Chiron Announces Pandemic Influenza Vaccine Contract with the UK Government; Chiron Submits Pandemic Influenza Vaccine ``Mock-U
February 24 2006 - 3:01PM
Business Wire
Chiron Corporation (NASDAQ:CHIR) today announced that it has
entered into a supply contract with the UK government for
pre-pandemic influenza vaccine(1) for a stockpile based on the H5N1
avian influenza virus strain. Health authorities have identified
H5N1 avian influenza as a strain with pandemic potential. Under the
UK contract, Chiron has agreed to supply the British government
with H5N1 avian influenza vaccine containing Chiron's MF59
adjuvant. An adjuvant is a substance that is added to a vaccine to
boost the body's immune response to the vaccine's active
constituent, called the antigen. Delivery of the stockpile remains
subject to internal and regulatory release procedures. The UK
stockpile vaccine is based on an inactivated influenza strain
similar to the H5N1 avian subtype that has circulated throughout
Southeast Asia and more recently in Central Asia and parts of
Europe. Chiron will produce vaccine for this stockpile at its
manufacturing facilities in Italy. As part of its avian influenza
vaccine strategy, Chiron expects that it can manufacture avian
influenza vaccines during the traditional break between seasonal
influenza vaccine campaigns, finishing these activities in time for
the seasonal influenza vaccine production to avoid interruption of
the normal manufacturing cycle. As with other influenza
manufacturers participating in stockpiling efforts, Chiron has also
submitted a "mock-up" file for pandemic influenza vaccine
containing its MF59 adjuvant to the European Medicines Agency
(EMEA). The mock-up file lays the groundwork for potentially a more
rapid approval of a vaccine once a pandemic occurs. As part of this
process, Chiron has submitted to the EMEA information on its
regulatory and development work for a pandemic influenza vaccine.
Chiron's mock-up file is based on previous avian influenza vaccine
clinical studies and will be augmented with an upcoming study of
H5N1 vaccine to take place in Italy this year. All of the studies
for the mock-up file involve Chiron's MF59 adjuvant. Assuming the
mock-up file gains approval, in the event of a pandemic Chiron
could submit a revision to the mock-up file for the relevant
pandemic strain. 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, please visit
www.chiron.com. About Chiron Vaccines Chiron Vaccines, the world's
fifth-largest vaccines business, is headquartered in Oxford, United
Kingdom, and has facilities located throughout Europe, the United
States and Asia. Chiron Vaccines is the world's second-largest
manufacturer of flu vaccines and has important meningococcal,
pediatric and travel vaccine franchises. The company's portfolio of
products includes vaccines for influenza, meningococcus C, rabies,
tick-borne encephalitis, Haemophilus influenzae B (Hib), polio,
mumps, measles and rubella (MMR) and diphtheria, tetanus and
pertussis (whooping cough). This news release contains
forward-looking statements, including statements regarding
development and manufacturing of pandemic influenza vaccines and
adjuvants, revenue from stockpiling programs, production and
release of stockpile H5N1 vaccine for the United Kingdom,
regulatory approvals, and the successful and timely completion of
the internal and regulatory release procedures, 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 September 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 and issues,
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 successfully develop, manufacture and
receive approval to market new products (including H5N1 and other
pandemic influenza vaccines), or achieve market acceptance for such
new products, or that the internal and regulatory release
procedures for the UK stockpile will be completed timely or
successfully. The company may face additional competition in the
influenza market in the future and challenges in distribution
arrangements as a result of vaccine developments. Chiron does not
undertake an obligation to update the forward-looking information
the company is giving today. (1) The stockpile vaccine is for
government supply and is not approved for general sale.
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