Jaguar Health Launches FDA-Approved Oral Mucositis Prescription Product Gelclair in the U.S.
Jaguar Health (NASDAQ:JAGX) has launched Gelclair, an FDA-approved oral mucositis prescription product, in the U.S. This marks Jaguar's third commercialized prescription product and initiates its commercial footprint in cancer supportive care. Gelclair is a gel that adheres to the mouth's mucosal surface, providing rapid and long-lasting pain relief without stinging or numbing.
Oral mucositis, affecting up to 90% of head and neck cancer patients treated with chemotherapy and radiotherapy, is a significant adverse event in oncology. It can lead to treatment interruptions and hospitalization. Jaguar's launch strategy includes a dedicated team of representatives and plans to exhibit at key oncology conferences.
Jaguar Health (NASDAQ:JAGX) ha lanciato Gelclair, un prodotto per la mucosite orale approvato dalla FDA, negli Stati Uniti. Questo segna il terzo prodotto prescritto commercializzato da Jaguar e avvia la sua presenza commerciale nel supporto ai pazienti oncologici. Gelclair è un gel che si adatta alla superficie mucosa della bocca, fornendo un rapido e duraturo sollievo dal dolore senza bruciare o intorpidire.
La mucosite orale, che colpisce fino al 90% dei pazienti affetti da tumori della testa e del collo trattati con chemioterapia e radioterapia, è un evento avverso significativo in oncologia. Può portare a interruzioni del trattamento e ricoveri. La strategia di lancio di Jaguar include un team dedicato di rappresentanti e prevede la partecipazione a importanti conferenze di oncologia.
Jaguar Health (NASDAQ:JAGX) ha lanzado Gelclair, un producto recetado para la mucositis oral aprobado por la FDA, en los EE. UU. Esto marca el tercer producto recetado comercializado por Jaguar e inicia su presencia comercial en cuidados de soporte oncológico. Gelclair es un gel que se adhiere a la superficie mucosa de la boca, proporcionando alivio del dolor rápido y duradero sin escozor ni entumecimiento.
La mucositis oral, que afecta hasta el 90% de los pacientes con cáncer de cabeza y cuello tratados con quimioterapia y radioterapia, es un evento adverso significativo en oncología. Puede llevar a interrupciones del tratamiento y hospitalizaciones. La estrategia de lanzamiento de Jaguar incluye un equipo dedicado de representantes y planes para exhibir en conferencias clave de oncología.
재규어 헬스 (NASDAQ:JAGX)는 미국에서 FDA 승인된 구강 점막염 처방 제품인 젤클레어를 출시했습니다. 이는 재규어의 세 번째 상업화된 처방 제품이며 암 환자 지원 치료에 대한 상업적 입지를 시작합니다. 젤클레어는 구강 점막 표면에 부착되는 젤로, 떨림이나 무감각 없이 빠르고 지속적인 통증 완화를 제공합니다.
구강 점막염은 화학 요법과 방사선 치료를 받은 90%의 두경부 암 환자에게 영향을 미치는 큰 부작용입니다. 이는 치료 중단 및 입원으로 이어질 수 있습니다. 재규어의 출시 전략에는 전담 대표팀이 포함되어 있으며 주요 종양학 학회에서 전시할 계획이 있습니다.
Jaguar Health (NASDAQ:JAGX) a lancé Gelclair, un produit sur ordonnance pour la mucite orale approuvé par la FDA, aux États-Unis. Cela marque le troisième produit prescription commercialisé par Jaguar et initie son empreinte commerciale dans le soin de soutien aux patients cancéreux. Gelclair est un gel qui adhère à la surface muqueuse de la bouche, fournissant un soulagement rapide et durable de la douleur sans picotement ni engourdissement.
La mucite orale, qui touche jusqu'à 90 % des patients atteints de cancer de la tête et du cou traités par chimiothérapie et radiothérapie, est un événement indésirable significatif en oncologie. Elle peut entraîner des interruptions de traitement et des hospitalisations. La stratégie de lancement de Jaguar comprend une équipe dédiée de représentants et prévoit d'exposer lors de conférences clés sur l'oncologie.
