Press Releases
PROCLEIX® West Nile Virus Assay Receives FDA Approval
New system further ensures safety of blood supply
EMERYVILLE, CA. - December 1, 2005
Novartis Vaccines and Diagnostics (NASDAQ:CHIR) today announced that the U.S. Food and Drug Administration (FDA) has approved the PROCLEIX® West Nile Virus (WNV) Assay to screen whole blood donations for use on the PROCLEIX® System. The assay, which was developed in collaboration with Gen-Probe Incorporated, has been used to screen more than 29 million units of blood on an investigational-use-only basis since June of 2003 and intercepted more than 1,500 WNV-positive donations.
"The approval of the PROCLEIX WNV Assay extends Chiron's leadership in the field of blood safety," said Gene Walther, president, Chiron Blood Testing. "We are committed to helping our customers safeguard the blood supply against emerging pathogens, such as West Nile virus. We continue to work in collaboration with our customers to meet the urgent need to provide a safe blood supply."
"The safety of the blood supply is a critical concern of the American Red Cross," said Jack McGuire, Executive Vice President of American Red Cross Biomedical Services. "Being able to screen blood donations for West Nile virus provides an additional layer of safety and reduces the risk of transmission of a potentially deadly virus."
West Nile virus is a mosquito-borne virus associated with a human form of the disease ranging from mild, flu-like symptoms to severe neurological disease. The first confirmed U.S. death resulting from transmission through donated blood was reported in 2002. In the fall of 2002, the FDA challenged the blood safety industry to develop a test for direct detection of the virus in donated blood by the summer of 2003. Within nine months, Gen-Probe and Chiron had developed the PROCLEIX WNV Assay and brought it to market on an investigational-use-only basis.
About PROCLEIX® Assays and Systems
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, the European Union, Australia 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 and also bears the CE Mark. For more information about Chiron Blood Testing, visit www.eBloodBank.com.
About Chiron
Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit www.chiron.com.
This news release contains forward-looking statements, including statements regarding regulatory approval for the PROCLEIX® ULTRIO® Assay and PROCLEIX® TIGRIS® System other product development initiatives, new product marketing, acquisitions, and 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-K for the year ended December 31, 2004, and the form 10-Q for the quarter ended September 30, 2005, 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, 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. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, regulatory approvals and the integration of operations.
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 registered trademark of Gen-Probe Incorporated.
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