Bioequivalence achieved between RHB-102 and Zofran
RedHill Biopharma has disclosed positive results in an advanced bioequivalence trial with RHB-102 for the prevention of nausea and vomiting in cancer patients. RedHill intends to approach the FDA in the coming weeks to request a pre-NDA meeting to discuss US marketing approval pathway.
The draft final report summarising the objectives and results of the trial demonstrates that the trial met its objectives and FDA's criteria for bioequivalence between RedHill's once-daily RHB-102, and GlaxoSmithKline's Zofran, an approved antiemetic drug administered three times per day. The trial, conducted in Montreal, Canada, was the third study in the RHB-102 development programme. Prior to the trial, RedHill obtained both an IND approval from the FDA and a trial application approval from Health Canada.
RHB-102, which combines Scolr Pharma's patent-protected, once-daily, controlled-release technology named CDT, with the active pharmaceutical ingredient ondansetron, belonging to a group of inhibitors of the serotonin receptor 5-HT3, is designed to prevent nausea and vomiting over 24 hours in order to avoid the need for additional drug administrations during the 24 hours post-treatment. The time window is significantly longer than the effective time of the oral drugs currently available on the market. As a result, RHB-102 potentially holds a promise for cancer patients who are undergoing radiotherapy and suffer considerable difficulty in eating and swallowing.
RHB-102 is targeting a significant segment in the oncology treatment support market. The global market for treatment of nausea and vomiting was estimated at over US$2 billion in 2010, of which the market share of serotonin receptor 5-HT3 drugs was estimated at approximately US$1 billion. Zofran - the reference drug in the clinical trial - is a leading drug in the family of inhibitors of the serotonin receptor 5-HT3, which together with its generic derivatives has global sales of approximately US$400 million.
In May 2010, Scolr granted RedHill the worldwide rights to market and sell ondansetron tablet formulations based on its CDT technology. Under the terms of the agreement, RedHill agreed to make upfront and additional payments to Scolr of up to US$600,000, based on the achievement of certain regulatory milestones and the first commercial sale of the product. Thereafter, RedHill will make payments to the company of up to a maximum of US$30 million, based on the aggregate net sales, by RedHill, of the licensed product over a ten-year period.