Jaguar Health (NASDAQ:JAGX) hat Gelclair, ein von der FDA zugelassenes Rezeptprodukt gegen orale Mukositis, in den USA auf den Markt gebracht. Dies markiert das dritte kommerzialisierte Rezeptprodukt von Jaguar und beginnt deren kommerziellen Fußabdruck im Bereich onkologische Unterstützungsversorgung. Gelclair ist ein Gel, das sich an die Schleimhaut der Mundhöhle anlegt und schnelle und langanhaltende Schmerzlinderung bietet, ohne zu brennen oder zu betäuben.
Die orale Mukositis betrifft bis zu 90% der Patienten mit Kopf- und Halskrebs, die mit Chemotherapie und Strahlentherapie behandelt werden, und stellt ein erhebliches unerwünschtes Ereignis in der Onkologie dar. Sie kann zu Behandlungsunterbrechungen und Krankenhausaufenthalten führen. Jaguars Launch-Strategie umfasst ein engagiertes Team von Vertretern und die Teilnahme an wichtigen Onkologie-Konferenzen.
- Launch of FDA-approved Gelclair, expanding product portfolio
- Entry into cancer supportive care market
- Potential to address a significant unmet medical need affecting up to 90% of head and neck cancer patients
- Product provides rapid and long-lasting pain relief without side effects like stinging or numbing
- Dedicated sales and educational team with oncology experience
- Competitive market in cancer supportive care
- Success dependent on market adoption and healthcare provider acceptance
- Potential challenges in patient education and awareness
Insights
The launch of Gelclair, an FDA-approved oral mucositis prescription product, is a significant development for Jaguar Health. Oral mucositis affects up to
Key points:
- Gelclair is Jaguar's third commercialized prescription product, expanding their portfolio in cancer supportive care.
- The product provides rapid, long-lasting pain relief without numbing or stinging, potentially improving patient quality of life and treatment adherence.
- Targeting head and neck cancer patients initially, which account for
4% of all U.S. cancers, with an estimated 71,110 cases in 2024. - Severe oral mucositis can lead to hospitalization, treatment interruptions and increased healthcare costs, with incremental costs exceeding
$17,244 per patient in one study.
This launch could positively impact Jaguar Health's revenue stream and market position in oncology supportive care, potentially driving growth for the company.
The commercial launch of Gelclair represents a significant revenue opportunity for Jaguar Health. With a current market cap of just
Key financial implications:
- Expanded product portfolio: Gelclair joins two other commercialized prescription products, diversifying revenue streams.
- Large addressable market: With 71,110 estimated head and neck cancer cases in 2024 and high incidence of oral mucositis, the potential patient base is substantial.
- High-value product: Given the
$17,244 incremental cost of oral mucositis per patient, even a modest market penetration could significantly boost revenues. - Strategic positioning: This launch aligns with Jaguar's focus on cancer supportive care, potentially leading to future product developments and market expansion.
Investors should monitor Gelclair's market uptake and its impact on Jaguar's revenue growth in upcoming quarters. The success of this launch could be a catalyst for the stock, particularly given the company's current low market capitalization.
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
Severe mucositis/pharyngitis occurred in
SAN FRANCISCO, CA / ACCESSWIRE / October 16, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals ("Napo") has initiated the commercial launch of the FDA-approved oral mucositis prescription product Gelclair in the U.S.
"Cancer is chaotic, because patients feel a loss of control - over their life, their treatment, and their supportive care needs," said Catherine Collis, Jaguar's Senior Vice President of Growth Strategy. "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 are thrilled to have begun our commercial launch of Gelclair. Oral mucositis 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."
