Jaguar Health Extends Collaboration for Possible Tropical Disease Priority Review Voucher and Cholera Indication for NP-300
Jaguar Health (NASDAQ:JAGX) and Napo Pharmaceuticals have extended their collaboration with Streeterville until January 2026 for developing NP-300, targeting cholera treatment and pursuing a Tropical Disease Priority Review Voucher (TDPRV). The FDA's TDPRV Program is currently the only active PRV program, potentially increasing voucher values which historically sold for up to $350 million.
NP-300 is a proprietary botanical extract distinct from crofelemer but with the same mechanism of action, sustainably derived from the Croton lechleri tree. The development targets cholera, which causes 1.3 to 4 million cases and 21,000 to 143,000 deaths annually worldwide. From January to July 2024, 307,433 cholera cases and 2,326 deaths were reported across 26 countries, leading WHO to classify it as a grade 3 emergency.
Jaguar Health (NASDAQ:JAGX) e Napo Pharmaceuticals hanno esteso la loro collaborazione con Streeterville fino a gennaio 2026 per lo sviluppo di NP-300, mirato al trattamento del colera e alla ricerca di un Tropical Disease Priority Review Voucher (TDPRV). Il programma TDPRV della FDA è attualmente l'unico programma PRV attivo, potenzialmente aumentando i valori dei voucher che storicamente sono stati venduti fino a 350 milioni di dollari.
NP-300 è un estratto botanico proprietario distinto dal crofelemer ma con lo stesso meccanismo d'azione, derivato in modo sostenibile dall'albero Croton lechleri. Lo sviluppo è mirato al colera, che causa da 1,3 a 4 milioni di casi e da 21.000 a 143.000 morti all'anno in tutto il mondo. Da gennaio a luglio 2024, sono stati segnalati 307.433 casi di colera e 2.326 morti in 26 paesi, portando l'OMS a classificarlo come un'emergenza di grado 3.
Jaguar Health (NASDAQ:JAGX) y Napo Pharmaceuticals han ampliado su colaboración con Streeterville hasta enero de 2026 para desarrollar NP-300, enfocado en el tratamiento del cólera y buscando un Tropical Disease Priority Review Voucher (TDPRV). El Programa TDPRV de la FDA es actualmente el único programa PRV activo, lo que podría aumentar los valores de los vouchers que históricamente se han vendido por hasta 350 millones de dólares.
NP-300 es un extracto botánico propietario distinto del crofelemer, pero con el mismo mecanismo de acción, derivado de manera sostenible del árbol Croton lechleri. El desarrollo se centra en el cólera, que causa entre 1,3 y 4 millones de casos y entre 21.000 y 143.000 muertes anuales en todo el mundo. Desde enero hasta julio de 2024, se reportaron 307.433 casos de cólera y 2.326 muertes en 26 países, lo que llevó a la OMS a clasificarlo como una emergencia de grado 3.
재규어 헬스 (NASDAQ:JAGX)와 나포 제약은 NP-300 개발을 위해 스트리트빌과의 협력을 2026년 1월까지 연장했습니다. 이 약물은 콜레라 치료를 목표로 하며 열대 질병 우선 검토 바우처(TDPRV)를 추구하고 있습니다. FDA의 TDPRV 프로그램은 현재 유일한 활성 PRV 프로그램으로, 역사적으로 최대 3억 5천만 달러에 판매된 바우처의 가치를 증가시킬 수 있습니다.
NP-300은 크로페레머와는 다른 독점 식물 추출물로, 동일한 작용 기전을 가지고 있으며, 크로톤 레클레리 나무에서 지속 가능하게 유래되었습니다. 이 개발은 전 세계적으로 매년 130만에서 400만 건의 콜레라 환자와 21,000에서 143,000명의 사망자를 초래하는 콜레라를 목표로 하고 있습니다. 2024년 1월부터 7월까지, 26개국에서 307,433건의 콜레라 사례와 2,326건의 사망자가 보고되어 WHO가 이를 3등급 비상사태로 분류했습니다.
Jaguar Health (NASDAQ:JAGX) et Napo Pharmaceuticals ont prolongé leur collaboration avec Streeterville jusqu'en janvier 2026 pour le développement de NP-300, visant à traiter le choléra et à obtenir un Tropical Disease Priority Review Voucher (TDPRV). Le programme TDPRV de la FDA est actuellement le seul programme PRV actif, ce qui pourrait augmenter la valeur des bons qui se sont historiquement vendus jusqu'à 350 millions de dollars.
