re: sbp long term trade paladin boy it will be 5 years before available
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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