile diarrhea, malabsorption and acid/base instability. The lack of effective treatments often necessitates intensive parenteral support for nutrition and fluid management. Crofelemer, as a novel plant-based drug, could potentially offer a groundbreaking therapeutic option for these patients.

The ongoing proof-of-concept studies for crofelemer in short bowel syndrome (SBS) and MVID are particularly noteworthy. SBS with intestinal failure is a debilitating condition often requiring parenteral nutrition (PN) and associated with significant morbidity, mortality and high medical expenses. If successful, crofelemer could address the severe chronic diarrhea in these patients, potentially reducing PN dependence and improving quality of life.

The expected results from these studies by the end of 2024 and throughout 2025 could be pivotal. Positive outcomes could:

• Pave the way for early patient access in certain EU countries
• Provide hope for patients with treatment options
• Potentially reduce the economic burden associated with these conditions

However, it's important to temper expectations. Rare disease drug development is challenging and success in proof-of-concept studies doesn't guarantee regulatory approval or market success. Investors should closely monitor the progress and results of these studies as they will be critical in determining the true potential of crofelemer in these indications.

New patent issued for core rare disease target indication for crofelemer

Jaguar has approximately 200 patents issued and pending

Jaguar is supporting investigator-initiated proof-of-concept studies of crofelemer for the rare disease indications of short bowel syndrome (SBS) and microvillus inclusion disease (MVID), an ultrarare CDD, in the US, EU, and Middle East/North Africa regions, with proof-of-concept results expected before the end of 2024 and throughout 2025

SAN FRANCISCO, CA / ACCESSWIRE / July 31, 2024 / Napo Pharmaceuticals (Napo), a Jaguar Health (NASDAQ:JAGX) (Jaguar) family company, today announced that the European Patent Office has issued a new patent to Napo for methods of preventing, ameliorating and/or treating diarrhea associated with congenital diarrheal disorders (CDDs) using a proanthocyanidin polymer composition 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 rare disease target indication of MVID, an ultrarare CDD," said Lisa Conte, Jaguar's founder, president, and CEO.

"As previously announced, Jaguar, with strong leadership and participation from Jaguar family companies Napo and Napo Therapeutics, is supporting third-party, investigator-initiated proof-of-concept studies of crofelemer for SBS with intestinal failure and MVID in the US, EU and Middle East/North Africa (MENA) regions, with results expected before the end of 2024 and throughout 2025," Conte said. "In accordance with the guidelines of specific EU countries, published data from clinical investigations in SBS and MVID could support early patient access to crofelemer for these debilitating conditions in those countries."

MVID is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management, and there are currently no approved drug treatments.

Some SBS patients are subject to intestinal failure, often requiring parenteral nutrition (PN) from a few days 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.

As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 153 patents and approximately 42 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.

About Crofelemer

Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established 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 the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com

Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that results of investigator-initiated proof-of-concept studies of crofelemer for SBS with intestinal failure and MVID will be available before the end of 2024 and throughout 2025, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from such clinical investigations could support early patient access to crofelemer for SBS or MVID. 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 several 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on accesswire.com

FAQ

What new patent did Jaguar Health (JAGX) receive for crofelemer?

Jaguar Health's subsidiary, Napo Pharmaceuticals, received a new European patent for methods of treating diarrhea associated with congenital diarrheal disorders (CDDs) using crofelemer, their plant-based prescription drug.

What rare diseases is Jaguar Health (JAGX) targeting with crofelemer?

Jaguar Health is targeting microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder, and short bowel syndrome (SBS) with intestinal failure as rare disease indications for crofelemer.

When are the results of Jaguar Health's (JAGX) proof-of-concept studies for crofelemer expected?

The results of the investigator-initiated proof-of-concept studies for crofelemer in treating SBS and MVID are expected before the end of 2024 and throughout 2025.

How many patents does Jaguar Health (JAGX) currently hold?

Jaguar Health, through its subsidiary Napo Pharmaceuticals, currently holds approximately 153 patents and has about 42 patents pending, totaling around 200 patents issued and pending.