Press Releases
Testing With PROCLEIX® West Nile Virus Assay Initiated on PROCLEIX® TIGRIS® System Under IND
Automated System Provides Blood Centers with Highest Process Control for Testing
EMERYVILLE, Calif. and SAN DIEGO, Sept. 1, 2004
Chiron (Nasdaq: CHIR) and Gen-Probe (Nasdaq: GPRO) announced today that testing with the PROCLEIX® West Nile Virus (WNV) Assay has been initiated under an investigational protocol on the PROCLEIX® TIGRIS® System. The high-throughput, fully automated nucleic acid testing (NAT) system, developed by Gen-Probe, is designed to allow blood centers to test individual blood samples with greater operator efficiency and is being introduced into blood testing centers under IND in regions with the highest prevalence of WNV. The PROCLEIX WNV Assay, which is labeled For Investigational Use Only, has detected 137 WNV-infected donations since May.
"We are pleased that we've been able to meet the needs of our customers by accelerating the availability of the PROCLEIX® TIGRIS® System under IND," said Andrew Heaton, M.D., vice president and chief medical officer, Chiron Blood Testing. "The PROCLEIX TIGRIS system is the first fully automated NAT system available for blood screening, and its use with the PROCLEIX WNV Assay will allow for maximum sensitivity by enabling individual donor testing and would bring a new level of quality assurance in detecting potential transfusion-transmitted viruses like WNV."
"Our TIGRIS System offers blood centers revolutionary levels of automation, throughput and process control," said Jim Godsey, Ph.D., executive vice president of development, Gen-Probe. "These attributes are especially important when testing of individual donor samples is warranted to safeguard the nation's blood supply from viruses such as West Nile that are infectious even at very low copy levels."
Blood centers using the PROCLEIX WNV Assay and experiencing a large number of WNV-positive donations have developed algorithms to determine when testing should be moved from pools of 16 to individual donor testing, which offers the best opportunity to detect the presence of the virus. Testing with the PROCLEIX WNV Assay on the PROCLEIX TIGRIS System is planned for epidemic areas at target sites in Arizona, California, Colorado, Florida and Oklahoma to improve the efficiency of high-volume testing.
In addition, a pivotal clinical trial for the PROCLEIX WNV Assay is currently being conducted at five U.S. blood centers to confirm the PROCLEIX WNV Assay's sensitivity, specificity and reproducibility on a semi-automated instrumentation platform, with an expected filing of this data in the first quarter of 2005. The PROCLEIX TIGRIS System data for the PROCLEIX WNV Assay is also expected to be submitted at that time.
Separately, a clinical trial for the PROCLEIX® ULTRIO® Assay on the PROCLEIX TIGRIS® System started in February 2004. The PROCLEIX ULTRIO Assay is specifically designed for the simultaneous detection of human immunodeficiency virus 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissues. Clinical trials for the PROCLEIX TIGRIS System have been completed, with FDA submissions for the TIGRIS System for blood screening and for the ULTRIO assay planned for later in 2004.
About West Nile Virus
West Nile virus (WNV) is a mosquito-borne virus associated with a human form of the disease, with effects 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 U.S. Food and Drug Administration challenged industry to develop a test for direct detection of WNV 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 under an IND. According to the U.S. Centers for Disease Control and Prevention, 843 human cases of WNV infection have been reported for the current mosquito season as of August 24, 2004.
About PROCLEIX® Assays and Systems
PROCLEIX Assays and Systems incorporate state-of-the-art amplified 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. For more information about Chiron Blood Testing, visit www.ebloodbank.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.
About Gen-Probe
Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid testing (NAT) products used for the clinical diagnosis of human diseases and for 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 around the world. Gen-Probe is headquartered in San Diego and employs nearly 900 people. Additional information about the company can be found at www.gen-probe.com.
Safe-Harbor Statement
This news release contains forward-looking statements about the companies' expectations, beliefs, plans, objectives, assumptions or future events or performance, including statements regarding product development initiatives and approvals, the success of clinical trials, new product marketing, and future product sales, that involve risks, uncertainties and assumptions and are subject to change. Forward-looking statements are not guarantees of performance. A full discussion of Chiron's and Gen-Probe's operations and financial conditions, including factors that may affect the companies' businesses, operating results and future prospects, is contained in documents the companies have filed with the SEC, including the forms 10-Q for the quarter ended June 30, 2004, and the forms 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 companies' actual performance to differ from current expectations, including the outcome and timing of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, marketing effectiveness, the success of collaborations, third-party distributors and suppliers. In particular, there can be no assurance that Chiron or Gen-Probe will successfully complete clinical trials of new products, develop and receive approval to market new products, or achieve market acceptance for such new products.
The companies do not undertake any obligation to update the forward- looking information we are giving today to reflect subsequent events.
NOTE: PROCLEIX and ULTRIO are registered trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a registered trademark of Gen-Probe Incorporated.
SOURCE Chiron
###