Chiron to Supply United States with Pandemic Influenza Vaccine for Stockpile; Contract with U.S. Department of Health & Human Se
27 Ottobre 2005 - 7:46PM
Business Wire
Chiron Corporation (NASDAQ:CHIR) today announced that it has won a
$62.5 million contract to supply the U.S. government with
pre-pandemic influenza vaccine for a stockpile to protect against
the H5N1 avian influenza virus strain. Under the agreement with the
Department of Health and Human Services (HHS), Chiron will provide
a bulk stockpile of H5N1 influenza vaccine, which the company will
produce at its Liverpool manufacturing facility using the
U.S.-licensed commercial-scale manufacturing process. Production of
the H5N1 stockpile vaccine under this agreement will not affect
production of Chiron's annual FLUVIRIN(R) influenza virus vaccine.
"Chiron commends the U.S. government's comprehensive approach to
pandemic preparedness," said Dan Soland, president of Chiron
Vaccines. "We have engaged in discussions with a number of
governments around the world on a range of pandemic measures,
including vaccine stockpiling and advance purchase contracts. Avian
influenza knows no boundaries, and public-private partnerships are
essential to address the threat it poses. As a leading influenza
vaccine manufacturer, we are pleased to bring the capabilities of
all of our influenza production facilities to this global effort."
The stockpile vaccine, which Chiron will provide to HHS in 2006, is
based on an inactivated influenza strain similar to the H5N1 avian
subtype that has circulated throughout Southeast Asia and more
recently in Eastern Europe. H5N1 is one of a number of avian
influenza viruses that do not usually infect humans. However, if
the virus acquired the ability to readily transmit from person to
person, it could result in a global outbreak of influenza to which
people have no natural immunity, commonly called a pandemic. With
pandemic vaccine research ongoing, providing the stockpile vaccine
in bulk will allow HHS to determine final dose and formulation,
including potentially adding an adjuvant, based on the most current
data available at the time of use. The stockpile vaccine
contributes to the U.S. National Strategic Stockpile, which HHS is
building to contain enough avian influenza vaccine for 20 million
people and enough antiviral medication for another 20 million
people. As part of its comprehensive approach to pandemic
preparedness, HHS has also voiced support for improved vaccine
production methods and dose-sparing vaccine approaches such as the
use of adjuvants. "Chiron has invested in research and development
to improve global capabilities to combat both annual and pandemic
influenza," said Rino Rappuoli, chief scientific officer of Chiron
and head of Research for Chiron Vaccines. "Stockpiling is an
important primary step toward readiness for this potential threat.
We expect that our work with adjuvants and, longer-term, flu cell
culture, may also contribute to efforts to prevent a pandemic."
Chiron has studied H5N1 since the avian influenza virus first
emerged in Hong Kong in 1997. In addition to its stockpile
contract, Chiron will provide an H5N1 avian influenza vaccine
candidate for a study by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH) under HHS, later this year. The NIAID/NIH has also
completed a study of Chiron's H9N2 avian influenza vaccine
candidate, including the MF59 adjuvant, designed to enhance vaccine
effectiveness, and data will be forthcoming. H9N2, like H5N1, is a
potential pandemic influenza strain, which caused serious illness
in three people in Hong Kong in 1999 and 2003. About Pandemic
Influenza Pandemic influenza occurs when a new virus emerges that
is easily transmitted among humans and causes serious illness. In
this situation, the virus can result in a worldwide outbreak of
disease, or pandemic. Pandemic influenza occurred three times in
the last century, with the 1918 outbreak killing at least 40
million people, with a mortality rate of approximately 2.5 percent
in the United States. Avian influenza, or "bird flu," does not
normally infect humans, but there have been several examples in
recent years of transmission to people, leading to fears of a
strain with the potential to result in a pandemic. The current
outbreak of H5N1 avian influenza in Southeast Asia has resulted in
more than 100 human cases, in Cambodia, Indonesia, Thailand and
Vietnam, with a mortality rate of approximately 50 percent. Despite
the death or destruction of an estimated 150 million birds, the
virus is now considered endemic in a number of regions in Southeast
Asia. 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 of pandemic
influenza vaccines and adjuvants, revenue from stockpiling
programs, regulatory approvals, improvements to manufacturing
facilities, 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, litigation and investigations relating to
influenza vaccines, the outcome of clinical trials, regulatory
review and approvals, manufacturing capabilities, intellectual
property protections and defenses, litigation, stock-price and
interest-rate volatility, and marketing effectiveness. In
particular, there can be no assurance 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
increase sales of existing products, successfully develop and
receive approval to market new products (including pandemic
influenza vaccine), 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. NOTE:
FLUVIRIN is a registered trademark of Chiron.
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