SOURCE: Radient Pharmaceuticals Corporation

Radient Pharmaceuticals Corporation

August 26, 2010 08:59 ET

Radient Pharmaceuticals Provides Domestic and International Target Market Details for Its Onko-Sure® IVD Cancer Diagnostic Test

TUSTIN, CA--(Marketwire - August 26, 2010) - Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today target market details for the domestic and international commercialization of its Onko-Sure® in vitro diagnostic (IVD) cancer test. 

RPC received USFDA for its Onko-Sure® IVD cancer test approximately 24 months ago, which marked the point at which RPC could begin commercialization. Since that time a considerable amount of work has gone into creating a domestic & international distribution network, plus the highly effort of validating RPC's USFDA approved Onko-Sure® test kits with oncologists, gastroenterologist and lab directors. RPC has added various needed validation tools that include the first edition of RPC's 2010 Onko-Sure® Reference Guide for physicians, oncologists, clinicians, consumers and patients, ("ODR") designed to significantly gain sales traction for Onko-Sure® in North America and other international markets. The Company is also working on additional clinical trials and inclusion in industry publications to determine the standard of care for cancer diagnosis and targeting additional validation tools, which are anticipated to be in place by year-end. The Company is now in a position to begin making significant headway in commercializing Onko-Sure® in target market.

According to Mr. Douglas MacLellan, Chairman and CEO of RPC, "RPC has focused 18 months of dedicated, diligent work related to product validation, and we expect the Company will demonstrate significantly improved sales results during the second half of FY2010. Given the timing of our US FDA approval and commercialization work, we are akin to a start-up Company. That said, we expect meaningful sales to begin over the next two quarters. We understand there is tremendous market pressure and encourage the investing community to look to the long-term success of RPC, especially given the current economic environment and the very competitive and sophisticated market we are operating in."

FY2010/ FY2011 Onko-Sure® Commercialization Plan
As RPC executes its domestic and international Onko-Sure® sales plan, the Company is focusing on 4 key target markets, that include:

  • US FDA approved use and sales of Onko-Sure® as a CRC Monitoring Test in the U.S. & eventually Canada;
  • US FDA approved use and sales of Onko-Sure® as a CRC Monitoring Test in various international markets;
  • Use and sales of Onko-Sure® as a general cancer screening test (predominately outside the US, currently in Taiwan and Korea); and,
  • Health Canada approved use and sales of Onko-Sure® as a lung cancer screening and monitoring test.

Target Market Segment Details:

  • US FDA approved use as a CRC Monitoring Test Market in the US & Canada: This market represents a US$200 million per year market at the wholesale level, and is growing at a 10% annual growth rate. The competing test for Onko-Sure® is the Carcinoembryonic Antigen (CEA) -- a test that typically only identifies cancer its latest stages when the probability of treating the disease is lowest. Onko-Sure® has been clinically shown to identify cancer in its earliest stages, and these studies also indicate Onko-Sure® to be a superior test to CEA. To capitalize on this, we are implementing an aggressive commercialization strategy in the US specifically targeted towards physicians, oncologists, clinicians, consumers, patients and reference labs that show demand for the test.

  • US FDA Approved use as a CRC Monitoring Test in International Markets: This market represents a US$250 million per year market at the wholesale level, and is also growing at a 10% annual growth rate. We expect sales of Onko-Sure® in North America will create new market share in the International CRC monitoring market by FY2011.

  • Government-backed General Cancer Screening Test (predominately outside the US): Government backed general cancer screening represents a potential US$1 billion per year market that is currently in its infancy. International recognition and demand for government-backed general cancer screening has only just begun. U.S. adoption of government back general cancer screening for high risk populations is expected to be commonplace by 2015. Based on RPC market analysis, we anticipate driving solid adoption and sales of Onko-Sure® in high risk populations specifically in India and Colombia by the fourth quarter 2010, and Brazil by the second quarter of 2011. We are actively targeting other countries and expect sales to ramp as RPC's initial commercialization program in the above markets demonstrates results. Additionally, through our US-based CLIA lab partner, we have initiated product sales for Onko-Sure® that is being used as a general cancer screen in the US and Canada and we are selling Onko-Sure® as a general cancer screen in Korea and Taiwan. In order for RPC to gain up to US$1 billion in Onko-Sure sales from government-backed general cancer screening initiatives ("GCSI"), which would be focused on "patients with a high risk of developing cancer," RPC will need to sell approximately 1,488,095 kits annually.

  • Health Canada Approved use as a Lung Cancer Screening & Monitoring Test: This represents a US$50 million per year market, also currently in an infancy stage. More Canadians are diagnosed with lung cancer than any other cancer type, with mortality from lung cancer higher than breast, colorectal and prostate cancer combined. In 2010 alone, 1 in 12 Canadians are expected to develop lung cancer. Smoking causes most lung cancers. That said, approximately 50% of patients diagnosed have never smoked (15%) or are former smokers (35%). Most lung cancers are diagnosed in late stages, due in part to lack of effective screening procedures, this is a primary factor that leads us to believe Onko-Sure® will become an important and high demand test for cancer screening. Lung cancer patients and their family members are often stigmatized by a widespread prejudice about smoking, and many feel isolated and hesitant to tell others about their diagnosis. Lung cancer receives little public or media attention. This is due, in part, to a small community of survivors to bring a voice and attention to lung cancer issues. We are seeking Canadian government support for a lung cancer screening program to high risk segments of the population.

Global Cancer Statistics & Onko-Sure®
The latest World Health Organization ("WHO") statistics indicate there are approximately 7.4 million cancer deaths worldwide annually. RPC's goal is to test approximately 70 million "high risk factor" patients per year with the goal of identifying cancer in approximately 10% of this high risk factor population. According to the WHO, the annual global cost for cancer is approximately US$1 Trillion. By implementing GCSI, and catching early stage cancer, the savings with a low cost test such as Onko-Sure™ could be at least 30% or approximately US$330 billion per year, to government health agencies.

For additional information on RPC and its portfolio of cancer products visit the Company's corporate website at www.Radient-Pharma.com. For Investor Relations information contact Kristine Szarkowitz at kszarkowitz@Radient-Pharma.com or 1.206.310.5323.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is an integrated pharmaceutical company devoted to the research, development, manufacturing, and marketing of in-vitro diagnostic products.

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

References:

  • Lung Cancer Canada, lungcancercanada.ca.
  • World Health Organization (WHO) Cancer Fact Sheet No. 297, February 2009
  • "Cancer costs the world nearly $1 trillion", By Aaron Smith, CNNMoney.com staff writer, August 17, 2010.

Contact Information

  • Radient Pharma Contact:
    Kristine Szarkowitz
    Director-Investor Relations
    Email Contact
    Tel: 206.310.5323