US-based pharmaceutical company Radient Pharmaceuticals Corporation (RPC) (NYSE Amex/exchange>: 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.
According to Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals Corporation, "We are extremely pleased with the KFDA approval. This is a significant milestone that greatly advances product awareness, adoption and potential sales in Korea. This is a strategic market where cancer incidents are rising by 3.6 percent annually and our Onko-Sure cancer test is in strong market demand. Our plan is to aggressively pursue this, and other, strategic markets where we have the potential of realizing strong product sales that enable us to reach profitability in the most efficient manner possible."
Onko-Sure is a simple, non-invasive, patent-pending and regulatory-approved cancer test. For tested patients, Onko-Sure measures the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP) -- products that are often underestimated by other tests. In Korea, cancer has been the most common cause of death since 1983 and is a major public health concern. In 2007, 325,683 new cancer cases and 68,912 cancer deaths occurred in Korea. The incidence rate for all cancer combined increased by 3.6% annually from 1999 to 2007. Significant increases have occurred in the incidence of colorectal, thyroid, female breast, and prostate cancers. The number of cancer deaths has increased over the past two decades, due mostly to population aging, while the age-standardized mortality rates have decreased in both men and women since 2002.
Radient Pharmaceuticals Corporation