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RedHill's Strategic Collaboration with Hyloris to Commercialize RHB-102 Globally

In an important development for both companies, RedHill Biopharma Ltd. has entered a licensing agreement with Hyloris Pharmaceuticals SA for the worldwide commercialization of RHB-102 (known as Bekinda®). The agreement grants Hyloris exclusive rights to develop and commercialize this innovative ondansetron formulation in territories outside North America, which includes a lucrative financial structure that offers RedHill substantial potential for growth.

Financial Terms and Implications

Under the terms of the agreement, Hyloris will provide RedHill with an upfront payment along with potential milestone payments that could total up to $60 million, depending on the achievement of specified commercial targets. Additionally, Hyloris will pay royalties based on revenues that could reach the mid-20s percent range. These financial incentives underscore the immense potential that RHB-102 holds, particularly in its targeted therapeutic areas, which promises significant returns for both companies involved.

Innovative Cancer Care

RHB-102 is a bimodal extended-release oral tablet formulation of ondansetron, placing it in a strategic position as a treatment for patients undergoing chemotherapy and radiotherapy who suffer from nausea and vomiting. As per the recent guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), a clear pathway has been established for a UK Marketing Authorization Application (MAA), positioning RHB-102 on the threshold of being the first-ever 24-hour extended-release oral ondansetron specifically aiming to treat chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV).

The prospects do not end there. RedHill is set to continue its pursuit of FDA approval for RHB-102 in the United States, underscoring its commitment to bring this innovative solution to the U.S. market as well. With Hyloris taking charge of all developmental, regulatory, and commercialization activities outside North America, RedHill can focus its resources on its core markets and strategic objectives.

Market Potential and Advancements

The global market for antiemetic drugs was estimated at approximately $7.5 billion in 2023, with predictions suggesting a robust compound annual growth rate (CAGR) of roughly 6% extending to 2030. This promising statistic serves as a backdrop for RHB-102's introduction into the market, especially as both companies leverage this agreement to make impactful strides in patient care.

RedHill has recently completed successful Phase 2 and Phase 3 studies in the U.S., showcasing promising outcomes for RHB-102 in the context of diarrhea-predominant irritable bowel syndrome and acute gastroenteritis treatment. Positive findings from these trials were published in reputable medical journals including The American Journal of Gastroenterology and JAMA Network Open, providing further validation to the efficacy and safety of RHB-102.

Vision for the Future

Thomas Jacobsen, Co-CEO of Hyloris, expressed excitement about the partnership: "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."

Meanwhile, Dror Ben-Asher, CEO of RedHill, noted, "Our new partners at Hyloris share our vision of RHB-102's significant potential, and we look forward to working closely with them to bring this product to patients on a global scale."

The collaboration between RedHill and Hyloris is set to revolutionize patient care in the oncology sector and beyond, with expectations that RHB-102 will greatly improve the quality of life for patients facing nausea and vomiting as a result of their treatments. As both companies navigate this promising agreement, they are poised to make meaningful advancements in the pharmaceutical industry, ultimately benefiting countless patients worldwide.