Patent Issued in Jordan Bolsters IP Protection for Jaguar Health in the Treatment of Short Bowel Syndrome (SBS)
Jaguar Health (NASDAQ:JAGX) announced that Jordan's Industrial Property Protection Directorate has issued a new patent to Napo Pharmaceuticals for methods of treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal using crofelemer. This patent strengthens Jaguar's intellectual property protection for its core rare disease target indication of SBS.
Jaguar is supporting independent investigator-initiated proof-of-concept studies for crofelemer in SBS and microvillus inclusion disease (MVID) across the US, EU, and Middle East/North Africa regions, with results expected by the end of 2024 and throughout 2025. These studies could potentially support early patient access to crofelemer in specific EU countries.
Napo currently holds approximately 173 patents and 60 patents pending. Crofelemer is the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance, providing additional exclusivity advantages.
Jaguar Health (NASDAQ:JAGX) ha annunciato che la Direzione della Protezione dei Proprietà Industriali di Giordania ha rilasciato un nuovo brevetto a Napo Pharmaceuticals per metodi di trattamento della sindrome da intestino corto (SBS), della diarrea da acidi biliari e della diarrea associata a resezioni dell'intestino tenue o rimozione della colecisti tramite crofelemer. Questo brevetto rafforza la protezione della proprietà intellettuale di Jaguar per la sua indicazione principale in malattie rare relativa alla SBS.
Jaguar sta supportando studi di prova di concetto indipendenti per crofelemer nella SBS e nella malattia da inclusione di microvilli (MVID) negli Stati Uniti, nell'UE e nelle regioni del Medio Oriente/Nord Africa, con risultati attesi entro la fine del 2024 e nel corso del 2025. Questi studi potrebbero potenzialmente sostenere l'accesso anticipato dei pazienti a crofelemer in specifici paesi dell'UE.
Napo attualmente detiene circa 173 brevetti e 60 brevetti in attesa. Crofelemer è l'unico farmaco vegetale per uso orale approvato secondo le linee guida botaniche della FDA, fornendo vantaggi aggiuntivi di esclusività.
Jaguar Health (NASDAQ:JAGX) anunció que la Dirección de Protección de Propiedad Industrial de Jordania ha emitido una nueva patente a Napo Pharmaceuticals para métodos de tratamiento de síndrome de intestino corto (SBS), diarrea por ácidos biliares y diarrea asociada a la resección del intestino delgado o la eliminación de la vesícula biliar utilizando crofelemer. Esta patente fortalece la protección de la propiedad intelectual de Jaguar para su objetivo principal en enfermedades raras relacionado con el SBS.
Jaguar está apoyando estudios independientes de prueba de concepto para crofelemer en SBS y enfermedad por inclusión de microvellosidades (MVID) en EE. UU., UE y las regiones de Medio Oriente/Norte de África, con resultados esperados a finales de 2024 y durante 2025. Estos estudios podrían potencialmente apoyar el acceso anticipado de los pacientes a crofelemer en países específicos de la UE.
Napo actualmente posee aproximadamente 173 patentes y 60 patentes en trámite. Crofelemer es el único medicamento a base de plantas de prescripción oral aprobado bajo las directrices botánicas de la FDA, proporcionando ventajas adicionales de exclusividad.
재규어 헬스(NASDAQ:JAGX)는 요르단 산업 재산 보호국이 Napo Pharmaceuticals에 짧은 장 증후군(SBS), 담즙산 설사 및 소장 절제 또는 담낭 제거와 관련된 설사를 치료하는 방법에 대한 새로운 특허를 발급했다고 발표했습니다. 이 특허는 재규어의 주요 희귀 질환 목표인 SBS에 대한 지적 재산 보호를 강화합니다.
재규어는 미국, EU 및 중동/북아프리카 지역에서 SBS 및 미세융모포함질환(MVID)에서 crofelemer에 대한 독립적인 연구자 주도의 개념 증명 연구를 지원하고 있으며, 2024년 말과 2025년 전반에 결과가 나올 것으로 예상하고 있습니다. 이러한 연구는 특정 EU 국가에서 환자들이 crofelemer에 조기에 접근할 수 있도록 도울 수 있습니다.
Napo는 현재 약 173개의 특허와 60개의 대기 중인 특허를 보유하고 있습니다. Crofelemer는 FDA의 식물 가이드라인에 따라 승인된 유일한 경구 식물 기반 처방 의약품으로, 추가적인 독점성 이점을 제공합니다.
Jaguar Health (NASDAQ:JAGX) a annoncé que la Direction de la Protection de la Propriété Industrielle de Jordanie a délivré un nouveau brevet à Napo Pharmaceuticals pour des méthodes de traitement du syndrome de l'intestin court (SBS), de la diarrhée par acides biliaires et de la diarrhée associée à la résection de l'intestin grêle ou à l'ablation de la vésicule biliaire à l'aide de crofelemer. Ce brevet renforce la protection de la propriété intellectuelle de Jaguar pour son indication principale en matière de maladies rares concernant le SBS.
