Issuance of New Hong Kong Patent Bolsters IP Protection for Jaguar Health in the Treatment of Short Bowel Syndrome (SBS)
Jaguar Health (NASDAQ:JAGX) announced that Hong Kong's Intellectual Property Department has issued a new patent to Napo Pharmaceuticals, a Jaguar family company, 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 IP protection for its core rare disease target indication of SBS.
Jaguar is supporting independent investigator-initiated proof-of-concept studies of crofelemer for SBS and microvillus inclusion disease (MVID) in 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 172 patents and 61 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 il Dipartimento della Proprietà Intellettuale di Hong Kong ha rilasciato un nuovo brevetto a Napo Pharmaceuticals, una società del gruppo Jaguar, per i metodi di trattamento della sindrome dell'intestino corto (SBS), della diarrea da acidi biliari e della diarrea associata a resezione dell'intestino tenue o rimozione della cistifellea utilizzando il crofelemere. Questo brevetto rafforza la protezione della proprietà intellettuale di Jaguar per la sua indicazione principale relativa a malattie rare, ossia la SBS.
Jaguar sta supportando studi di prova di concetto iniziati da investigatori indipendenti sul crofelemere per la SBS e la malattia da inclusione microvillosa (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 precoce al crofelemere in specifici paesi dell'UE.
Napo attualmente detiene circa 172 brevetti e 61 brevetti in attesa. Il crofelemere è l'unico farmaco vegetale orale approvato sotto le linee guida botaniche della FDA, fornendo ulteriori vantaggi di esclusività.
Jaguar Health (NASDAQ:JAGX) anunció que el Departamento de Propiedad Intelectual de Hong Kong ha emitido una nueva patente a Napo Pharmaceuticals, una empresa del grupo Jaguar, para métodos de tratamiento de síndrome del intestino corto (SBS), diarrea por ácidos biliares y diarrea asociada con resección del intestino delgado o extirpación de la vesícula biliar utilizando crofelemere. Esta patente refuerza la protección de la propiedad intelectual de Jaguar para su indicación principal de enfermedades raras, que es el SBS.
Jaguar está apoyando estudios de prueba de concepto iniciados por investigadores independientes sobre el crofelemere para SBS y enfermedad por inclusión microvilos (MVID) en EE. UU., UE y las regiones de Medio Oriente/Norte de África, con resultados esperados para finales de 2024 y durante 2025. Estos estudios podrían potencialmente apoyar el acceso temprano al crofelemere en países específicos de la UE.
Napo actualmente posee aproximadamente 172 patentes y 61 patentes pendientes. El crofelemere es el único medicamento de prescripción vegetal oral aprobado bajo la Guía Botánica de la FDA, proporcionando ventajas de exclusividad adicionales.
재규어 헬스(NASDAQ:JAGX)는 홍콩 지식재산부가 재규어 가족 회사인 나포 제약에게 짧은 장 증후군(SBS), 담즙 산 설사 및 장 절제 또는 담낭 제거와 관련된 설사를 치료하는 방법에 대한 새로운 특허를 발급했다고 발표했습니다. 이 특허는 SBS라는 주요 희귀 질환 치료목적에 대한 재규어의 지식재산 보호를 강화합니다.
재규어는 미국, EU 및 중동/북아프리카 지역에서 SBS와 미세 융모 포함 질병(MVID)에 대한 크로 페렘레의 독립 연구자 주도 개념 증명 연구를 지원하고 있으며, 2024년 말과 2025년 내내 결과가 나올 것으로 기대하고 있습니다. 이 연구들은 특정 EU 국가에서 크로 페렘레에 대한 조기 환자 접근을 지원할 수 있습니다.
나포는 현재 약 172개 특허와 61개 특허 출원 중입니다. 크로 페렘레는 FDA의 식물 지침에 따라 승인된 유일한 경구 식물 기반 처방약으로, 추가적인 독점성 이점을 제공합니다.
Jaguar Health (NASDAQ:JAGX) a annoncé que le Département de la Propriété Intellectuelle de Hong Kong a délivré un nouveau brevet à Napo Pharmaceuticals, une société du groupe Jaguar, pour des méthodes de traitement du syndrome de l'intestin court (SBS), de la diarrhée par acides biliaires et de la diarrhée associée à une résection de l'intestin grêle ou à l'ablation de la vésicule biliaire en utilisant le crofelemere. Ce brevet renforce la protection de la propriété intellectuelle de Jaguar pour son indication principale ciblant les maladies rares, à savoir le SBS.
