Press Releases
U.S. Biologics License Application Submitted for PROCLEIX® West Nile Virus Assay for Blood Screening
EMERYVILLE, Calif. and SAN DIEGO, Feb. 2, 2005
Gen-Probe Incorporated (Nasdaq: GPRO) and Novartis Vaccines and Diagnostics (Nasdaq: CHIR) announced today that a Biologics License Application (BLA) for the PROCLEIX® West Nile Virus (WNV) Assay for blood screening has been submitted to the U.S. Food and Drug Administration (FDA).
"Gen-Probe's submission of the BLA for the PROCLEIX® West Nile Virus Assay ahead of schedule is another important milestone in our efforts to help safeguard the U.S. blood supply with the most sensitive nucleic acid testing technologies," said Henry L. Nordhoff, Gen-Probe's chairman, president and chief executive officer. "We responded to an urgent medical need by developing the assay in record time, and we are proud to see it move closer to commercial approval."
"Using the PROCLEIX® West Nile Virus Assay, our customers are making an important contribution to blood safety, especially those that serve areas where there is a high incidence of mosquitoes carrying the virus," said Gene Walther, acting president of Chiron Blood Testing. "Regulatory submission of the West Nile Virus Assay fulfills one of the five Blood Testing goals Chiron has established for 2005."
Since July of 2003, U.S. blood centers have used the PROCLEIX® WNV Assay to screen more than 19 million units of donated blood under an Investigational New Drug (IND) application. This testing has intercepted approximately 1,200 WNV-infected units, thereby preventing transfusion of contaminated blood into as many as 3,600 people. This investigational testing is expected to continue during the regulatory review process.
The companies intend to seek approval to run the assay on both the semi-automated PROCLEIX® system and on the fully automated, high-throughput PROCLEIX® TIGRIS® System. Most blood centers currently run the assay on the semi-automated platform. However, during the summer of 2004, several blood centers in regions with the highest prevalence of WNV used the assay on the PROCLEIX® TIGRIS® System under an IND. This fully automated, high-throughput system is designed to allow blood centers to test individual blood samples with greater operator efficiency. Testing individual blood donations provides for maximum sensitivity, which is especially important for viruses such as West Nile that are infectious even at very low levels in the blood.
WNV 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 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, nearly 2,500 human cases of WNV infection occurred in 2004.
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. For more information about Chiron Blood Testing visit, www.ebloodbank.com.About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests for diagnosing human diseases and screening donated human blood. Using its patented 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. In addition, Gen-Probe's TIGRIS® instrument is the only fully automated, high-throughput system in the molecular diagnostics industry. The Company also developed and manufactures the only FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Novartis Vaccines and Diagnostics. Gen-Probe has more than 20 years of nucleic acid detection research and product development experience, 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 approximately 900 people. For more information, go to www.gen-probe.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, please visit www.chiron.com.Caution Regarding Forward-Looking Statements
This news release contains forward-looking statements about Gen-Probe's and Chiron's expectations, beliefs, plans, objectives, assumptions, future events and performance. These include statements regarding product development initiatives and regulatory approvals, the success of clinical trials, new product marketing, and future product sales. These statements involve risks, uncertainties and assumptions and are subject to change. Forward-looking statements are not guarantees of performance. A full discussion of the companies' 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 September 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 and expressly disclaim any obligation to update any forward-looking information to reflect subsequent events.NOTE: PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a registered trademark of Gen-Probe Incorporated.
SOURCE Gen-Probe Incorporated; Novartis Vaccines and Diagnostics
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