Jaguar soutient des études de preuve de concept initiées par des chercheurs indépendants pour crofelemer dans le cadre du SBS et de la maladie d'inclusion des microvillosités (MVID) aux États-Unis, en UE et dans les régions du Moyen-Orient/Afrique du Nord, avec des résultats attendus d'ici la fin de 2024 et tout au long de 2025. Ces études pourraient potentiellement soutenir l'accès précoce des patients à crofelemer dans certains pays de l'UE.
Napo détient actuellement environ 173 brevets et 60 brevets en attente. Crofelemer est le seul médicament à base de plantes prescrit par voie orale approuvé selon les directives botaniques de la FDA, offrant des avantages d'exclusivité supplémentaires.
Jaguar Health (NASDAQ:JAGX) hat angekündigt, dass die jordanische Direktion für industrielle Eigentumsschutz ein neues Patent an Napo Pharmaceuticals für Methoden zur Behandlung von Kurzdarmsyndrom (SBS), Gallensäure-Durchfall und Durchfall im Zusammenhang mit der Resektion des Dünndarms oder der Entfernung der Gallenblase über Crofelemer erteilt hat. Dieses Patent stärkt den Schutz des geistigen Eigentums von Jaguar für seine zentrale Zielvorgabe bei seltenen Krankheiten, dem SBS.
Jaguar unterstützt von unabhängigen Forschern initiierte Machbarkeitsstudien für Crofelemer bei SBS und Mikrovilluseinschlusskrankheit (MVID) in den USA, der EU sowie den Regionen Naher Osten/Nordafrika, wobei Ergebnisse bis Ende 2024 und im Jahr 2025 erwartet werden. Diese Studien könnten potenziell den frühen Zugang von Patienten zu Crofelemer in bestimmten EU-Ländern unterstützen.
Napo hält derzeit etwa 173 Patente und 60 Patente in der Warteschleife. Crofelemer ist das einzige pflanzenbasierte verschreibungspflichtige Medikament in Tablettenform, das gemäß den botanischen Richtlinien der FDA genehmigt wurde, was zusätzliche Exklusivitätsvorteile bietet.
- New patent issued in Jordan for treating short bowel syndrome (SBS) using crofelemer
- Ongoing proof-of-concept studies for crofelemer in SBS and MVID across multiple regions
- Potential for early patient access to crofelemer in specific EU countries based on study results
- Strong intellectual property portfolio with 173 patents and 60 patents pending
- Crofelemer's unique status as the only FDA-approved oral plant-based prescription medicine under Botanical Guidance
- Results from proof-of-concept studies not expected until end of 2024 and throughout 2025
Insights
This patent issuance in Jordan strengthens Jaguar Health's intellectual property portfolio for crofelemer in treating Short Bowel Syndrome (SBS). The ongoing proof-of-concept studies for SBS and Microvillus Inclusion Disease (MVID) could potentially lead to early patient access in certain EU countries. This is particularly significant given the lack of approved drug treatments for MVID and the severe complications associated with SBS.
The potential impact on patients with these rare diseases is substantial. SBS patients often require parenteral nutrition, which is associated with high morbidity, mortality and medical expenses. MVID patients, especially infants, face life-threatening complications. If crofelemer proves effective, it could significantly improve quality of life and reduce healthcare costs for these patient populations.
However, it's important to note that the studies are still ongoing, with results expected by the end of 2024 and throughout 2025. The market potential remains uncertain until clinical efficacy is established.
The issuance of this patent in Jordan is a strategic move for Jaguar Health, bolstering its global IP protection for crofelemer. With approximately 230 patents issued and pending, the company is building a robust barrier to competition. The patent specifically covers methods for treating SBS, bile acid diarrhea and diarrhea associated with small intestine resection or gallbladder removal using crofelemer.
Notably, 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 potential competitors to develop generic versions, further strengthening Jaguar's market position.
However, investors should be aware that patent protection is time- and varies by country. The specific duration of this new patent and its impact on Jaguar's overall IP strategy in the MENA region would require further investigation.
New patent issued for core rare disease target indication for crofelemer
Napo has approximately 230 patents issued and pending
Jaguar is supporting independent investigator-initiated proof-of-concept studies of crofelemer for the rare disease indications of SBS and microvillus inclusion disease (MVID), an ultrarare congenital diarrheal disorder (CDD), in the US, EU, and Middle East/North Africa regions, with results expected by the end of 2024 and throughout 2025
SAN FRANCISCO, CA / ACCESSWIRE / August 27, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the country of Jordan's Industrial Property Protection Directorate has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar's novel plant-based prescription drug.
"We are very pleased 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 SBS," 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 independent 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 by 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."
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.
MVID, an ultrarare CDD, 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.
As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 173 patents and approximately 60 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
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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 in 2024 and 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.
Source: Jaguar Health, Inc.
Contact:
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SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
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