US-based pharmaceutical company Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today the Korean Food & Drug Administration (KFDA) has approved RPC's Onko-Sure™ in Vitro Diagnostic cancer test for routine clinical testing and government reimbursement throughout Korea.
The Company has been selling its Onko-Sure IVD cancer test kits in Korea through an import certification to the esoteric market since 2003. KFDA approval allows Radient Pharmaceuticals to initiate a more robust commercialization plan where RPC will provide Onko-Sure test kits for both routine clinical and esoteric cancer testing in Korea; enables Radient Pharmaceuticals to expand Onko-Sure product sales throughout Korea; and ensures patients who are administered the Onko-Sure test will receive government reimbursement.
Based upon Radient Pharmaceutical's 5-year product sales projections, the Company anticipates gross product revenues in the Korean market alone of approximately US$14.85 million with approximately US$1.02 million in Onko-Sure sales in FY2010. The Company believes expanded sales in Korea, combined with consistently growing product sales in US, Canada, Europe, Taiwan, Vietnam and India, places Radient Pharmaceuticals on a path to profitability by the second quarter FY2010.
Korea is the latest market entry for Radient Pharmaceuticals and its Onko-Sure IVD cancer test. In FY2010 the Company intends to enter an additional seven global markets with the same market and product sales profile as Korea. These markets include Latin America, Taiwan, China, Hong Kong, Asia-Pacific, Europe and Israel. For FY2010 in total, Radient Pharmaceuticals is forecasting approximately US$17 million in gross revenues for Onko-Sure product sales and various cancer testing services.