The company is about to begin a Phase II/III clinical trial of the drug on people with Crohn's disease.
RedHill Biopharma Ltd. (TASE: RDHL) has obtained FDA orphan drug status for its RHB-104 drug for the treatment of childhood Crohn's disease.
The company is about to begin a Phase II/III clinical trial of the drug on people with Crohn's disease who carry the mycobacterium avium paratuberculosis (MAP) bacteria, a suspected trigger of the disease.
Orphan drug status applies to drugs for treating diseases that affect a small number of people; the FDA sets a figure of a disease that affects fewer than 200,000 persons a year. FDA orphan status grants various incentives for developing these drugs, including shortened approval procedures, tax breaks on R&D costs, and financing assistance. If the drug is the first to reach market, it also receives seven years exclusivity.
RedHill's share price rose 2.1% by midday to NIS 3.40, giving a market cap of NIS 180 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 28, 2011
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