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- 01/23/2018

U.S. Orphan Drug Designation for Benitec Biopharma Limited

Pharma Horizon

Benitec Biopharma Limited announced that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to BB-301 for the treatment of oculopharyngeal muscular dystrophy (OPMD).  Please find today’s full press release attached for your reference.

The Orphan Drug Designation granted to Benitec may provide a range of valuable benefits, including fast track process for clinical regulatory approval, potential extension of patent life with a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees. In short, a clear and expeditious path for cost-efficient development and commercialisation. The granting of orphan status from the FDA in the US follows on from receiving orphan designation from the European Medicines Agency in early 2017.


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