Press Releases
U.S. Biologics License Application Submitted for PROCLEIX® ULTRIO® Assay For Blood Screening
SAN DIEGO and EMERYVILLE, CA, September 30, 2004
Gen-Probe Incorporated (NASDAQ: GPRO) and Novartis Vaccines and Diagnostics (NASDAQ: CHIR) announced today that a Biologics License Application (BLA) for the PROCLEIX® ULTRIO® Assay for blood screening has been submitted to the U.S. Food and Drug Administration 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. The companies intend to seek approval to run the test on both the semi-automated PROCLEIX® System and on the fully automated, high-throughput PROCLEIX® TIGRIS®. "Submitting the BLA for the PROCLEIX ULTRIO Assay on time is another important milestone in our efforts to help safeguard the U.S. blood supply with the most sensitive nucleic acid testing technologies and the most sophisticated instrument platforms," said Henry L. Nordhoff, Gen-Probe's chairman, president and chief executive officer. "This submission underscores Chiron's ongoing commitment to protect health by improving the safety of blood transfusions received by patients around the world," said Jack Goldstein, president, Chiron Blood Testing. "The submission also represents an important corporate milestone for Chiron in 2004. We are pleased with the progress of the PROCLEIX ULTRIO Assay and look forward to its approval."
The PROCLEIX ULTRIO Assay adds a test for HBV to the previously approved PROCLEIX® HIV-1/HCV Assay. The assay is designed to detect the presence of all known HIV-1 groups and subtypes and HCV and HBV genotypes during the very early stages of infection, when these agents cannot be detected by immunodiagnostic tests. Approval of the TIGRIS system for the PROCLEIX ULTRIO Assay would enable individual donor testing for HBV, which in turn has the potential to reduce the window period between infection and detection of hepatitis B by as much as 40% compared to currently available tests. Hepatitis B is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. Hepatitis B infection can lead to liver failure, cirrhosis or cancer. According to the World Health Organization, more than 350 million people worldwide are chronically infected with the hepatitis B virus. More than one million people die annually as a result of HBV infections.
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.
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. For more information about Chiron, please visit www.chiron.com.
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.
Caution Regarding Forward-Looking Statements
Gen-Probe
Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions, or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure are all forward-looking statements. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. For example, there can be no assurance that U.S. or European regulators will approve any new assay or instrument, or that commercialization of these new products will be successful. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we have filed with the SEC, including our respective form 10-Qs for the quarter ended June 30, 2004, and all our periodic filings made with the SEC. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Chiron
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 Chiron'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 June 30, 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 registered trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a registered trademark of Gen-Probe Incorporated.
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