Schering-Plough and OraSure Technologies Sign Agreement for Development and Promotion of Rapid Point-of-Care Oral Hepatitis C Test
Test Will Utilize OraSure's OraQuick(R) Technology Platform
KENILWORTH, N.J. and BETHLEHEM, Pa., Jan. 4 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) and OraSure Technologies, Inc. (Nasdaq: OSUR) today announced an agreement to collaborate on the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus (HCV) utilizing OraSure Technologies' OraQuick(R) technology platform.
The agreement brings together OraSure - the leader in oral fluid diagnostics and developer and manufacturer of the OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test, the first and only U.S. Food and Drug Administration (FDA) approved rapid oral fluid HIV-1/2 Test, and Schering-Plough Corporation, a worldwide leader in the discovery and development of novel HCV therapies.
"As a long-term innovator and leader in the hepatitis therapy area, Schering-Plough is the ideal partner to help us introduce our rapid, point-of- care oral HCV test to the U.S. physicians' office market once our product receives FDA approval. We believe a rapid oral fluid HCV test has significant commercial and medical value in that it will help identify more individuals who are infected, thus enabling them to receive appropriate treatment. We look forward to a long and successful collaboration with Schering-Plough on this important product," said Douglas A. Michels, President and CEO of OraSure Technologies.
Under terms of the agreement, Schering-Plough will reimburse OraSure for a portion of the costs incurred by OraSure to develop the rapid oral HCV test and also will provide certain promotional support in the physicians' office market in the United States. All sales of the HCV test will be made by OraSure, and OraSure will retain the rights to market and sell the test in all markets throughout the United States. The tests sold to U.S. physicians' offices will be co-branded and will incorporate OraSure's OraQuick(R) tradename and Be In Charge(R), the name of Schering-Plough's free patient support program that provides access to in-depth, easy-to-understand educational information about chronic hepatitis C and its treatment. The agreement has an initial term of two years from the date that the test is first sold commercially.
Hepatitis C is the most common blood-borne infection in America, affecting approximately four million people or about one in every 50 adults, according to the Centers for Disease Control and Prevention (CDC). Because the prevalence of HCV infection is threefold higher among persons now between the ages of 30 and 49, the number of deaths resulting from HCV-related liver disease could increase substantially during the next 10 to 20 years due to progression of liver disease as the infected population ages. Chronic hepatitis C can cause cirrhosis, liver failure and liver cancer. About half of all cases of primary liver cancer in the developed world are caused by hepatitis C, and hepatitis C related liver disease is now the leading cause for liver transplants. Most people who develop chronic hepatitis C infection are not aware that they have the disease.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
In addition, OraSure sells products for the cryosurgical removal of common and plantar warts in the over-the-counter or retail market in the United States, Canada, certain European countries, Australia and New Zealand, and a product for the cryosurgical removal of common and plantar warts and several other benign skin lesions to the professional or physician office market in the United States and many foreign countries. For more information on the Company, please go to http://www.orasure.com.
OraSure Technologies Forward-Looking Statement
This press release contains certain forward-looking statements, including with respect to product development and commercialization. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for our products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other new products or technology; changes in market acceptance based on product performance; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties; ability to obtain, and timing and cost of obtaining, necessary regulatory approval for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to product liability, patent infringement, and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to complete consolidation or restructuring activities; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission ("SEC") filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2005, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward- looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
Schering-Plough Forward-Looking Statement
The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's strategy and the potential chronic hepatitis C market. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.
SOURCE Schering-Plough Corporation; OraSure Technologies, Inc.
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