Press Releases
New Test Developed to Screen Donated Blood for West Nile Virus by July 1 Deadline
First Blood Centers Now Using Only Test Specific to West Nile
EMERYVILLE, CA. - June 18, 2003
Novartis Vaccines and Diagnostics (NASDAQ: CHIR) announced today the availability of the PROCLEIX® West Nile Virus Assay, the first and only test available to screen donated blood specifically for the West Nile virus (WNV). As early as this week, blood centers in the United States will begin using the new test to screen all blood donations for West Nile virus. By the July 1 deadline set by the FDA, more than 80 percent of U.S. blood donations will be screened for WNV using the new PROCLEIX test, available under a FDA-approved Investigational New Drug (IND) protocol.
In November of last year, the FDA asked manufacturers of blood screening technologies to create a test that could effectively screen donated blood for WNV after several cases of transmission were linked to blood transfusions. The vast majority of WNV cases in 2002 occurred after July 1, the date the FDA targeted to have a test in place.
"Blood is needed somewhere in our country every three seconds, so having a test available now that can screen for West Nile virus quickly and effectively is key to maintaining the availability and safety of our blood supply," said Jim MacPhearson, Chief Executive Officer of America's Blood Centers. "It should also give Americans some increased peace of mind about transmission of this virus."The PROCLEIX System, a highly sophisticated and sensitive blood-screening tool developed by Novartis Vaccines and Diagnostics and its collaborator Gen-Probe Incorporated, has demonstrated in pre-clinical testing the ability to detect very low levels of the virus in blood, even before the body develops antibodies against the virus. The new test uses the same instrumentation as the already FDA-approved PROCLEIX HIV-1/HCV Assay, minimizing the need for any additional investment in staff or equipment.
"We were able to develop the West Nile Virus Assay in half the normal time," said Jack Goldstein, President of Chiron Blood Testing, "due in large part to the superb cooperation given to us by the FDA and fellow members of the blood banking community."
The West Nile virus, which was first identified in the United States in 1999, causes flu-like symptoms in about 20 percent of those infected and can cause life-threatening illness in about 1 in 150. While the majority of West Nile infections are spread by insects - primarily mosquitoes -scientists confirmed last year that the virus can also be spread through blood transfusion and organ transplantation. An average 14 million blood donations are made annually in the United States, and 4.5 million lives are saved each year by blood transfusions.
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.
This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, new product marketing, acquisitions 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 ended March 31, 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 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 activity 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 is 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.
PROCLEIX is a trademark of Novartis Vaccines and Diagnostics, Inc.
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