SBP solbec pharmaceuticals limited

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    Solbec cancer drug given orphan status by FDA
    12:46, Friday, 11 November 2005

    Sydney - Friday - November 11: (RWE Australian Business News) -
    Solbec Pharmaceuticals Limited (ASX: SBP) today announced that it has
    received orphan drug designation from the US Food and Drug
    Administration (FDA) for its lead anti-cancer compound Coramsine for the
    treatment of metastatic renal cell carcinoma.
    Solbec's strategy is to pursue an aggressive timeline to advance
    Coramsine® to the market within 3-5 years. This will be achieved by
    targeting orphan drug indications such as metastatic renal cell
    carcinoma.
    Orphan drug status is a useful method for compressing the
    clinical development timeframe from 5-9 years down to as little as 2-3
    years. Other benefits include: market protection upon registration (7
    years against generic products), a reduction in clinical data required
    for product registration, tax incentives and reduced filing fees.
    In granting orphan drug status for Coramsine, the FDA is
    essentially acknowledging Coramsine's potential ability to improve the
    currently low survival rate of metastatic renal cell carcinoma
 
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