NP-300 est un extrait botanique exclusif différent du crofelemer mais ayant le même mécanisme d'action, dérivé de manière durable de l'arbre Croton lechleri. Le développement vise le choléra, qui cause entre 1,3 et 4 millions de cas et entre 21 000 et 143 000 décès chaque année dans le monde. De janvier à juillet 2024, 307 433 cas de choléra et 2 326 décès ont été signalés dans 26 pays, amenant l'OMS à le classer comme une urgence de niveau 3.
Jaguar Health (NASDAQ:JAGX) und Napo Pharmaceuticals haben ihre Zusammenarbeit mit Streeterville bis Januar 2026 verlängert, um NP-300 zu entwickeln, das sich auf die Behandlung von Cholera konzentriert und ein Tropical Disease Priority Review Voucher (TDPRV) anstrebt. Das TDPRV-Programm der FDA ist derzeit das einzige aktive PRV-Programm, das potenziell die Werte der Gutscheine erhöhen kann, die historisch für bis zu 350 Millionen Dollar verkauft wurden.
NP-300 ist ein proprietärer botanischer Extrakt, der sich von Crofelemer unterscheidet, aber denselben Wirkmechanismus hat und nachhaltig aus dem Croton lechleri-Baum gewonnen wird. Die Entwicklung zielt auf Cholera ab, die weltweit jährlich 1,3 bis 4 Millionen Fälle und 21.000 bis 143.000 Todesfälle verursacht. Von Januar bis Juli 2024 wurden in 26 Ländern 307.433 Cholera-Fälle und 2.326 Todesfälle gemeldet, was die WHO dazu veranlasste, dies als Notlage der Stufe 3 einzustufen.
- Potential to acquire a valuable TDPRV that historically sold for up to $350 million
- Extended funding timeline with Streeterville until January 2026
- NP-300 received orphan-drug designation for cholera
- Large market opportunity with 1.3-4 million annual cholera cases globally
- Development outcomes and timeline for NP-300 remain uncertain
- Competition from existing cholera treatments not addressed
- No guaranteed success in obtaining TDPRV approval
Insights
The extension of Jaguar Health's collaboration for NP-300 development represents a strategically timed opportunity in the evolving PRV landscape. With both the Rare Pediatric Disease and Medical Countermeasures PRV programs now sunset, the TDPRV program stands as the FDA's sole active voucher initiative. This scarcity effect could potentially drive PRV values above the historical
The development strategy appears particularly well-calculated for several reasons:
- The WHO's classification of cholera as a grade 3 emergency - their highest internal emergency level - creates an urgent market need and potential regulatory tailwinds
- The global impact of 307,433 cholera cases and 2,326 deaths in just the first half of 2024 demonstrates the scale of the unmet medical need
- The Streeterville funding extension to January 2026 provides important development runway while maintaining financial flexibility
The company's broader rare disease portfolio strategy shows methodical diversification, with three proof-of-concept trials and two Phase 2 studies in SBS-IF and MVID. This multi-pronged approach in rare diseases, combined with the cholera program, creates multiple value-creation opportunities throughout 2025.
A key differentiator lies in NP-300's botanical nature and sustainable sourcing from the Croton lechleri tree. This approach could provide advantages in manufacturing scalability and cost structure, particularly important for developing markets where cholera is endemic. The existing orphan-drug designation for crofelemer in cholera provides regulatory precedent that could streamline NP-300's development pathway.
Priority Review Vouchers (PRVs) are transferable and, in past transactions by other companies, have sold for prices up to
1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year worldwide
SAN FRANCISCO, CA / ACCESS Newswire / February 18, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") and Jaguar family company Napo Pharmaceuticals ("Napo") today announced that, on January 29, 2025, they extended their collaboration with Streeterville related to Napo's plans to develop its NP-300 drug product candidate for the symptomatic relief of diarrhea and dehydration in cholera patients and pursue a possible Tropical Disease Priority Review Voucher ("TDPRV") from the U.S. Food and Drug Administration ("FDA") for this indication.
