RedHill Biopharma secures $60m licensing agreement with Hyloris for global commercialization of RHB-102

RedHill Biopharma Ltd. has entered into an exclusive licensing agreement with Hyloris Pharmaceuticals SA, granting the Belgian company the rights to develop and commercialize RHB-102 worldwide, excluding North America. As part of the deal, RedHill will receive an upfront payment along with potential milestone payments of up to $60 million, in addition to mid-20s percent royalties on sales revenue.

Hyloris Pharmaceuticals, a specialty pharmaceutical company focused on reformulating and optimizing existing medications, will take responsibility for securing regulatory approvals, conducting clinical development, and overseeing the commercial launch of RHB-102 in all licensed territories. RedHill, meanwhile, will retain FDA approval rights for the U.S. market, where it plans to continue its efforts to gain regulatory clearance.

This agreement follows recent guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which outlined a potential pathway for a Marketing Authorization Application (MAA). If approved, RHB-102 could become the first oral 24-hour extended-release ondansetron for chemotherapy- and radiotherapy-induced nausea and vomiting (CINV/RINV), addressing a significant need in oncology supportive care.

What Is RHB-102 and Why Is It Important?

RHB-102, marketed under the name Bekinda, is a once-daily, bimodal extended-release oral tablet that contains ondansetron, a widely used 5-HT3 antagonist for preventing nausea and vomiting. The drug is designed to provide sustained relief for patients undergoing oncology treatments, as well as those suffering from acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D).

The medication is available in two dose strengths—12mg and 24mg—allowing for extended-release nausea relief with a single daily dose. This long-acting formulation reduces the need for multiple doses throughout the day, making it particularly beneficial for cancer patients undergoing chemotherapy or radiotherapy. By offering prolonged symptom control, RHB-102 could improve patient comfort and adherence to treatment regimens.

Clinical trials have demonstrated the drug’s strong potential across multiple indications. A U.S. Phase 2 study of the 12 mg dose for IBS-D, published in The American Journal of Gastroenterology, showed promising results in treating diarrhea-predominant irritable bowel syndrome. Additionally, a Phase 3 GUARD study evaluating the 24 mg dose for acute gastroenteritis and gastritis, published in JAMA Network Open, confirmed its efficacy in reducing nausea and vomiting.

Why Did Hyloris Pursue the Licensing Agreement With RedHill Biopharma?

Hyloris Pharmaceuticals has established itself as a company focused on redefining and optimizing existing medications to improve patient outcomes. Acquiring the commercialization rights for RHB-102 aligns with its strategy of developing high-value treatments with strong market potential. The company’s expertise in reformulation and innovative drug delivery solutions positions it well to drive the global rollout of the drug.

Thomas Jacobsen, Co-CEO of Hyloris Pharmaceuticals, emphasized the significance of ondansetron extended-release in oncology supportive care. He noted that the ability to provide sustained relief from chemotherapy-related nausea could make a meaningful difference for patients, particularly those undergoing intensive cancer treatment. He highlighted Hyloris’ commitment to enhancing patient comfort and streamlining therapy through innovative pharmaceutical solutions.

Dror Ben-Asher, CEO of RedHill Biopharma, stated that the agreement with Hyloris reflects the significant potential of RHB-102. He pointed to the company’s broader drug development pipeline, including a Bayer-funded Phase 2 study investigating the combination of opaganib and darolutamide for advanced prostate cancer. He emphasized that this licensing deal further strengthens RedHill’s position in the specialty pharmaceutical market by allowing the company to focus its efforts on securing FDA approval rights in the U.S.

What Are the Regulatory Prospects for RHB-102?

The MHRA approval pathway has provided a clear framework for RedHill Biopharma to pursue a Marketing Authorization Application (MAA) for RHB-102 in oncology supportive care in the UK. If granted, the approval could serve as a stepping stone for additional regulatory submissions in other international markets.

While Hyloris will handle regulatory and commercial activities for RHB-102 in its designated territories, RedHill will continue working toward securing FDA approval rights for the U.S. market. If successful, this could pave the way for the drug’s introduction in North America, expanding access to extended-release nausea relief for patients in need.

How Does RHB-102 Fit Into the Expanding Antiemetics Market?

The global antiemetics drug market was valued at approximately $7.5 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6% from 2024 to 2030. With increasing demand for oncology supportive care and improved nausea management, RHB-102 could become a key player in the antiemetics market.

Beyond its primary applications for CINV and RINV treatment, RHB-102 has also shown potential for post-operative nausea and vomiting (PONV), further expanding its therapeutic reach. Its once-daily, extended-release formulation could offer a competitive advantage over existing antiemetic therapies that require multiple doses per day.

What Are the Next Steps for RedHill and Hyloris Pharmaceuticals?

With the licensing agreement now in effect, Hyloris Pharmaceuticals will focus on obtaining regulatory approvals across its licensed territories, starting with the UK. Manufacturing activities are already underway to align with MHRA requirements, and additional regulatory submissions are expected in other markets.

RedHill Biopharma, on the other hand, remains focused on securing FDA approval rights for RHB-102 in the U.S. If approved, the drug could be positioned as a leading option for extended-release nausea relief in North America. The company continues to invest in its late-stage clinical development programs, reinforcing its commitment to bringing innovative treatments to market.

The collaboration between RedHill Biopharma and Hyloris Pharmaceuticals represents a strategic step forward in advancing RHB-102 commercialization. As both companies work to navigate the regulatory process, their shared goal remains the same: to ensure that patients worldwide have access to a next-generation antiemetic that enhances oncology supportive care and improves overall quality of life.