Perth, Nov 11, 2005 (ABN Newswire) - Solbec Pharmaceuticals Limited (ASX: SBP) today announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead anti-cancer compound Coramsine R for the treatment of metastatic renal cell carcinoma.

Solbec's strategy is to pursue an aggressive timeline to advance Coramsine R 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(R) , the FDA is essentially acknowledging Coramsine's(R) potential ability to improve the currently low survival rate of metastatic renal cell carcinoma.

Coramsine's proposed new mode of action has the potential to redefine cancer chemotherapy for advanced stage cancers such as renal cell carcinoma. "Receiving orphan drug designation for Coramsine(R) is an important step forward in Solbec's mission to expedite the clinical development program of Coramsine R ." said Stephen Carter, Solbec's Managing Director. "Orphan drug designation has the potential to markedly reduce Coramsine's drug registration timeframe and ultimately time to market."

In addition to the potential benefits of orphan drug designation, targeting renal cell carcinoma allows Solbec the opportunity to apply to the FDA for "Fast Track" review of Coramsine's clinical dossier. Once registered, Coramsine's clinical development program may then be expanded to demonstrate its efficacy in treating an extensive range of cancer types.

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