RedHill Biopharma Ltd. (TASE: RDHL) has obtained permission from Health Canada to begin a bioequivalence clinical trial (corresponding to a Phase III clinical trial) for the company's RHB-102 controlled-release drug for the prevention of nausea and vomiting in cancer patients undergoing chemotherapy. RedHill licensed the drug from SCOLR Pharma Inc. (Amex: DDD) in May 2010.
RedHill submitted the application to Canada Health, partly on the basis of an expert opinion that this would expedite its New Drug Application with the US Food and Drug Administration (FDA), assuming positive results from the Canadian trial.
RedHill has an agreement with Canada's Algorithme Pharma Inc. to conduct the clinical trial. The trial will test the pharmacological equivalence of RHB-102 to Zofran, made by GlaxoSmithKline plc (NYSE; LSE: GSK), the leading treatment for nausea in cancer patients. The trial will begin during the current quarter, and should take several months.
RHB-102 uses patented technology for a once-daily controlled release of the active pharmaceutical ingredient Ondansetron, one of a family of inhibitors which blocks the 5-HT3 receptor in the enteric nervous system, thereby reducing nausea, vomiting, colonic contractions, etc.
RedHill estimates the market for Ondansetron drugs at $1 billion a year.
RedHill's share price rose 0.3% by early afternoon to NIS 2.21, giving a market cap of NIS 115 million.
Published by Globes [online], Israel business news - www.globes-online.com - on February 5, 2012
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