Chiron (NASDAQ:CHIR)
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Chiron Corporation (NASDAQ:CHIR)
-- Development of Next-Generation Influenza Vaccine Could Improve
Annual Vaccine Production Process and Contribute to Long-Term
Pandemic Preparedness --
-- Second Phase III Study in Europe Completes Enrollment --
Chiron Corporation (NASDAQ:CHIR) today announced that it has
initiated a Phase I/II study of an investigational cell
culture-derived influenza vaccine in the United States. Cell
culture-derived influenza vaccine (commonly referred to as "flu cell
culture" vaccine) represents the next generation of influenza vaccine,
both for annual vaccine production and for long-term pandemic
preparedness.
Production of influenza vaccine using cell-culture technology may
offer significant advantages over traditional manufacturing methods by
eliminating the dependence on chicken eggs for production. The removal
of egg supply lead times would enable flexible and faster start-up of
vaccine production in the event of an annual vaccine supply shortfall
or an avian influenza pandemic.
The company has also completed enrollment of a second Phase III
study of investigational flu cell culture vaccine in Europe. A first
pivotal Phase III study of flu cell culture vaccine in Europe,
conducted in 2004, met the safety and immunogenicity endpoints of the
study.
"Chiron is an industry leader in developing flu cell culture, and
we are committed to supporting public health authorities globally by
working to make this next-generation vaccine available, both for
prevention of annual influenza and as an important platform for
pandemic preparedness," said Dan Soland, president of Chiron Vaccines.
"In addition to our return of FLUVIRIN(R) influenza virus vaccine to
the U.S. annual influenza vaccine market, Chiron has several programs
underway to enhance our capability to help protect people from the
threat of influenza. Flu cell culture, along with our research on
avian pandemic influenza vaccines and adjuvants, could contribute to a
flexible and cutting-edge infrastructure to meet current and future
influenza threats and help save lives."
Chiron's flu cell culture vaccine is produced from virus
propagated in the Madin-Darby Canine Kidney (MDCK) cell line. The
company filed an investigational new drug application (IND) for flu
cell culture vaccine in the United States last year, after regaining
its U.S. rights to the technology. The investigational vaccine is
produced at Chiron's state-of-the-art flu cell culture vaccine
manufacturing facility in Marburg, Germany.
"Moving from egg-based to cell-based influenza vaccine production
is an important step in enhancing our preparedness against pandemic
influenza and provides flexibility in meeting surges in influenza
vaccine demand," said Walter A. Orenstein, M.D., professor of medicine
of pediatrics and associate director of the Emory Vaccine Center in
Atlanta, Georgia. "This effort will help address the challenge of
responding to a pandemic."
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 about Chiron, please visit www.chiron.com.
This news release contains forward-looking statements, including
statements regarding development plans for influenza cell culture
vaccine, likelihood of regulatory approvals, improvements to
manufacturing facilities, product development initiatives, and product
marketing, which involve risks and uncertainties and are subject to
change. A discussion of the company's operations and financial
condition, including factors that may affect its business and future
prospects that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements, is contained in documents the company has filed with the
SEC, including the Form 10-K for the year ended December 31, 2004, and
the Form 10-Q for the quarter ended June 30, 2005, 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,
among others, the outcome of clinical trials, regulatory review and
approvals, manufacturing capabilities, intellectual property
protections and defenses, litigation, stock-price and interest-rate
volatility, marketing effectiveness, and the severity of the 2005-2006
influenza season. In particular, there can be no assurance that
Chiron's flu cell culture vaccine will be successfully developed and
then approved by U.S., European or other regulatory agencies or that
additional issues with respect to influenza vaccines or Chiron's
manufacturing generally will not arise in the future, or that Chiron
will be able to market such new products or achieve market acceptance
for such new products. The company may face additional competition in
the influenza market in the future and challenges in distribution
arrangements as a result of vaccine developments. In addition, the
company may engage in business opportunities, the successful
completion of which is subject to certain risks, including approval by
Novartis AG, regulatory approvals and the integration of operations.
Chiron does not undertake an obligation to update the
forward-looking information the company is giving today.
NOTES:
Chiron's investigational flu cell culture vaccine has not been
approved by U.S., European or other regulatory agencies.
FLUVIRIN is a registered trademark of Chiron.