RedHill Biopharma Ltd. (TASE: RDHL) today announced success in the pivotal bioequivalence clinical trial of RHB-102 for the prevention of nausea in cancer patients. The trial met the US Food and Drug Administration (FDA) endpoints comparing the once-a-day controlled release of RHB-102 with Zofran, made by GlaxoSmithKline plc (NYSE; LSE: GSK), the leading treatment for the prevention of nausea in cancer patients, which is taken several times a day.
The trial corresponds to a Phase III clinical trial. The trial, the third clinical trial for RHB-102, was conducted in Montreal, and completes the clinical development of the drug. The trial is for an FDA Investigational New Drug (IND) application and a Health Canada Clinical Trial Application (CTA).
On the basis of the successful trial, Redhill plans to apply to the FDA within a few weeks for a pre-New Drug Application (NDA) hearing for marketing approval for RHB-102.
The estimated global market for nausea prevention in cancer patients was estimated at over $2 billion in 2010.
Redhill's share price rose 27.3% by early afternoon to NIS 2.75, giving a market cap of NIS 140 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 17, 2012
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