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Baxter Awarded Pandemic Advanced Supply Contract From The Department Of Health
Baxter
International Inc. (NYSE: BAX) announced today that Baxter's European
subsidiary in the United Kingdom has entered into an advanced supply
agreement with the Department of Health that contains an option to purchase
pandemic influenza vaccine in the event the World Health Organization (WHO)
declares a pandemic.
Baxter will manufacture its pandemic vaccine in a serum-free, vero
cell-based system, at one of the largest cell culture vaccine facilities in
the world. The use of vero cell culture, rather than conventional egg-based
technology, offers several advantages. Baxter's vero cell culture process
can be initiated more rapidly due to its use of a "native" virus that does
not need to be modified to allow growth in eggs, thus accelerating vaccine
availability. Vaccines produced using this process can be released within
approximately 12 weeks, significantly earlier than with traditional
egg-based systems. In addition, all influenza strains with pandemic
potential tested for growth in vero cells have produced replicable high
yields, providing the company with the flexibility to quickly respond to
emerging variant pandemic virus strains.
"We are proud to provide the necessary technology, manufacturing
capability and other resources to assist the Department of Health in its
efforts to protect the UK population from the threat of a flu pandemic,"
said Kim Bush, president of Baxter's vaccines business.
Baxter is conducting clinical testing of the adjuvant-free candidate
H5N1 (avian) influenza vaccine. A Phase I/II study in Europe indicated that
study subjects administered Baxter's H5N1 candidate vaccine developed
excellent antibody responses at doses as low as 3.75 micrograms and
substantial levels of cross immunity against widely divergent H5N1 strains.
In the study, the tolerability profile of Baxter's H5N1 candidate appeared
to be similar to that of seasonal flu vaccines. Baxter recently completed
enrollment in a 550 subject Phase III trial of the H5N1 candidate vaccine
for mock-up licensure in Europe, with data from this clinical study
expected to be available in late 2007. By this time, Baxter is planning to
initiate an additional large Phase III clinical study intended to satisfy
all European requirements for pre-pandemic licensure. Baxter is also
working with the U.S. National Institute of Allergy and Infectious
Diseases, part of the National Institutes of Health, in partnership with
Fisher BioServices Inc., and with the U.S. Department of Health and Human
Services, in partnership with DVC LLC, a Computer Science Corporation
Company, to further develop vero cell culture-based candidate pandemic and
seasonal influenza vaccines in the United States.
Baxter's candidate vaccine's antigen composition and structure closely
resembles the actual pathogen circulating in nature. The candidate vaccine
induces an immune response that is similar to the body's defense against a
natural virus, without the need to incorporate additional agents
(adjuvants) to enhance immune response. It is believed that adjuvants may
contribute to additional side effects in vaccines.
Supporting Pandemic Preparedness
In addition to pursuing a rapid clinical development program, Baxter is
working closely with governments around the world on pandemic preparation.
Baxter has already delivered several million doses of H5N1 pre-pandemic
vaccine to various governments worldwide. In 2006, Baxter entered into a
pandemic preparedness contract with the Austrian Ministry of Health to
supply 16 million doses of pandemic influenza vaccine in the event a
pandemic is declared.
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including cancer, hemophilia, immune disorders, kidney disease
and trauma. The company applies its expertise in medical devices,
pharmaceuticals and biotechnology to make a meaningful difference in
patients' lives.
This release includes forward-looking statements concerning the
company's vaccine products, including with respect to clinical trials,
additional stockpiles, and the advantages of the vaccine products. The
statements are based on assumptions about many important factors, including
the following, which could cause actual results to differ materially from
those in the forward-looking statements: additional clinical results
demonstrating the safety and efficacy of the products; market acceptance of
vaccines developed with vero cell technology relative to egg-based or other
alternatives; continued public commitment to addressing avian flu and other
pandemic threats; and other risks identified in the company's most recent
filing on Form 10-Q and other SEC filings, all of which are available on
the company's web site. The company does not undertake to update its
forward-looking statements.
Baxter International Inc.
http://www.baxter.com
Baxter atribuit contract de furnizare de pandemie avansat de la Departamentul de sãnãtate - Baxter Awarded Pandemic Advanced Supply Contract From The Department Of Health - articole medicale engleza - startsanatate