RedHill Licenses RHB-102 for Commercialization Worldwide Excluding North America to Hyloris for up to $60 Million in Potential Milestone Payments Plus Royalties

Rhea-AI Summary

RedHill Biopharma has licensed RHB-102 (Bekinda®) to Hyloris Pharmaceuticals for commercialization worldwide excluding North America. The deal includes an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues.

RHB-102 is a once-daily, extended-release oral tablet formulation of ondansetron in development for multiple indications. The UK MHRA has provided a clear pathway for a Marketing Authorization Application, potentially making it the first oral 24-hour extended-release ondansetron for treating chemotherapy/radiotherapy-induced nausea and vomiting.

RedHill will continue development for FDA approval in the U.S., while Hyloris handles development, regulatory and commercialization activities in its territories. The global antiemetics market was valued at approximately $7.5 billion in 2023 with expected growth at 6% CAGR through 2030.

Positive

• Licensing deal worth up to $60 million in milestone payments plus royalties up to mid-20s percent
• Clear regulatory pathway from UK MHRA for Marketing Authorization Application
• Potential to be first oral 24-hour extended-release ondansetron for CINV/RINV
• Successful Phase 3 GUARD study for gastroenteritis and Phase 2 IBS-D study completed
• Global antiemetics market valued at $7.5 billion with 6% CAGR expected

Negative

• Milestone payments contingent on achieving commercial targets
• RedHill still needs to complete certain manufacturing activities
• FDA approval in the U.S. not yet secured

Insights

Biotech Financial Analyst

RedHill Biopharma's exclusive licensing agreement with Hyloris for RHB-102 (Bekinda®) represents a potentially transformative deal for this micro-cap company. With RedHill's current market capitalization of just $6.27 million, the agreement's potential value of up to $60 million in milestone payments plus up to mid-20s percent royalties could significantly alter the company's financial trajectory.

The royalty structure is particularly noteworthy in today's biopharmaceutical licensing landscape. Typical royalty rates for late-stage assets generally range from 10-15%, making RedHill's negotiated rate of up to mid-20s percent exceptionally favorable. While the exact upfront payment wasn't disclosed, this deal provides RedHill with a capital infusion while offloading development and commercialization costs outside North America.

RHB-102's once-daily formulation addresses a significant unmet need in the $7.5 billion antiemetics market. Current ondansetron formulations typically require multiple daily doses, creating adherence challenges for cancer patients already managing complex medication regimens. The 24-hour extended-release profile could provide meaningful clinical differentiation in the competitive antiemetics landscape.

This agreement follows a strategic pattern for RedHill, coming after their recent Bayer-funded Phase 2 study of opaganib and darolutamide in advanced prostate cancer. These partnerships suggest management is effectively leveraging their pipeline assets to generate non-dilutive capital while retaining valuable rights in the lucrative North American market.

The multi-indication development strategy for RHB-102 (CINV/RINV, gastroenteritis, IBS-D, and potentially PONV) creates multiple commercialization pathways, diversifying risk and expanding market potential. With positive Phase 3 data for gastroenteritis and Phase 2 data for IBS-D already in hand, these additional indications represent significant upside beyond the oncology support applications.

The positive MHRA feedback provides regulatory validation and potentially accelerates the path to commercialization in the UK and potentially other markets. For investors, this deal transforms RedHill's risk profile by providing near-term capital while maintaining substantial long-term upside through milestone payments and royalties. Given RedHill's current market valuation, the market appears to be significantly undervaluing this asset and the company's broader pipeline potential.

Pharmaceutical Market Analyst

RedHill's licensing deal with Hyloris for RHB-102 represents a potentially transformative transaction for a company with a market capitalization of just $6.27 million. The agreement's potential value of $60 million plus royalties is nearly 10 times RedHill's current market cap, suggesting the market may be significantly undervaluing this asset and the company's potential.

The royalty structure deserves particular attention. The negotiated rate of up to mid-20s percent substantially exceeds typical biopharmaceutical licensing agreements, which generally range from 8-15% for late-stage assets. This premium rate likely reflects RHB-102's differentiated profile and substantial market potential across multiple indications.

