Motif Bio announces iclaprim granted Orphan Drug Designation by US FDA for treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis
MOTIF BIO PLC ADRS (MTFB)
US:NASDAQ Investor Relations:
ir.motifbio.com
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Source: GlobeNewswire
NEW YORK, Sept. 15, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (Nasdaq:MTFB), a clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the US Food and Drug Administration (“FDA”) has granted its investigational drug candidate, iclaprim, Orphan Drug Designation for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis. Orphan designation grants special status to a drug or biologic under development to treat a rare disease or condition and qualifies the sponsor of the product for various development incentives, including tax credits for qualified clinical testing, waiver of user fees and potentially up to seven years of market exclusivity for the given indication, if approved. “Staphylococcus aureus, including MRSA, is one of the common causes of lung infections in patients with cystic fibrosis and we do not believe that any antibiotic has been approved for this indication. Some 80% or mor
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