Press Releases
PROCLEIX® ULTRIO® Assay Receives European CE Mark
First CE-Marked Triplex Nucleic Acid Test for Blood Screening
Chiron Expects to Roll Out Assay in European Economic Area (EEA) Early This Year
EMERYVILLE, Calif., Jan. 15, 2004
Novartis Vaccines and Diagnostics (Nasdaq: CHIR) announced today that the PROCLEIX® ULTRIO® Assay used for the simultaneous detection of human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood now bears the CE (Conformite Europeenne) Mark in accordance with Directive 98/79/EC. The PROCLEIX ULTRIO Assay is the first CE-Marked triplex nucleic acid test (NAT) for blood screening. The PROCLEIX ULTRIO Assay was developed by Gen-Probe Incorporated in collaboration with Chiron and is designed to detect the presence of all known HIV-1 groups and subtypes and all known HCV and HBV genotypes in human plasma during the very early stages of infection, when those agents are present but cannot be detected by immunodiagnostic tests.
"CE Marking of the PROCLEIX ULTRIO Assay demonstrates the long-standing commitment of Chiron and Gen-Probe to ensuring the highest possible standards for the safety and supply of blood products in Europe and around the world," said Jack Goldstein, president, Chiron Blood Testing. "The PROCLEIX ULTRIO Assay represents the next step in the continued growth of our blood testing business, and we expect to roll out the assay in the EEA and other international markets in early 2004."
Hepatitis B is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. According to the World Health Organization, more than 350 million people worldwide are chronically infected with the virus and more than one million people die annually as a result of HBV infections.
Background
A CE Mark demonstrates conformance with the Essential Requirements and Common Technical Specifications of the IVDD (In Vitro Diagnostic Medical Devices Directive EC/98/79 of the European Commission). CE Marks on IVDD Annex II List A products reflect approval of their design with respect to safety, health, environment and consumer protection. The CE Mark is required on products in the member countries of the EEA to facilitate trade among them.
Amplified nucleic acid testing (NAT) is a highly sensitive method of detecting infectious organisms in donated blood, thereby improving the safety of the world's blood supply. NAT is used worldwide and is mandated by many European national health authorities to screen blood donations for HIV-1 and HCV.
About PROCLEIX
PROCLEIX Assays and Systems incorporate state-of-the-art NAT technology to detect viral RNA and DNA in donated blood and plasma during the very early stages of infection, when those infectious agents are present but cannot be detected by immunodiagnostic tests. The PROCLEIX® HIV-1/HCV Assay, developed in collaboration with Gen-Probe Incorporated, has been commercially available in Europe since 1999 and also bears the CE Mark. The PROCLEIX HIV-1/HCV Assay is approved for use in the United States, Australia and major markets in Europe. The PROCLEIX ULTRIO Assay for the simultaneous detection of HIV-1, HCV and HBV will be commercially available in Europe in early 2004. For more information about Chiron Blood Testing visit, www.ebloodbank.com.
About Chiron
Novartis Vaccines and Diagnostics, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: BioPharmaceuticals, Vaccines and Blood Testing. For more information about Chiron, visit the company's website at www.chiron.com.
This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives and new product marketing that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q for the quarter ended September 30, 2003, and the form 10-K for year ended December 31, 2002, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcomes of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activity will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties.
Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today.
NOTE: PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc.
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