RedHill Licenses RHB-102 Worldwide Excluding North America To Hyloris For Up To $60M In Potential Milestone Payments Plus Royalties

One of the reasons up to 9% of cancer patients refuse treatment is the fear of side effects. Chemotherapy and radiotherapy, common treatments for cancer, often cause nausea and vomiting that can last from 24 hours to several days. These side effects lower quality of life and the dread of experiencing severe nausea and vomiting during the next round of chemotherapy or radiotherapy can lead to hesitation or even treatment discontinuation. There are several medicines on the market to treat nausea and vomiting, but oral ondansetron requires multiple doses throughout the day, and a once-a-day oral option, that could be taken in an outpatient capacity, could be key for patients going through chemotherapy and/or radiotherapy.

RedHill Biopharma Ltd. RDHL is partnering with Hyloris Pharmaceuticals SA (HYL.BR) in bringing its drug RHB-102 (BEKINDA®) to market. Under the terms of the deal, Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments contingent upon achieving targets. Hyloris will also pay RedHill up to mid-20s percent royalties on revenues, subject to certain cost recoupments. If approved, RedHill said RHB-102 could be the first oral 24-hour extended-release ondansetron antiemetic drug for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting. 

RHB-102 is an investigational drug in development for the management of chemotherapy- and radiotherapy-induced nausea and vomiting, otherwise known as CINV and RINV. It is a once-daily, bimodal release, oral tablet formulation of the antiemetic drug ondansetron, a 5-HT3 antagonist. It's intended to provide adults with relief from nausea and vomiting symptoms for a 24-hour period with a single oral tablet. 

Already at an advanced stage of development, RHB-102 could be just a step or two away from a first approval, with recent positive UK Medicines and Healthcare products Regulatory Agency (MHRA) advice providing a clear pathway for a UK Marketing Authorisation Application (MMA) based on the existing clinical dossier. RedHill intends to continue development of RHB-102 for FDA approval in the U.S., if granted. In clinical trials, RHB-102 also showed positive results in treating acute gastroenteritis and gastritis and diarrhea-predominant Irritable Bowel Syndrome causing increased diarrhea (IBS-D), the most common form of IBS in the U.S. 

"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. "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." 

By 2040, the number of new cases of cancer is expected to rise to 26 million a year – with more than half likely to need chemotherapy and/or radiotherapy and thus may suffer from nausea and vomiting requiring treatment. The incidence of acute gastroenteritis and gastritis dwarfs these numbers with around 700 million cases globally per year, as does the number of people with IBS-D, estimated at between 5% to 10% of the population. With RHB-102, the company is aiming to improve the quality of life for tens of millions of people around the globe.

Big Opportunity

It's potentially a big opportunity for RedHill and Hyloris. In 2024 the market for drugs to fight chemo-induced nausea and vomiting was about $3.6 billion, and it is projected to surpass $5 billion by 2030 – growing at a CAGR of 5%. "There is a reason that ondansetron is on the WHO list of essential medicines – nausea and vomiting are highly debilitating and are amongst the top reasons for emergency department visits. As far as cancer treatment is concerned the fear of violent nausea and vomiting associated with chemotherapy and radiotherapy can be so bad that patients stop therapy, with potentially devastating effects," said Dr. Mark Levitt, MD, PhD, Board Certified Medical Oncologist and Chief Scientific Officer at RedHill. "There is a clear clinical and patient need for effective and convenient antiemetic therapy and the benefit of a potential once-a-day oral dosing regimen such as RHB-102 offers is significant, and may help keep patients on their life-saving chemotherapy and/or radiotherapy."

Beyond treating the side effects of chemotherapy, RedHill has made progress in the use of RHB-102 to treat gastroenteritis, gastritis and IBD-D. The company has completed a U.S. phase 3 study with RHB-102 for acute gastroenteritis and a U.S. phase 2 study for IBS-D, both of which met their primary endpoints. 

From the side effects of chemotherapy to illnesses of the gut, RedHill is trying to improve the quality of life for millions of patients with a single-dose oral treatment that lasts 24 hours. Its hard work appears to be paying off, successfully completing clinical trials, inking exclusive licensing deals, and getting closer to realizing its goal to bring relief to people with its one-a-day pill. To learn more about RedHill and RHB-102, click here. 

Feature photo by Hans Reniers on Unsplash.

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