Chiron Initiates U.S. Phase I/II Study of Influenza Cell Culture Vaccine
October 25 2005 - 8:00AM
Business Wire
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.
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