Press Releases
European Regulatory Application Submitted for PROCLEIX® ULTRIO® Assay on Fully Automated TIGRIS® System
SAN DIEGO and EMERYVILLE, CA, October 19, 2004
Novartis Vaccines and Diagnostics (NASDAQ:CHIR) and Gen-Probe Incorporated (NASDAQ:GPRO) today announced that a design dossier amendment for use of the PROCLEIX® ULTRIO® Assay on the PROCLEIX® TIGRIS® System has been submitted to Gen-Probe's European notified body. This amendment would allow the already CE Marked assay to be run on the TIGRIS fully automated, high-throughput instrument platform, as well as on the PROCLEIX® System, the semi-automated instrument platform currently used. The PROCLEIX ULTRIO Assay was developed to simultaneously detect HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue.
"Chiron is committed to meeting our customers' needs to protect health," said Jack Goldstein, president, Chiron Blood Testing. "We have been pleased with the acceptance of the PROCLEIX ULTRIO Assay in the European Union since the assay received its CE Mark at the beginning of the year, and we believe that the PROCLEIX TIGRIS System would provide blood centers in the European Union with additional convenience and throughput that comes with automation."
"One fully automated PROCLEIX TIGRIS System can process 1,000 samples in about 14 hours, resulting in productivity and efficiency that is far superior to any other platform," said Henry L. Nordhoff, Gen-Probe's chairman, president and chief executive officer. "This level of throughput even enables individual donor testing for the hepatitis B virus, which in turn can reduce the window period between infection and detection by as much as 40 percent compared to immunoassay tests."
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 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. For more information about Chiron, please visit www.chiron.com.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid testing products for diagnosing human diseases and screening donated human blood. Using its patented NAT technologies, Gen-Probe has received FDA approvals or clearances for a broad portfolio of products that detect a variety of infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Additionally, the Company developed and manufactures the only FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Chiron. Gen-Probe has more than 20 years of expertise in nucleic acid detection, and its products are used daily in clinical laboratories and blood collection centers throughout the world. Gen-Probe is headquartered in San Diego, California and employs nearly 900 people. For more information, go to www.gen-probe.com.
Forward-Looking Statements
This news release contains forward-looking statements, including statements regarding regulatory approval of the PROCLEIX ULTRIO assay and the PROCLEIX TIGRIS System, sales growth, product development initiatives, new product indications, and new product marketing that involve risks and uncertainties and are subject to change. A full discussion of the companies' operations and financial conditions, including factors that may affect their businesses and future prospects, is contained in documents the companies have filed with the SEC, including the respective form 10-Qs for the quarter ended June 30, 2004, and the form 10-Ks 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 companies' 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 the companies 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 out-licensing activities will generate significant revenue, nor that in-licensing activities will fully protect the companies from claims of infringement by third parties. In addition, the companies 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 registered trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a registered trademark of Gen-Probe Incorporated.
###