Speciality biopharmaceutical company RedHill Biopharma has announced a global licensing deal with Hyloris Pharmaceuticals for its RHB-102 (Bekinda) asset, excluding North America.
The agreement covers the development and commercialisation rights for RHB-102.
The asset is a once-daily, proprietary, bimodal extended-release oral tablet of ondansetron, a 5-HT3 antagonist. It is in advanced development for oncology support, acute gastroenteritis, gastritis, and diarrhoea-predominant irritable bowel syndrome (IBS-D).
Under the agreement, Belgium-based Hyloris will pay RedHill an upfront fee and up to $60m in potential milestone payments contingent on specific commercial targets.
Hyloris will also pay royalties of up to the mid-20s percent on revenue, with minimum annual payments to the biopharmaceutical company.
In exchange, Hyloris gains exclusive rights to RHB-102 across all indications outside of the US, Canada, and Mexico.
Nasdaq-listed RedHill will continue developing RHB-102 for US Food and Drug Administration (FDA) approval.
The Belgian pharmaceutical company will handle all developmental, regulatory, and commercialisation efforts in its territories.
Hyloris co-CEO Thomas Jacobsen said: “Ondansetron ER will be a valuable addition to supportive care in oncology and post-surgical settings, where sustained relief from nausea is essential.
“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.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently provided positive advice, outlining a clear approval pathway for RHB-102 as an oncology support therapy.
RedHill has successfully completed a Phase 3 trial in the US for RHB-102 for acute gastroenteritis and gastritis and a Phase 2 trial for IBS-D, both of which met their primary endpoints.
The investigational therapy has also shown potential for use in post-operative nausea and vomiting (PONV).
RedHill CEO Dror Ben-Asher said: “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.”
In August 2024, RedHill Biopharma launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the UAE.
The biopharmaceutical firm’s late-stage development pipeline includes the cancer drug opaganib, RHB-107 (upamostat) for COVID-19, RHB-104 for Crohn’s disease, and RHB-204 for nontuberculous mycobacteria (NTM) pulmonary disease.