In the $7.5 billion antiemetics market, RHB-102 addresses critical limitations of current standard-of-care treatments. Conventional ondansetron formulations require multiple daily doses (typically three times daily), creating adherence challenges for cancer patients already managing complex medication regimens and suffering from treatment-related fatigue. The once-daily extended-release formulation represents meaningful innovation in a market segment that hasn't seen significant delivery advancements in years.

Market segmentation analysis reveals multiple substantial opportunities. The CINV/RINV segment alone represents approximately $4 billion of the antiemetics market. The additional indications—gastroenteritis, IBS-D, and potentially PONV—expand the addressable market considerably, with IBS-D affecting approximately 30 million Americans alone.

Hyloris brings valuable commercialization capabilities to this partnership as a specialty pharmaceutical company focused on value-added reformulations. Their European presence and reformulation expertise make them well-positioned to navigate the regulatory pathway opened by the positive MHRA feedback. With manufacturing activities as the primary remaining hurdle before submission, commercial launch in the UK could potentially occur within 12-18 months.

For RedHill, this agreement provides critical non-dilutive capital while retaining rights to the lucrative North American market. The deal significantly extends their cash runway and reduces overall development risk. Coming after their Bayer collaboration for opaganib, this second major partnership validates management's strategy of leveraging their pipeline through strategic alliances while maintaining core assets.

The primary risks include potential regulatory delays, manufacturing challenges, and the competitive landscape evolution. However, the positive MHRA feedback and successful Phase 2/3 studies substantially mitigate regulatory risk, making this an unusually de-risked opportunity for a company of RedHill's size.

- Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda^®) across all indications and territories outside the United States, Canada and Mexico

- Recent positive UK MHRA advice provided a clear pathway for a UK Marketing Authorization Application (MAA). If approved, RHB-102 could be the first oral 24-hour extended-release ondansetron for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV)

- RedHill intends to continue development of RHB-102 for FDA approval in the U.S., if granted. Hyloris will be responsible for all development, regulatory and commercialization activities related to RHB-102 in its territories 

- The global antiemetics drugs market size was valued at approximately $7.5 billion in 2023 and is expected to grow at a CAGR of approximately 6% from 2024 to 2030 

- Positive results from the successful U.S. Phase 2 IBS-D study (RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24 mg) were published in The American Journal of Gastroenterology and JAMA Network Open, respectively

TEL AVIV, Israel and RALEIGH, N.C., Feb. 25, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America (the "Agreement"), with Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) ("Hyloris") for RedHill's RHB-102 (Bekinda^®).

Under the terms of the Agreement, Hyloris will pay RedHill an upfront payment, in addition to up to $60 million in potential milestone payments, contingent upon achieving specified commercial targets, plus up to mid-20s percent royalties on revenues, subject to certain cost recoupments, with minimum annual payments to RedHill, in return for exclusive rights to RHB-102 across all indications and territories outside the United States, Canada and Mexico. RedHill intends to continue development of RHB-102 for FDA approval in the U.S., if granted. Hyloris will be responsible for all development, regulatory and commercialization activities related to RHB-102 in its territories.

RHB-102 is a once-daily, proprietary, bimodal extended-release oral tablet formulation of ondansetron, a 5-HT3 antagonist in advanced development for oncology support, acute gastroenteritis and gastritis^[1], and diarrhea-predominant irritable bowel syndrome (IBS-D) at two dose strengths: 12mg and 24mg.

"Ondansetron ER will be a valuable addition to supportive care in oncology and post-surgical settings, where sustained relief from nausea is essential," said Thomas Jacobsen, Co-Chief Executive Officer of Hyloris. "We are committed to delivering innovative solutions that enhance patient comfort and streamline therapy, especially in areas where reducing treatment burden can make a meaningful impact. We look forward to collaborating with RedHill to bring this product to patients."

