Press Releases
PROCLEIX® ULTRIO® Study Presented at International Society of Blood Transfusion Conference
Data Highlight the Value of ULTRIO
Hepatitis B-Positive Blood Donation Detected
EMERYVILLE, Calif., July 14, 2004
Novartis Vaccines and Diagnostics (Nasdaq: CHIR) today announced the results of a multicenter trial of the PROCLEIX® ULTRIO® Assay presented at a symposium at the International Society of Blood Transfusion (ISBT) meeting in Edinburgh. The data, presented by Dr. Claudio Velati, director of the Sondrio Transfusion Center in Italy, indicated that the PROCLEIX ULTRIO Assay detected a hepatitis B-positive blood donation that would otherwise have gone undetected by previously approved blood testing assays. The PROCLEIX ULTRIO Assay, which adds an assay for hepatitis B virus (HBV) to the previously approved assay for HIV-1 and hepatitis C virus (HCV), received CE marking for marketing in the European Union at the beginning of 2004.
"These data confirm the importance of the PROCLEIX ULTRIO Assay in preventing transmission of hepatitis B in donated blood," said Jack Goldstein, president, Chiron Blood Testing, "The prevalence of HBV is significantly higher than HIV and HCV in many parts of the world, and this test will be valuable in identifying those cases that would otherwise enter the blood supply. We look forward to the expanded use of PROCLEIX ULTRIO geographically, including in the United States, where we expect to file a BLA later this year."
The data presented by Dr. Valeti confirmed the sensitivity and specificity of the PROCLEIX ULTRIO Assay. In a trial of over 10,000 donations at 14 sites, the Italian study looked at use of the assay in pools of eight or in individual donation testing (IDT). The trial identified three positive HCV cases and one positive HIV-1 case, all of which were also identified by serology testing. The trial also identified six HBV cases, of which five were surface antigen positive and one surface antigen negative. The data showed a 12-day HBV window period closure over surface antigen when the PROCLEIX ULTRIO Assay was used in pools of eight and a 16-day closure when used in IDT.
Additional data was presented at the ISBT conference about the potential value of the automated nucleic acid testing (NAT) instrument, TIGRIS®, in reducing workload at blood testing centers. The study, conducted by Argent Global Services, indicated that TIGRIS, which is expected to be launched in the EU later this year, can reduce a blood-center's "hands on" labor needs for testing by 60 percent, at the same time significantly reducing the center's paper work and space needs.
About vCJD
Variant Creutzfeldt-Jakob disease is a slow, progressive disease of the central nervous system, characterized by dementia and involuntary muscle contractions, that is believed to be caused by an infectious prion, a protein particle. More than 150 cases of vCJD have been recorded in Europe and have been linked to eating or contact with cattle infected with bovine spongiform encephalopathy, or mad-cow disease. Two cases have been reported to date in the United Kingdom, where blood from a donor who was later identified to have vCJD was transfused to a patient who has subsequently developed vCJD. The cases suggest the possibility that vCJD may be transmitted through transfusion.
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, the European Union and major markets in Asia. The PROCLEIX ULTRIO Assay for the simultaneous detection of HIV-1, HCV and HBV has been commercially available in Europe since early 2004. For more information about Chiron Blood Testing visit, www.ebloodbank.com.
About Chiron
Through its global Blood Testing, Vaccines and BioPharmaceuticals businesses, Novartis Vaccines and Diagnostics addresses human suffering with more than 50 diverse products to detect, prevent and treat disease worldwide. The company's consistent success has come from its pioneering science, skill in delivering innovations in biotechnology and disciplined business approach. Chiron believes that science has the power to improve people's lives and harnesses that power to transform human health.
This year, Chiron Vaccines celebrates 100 years of advancing medicine with the anniversary of two founding companies. In 1904, Emil von Behring and Achille Sclavo independently started companies in Germany and Italy, respectively, dedicated to the research, development and manufacture of vaccines to protect humanity from infectious disease. As the fifth-largest vaccine manufacturer in the world, Chiron remains dedicated to the legacies of von Behring and Sclavo to prevent disease and develop new vaccines to improve human health globally.
This news release contains forward-looking statements, including statements regarding product development initiatives and in- and out-licensing activities 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 ending March 31, 2004 and the form 10-K for the year ended December 31, 2003, 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 outcome 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 activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including shareholder and regulatory approvals and the integration of operations.
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. TIGRIS is a trademark of Gen-Probe Incorporated.
SOURCE Novartis Vaccines and Diagnostics
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