Press Releases
Chiron's PROCLEIX® HIV-1/HCV Assay Receives FDA Approval
New System Further Ensures Safety of Blood Supply
Webcast/Conference Call to be Held at 12:30 EST
EMERYVILLE, Calif., Feb. 28, 2002
Novartis Vaccines and Diagnostics (Nasdaq: CHIR) today announced that the U.S. Food and Drug Administration (FDA) has approved the PROCLEIX® HIV-1/HCV Assay for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV). The nucleic acid amplification test (NAT) is designed to detect the presence of all known HIV-1 subtypes and HCV genotypes in whole blood during the very early stages of infection, when those agents appear but cannot be detected by immunodiagnostic screening technologies.
"Chiron has a long-standing commitment to the safety and supply of blood products in the US. and around the world," said Sean Lance, Chiron's chairman and chief executive officer. "FDA's approval of PROCLEIX builds upon our leadership in the field of HCV and HIV research and allows us to move quickly toward full commercialization of PROCLEIX in the US."
Chiron and its collaborator, Gen-Probe Incorporated, confirmed the clinical value of the PROCLEIX technology in a program that demonstrated the ability of the test to detect HIV-1 and HCV in blood donations during the time between infection and detection, known as the "window period." Since March 1999, the PROCLEIX Assay has been used to screen over 20 million donations from U.S. blood banks. The test has identified seven HIV-1 positive and 88 HCV positive donations that would otherwise have entered the blood supply. The significance of this is increased by the fact that a single unit of donated blood can be transfused into as many as three recipients.
The donations were collected at sites run by the American Red Cross, America's Blood Centers, the Association of Independent Blood Centers, and the United States military. Combined, this group collects more than 13 million whole blood donations annually, 70% of which are now being tested with the PROCLEIX System.
In target markets throughout the world approximately 50 million units of whole blood are donated and tested annually. Outside of North America, the PROCLEIX Assay has been approved for sale and use in ten countries and is under evaluation in others within Europe, Asia/Pacific, South America, and Africa.
"As a leader in the safe-guarding of our nation's blood supply, we are excited to usher in the next important advancement in blood screening technology," stated Rajen Dalal, president, Chiron's Blood Testing Division. "Today's approval is particularly significant since PROCLEIX can be used as an alternative to the currently-licensed p24 antigen test for HIV-1. The approval is also important as it pertains to hepatitis C, a condition that remains poorly understood despite its continued spread across the nation and around the world."
About the PROCLEIX System
The PROCLEIX System uses innovative NAT technology to detect HIV-1/HCV in donated blood. The five-part system is comprised of an assay to detect HIV-1 and HCV, and the enhanced semi-automated instrument system used to process the test (the eSAS), supported by software systems, proficiency panels and external quality controls. All parts of the PROCLEIX System have now received FDA approval and/or clearance.
About HCV
HCV is a virus that infects the liver and is linked to liver disease, liver failure and death. More common and more infectious than the HIV-1 virus, HCV affects 170 million people worldwide with approximately four million of those located in the United States. HCV is transmitted from individual to individual via body fluids, particularly blood and blood products. The cost of HCV infection, including medical expenses and lost earnings, has been estimated at more than $5 billion annually in the US.
Chiron's leadership in the field of HCV began with the company's discovery and successful cloning of the virus in 1987. Chiron has licensed HCV technologies to several companies working to prevent and treat this disease as part of an active out-licensing program. Major licensees of Chiron HCV technology include Abbott Laboratories, Bayer AG, Ortho-Clinical Diagnostics (a Johnson & Johnson company), F. Hoffmann-LaRoche, Bristol-Myers Squibb, BioRad Laboratories and Gen-Probe for diagnostics, and Pharmacia, GlaxoSmithKline and others for therapeutic applications.
About HIV
HIV is the retrovirus that causes acquired immunodeficiency syndrome (AIDS), which has a wide range of clinical manifestations varying from asymptomatic carrier states to severely debilitating and fatal disorders. The Centers for Disease Control and Prevention (CDC), estimate that as many as 950,000 people are currently living with HIV infection in the United States.
In 1984 Chiron successfully cloned and sequenced important regions of the HIV genome. Major licensees of Chiron's HIV technology include Abbott, Ortho-Clinical Diagnostics, F. Hoffmann-La Roche, BioRad, Organon Teknika and bioMerieux, Inc.
Conference Call
Chiron will be holding a conference call and webcast, Thursday, February 28, 2002, at 12:30 p.m. E.S.T. to discuss the FDA approval of PROCLEIX. To access the live call or the 3-day archive via the internet, please logon to http://www.chiron.com . Please connect to the Company's website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-888-306-2701 (US) or 706-634-2118 (international). Replay is available approximately 2 hours after the call through 11:59 p.m. E.S.T., March 4, 2002. To access the replay, please call 1-800-642-1687 (US) or 706-645-9291 (international). The conference ID number is 3415251.
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. For more information about Chiron, visit the company's website at www.chiron.com. For more information about Chiron Blood Testing, visit www.ebloodbank.com.
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 September 30, 2001 and the form 10-K for the year ended December 31, 2000, 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, including , for example, the proposed acquisition of Matrix Pharmaceutical Inc., or similar transactions. The successful completion of such business opportunities, including the Matrix acquisition, 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.
NOTE: PROCLEIX is a trademark of Novartis Vaccines and Diagnostics, Inc.
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