Jaguar Health Licenses FDA-Approved Oral Mucositis Product for U.S. Market, Initiating Commercial Footprint in its Core Focus Area of Cancer Supportive Care

Rhea-AI Summary

Jaguar Health licenses FDA-approved oral mucositis product, Gelclair, for the U.S. market, aiming to address the significant adverse event in oncology. The company plans to launch in Q3 2024, expanding its focus to cancer supportive care.

Positive

• Jaguar Health secures an exclusive 5-year in-license agreement with Venture Life Group PLC for Gelclair.
• Oral mucositis is a prevalent and debilitating side effect of cancer treatment, affecting up to 40% of chemotherapy patients.
• Gelclair is a protective gel that adheres to the mouth's mucosal surface, providing pain relief without numbing or stinging.
• The partnership allows Jaguar to enter the cancer supportive care market, complementing its HIV-related supportive care products.
• Gelclair's efficacy in managing oral mucositis can potentially reduce hospitalizations, treatment delays, and improve patients' quality of life.
• The economic burden of oral mucositis can exceed $17,000 for head and neck cancer patients, highlighting the need for effective treatment options.
• Jaguar's strategic expansion into cancer-related supportive care aligns with the growing demand for targeted therapies in oncology.
• The company's ongoing Phase 3 OnTarget trial of crofelemer for chemotherapy-induced overactive bowel syndrome demonstrates its commitment to addressing cancer therapy-related side effects.
• Gelclair's FDA approval enables Jaguar to commercialize the product without additional clinical development costs, enhancing its market competitiveness.

Negative

• None.

Insights

Oncology Doctor

The licensing of Gelclair by Jaguar Health represents a strategic expansion into the cancer supportive care market. As an oncologist, understanding the significance of oral mucositis in cancer treatment is paramount. It's one of the most common side effects of chemotherapy, especially in head and neck cancer patients, where its prevalence can be as high as 90%. The impact of such a condition on a patient's quality of life cannot be overstated, as it often leads to nutritional deficiencies, increased risk of infection and potential interruptions in cancer therapy.

Gelclair, being a non-numbing agent, can indeed offer a differentiated approach to managing oral mucositis compared to other treatments that simply numb the mouth. By forming a protective barrier over mucosal lesions, Gelclair may enhance patient compliance with cancer treatments by reducing the severity and pain of oral mucositis, potentially impacting the long-term outcomes for patients.

For investors, the adoption of Gelclair into Jaguar's portfolio may signal a promising venture into a niche but significant market, enhancing Jaguar's overall market offering and potentially improving long-term shareholder value.

Financial Analyst

From a financial standpoint, Jaguar Health's in-license agreement for Gelclair could be a prudent move. The oral mucositis market is substantial, given its high incidence rate in chemotherapy patients. With Gelclair already FDA approved, Jaguar eliminates the risk and cost associated with clinical development, allowing for a faster path to market and revenue generation.

Furthermore, the cost burden of oral mucositis management on the healthcare system, which exceeds 17,000 in incremental costs for head and neck cancer patients, suggests that effective treatments can offer significant cost savings. This economic angle may present Gelclair as both a clinical and cost-effective solution, potentially leading to favorable adoption rates once launched. Investors should monitor upcoming financial reports for updates on sales projections and market penetration post-launch.

Market Research Analyst

Analyzing the market dynamics, the exclusive 5-year license for Gelclair places Jaguar Health in a strong position within the cancer supportive care space. This move not only diversifies their portfolio but also enables them to capitalize on a growing need for supportive care in oncology, as targeted therapies continue to extend patient lifespans but come with severe side effects.

Moreover, the emphasis on Gelclair's unique attributes such as not numbing the mouth and reducing the need for feeding tubes and heavy prescription medications can resonate well with healthcare providers. These differentiators can be leveraged in marketing strategies to gain a competitive edge. Keeping an eye on the acceptance of Gelclair by oncologists and the feedback from patients post-launch will be vital for investors to gauge the product's traction within the market.

Jaguar planning to begin commercial launch in Q3 2024 for Gelclair^®, the company's third prescription product

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

SAN FRANCISCO, CA / ACCESSWIRE / April 16, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has signed an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC ("Venture Life"), an international consumer health company focused on the global self-care market, for Venture Life's FDA-approved oral mucositis prescription product, Gelclair, for the U.S. market.

"We are very happy to have executed the in-license agreement for Gelclair - and thus to have initiated 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 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."

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. 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

"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.

"Gelclair is an FDA-approved prescription product and can be commercialized without any clinical development costs for Jaguar," added Conte. "We are expanding our footprint beyond HIV-related supportive care to include cancer-related supportive care, and the in-license of Gelclair is a first building block while we await the forthcoming results from our pivotal Phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea, an indication we also refer to as chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as unpredictable and/or chronic debilitating diarrhea and GI urgency. We live in the age 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."

Oral mucositis can negatively affect diet, nutrition, oral hygiene, and 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, with the incremental cost of oral mucositis exceeding $17,000 for patients with head and neck cancer.⁴

Gelclair is a clinically proven, 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, swallow, speak and sleep. Gelclair also reduces the need to use parenteral feeding or opiate analgesics.

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 focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted 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 Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/

Visit Jaguar on X: https://twitter.com/Jaguar_Health

Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that top line results from the OnTarget study are forthcoming. 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 Oronsky B, et al. Transl Oncol. 2018;11(3):771-778.

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. J Oral Pathol Med. 2014;43(2):81-90.

⁴ Nonzee NJ, et al. Cancer. 2008;113(6):1446-1452.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on accesswire.com

FAQ

What product did Jaguar Health license for the U.S. market?

Jaguar Health licensed Gelclair, an FDA-approved oral mucositis product, for the U.S. market.

What is the significance of oral mucositis in oncology?

Oral mucositis is a common and debilitating side effect of cancer treatment, affecting up to 40% of chemotherapy patients.

How does Gelclair differ from other oral mucositis products?

Gelclair is a protective gel that provides pain relief by adhering to the mouth's mucosal surface without numbing or stinging.

What are the potential benefits of Gelclair for cancer patients?

Gelclair can improve patients' ability to eat, drink, swallow, speak, and sleep, reducing the need for parenteral feeding or opiate analgesics.

What are the economic implications of oral mucositis for head and neck cancer patients?

The incremental cost of oral mucositis can exceed $17,000 for head and neck cancer patients, highlighting the financial burden.

How does Jaguar Health plan to expand its focus beyond HIV-related supportive care?

Jaguar Health aims to enter the cancer supportive care market by licensing Gelclair and conducting trials for chemotherapy-induced overactive bowel syndrome.

What is the strategic significance of Jaguar Health's partnership with Venture Life Group PLC?

The partnership allows Jaguar Health to commercialize Gelclair in the U.S. market, enhancing its presence in cancer supportive care.

What is the purpose of Jaguar Health's Phase 3 OnTarget trial of crofelemer?

Jaguar Health is conducting the trial to address chemotherapy-induced overactive bowel syndrome, a common side effect of cancer therapy.

How does Gelclair's FDA approval benefit Jaguar Health's market position?

Gelclair's FDA approval enables Jaguar Health to commercialize the product without additional clinical development costs, enhancing its market competitiveness.