With the sunset of the FDA's Rare Pediatric Disease PRV program in December 2024, and the sunset of the FDA's Medical Countermeasures PRV Program in October 2023, the TDPRV Program is currently the FDA's only active PRV program - so there will possibly be fewer PRVs available for purchase, which could increase the value of TDPRVs, spurring increased interest and investment in tropical diseases.
"We at Jaguar and Napo find it very rewarding to work in the pharmaceutical industry and be in a position to possibly help address such an important global health need and meet stakeholder expectations," stated Lisa Conte, Jaguar's founder, president, and CEO. "We are thankful to both the FDA for creating the TDPRV Program to drive development of drugs to benefit patients suffering from serious but often neglected tropical diseases, and to Streeterville for their commitment to this unmet need in cholera patients. Streeterville has extended the due date until January 2026 for the funding they provided Napo for this clinical development program."
PRV programs incentivize the development of therapies for underfunded diseases. A PRV entitles the bearer to regulatory review by the FDA in approximately six months rather than the standard ten months. Under the TDPRV Program, the FDA may award a PRV following approval of a treatment for a neglected tropical disease such as cholera. PRVs are transferable and, in past transactions by other companies, have sold for prices up to
More than a billion people - mostly in developing countries - are infected with one or more of the neglected tropical diseases.1 Established in 2007, the TDPRV Program is the only FDA PRV program without a sunset provision. Although cholera is an orphan indication in the U.S., it is estimated that, worldwide, 1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year, according to the Centers for Disease Control and Prevention of the U.S. Department of Health & Human Services.2
Napo has received orphan-drug designation for cholera with crofelemer, the Company's FDA-approved drug product. NP-300 is a drug candidate under the botanical guidance of the FDA. It is a standardized and proprietary Napo botanical extract that is distinct from crofelemer with the same paradigm-shifting first-in-class mechanism of action. NP-300 is sustainably derived from the same source as crofelemer: the Croton lechleri tree.
Rare/orphan diseases are a core Jaguar focus. Jaguar is supporting three proof-of-concept (POC) investigator-initiated trials (IIT), and conducting two Phase 2 studies, of crofelemer for the rare diseases short bowel syndrome with intestinal failure (SBS-IF) and/or microvillus inclusion disease (MVID) in the US, EU, and/or Middle East/North Africa regions. The first POC IIT result is expected to potentially be available in H1 2025, with additional POC IIT results expected for SBS-IF and MVID throughout 2025.
Approximately one in 10 persons infected with cholera will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps. In these people, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours. Cholera is now endemic in many countries outside the U.S. From January 1, 2024 to July 28, 2024, a cumulative total of 307,433 cholera cases and 2,326 deaths were reported from 26 countries across five World Health Organization (WHO) regions.3 WHO classified the global resurgence of cholera as a grade 3 emergency in January 2023, the highest internal level for emergencies in WHO.2 Based on the number of outbreaks and their geographic expansion, alongside the shortage of vaccines and other resources, WHO continues to assess the risk at the global level as very high and the event remains classified as a grade 3 emergency.3
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
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Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Napo's plans to develop NP-300 for the symptomatic relief of diarrhea and dehydration in cholera patients and pursue a possible TDPRV from the FDA for this indication, the expectation that NP-300 may receive FDA approval for the symptomatic relief of diarrhea and dehydration in cholera patients and that, upon such approval, the FDA may award a TDPRV for NP-300 for this indication, the expectation that, due to the sunset of the FDA's other two PRV program, there will possibly be fewer PRVs available for purchase - which could increase the value of TDPRVs and spur increased interest and investment in tropical diseases, the expectation that the first POC IIT result may be available in H1 2025 for crofelemer for SBS-IF or MVID - with additional POC IIT results expected for SBS-IF and MVID throughout 2025, and the expectation that the Company will submit a briefing package to the FDA in H1 2025 on the OnTarget results in breast cancer patients for CTD. 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 a number of 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.
1 Tropical Medicine and Infectious Disease. August 5, 2027. Amal K. Mitra and Anthony R. Mawson. Neglected Tropical Diseases: Epidemiology and Global Burden
Contact Info:
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SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire
FAQ
What is the potential value of the TDPRV that JAGX is pursuing for NP-300?
When did JAGX extend its collaboration with Streeterville for NP-300 development?
How many cholera cases occur annually according to JAGX's press release?
What is NP-300's source material and how does it compare to crofelemer?
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