RedHill Biopharma has signed an exclusive licensing agreement with Hyloris Pharmaceuticals for the global development and commercialisation of RHB-102 (Bekinda), excluding North America.
RedHill will obtain an upfront payment from Hyloris and may receive up to $60m in milestone payments, plus royalties on revenues for exclusive rights to RHB-102 outside Canada, Mexico and the US.
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RedHill plans to progress the drug’s development for approval from the US Food and Drug Administration.
Hyloris will be accountable for overseeing all aspects of development, regulatory processes and commercialisation efforts associated with the drug within its designated territories.
RedHill Biopharma CEO Dror Ben-Asher stated: “This agreement follows the recent initiation of the Bayer-funded Phase II study of opaganib and darolutamide in advanced prostate cancer and is a further demonstration of the potential of RedHill’s research and development 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 diarrhoea-predominant irritable bowel syndrome (IBS-D).”
The one-time-a-day bimodal extended-release oral tablet formulation of ondansetron, RHB-102 comes in 12mg and 24mg dose strengths and is being developed for indications such as acute gastroenteritis and gastritis, as well as (IBS-D).
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided positive advice for the tablet, paving the way for a marketing authorisation application.
This could lead to RHB-102 being the first oral 24-hour extended-release ondansetron antiemetic drug for chemotherapy/radiotherapy-induced nausea and vomiting treatment.
A US Phase III study of the tablet was completed by the company for treating acute gastroenteritis and gastritis as well as a Phase II study for IBS-D. Both studies met the primary endpoints.
In July 2023, the company received additional funds of $1.7m from the US government to further develop opaganib as a medical countermeasure for gastrointestinal acute radiation syndrome.
