Napo Pharmaceuticals, a Jaguar Health Family Company, Exhibiting at the Oncology Nursing Society (ONS) Congress for the FDA-Approved Gelclair Oral Mucositis Prescription Product
Napo Pharmaceuticals, a Jaguar Health company (NASDAQ:JAGX), is showcasing Gelclair, their FDA-approved oral mucositis prescription product, at the Oncology Nursing Society Congress in Denver. Gelclair represents the company's third commercialized prescription product and marks their expansion into cancer-related supportive care.
Gelclair is a protective gel that provides pain relief for oral mucositis ('chemo mouth'), a common side effect affecting up to 40% of chemotherapy patients and 90% of head and neck cancer patients receiving chemo and radiotherapy. The product uniquely offers soothing relief without stinging or burning effects.
The company's core target audiences are head and neck cancer patients (71,110 US cases in 2024) and bone marrow transplant patients (approximately 23,000 annually). Notably, oral mucositis has been identified as the most significant adverse event in oncology by the National Comprehensive Cancer Network task force, with 19% of head and neck cancer patients requiring hospitalization due to high-grade mucositis.
Napo Pharmaceuticals, una società di Jaguar Health (NASDAQ:JAGX), sta presentando Gelclair, il loro prodotto prescritto per la mucosite orale approvato dalla FDA, al Congresso della Società di Infermieristica Oncologica a Denver. Gelclair rappresenta il terzo prodotto prescritto commercializzato dall'azienda e segna la loro espansione nella cura di supporto legata al cancro.
Gelclair è un gel protettivo che offre sollievo dal dolore per la mucosite orale ('bocca da chemioterapia'), un effetto collaterale comune che colpisce fino al 40% dei pazienti in chemioterapia e il 90% dei pazienti con cancro alla testa e al collo che ricevono chemioterapia e radioterapia. Il prodotto offre un sollievo unico senza effetti di bruciore o pizzicore.
Il pubblico principale dell'azienda sono i pazienti con cancro alla testa e al collo (71.110 casi negli Stati Uniti nel 2024) e i pazienti sottoposti a trapianto di midollo osseo (circa 23.000 all'anno). È importante notare che la mucosite orale è stata identificata come l'evento avverso più significativo in oncologia dal gruppo di lavoro della National Comprehensive Cancer Network, con il 19% dei pazienti con cancro alla testa e al collo che richiedono ospedalizzazione a causa di mucosite di alto grado.
Napo Pharmaceuticals, una empresa de Jaguar Health (NASDAQ:JAGX), está presentando Gelclair, su producto recetado para la mucositis oral aprobado por la FDA, en el Congreso de la Sociedad de Enfermería Oncológica en Denver. Gelclair representa el tercer producto recetado comercializado por la empresa y marca su expansión en el cuidado de apoyo relacionado con el cáncer.
Gelclair es un gel protector que proporciona alivio del dolor para la mucositis oral ('boca de quimioterapia'), un efecto secundario común que afecta hasta al 40% de los pacientes en quimioterapia y al 90% de los pacientes con cáncer de cabeza y cuello que reciben quimioterapia y radioterapia. El producto ofrece un alivio único sin efectos de ardor o escozor.
El público objetivo principal de la empresa son los pacientes con cáncer de cabeza y cuello (71,110 casos en EE. UU. en 2024) y los pacientes de trasplante de médula ósea (aproximadamente 23,000 anualmente). Es notable que la mucositis oral ha sido identificada como el evento adverso más significativo en oncología por el grupo de trabajo de la National Comprehensive Cancer Network, con el 19% de los pacientes con cáncer de cabeza y cuello requiriendo hospitalización debido a mucositis de alto grado.
나포 제약은 재규어 헬스(NASDAQ:JAGX)의 회사로서 덴버에서 열리는 종양 간호학회에서 겔클레어, FDA 승인 구강 점막염 처방 제품을 선보이고 있습니다. 겔클레어는 회사의 세 번째 상용화된 처방 제품이며, 암 관련 지원 치료로의 확장을 의미합니다.
겔클레어는 구강 점막염('화학 요법 입')에 대한 통증 완화를 제공하는 보호 젤로, 이는 화학 요법 환자의 최대 40%와 화학 요법 및 방사선 치료를 받는 두경부 암 환자의 90%에 영향을 미치는 일반적인 부작용입니다. 이 제품은 따끔거림이나 화끈거림 없이 진정 효과를 독특하게 제공합니다.
