RedHill Biopharma Ltd., a specialty biopharmaceutical company, has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America, 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 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, 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).

RedHill also completed successful U.S. Phase 3 and 2 studies for acute gastroenteritis & gastritis (24 mg) and IBS-D (12 mg), meeting primary endpoints. RHB-102 may also be used for post-operative nausea and vomiting (PONV).