Can-Fite BioPharma Ltd. (TASE:CFBI) has applied to the US Food and Drug Administration (FDA) for orphan drug status for its anti-inflammatory drug CF101 for the treatment of uveitis, an eye disease that can cause blindness.
Can-Fite estimate the uveitis treatment market at $500 million a year. The FDA grants orphan drug status for treatments targeting diseases that affect fewer than 200,000 people a year in order to encourage development of treatment. FDA orphan drug 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. The European Medicines Agency (EMEA) also grants orphan drug status for the EU.
Can-Fite's ophthalmology activity is based on one molecule - CF101 - which is undergoing three clinical trials: a Phase III trial for dry-eye syndrome, a Phase II trial for glaucoma, and it is about to begin a Phase II trial for uveitis. CF101 is also undergoing trials for psoriasis and rheumatoid arthritis. The company is spinning off its ophthalmology business through a reverse merger with US stock market shell Denali Concrete Management Inc. (Bulletin Board: DCMG).
Can-Fite's share price rose 5.5% by early afternoon to NIS 0.59, giving a market cap of NIS 152 million.
Published by Globes [online], Israel business news - www.globes-online.com - on June 29, 2011
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