RedHill Biopharma's Chief Business Officer, Guy Goldberg, presented a comprehensive business update at the Sachs Associates' 18th Annual European Life Sciences CEO Forum in Zurich, highlighting significant progress across multiple fronts during early 2025.
Strategic Partnerships Bolster Pipeline Development
The company recently finalized an out-licensing agreement with Hyloris for RHB-102, potentially worth up to $60 million in milestone payments plus additional royalties on revenues. This deal represents a significant financial opportunity for RedHill while advancing the development of this investigational drug.
In another major development, RedHill has initiated a Bayer-funded Phase 2 clinical study evaluating opaganib in combination with Bayer's darolutamide for advanced prostate cancer. This collaboration targets patients with limited treatment options and demonstrates growing industry confidence in RedHill's pipeline.
"We have had a very positive start to 2025, making significant progress on multiple fronts," said Goldberg during his presentation. "This is in addition to the multiple U.S. government- and academia-supported R&D programs with key 2025 potential catalysts, including for radiation injury protection, oncology, and various pandemic preparedness indications."
Talicia® Commercial Success Continues to Build
RedHill's flagship product Talicia®, for the treatment of Helicobacter pylori infection, has achieved several important commercial milestones. The therapy has surpassed 100,000 prescriptions and maintains its position as the number one branded H. pylori therapy prescribed by gastroenterologists.
The company secured a significant win with Humana®'s Part D Plan coverage, adding access for more than eight million additional Medicare lives without requiring prior therapeutic steps or authorization. This expanded coverage is expected to drive further prescription growth.
Talicia® also received recognition from the medical community with its inclusion as a first-line treatment option in the American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection.
Operational Improvements and Global Expansion
RedHill is actively working to enhance Talicia®'s profitability through cost reduction initiatives. "Subject to the successful completion of our ongoing discussions, we expect to substantially reduce Talicia's COGS, directly boosting the bottom line," Goldberg noted.
The company has also improved patient convenience with FDA approval for a three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supported by new data published in the Journal of Clinical Pharmacology.
International expansion is underway with the recent commercial launch in the United Arab Emirates and evaluation of additional marketing authorization applications in other countries.
Diverse R&D Pipeline with Government Support
RedHill's R&D pipeline includes several promising late-stage development programs with significant government and academic support:
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Opaganib (ABC294640): A first-in-class, orally administered sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory, and antiviral activity. Development programs include GI-Acute Radiation Syndrome (GI-ARS), COVID-19, and prostate cancer.
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RHB-107 (upamostat): An oral broad-acting, host-directed, serine protease inhibitor in late-stage development for non-hospitalized symptomatic COVID-19 and other inflammatory gastrointestinal diseases.
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RHB-204: A Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
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RHB-104: Showed positive results from a first Phase 3 study for Crohn's disease.
The company's innovative warranty program for Talicia® has seen minimal claimed refunds, reflecting positive patient experiences and treatment efficacy.
"With new potential markets on the horizon, we are optimistic about the future for Talicia and the value it can deliver," concluded Goldberg.
RedHill Biopharma (NASDAQ: RDHL) continues to focus on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology, with a strategic approach balancing commercial growth and pipeline advancement.
