Schering-Plough and OraSure Technologies Sign Agreement for Development and Promotion of Rapid Point-Of-Care Oral Hepatitis C Test


KENILWORTH, N.J. and BETHLEHEM, Pa. -- Schering-Plough Corporation and OraSure Technologies, Inc. announce 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, a 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 bloodborne 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.


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