Here is the announcement. Looks like their decision to put...

Here is the announcement. Looks like their decision to put mesothelioma on hold to go after renal cell carcenoma has paid off in spades.Notice at the end of the announcement they have left the door open to add other applications. Melanoma?Mesothelioma?NSCLC?
"Summary
Coramsine® receives Orphan Drug Designation for the treatment of metastatic Renal
Cell Carcinoma from the United States Food and Drug Administration
Perth, Australia. 11 November 2005: 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® 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. 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® is an important step forward in
Solbec’s mission to expedite the clinical development program of Coramsine®.” 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."