Chiron/Gen-Probe news release... Any relevance here?
Chiron and Gen-Probe Form Strategic Alliance to Further Improve the Safety of the World's Blood Supply.
EMERYVILLE, Calif.--(BW HealthWire)--July 1, 1998--
Chiron and Gen-Probe Join Forces to Apply Probe Technology to
Blood Screening and Diagnostics
Chiron Corporation (NASDAQ:CHIR) and Gen-Probe Inc. announced today that the two companies have signed an agreement to form a strategic alliance to develop, manufacture and market nucleic acid probe assay
systems for blood screening and certain areas of diagnostics.
Financial details were not disclosed.
Terms of the Agreement
Under the terms of the agreement, Chiron will market and sell products that utilize Chiron's intellectual property relating to hepatitis C (HCV) and human immunodeficiency virus (HIV) and Gen-Probe's patented transcription-mediated amplification (TMA), target capture, hybridization protection assay (HPA) and dual
kinetic assay (DKA) technologies.
Gen-Probe is scheduled to complete this year the development of the first fully automated high-throughput DNA probe instrument system, TIGRIS, for blood screening and diagnostic applications.
Initially the alliance will concentrate its efforts on developing, manufacturing and marketing a combination HIV-1/HCV assay for qualitative screening of the world's blood supply. Currently in evaluation studies, this combination assay is expected to enter worldwide clinical trials in the latter part of this year.
Testing
Currently, the world's blood banks process over 50 million samples of blood per year. While the blood banking industry has continually improved the safety and purity of the world's blood supply, the industry recognizes the need for highly sensitive probe technology in addition to certain existing immunological methods to continue safety improvements.
A relatively simple, reproducible, automated system and methodology will be critical for the blood banks to meet the public health need as well as meet the world demand for blood and blood products.
"Further ensuring the safety of the world's blood supply is one of the single, most significant advances we can make as a company," said Sean Lance, president and chief executive officer for Chiron.
"The world health ministries and regulatory agencies are pushing hard for probe technology to reduce the potential for contaminated blood donated by persons without antibodies to HIV or HCV. We believe that a combination of Chiron's expertise in infectious disease blood screening and Gen-Probe's innovative amplification and testing technologies will offer the best solution to meet this need in the very near future."
"We feel that our TMA technology and the TIGRIS system have the greatest potential for meeting the public's need for a highly sensitive, reliable method for detecting both HIV and HCV in blood samples," said Henry Nordhoff, Gen-Probe's president and chief executive officer.
"Combining these technologies with Chiron's intellectual property and expertise in the blood bank industry forms a powerful approach to minimizing the risk of transmitting these viral diseases via blood transfusions."
"In selecting Gen-Probe, Chiron based its decision on the needs that exist in the plasma and blood screening industry today," said Dr. Mickey Urdea, senior vice president of Nucleic Acid Diagnostics of
Chiron.
"We based our evaluation on the criteria that leading blood banks have defined including: sensitivity, specificity, positive identification of sample, automation and ease of use, rapid throughput and the ability to perform a combination HCV/HIV test. Gen-Probe's TMA and system technology can meet the criteria in all
categories within a timeframe that's acceptable to the blood screening industry."
About Gen-Probe
Gen-Probe was awarded a contract from the National Heart, Lung and Blood Institute, which is an arm of the National Institute of Health, to develop a screening program for both HIV and HCV using amplification of nucleic acid sequences. Gen-Probe has also been selected to work with American Red Cross Blood Services to integrate this gene amplification technology (GAT) into the blood screening process.
GAT offers the earliest detection of infectious disease possible and minimizes the "window period," which is the period from original infection to levels of detectability. Current detection of HIV-1 or HCV infection in donated blood products is based on serological screening for virus-specific antibodies.
It is estimated that this GAT technology would reduce the HIV-1 window from an average of 22 days to 11-14 days after infection and reduce the HCV window from greater than 80 days to 7-14 days. Utilizing these tests would therefore prevent more than half of the HIV-1 and HCV infections that are caused by blood transfusion.
Gen-Probe is a recognized leader in the development, manufacturing and commercialization of diagnostic products based on its patented genetic probe technologies. The company has received 40 FDA clearances for genetic probe tests to detect a wide range of microorganisms, including those causing sexually transmitted disease, tuberculosis, strep throat, pneumonia and fungal infections.
Gen-Probe is a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. Chugai, the ninth largest pharmaceutical company in Japan, spends a higher percentage of its sales on research and development
than any other major Japanese pharmaceutical company.
About Chiron
Based on its initial discovery of the HCV virus in 1987, Chiron, through its joint business with Ortho Diagnostic Systems Inc., a Johnson & Johnson Company, has developed several immunoassay tests to
detect the presence of HCV antibodies, and has supplied HCV antigen for use in blood screening assays since 1989.
Chiron has also developed probe assays for HCV based on branched DNA (bDNA) technology. The Chiron HCV bDNA assay, Quantiplex HCV RNA Assay, sold in Japan by Daiichi Pure Chemicals, Co. Ltd., received
regulatory approval in 1994. Since that time, Japan has significantly improved the efficiency of therapeutic treatment and reduced overall spending in HCV treatment by nearly $1 billion annually.
Chiron will continue to develop, manufacture and sell its complementary assays based upon branched DNA (bDNA) technology for quantitative measurement of viral load. In 1984 Chiron scientists cloned and sequenced the entire HIV genome leading to major breakthroughs in the research of HIV and the diagnosis and management of patients with HIV.
Chiron recently announced the introduction of the Quantiplex(R) HIV-1 RNA 3.0, a highly sensitive quantitative assay based on bDNA technology, available for research use.
Chiron Corp., headquartered in Emeryville, is a leading biotechnology company that participates in three global healthcare markets: diagnostics, therapeutics and vaccines. Chiron also conducts research and development in the fields of biological proteins, gene therapy and combinatorial chemistry.
Note to Editors: This news release contains forward-looking statements that involve risks and uncertainties which might affect the initiation and completion of clinical trials and the launch of products. A full discussion of the companies' operations and financial condition, including factors that may affect their business and future prospects, is contained in documents the companies file with the SEC, such as form 10-Q and 10-K and 40F reports. These documents identify important factors that could cause the companies' actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness.
CONTACT: Chiron Diagnostics
Victoria DeMoranville, 508/660-4581 (Corp. Comm.)
Jim Knighton, 510/923-6055 (I.R.)
or
Gen-Probe Incorporated
Rita Mattivi, 619/410-8903 |
