Press Releases
The BLA for the Chiron PROCLEIX® HIV-1/HCV Assay Accepted for Review by the FDA
EMERYVILLE, CA, and SAN DIEGO, CA, March 12, 2001
Novartis Vaccines and Diagnostics (NASDAQ: CHIR) and Gen-Probe Incorporated announced today that the Biologics License Application (BLA) for the Chiron PROCLEIX® HIV-1/HCV Assay for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) has been accepted for review by the U.S. Food and Drug Administration (FDA). The acceptance means that the FDA has determined that the submission contains sufficient information for the agency to perform a meaningful review for marketing authorization. The application was previously designated for "Fast Track" review.
The assay is a nucleic acid amplification test (NAT) designed to detect the presence of HIV-1 and HCV in whole blood and plasma during the earliest stages of infection, when these infectious agents appear in the blood but cannot yet be detected by current serological screening technologies. Utilizing state of the art transcription mediated amplification (TMA) technology developed by Gen-Probe, the assay may significantly reduce the time between infection and detection, known as the "window period". Industry data show that NAT can reduce the window period by as much as 85 percent in the case of HCV and 50 percent in the case of HIV-1.
Chiron and Gen-Probe confirmed the performance of NAT technology in a clinical program that demonstrated the ability of the system to detect a significant number of HIV-1 and HCV contaminated donations during the window period that otherwise would have entered the blood supply. The BLA submission is based on a pivotal study of more than 180,000 U.S. donor samples. The submission also describes data from among 7.7 million blood donations collected between March 1999, and March 2000 from U.S. blood banks of the American Red Cross, Americas' Blood Centers and the Association of Independent Blood Centers.
"NAT has been successfully tested by U.S. blood centers since 1999 under an investigational new drug (IND) application. The acceptance of this BLA is a key milestone on the path to licensure and standardization of testing nationwide," commented Rajen Dalal, president of Chiron's Blood Testing Division.
"This novel test, driven by Gen-Probe's TMA technology, is an important tool that further ensures the world's blood supply is safe from HIV-1 and HCV," said Henry L. Nordhoff, president and chief executive officer of Gen-Probe Incorporated.
Approximately 50 million units of whole blood and plasma are donated and screened annually in target markets throughout the world. In 2000, over 70% of the 13 million annual whole blood donations in the US. were tested with the assay under a U.S. IND from the FDA. Outside of North America, the Chiron PROCLEIX HIV-1/HCV System is available for commercial sale and is undergoing evaluation in countries within Europe, Asia/Pacific, South America, and Africa.
About Novartis Vaccines and Diagnostics
Novartis Vaccines and Diagnostics, headquartered in Emeryville, California, is a leading biotechnology company that participates in three global healthcare markets: biopharmaceuticals, vaccines, and blood testing. The company is applying an integrated scientific approach to the development of innovative products for preventing and treating cancer and infection. For more information about Chiron, visit the company's web site at www.chiron.com.
Chiron Blood Testing, a division of Novartis Vaccines and Diagnostics, is a leading provider of products used by the blood banking industry to ensure the safety of the world's blood supply and to protect the public health. In 1998, Chiron and Gen-Probe began a collaboration for the development and marketing of improved infectious disease blood screening tests, such as HIV-1, HCV, and hepatitis B virus (HBV), incorporating a novel and highly sensitive nucleic acid amplification technology. Chiron develops and markets immunoassay screening and supplemental tests, including Chiron RIBA SIA confirmatory tests, as well as hepatitis and retroviral antigens through its joint business with Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson Company.
About Gen-Probe Incorporated
Gen-Probe Incorporated, a San Diego-based company, is a recognized world leader in the development, manufacture and commercialization of diagnostic products based on its patented genetic probe technologies. The company has received over 40 FDA clearances for nucleic acid based probe tests to detect a wide range of microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Gen-Probe is currently developing novel viral nucleic acid tests for screening the blood supply for HIV-1, HCV, and HBV. For copies of press releases and additional information about the Company, please consult Gen-Probe's web site at www.gen-probe.com.
TMA Technology
Gen-Probe's TMA technology used in the Chiron PROCLEIX HIV-1/HCV Assay specifically amplifies the nucleic acids of viruses to allow direct detection when the virus appears in the blood. This technology provides earlier and more sensitive identification of virus particles in the blood than do current tests that rely on antibody or viral protein detection. Antibodies to these viruses are formed in response to infections and their development to detectable levels can take as long as 22 days for HIV-1 and 80 days for HCV.
This news release contains forward-looking statements that involve risks and uncertainties. A full discussion of the Chiron's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company files with the SEC, such as forms 10-Q and 10-K. 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, manufacturing capabilities and marketing effectiveness.
In line with the new SEC Rule FD, Novartis Vaccines and Diagnostics does not undertake an obligation to update the forward-looking information we are giving today. PROCLEIX and Riba are trademarks of Novartis Vaccines and Diagnostics, Inc.
For additional information, please see the March 12th, 2001 press release on Chiron's corporate Web site, www.chiron.com.
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