회사의 주요 목표 청중은 두경부 암 환자 (2024년 미국에서 71,110건)와 골수 이식 환자 (연간 약 23,000건)입니다. 특히 구강 점막염은 National Comprehensive Cancer Network 태스크 포스에 의해 종양학에서 가장 중요한 부작용으로 확인되었으며, 두경부 암 환자의 19%가 고도 점막염으로 인해 입원이 필요합니다.
Napo Pharmaceuticals, une entreprise de Jaguar Health (NASDAQ:JAGX), présente Gelclair, son produit prescrit pour la mucosite orale approuvé par la FDA, lors du Congrès de la Société d'Infirmière en Oncologie à Denver. Gelclair représente le troisième produit prescrit commercialisé par l'entreprise et marque son expansion dans les soins de soutien liés au cancer.
Gelclair est un gel protecteur qui soulage la douleur causée par la mucosite orale ('bouche de chimiothérapie'), un effet secondaire courant touchant jusqu'à 40 % des patients sous chimiothérapie et 90 % des patients atteints de cancer de la tête et du cou recevant une chimiothérapie et une radiothérapie. Le produit offre un soulagement unique sans effets de picotement ou de brûlure.
Les principaux publics cibles de l'entreprise sont les patients atteints de cancer de la tête et du cou (71 110 cas aux États-Unis en 2024) et les patients ayant subi une transplantation de moelle osseuse (environ 23 000 par an). Il est à noter que la mucosite orale a été identifiée comme l'événement indésirable le plus significatif en oncologie par le groupe de travail du National Comprehensive Cancer Network, 19 % des patients atteints de cancer de la tête et du cou nécessitant une hospitalisation en raison de mucosite de haut grade.
Napo Pharmaceuticals, ein Unternehmen von Jaguar Health (NASDAQ:JAGX), präsentiert Gelclair, ihr von der FDA zugelassenes Rezeptprodukt gegen orale Mukositis, auf dem Kongress der Oncology Nursing Society in Denver. Gelclair ist das dritte kommerzialisierte Rezeptprodukt des Unternehmens und markiert deren Expansion in die unterstützende Krebsversorgung.
Gelclair ist ein schützendes Gel, das Schmerzlinderung bei oraler Mukositis ('Chemotherapie-Mund') bietet, einem häufigen Nebenwirkung, die bis zu 40% der Chemotherapie-Patienten und 90% der Patienten mit Kopf- und Halskrebs, die Chemotherapie und Strahlentherapie erhalten, betrifft. Das Produkt bietet einzigartigen Linderung ohne stechende oder brennende Effekte.
Die Hauptzielgruppen des Unternehmens sind Patienten mit Kopf- und Halskrebs (71.110 Fälle in den USA im Jahr 2024) und Patienten nach einer Knochenmarktransplantation (jährlich etwa 23.000). Bemerkenswert ist, dass orale Mukositis von der National Comprehensive Cancer Network Task Force als das bedeutendste unerwünschte Ereignis in der Onkologie identifiziert wurde, wobei 19% der Patienten mit Kopf- und Halskrebs aufgrund von hochgradiger Mukositis hospitalisiert werden müssen.
- FDA-approved product expanding into cancer supportive care market
- Large addressable market with 71,110 head and neck cancer cases plus 23,000 annual bone marrow transplant patients
- Product differentiator: provides relief without stinging/burning unlike competitors
- High market need: affects up to 90% of head and neck cancer patients on chemo/radiotherapy
- None.
Gelclair® is the company's third commercialized prescription product
Oral mucositis, also called "chemo mouth," a painful inflammation of the mouth's mucous membranes, has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force
Napo's core target patient audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients
SAN FRANCISCO, CA / ACCESS Newswire / April 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals ("Napo") is exhibiting at the 50th anniversary Oncology Nursing Society (ONS) Congress taking place April 9-13, 2025 in Denver, Colorado as part of ongoing commercial activities for Gelclair.
"We have expanded our footprint beyond HIV-related supportive care to include cancer-related supportive care, and our recent in-licensing of the FDA-approved oral mucositis product Gelclair is a first building block," said Lisa Conte, Jaguar's president and CEO.
