Solbec earns orphan drug status for carcinoma treatment

Solbec Pharmaceuticals (ASX:SBP) has received orphan drug designation from the US Food and Drug Administration for its lead anti-cancer compound Coramsine for the treatment of metastatic renal cell carcinoma (mRCC).

"It is a big step for the company to get the acknowledgement that the FDA believes the product has the potential in treating metastatic renal cell carcinoma," said Solbec's CEO and managing director Stephen Carter. "Orphan drug designation has the potential to markedly reduce Coramsine's drug registration timeframe and ultimately time to market."

Orphan drug status is granted to treatment aimed at serious or life-threatening diseases. Under the orphan drug status, Solbec has a seven-year period of market exclusivity. Other benefits include a reduction in clinical data required for product registration, tax incentives and reduced filing fees.

"Metastatic renal cell carcinoma is a late stage kidney cancer -- grade 3 and 4," Carter said. "After stage two the prognosis is very poor with a survival rate of approximately 10 per cent. There are currently no effect chemotherapy agents available."

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.

At the end of October Solbec selected malignant melanoma and mRCC as the first two tumour types for multiple target activity phase II trials of its lead compound Coramsine in the treatment of advanced tumours. Solbec anticipates the first patients will be enrolled late Q2 of 2006. These proposed trials will generate additional clinical activity data on Coramsine to enable selection of priority tumour targets for subsequent phase III drug registration trials.

CEO hunt

Carter is due to step down as Solbec's CEO on December 31. The company is looking for his replacement.