Jaguar soutient des études de preuve de concept initiées par des enquêteurs indépendants sur le crofelemere pour le SBS et la maladie d'inclusion microvillositaire (MVID) aux États-Unis, en UE et dans les régions du Moyen-Orient/Afrique du Nord, avec des résultats attendus d'ici fin 2024 et tout au long de 2025. Ces études pourraient potentiellement soutenir un accès précoce au crofelemere dans certains pays de l'UE.
Napo détient actuellement environ 172 brevets et 61 demandes de brevet en cours. Le crofelemere est le seul médicament prescription à base de plantes administré par voie orale approuvé selon les lignes directrices botaniques de la FDA, offrant ainsi des avantages d'exclusivité supplémentaires.
Jaguar Health (NASDAQ:JAGX) hat bekannt gegeben, dass die Hongkonger Behörde für geistiges Eigentum ein neues Patent an Napo Pharmaceuticals, ein Unternehmen der Jaguar-Gruppe, für Methoden zur Behandlung von Short-Bowel-Syndrom (SBS), Gallensäure-Diarrhö und Diarrhö, die mit einer Rektumresektion oder der Entfernung der Gallenblase verbunden sind, unter Verwendung von Crofelemere erteilt hat. Dieses Patent stärkt den IP-Schutz von Jaguar für seine zentrale Zielindikation von SBS bei seltenen Krankheiten.
Jaguar unterstützt von unabhängigen Forschern initiierte Proof-of-Concept-Studien zu Crofelemere für SBS und Mikrovillushyperplasie (MVID) in den USA, der EU und den Regionen Naher Osten/Nordafrika, mit Ergebnissen, die bis Ende 2024 und im Laufe des Jahres 2025 erwartet werden. Diese Studien könnten potenziell den frühen Zugang der Patienten zu Crofelemere in bestimmten EU-Ländern unterstützen.
Napo hält derzeit etwa 172 Patente und 61 Patentanmeldungen. Crofelemere ist das einzige pflanzliche orale Rezepturarzneimittel, das gemäß den botanischen Richtlinien der FDA zugelassen ist, was zusätzliche Exklusivitätsvorteile bietet.
- New patent issued for treating short bowel syndrome (SBS) and related conditions
- Ongoing proof-of-concept studies for SBS and MVID with results expected by end of 2024 and throughout 2025
- Potential for early patient access to crofelemer in specific EU countries based on study results
- Strong IP portfolio with 172 patents and 61 patents pending
- Crofelemer's unique status as the only FDA-approved oral plant-based prescription medicine under Botanical Guidance
- None.
Insights
The issuance of a new patent in Hong Kong for Jaguar Health's crofelemer drug is a significant development in their intellectual property strategy. This patent specifically covers methods for treating short bowel syndrome (SBS), bile acid diarrhea and diarrhea associated with small intestine resection or gallbladder removal. The expansion of patent protection to Hong Kong strengthens Jaguar's global IP position, particularly in the Asian market.
With approximately 230 patents issued and pending, Jaguar is building a robust patent portfolio. This strategy is important for protecting their novel plant-based drug from potential competitors. The fact that crofelemer is currently the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance provides an additional layer of market exclusivity, making it challenging for generic versions to enter the market.
Investors should note that strong IP protection can extend the commercial lifespan of a drug and potentially increase its market value. However, it's important to monitor ongoing clinical studies and regulatory approvals to fully realize the potential of this expanded patent protection.
The ongoing investigator-initiated proof-of-concept studies for crofelemer in short bowel syndrome (SBS) and microvillus inclusion disease (MVID) are important developments to watch. These studies, spanning the US, EU and MENA regions, could potentially open new markets for Jaguar Health if successful.
SBS with intestinal failure is a severe condition often requiring parenteral nutrition (PN), which is associated with high morbidity, mortality and medical expenses. MVID, an ultrarare congenital diarrheal disorder, currently has no approved drug treatments. If crofelemer proves effective in these indications, it could address significant unmet medical needs.
The expected results timeline of end of 2024 and throughout 2025 provides a clear horizon for potential catalysts. Positive outcomes could lead to early patient access in specific EU countries, potentially accelerating market entry. However, investors should be aware that clinical trial results are never guaranteed and negative outcomes could significantly impact the company's prospects in these indications.
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 19, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Hong Kong's Intellectual Property Department has issued a new patent to Jaguar family company Napo Pharmaceuticals 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 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 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 172 patents and approximately 61 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.
Contact:
hello@jaguar.health
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SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
FAQ
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