Business Update from RedHill Biopharma: Recent Developments and Future Prospects
Guy Goldberg, the Chief Business Officer of RedHill Biopharma, recently presented an update at the European Life Sciences CEO Forum, shedding light on the company’s recent achievements and upcoming milestones. In this blog post, we will delve deeper into the key aspects of his presentation.
Out-licensing of RHB-102 to Hyloris: A Potential $60 Million Deal
RedHill Biopharma announced the out-licensing of RHB-102, its proprietary oral formulation of rifaximin, to Hyloris Pharmaceuticals (Euronext Brussels: HYL) for the treatment of travelers’ diarrhea. The deal includes an upfront payment of $10 million and potential milestone payments of up to $50 million, bringing the total potential value to $60 million. With this transaction, Hyloris gains exclusive rights to commercialize RHB-102 in Europe, South America, and other select countries.
Initiation of Phase 2 Study of Opaganib in Combination with Darolutamide
RedHill Biopharma also announced the initiation of a Phase 2 clinical study of opaganib in combination with Bayer’s (ETR: BAYN) darolutamide for the treatment of advanced prostate cancer. This study follows positive results from a Phase 1b trial, which demonstrated the safety and tolerability of the combination. The trial is being conducted under a collaboration agreement between RedHill Biopharma and Bayer.
U.S. Government-Supported Pipeline Programs and Expected 2025 Catalysts
Goldberg discussed the status of RedHill Biopharma’s pipeline programs supported by the U.S. government. These include RHB-104 for the treatment of Helicobacter pylori (H. pylori) infection and RHB-204 for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company anticipates significant catalysts for these programs in 2025.
Commercial Progress with Talicia® and Marketing Authorization Applications
RedHill Biopharma reported significant commercial progress with Talicia® (rifaximin) for the treatment of H. pylori infection. The company is currently evaluating marketing authorization applications in new markets, including the European Union, Israel, and additional countries in Asia and South America. This expansion is expected to increase the potential market size for Talicia® significantly.
Discussions on Cost of Goods Reduction
Goldberg mentioned ongoing discussions with suppliers to achieve significant cost reductions for the production of RedHill Biopharma’s products. These efforts are aimed at improving the company’s profitability and competitiveness in the market.
First-line Option for H. pylori Infection in American College of Gastroenterology Clinical Guideline
The American College of Gastroenterology (ACG) has included Talicia® as a first-line option for the treatment of H. pylori infection in its latest clinical guideline. This recommendation is expected to increase market demand for the product and further solidify its position as the leading brand prescribed by gastroenterologists.
Humana’s Part D Plan Coverage and Access to More Than Eight Million Additional Medicare Lives
RedHill Biopharma announced that Humana’s Part D Plan now covers Talicia® without prior therapeutic steps or authorization. This change grants access to more than eight million additional Medicare lives, expanding the potential customer base for the product.
Surpassed 100,000 Prescriptions Milestone
The company reported that it has surpassed the 100,000 prescriptions milestone for Talicia®, maintaining its position as the #1 brand prescribed by gastroenterologists.
Ground-breaking Warranty Program and New Data on Three-Times Daily Dosing
RedHill Biopharma launched a ground-breaking warranty program for Talicia®, which offers a full refund to patients who do not achieve a successful eradication of H. pylori infection. The company also published new data in the Journal of Clinical Pharmacology, supporting the prior FDA sNDA approval for the three-times daily (TID) dosing routine of Talicia®.
Out-license, Approval, and Launch in the United Arab Emirates
Goldberg announced that Talicia® has been out-licensed, approved, and launched in the United Arab Emirates, further expanding the product’s global reach.
Implications for Individuals and the World
The recent developments at RedHill Biopharma have significant implications for individuals and the world. For individuals, the approval and availability of Talicia® as a first-line option for H. pylori infection treatment and the ground-breaking warranty program offer improved access to effective treatment and financial protection. The potential $60 million deal with Hyloris and the initiation of the Phase 2 clinical study with Bayer further demonstrate RedHill Biopharma’s commitment to innovation and advancing patient care. For the world, these developments contribute to the ongoing advancement of healthcare and the pharmaceutical industry, increasing the availability of effective treatments and improving patient outcomes.
Conclusion
In conclusion, RedHill Biopharma’s recent business update at the European Life Sciences CEO Forum highlighted significant achievements and upcoming milestones. From the out-licensing of RHB-102 to Hyloris to the initiation of the Phase 2 clinical study of opaganib in combination with darolutamide, these developments underscore RedHill Biopharma’s commitment to innovation and advancing patient care. The implications of these achievements for individuals and the world are profound, paving the way for improved access to effective treatments, financial protection, and overall advancements in healthcare and the pharmaceutical industry.