"Our new partners at Hyloris share our vision of RHB-102's significant potential, and we look forward to working with them to bring RHB-102 to patients worldwide," said Dror Ben-Asher, CEO of RedHill. "This agreement follows the recent initiation of the Bayer-funded Phase 2 study of opaganib and darolutamide in advanced prostate cancer and is further demonstration of the potential of RedHill's R&D pipeline. If approved, RHB-102 will provide the opportunity to deliver 24-hour relief from nausea and vomiting in a single pill for outpatient use by cancer patients undergoing chemotherapy or radiotherapy, and those with acute gastroenteritis, gastritis or IBS-D."

Recent positive advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) provided a clear pathway for a UK Marketing Authorization Application (MAA) for RHB-102 (24 mg) for oncology support (CINV and RINV) in the UK, and potentially in other countries, subject to completion of certain manufacturing activities. If approved, RHB-102 could be the first oral 24-hour extended-release ondansetron antiemetic drug for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV).

The global antiemetics drugs market size was valued at approximately $7.5 billion in 2023 and is expected to grow at a CAGR of approximately 6% from 2024 to 2030^[2].

RedHill have successfully completed a U.S. Phase 3 study with RHB-102 for acute gastroenteritis & gastritis (24 mg) and a U.S. Phase 2 study for IBS-D (12 mg), both meeting their primary endpoints. There is also additional potential for use in post-operative nausea and vomiting (PONV).

About RHB-102 (Bekinda^®):

RHB-102 is a proprietary, once-daily, bimodal extended-release, oral tablet formulation of ondansetron, a 5-HT3 antagonist, targeting oncology support, acute gastroenteritis and gastritis, and IBS-D at two dose strengths: 12mg and 24mg.

Positive results from the successful U.S. Phase 2 IBS-D study (RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24 mg) were published in The American Journal of Gastroenterology^[3] and JAMA Network Open^[4], respectively.

About Hyloris Pharmaceuticals SA

Hyloris (EBR: HYL) is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com or LinkedIn.

About RedHill Biopharma 

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia^®, for the treatment of Helicobacter pylori (H. pylori) infection in adults^[5]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential arrangement and relationship with Hyloris. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company will not benefit from the agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com 

Category: Corporate

 

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^[1] Acute gastroenteritis and gastritis are characterized by inflammation of the mucus membranes of the gastrointestinal tract, most commonly caused by viral infection, with symptoms including nausea, vomiting, diarrhea and abdominal pain.
^[2] Antiemetics Drugs Market Size & Share Analysis Report 2030, Grandview research.
^[3] Plasse TF, Barton G, Davidson E, et al. Bimodal release ondansetron improves stool consistency and symptomatology in diarrhea-predominant irritable bowel syndrome: A randomized, double-blind trial. Am J Gastroenterol 2020;115:1466-73.
^[4] Silverman RA, House SL, Meltzer AC, et al. Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial. JAMA Netw Open. 2019;2(11):e1914988. doi:10.1001/jamanetworkopen.2019.14988
^[5] Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

 

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SOURCE RedHill Biopharma Ltd.

FAQ

What is the value of RedHill's licensing deal with Hyloris for RHB-102?

RedHill (RDHL) will receive an upfront payment plus up to $60 million in potential milestone payments and up to mid-20s percent royalties on revenues from Hyloris for the rights to RHB-102 outside North America.

What indications is RedHill's RHB-102 (RDHL) being developed for?

RHB-102 is being developed for oncology support (CINV/RINV), acute gastroenteritis and gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D) at two dose strengths: 12mg and 24mg.

What is the market size for antiemetics drugs that RedHill's RHB-102 (RDHL) is targeting?

The global antiemetics drugs market was valued at approximately $7.5 billion in 2023 and is expected to grow at a CAGR of approximately 6% from 2024 to 2030.

What clinical studies has RedHill (RDHL) completed for RHB-102?

RedHill has successfully completed a U.S. Phase 3 study with RHB-102 for acute gastroenteritis & gastritis (24 mg) and a U.S. Phase 2 study for IBS-D (12 mg), both meeting their primary endpoints.

What regulatory progress has RedHill's RHB-102 (RDHL) made in the UK?

RedHill received positive advice from the UK's MHRA providing a clear pathway for a Marketing Authorization Application for RHB-102 (24 mg) for oncology support, subject to completion of certain manufacturing activities.