"Cancer is chaotic, because patients feel a loss of control - over their life, their treatment, and their supportive care needs," said Conte. "Jaguar's mission is to change patients' lives for the better, especially in the area of supportive care for complex disease states like cancer. We look forward to driving awareness among the oncology nursing community at ONS about Gelclair. Oral mucositis, also called "chemo mouth," is among the most common, painful, and debilitating cancer treatment-related side effects, and it is undertreated and underappreciated. We believe we can help cancer patients by giving them a supportive care product for oral mucositis that provides soothing, quick, and lasting pain relief without stinging, drying or burning."
"If it weren't for Gelclair, I don't know if I would have continued with chemo. It was that painful. Gelclair gave me relief when nothing else did - it allowed me to keep going," said Megan-Claire, a Gelclair patient brand ambassador for Napo.
Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth.
"Nurses play a vital role in providing integrated supportive care to cancer survivors to meet various physical, psychological, and social support needs," added Conte. "Jaguar and Napo acknowledge the rigors of both short-term and chronic treatment and do not believe any cancer therapy-related side effect, whether it is extreme fatigue, debilitating diarrhea, oral mucositis, hair loss, chronic pain, or others, should ever be viewed as ‘acceptable' or ‘tolerable.' We live in the age of targeted therapies, and thanks to these amazing drugs, cancer patients are living longer - 5, 10, 20 years. Targeted therapies often lead to more severe side effects, however, and patients want to live, not just survive."
Napo's core target audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients, and oncology-focused health care professionals. Head and neck cancers account for nearly 4 percent of all cancers in the United States, according to the National Cancer Institute (NCI).1 Counting cancers of the oral cavity, pharynx, and larynx, the NCI estimates that about 71,110 cases were diagnosed in the U.S. in 2024.2 Approximately another 23,000 patients each year undergo bone marrow transplant procedures.
Oral mucositis has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force.3 Up to
"Those of us working in the oncology field know the impact that side effect-related delays or cessation of cancer treatment can have on overall survival and on the efficacy of treatment," Conte said. "Of patients with head and neck cancers treated with chemotherapy and radiotherapy who develop oral mucositis, half of the cases are typically considered severe - meaning oral mucositis of grade 3 or 4, which may require hospitalization and may require parenteral nutrition and IV hydration, and the morbidity and expense associated with those interventions."
Jaguar also remains focused on development of crofelemer for cancer therapy-related diarrhea (CTD). As announced, the analysis of the prespecified subgroup of adult patients with breast cancer from Napo's recently conducted Phase 3 prophylactic OnTarget clinical trial for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy indicates that crofelemer achieved statistically significant results in this subgroup. These results were the subject of a December 11, 2024 poster presentation at the San Antonio Breast Cancer Symposium and the late-breaker abstract recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC) for consideration for presentation at the June 2025 MASCC Annual Meeting. As also announced, the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in OnTarget. The company's goal is to discuss the most efficient pathways to make crofelemer available to this patient population for CTD.
The annual ONS Congress is a prominent event for professionals and organizations who are committed to the promotion of excellence in oncology nursing and the transformation of cancer care. ONS is a professional association that represents 100,000 nurses and is the professional home to more than 35,000 members. Since 1975, ONS has provided a professional community for oncology nurses, developed evidence-based education programs and treatment information, and advocated for patient care, all in an effort to improve the quality of life and outcomes for patients with cancer and their families. Learn more at www.ons.org.
About Gelclair®
INDICATIONS
GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.
Please see full Prescribing Information at:
https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf
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 on Bluesky, X, Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Napo will exhibit at the April 2025 ONS Congress, and the expectation that Napo will meet with the FDA in the second quarter of 2025 regarding the statistically significant results of the OnTarget trial in the prespecified subgroup of patients with breast cancer. 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 https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet
2 https://www.aacr.org/patients-caregivers/awareness-months/head-and-neck-cancer-awareness-month/
3 NCCN Task Force Report: Prevention and Management of Mucositis in Cancer Care. Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw, 6(S1), S-1-S-21. https://doi.org/10.6004/jnccn.2008.2001
4 Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7. PMID: 33028357; PMCID: PMC7542970
5 Vera-Llonch M, Oster G, Hagiwara M, Sonis S. Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer. 2006;106(2):329-336. doi:10.1002/cncr.21622.
6 Trotti A, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8 . PMID: 12742264.
Contact:
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
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FAQ
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What percentage of head and neck cancer patients face treatment interruption due to oral mucositis that JAGX's Gelclair addresses?
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