EMERYVILLE, Calif., March 25 /PRNewswire-FirstCall/ --
Chiron Corporation (Nasdaq: CHIR) today announced that the U.S. Food and Drug
Administration (FDA) has accepted the investigational new drug (IND)
application submitted by Chiron's collaborator, Gen-Probe Incorporated, for an
assay to screen blood donations for West Nile virus, a blood-borne pathogen
transmitted by mosquitoes. The nucleic acid test (NAT) assay, marketed by
Chiron and developed by Gen-Probe, is expected to be available for use under
the IND in time for the upcoming U.S. mosquito season.
"West Nile virus only emerged as a threat to the safety of the blood
supply in 2002. This assay reflects the commitment of both Chiron and
Gen-Probe to move quickly to meet a critical public health need," said Jack
Goldstein, president, Chiron Blood Testing. "We were able to respond rapidly
because of the nature of the Procleix(R) system, which allows this assay to
use the same instrumentation as the currently approved HIV-1/HCV test. We are
working with our customers to ensure that they will be ready to implement the
new assay and meet the timeline established by federal health officials."
West Nile virus is transmitted by mosquitoes carrying the virus. Infection
with the virus can cause mild disease with flu-like symptoms or more severe
disease characterized by encephalitis or meningitis. The FDA called upon the
blood testing industry last year to develop an NAT assay to detect West Nile
virus by mid-year 2003. Out of a total of more than 3,500 cases of West Nile
infections documented in the U.S. last year, approximately 21 were believed to
have been caused by blood transfusions or transplants, according to the FDA.
In 2002, Gen-Probe Incorporated received FDA approval for the Procleix(R)
HIV-1/HCV Assay, an NAT test designed to detect the presence of all known
HIV-1 subtypes and hepatitis C virus (HCV) genotypes during the very early
stages of infection, when those agents cannot be detected by immunodiagnostic
screening technologies. The Procleix HIV-1/HCV Assay is currently available
commercially in 16 countries.
Chiron and Gen-Probe are currently developing the Procleix(R) Ultrio(TM)
Assay, which adds an assay for hepatitis B virus (HBV) to the test for HIV-1
and HCV. The HBV component of this assay has the potential to close the window
period between infection and detection of hepatitis B from 59 to 34 days, a
reduction of 42% over currently available tests. European marketing
evaluations for the Procleix Ultrio Assay are anticipated to begin in the
first half of 2003. U.S. clinical trials are expected to begin in the second
half of 2003.
Chiron Corporation, 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 http://www.chiron.com. For more
information about Chiron Blood Testing, visit http://www.ebloodbank.com.
This news release contains forward-looking statements, including
statements regarding product development initiatives, new product marketing,
and future product sales, 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-K for the year ended December 31, 2002, 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, and marketing effectiveness.
In particular, there can be no assurance that Chiron will successfully develop
and receive approval to market new products, or achieve market acceptance for
such new products.
Consistent with SEC Regulation FD, we do not undertake an obligation to
update the forward-looking information we are giving today.
NOTE: Procleix and Ultrio are trademarks of Chiron Corporation.
SOURCE Chiron Corporation
Web Site: http://www.chiron.com