"We are very happy to have initiated the commercial launch for Gelclair - our third commercialized prescription product. This important milestone initiates Jaguar's commercial footprint in our core focus area of cancer supportive care," said Lisa Conte, Jaguar's president and CEO. "Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth. It coats and protects the oral mucosa, which supports healing. Gelclair is convenient and easy to use, provides rapid and long-lasting pain relief, and improves the ability of oral mucositis patients to eat, drink, and swallow. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth."
"A key attribute in the management of head and neck cancer patients with Gelclair is, in my experience, to delay the onset which may decrease the severity of oral mucositis, allowing the patients to continue meeting their nutritional needs without having to go on a feeding tube, supporting their ability to withstand their 6 weeks of radiation therapy without having to go to lower doses or treatment interruptions, and to avoid the need for heavy prescription meds for oral mucositis-related pain," said Maged Ghaly, MD, a radiation oncologist at Northwell Health Cancer Institute, Monter Cancer Center.
Napo's core target audiences for the Gelclair launch are patients with head and neck cancer and oncology-focused health care practitioners. 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 will occur in the U.S. in 2024.2
Oral mucositis, also called "chemo mouth," 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," Collis 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 typically puts a patient in the hospital requiring parenteral nutrition and iv hydration, and the morbidity and expense associated with that."
"We've dedicated a great deal of effort to ensuring that our commercial launch plan for Gelclair is executed with sharp strategic focus. Given Jaguar's core focus on cancer supportive care, we've developed a dedicated team of educational, promotional and sales representatives with extensive experience in this area. This positions us well as we anticipate future new products in the cancer supportive care space," added Collis.
As part of the ongoing Gelclair launch, Napo plans to exhibit at several key oncology conferences in the coming months, and there will also be a strong digital marketing component to the launch, targeting health care providers and providing information and education for patients to self-advocate.
Tom Barnes, a cancer patient and a paid consultant to Napo, commented: "I would say that the BIGGEST impact oral mucositis has had on my treatment plan has been a delay in me getting comfortable with being able to eat solid foods again. Even though the mucositis is relatively confined to the interior of my mouth, the sense of it being there also contributes towards that sense of body image being damaged."
Oral mucositis can negatively affect diet, nutrition, oral hygiene, and quality of life.7 Its adverse physical, social and psychological impacts on patients are manifest and include the need for total parenteral nutrition, higher risk of systemic infections, increased use of antifungals and opioid analgesics, increased hospitalizations with longer hospital stays, social isolation and depression due to the inability to talk and eat, subsequent dose reductions, treatment interruptions and discontinuations, and as a corollary to dose reductions and treatment interruptions/discontinuations, diminished anti-tumor responses and shorter survival.8
The economic consequences are far from trivial. In a third-party study, severe mucositis/pharyngitis occurred in
For more information about Gelclair, visit www.gelclair.com.
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
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.
IMPORTANT SAFETY INFORMATION
Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.
No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.
If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.
If no improvement is seen within 7 days, a physician should be consulted.
You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, call 1-855-273-0468 or fill-in the form at this link.
Please see full Prescribing Information at:
https://gelclair.com/assets/Gelclair_PI_Decemeber_2021.pdf
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will have additional products for the cancer supportive care space in the future, and Jaguar's expectation that, as part of the ongoing Gelclair launch, Napo will exhibit at several oncology conferences in the coming months and there will also be a strong digital marketing component to the launch. 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.
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.
7 Jensen SB, Peterson DE. Oral mucosal injury caused by cancer therapies: current management and new frontiers in research. J Oral Pathol Med. 2014;43(2):81-90.
8 Nonzee NJ, et al. A Review of Clinical Radioprotection and Chemoprotection for Oral Mucositis. Transl Oncol. 2018 Jun; 11(3): 771-778.
9 Nonzee NJ, et al. Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis: results from a Northwestern University Costs of Cancer Program pilot study with head and neck and nonsmall cell lung cancer patients who received care at a county hospital, a Veterans Administration hospital, or a comprehensive cancer care center. Cancer. 2008;113:1146-1152.
CONTACT:
hello@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on accesswire.com
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