Chiron (NASDAQ:CHIR)
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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.