Jaguar Health to Spotlight Company's Commercial Focus on Cancer Supportive Care at American Society for Radiation Oncology (ASTRO) Annual Meeting for FDA-Approved Gelclair Oral Mucositis Product in Advance of October 2024 Gelclair Launch

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced that its subsidiary, Napo Pharmaceuticals, will exhibit Gelclair, an FDA-approved oral mucositis prescription product, at the American Society for Radiation Oncology (ASTRO) Annual Meeting from September 29 to October 2, 2024, in Washington, DC. Jaguar plans to launch Gelclair commercially in the U.S. in October 2024.

Gelclair is a protective gel that manages pain by adhering to the mouth's mucosal surface, providing relief for oral lesions, including those caused by oral mucositis/stomatitis. Unlike other products, it doesn't numb or sting the mouth. Oral mucositis, also known as "chemo mouth," affects up to 40% of chemotherapy patients and 90% of head and neck cancer patients treated with chemotherapy and radiotherapy. It can lead to hospitalization, treatment delays, and increased management costs.

The economic impact is significant, with a study showing that severe mucositis/pharyngitis in head and neck cancer patients can result in incremental costs exceeding $17,244 per patient. Jaguar aims to raise awareness among oncologists about Gelclair and its expanding focus on cancer supportive care at the ASTRO Annual Meeting.

Positive

• FDA-approved Gelclair product for oral mucositis management
• Planned U.S. commercial launch of Gelclair in October 2024
• Large potential market with up to 40% of chemotherapy patients and 90% of head and neck cancer patients affected by oral mucositis
• Gelclair offers advantages over other products (non-numbing, non-stinging)
• Opportunity to raise product awareness at ASTRO Annual Meeting

Negative

• None.

Insights

Medical Research Analyst

Jaguar Health's focus on Gelclair for oral mucositis represents a significant opportunity in the cancer supportive care market. Oral mucositis affects a large percentage of cancer patients undergoing chemotherapy and radiotherapy, with up to 90% of head and neck cancer patients experiencing this side effect. The condition's impact on patient quality of life and treatment outcomes is substantial.

Gelclair's unique mechanism of action, which provides a protective barrier without numbing or stinging, addresses a critical need in managing this common side effect. The planned October 2024 launch aligns well with the ASTRO Annual Meeting, potentially generating interest among oncologists.

The economic burden of oral mucositis, with incremental costs exceeding $17,244 per patient in severe cases, underscores the market potential for effective management solutions. Jaguar Health's strategic focus on this area could position them favorably in the growing cancer supportive care market, potentially driving future revenue growth.

Financial Analyst

Jaguar Health's strategic move into the cancer supportive care market with Gelclair presents a promising revenue opportunity. With a current market cap of just $9,959,275, the company is positioning itself in a niche with significant growth potential. The oral mucositis market is substantial, given that up to 40% of all chemotherapy patients and 90% of head and neck cancer patients develop this condition.

The planned October 2024 launch of Gelclair in the U.S. could be a catalyst for Jaguar's stock performance. Investors should monitor the reception at the ASTRO Annual Meeting and subsequent sales traction. The $17,244 incremental cost per severe case indicates a sizable addressable market. However, it's important to assess Jaguar's marketing capabilities and potential market share gains against existing competitors in this space.

While the opportunity is significant, investors should also consider the company's current financial position and ability to execute a successful product launch.

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

Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy

SAN FRANCISCO, CA / ACCESSWIRE / September 24, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals (Napo) is exhibiting Gelclair ^® , the FDA-approved oral mucositis prescription product, at the American Society for Radiation Oncology (ASTRO) Annual Meeting , which takes place September 29 - October 2, 2024 in Washington, DC. Jaguar plans to begin the U.S. commercial launch in October 2024 for Gelclair.

"Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. 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," said Lisa Conte, Jaguar's president and CEO. "We look forward to driving awareness among oncologists at the ASTRO Annual Meeting about Gelclair and Jaguar's expanding focus on cancer supportive care."

Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network (NCCN) task force. ¹ Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy. ² Of the latter, 19% may end up being hospitalized, experiencing a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis, and an increase in patient management costs. ²

Oral mucositis can negatively affect diet, nutrition, oral hygiene, as well as quality of life. ³ 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. ¹

The economic consequences are far from trivial. In a third-party study, severe mucositis/pharyngitis occurred in 70.1% of 99 patients with head and neck cancer, with the incremental cost of oral mucositis exceeding $17,244 for these patients. ⁴

Gelclair is a convenient and easy to use gel that provides rapid and long-lasting pain relief and improves the ability of oral mucositis patients to eat, drink, and swallow.

About the American Society for Radiation Oncology
The American Society for Radiation Oncology (ASTRO) is a professional association in radiation oncology that is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO has a membership of more than 10,000 members covering a range of professions including Radiation Oncologist, Radiation Therapists, Medical Dosimetrists Medical Physicists, Radiation Oncology Nurses and Radiation Biologists. Learn more at www.astro.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.

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

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

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 2024 ASTRO Annual Meeting, and Jaguar's expectation that it will begin the U.S. commercial launch in October 2024 for Gelclair. 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 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

² 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.

³ 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.

⁴ 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

FAQ

When is Jaguar Health (JAGX) planning to launch Gelclair in the U.S. market?

Jaguar Health plans to begin the U.S. commercial launch of Gelclair in October 2024.

What is the purpose of Gelclair, the product Jaguar Health (JAGX) is exhibiting at ASTRO?

Gelclair is an FDA-approved prescription product for managing pain and providing relief for oral lesions, including those caused by oral mucositis/stomatitis in cancer patients.

How common is oral mucositis in cancer patients, according to the Jaguar Health (JAGX) press release?

Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy.

What is the economic impact of severe oral mucositis in head and neck cancer patients, as mentioned in the Jaguar Health (JAGX) announcement?

According to a third-party study cited in the press release, the incremental cost of oral mucositis exceeded $17,244 for head and neck cancer patients with severe mucositis/pharyngitis.