RedHill Licenses RHB-102 Globally to Hyloris Pharma for Up to $60M

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that it has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America (the ""Agreement""), with Hyloris Pharmaceuticals SA 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 US, 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, and diarrhoea-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.

RedHill have successfully completed a US phase 3 study with RHB-102 for acute gastroenteritis & gastritis (24 mg) and a US 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).

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 US 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.

Hyloris 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.

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on US development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology.

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