Baxter Advances to Full-Scale Production of A/H1N1 Vaccine
Baxter Advances to Full-Scale Production of A/H1N1 Vaccine
Anticipates Delivery As Early As July
Business Wire
DEERFIELD, Ill. -- June 12, 2009
Baxter International Inc. (NYSE: BAX) announced today that it has completed
testing and evaluation of the A/H1N1 influenza virus and is now in full-scale
production of a commercial A/H1N1 vaccine using its Vero cell culture
technology. Baxter received an A/H1N1 strain from the U.S. Centers for Disease
Control and Prevention [a World Health Organization (WHO) Collaborating
Center] in early May and is diligently working to deliver a pandemic vaccine
for use as early as July.
WHO raised the pandemic alert level to phase 6, indicating a global influenza
pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and
other global public health authorities regarding the pandemic. A number of
national public health authorities have existing pandemic agreements with
Baxter that allow them to place orders for a vaccine now that a pandemic has
been declared by WHO. These public health authorities will be evaluating their
needs to determine their orders for vaccine supply. Despite the company’s
existing obligations to supply vaccine under a pandemic phase 6 alert, Baxter
is also committed to working with WHO to allocate a portion of the company’s
commercial production to address global public health issues deemed most
urgent.
Using its Vero cell technology, Baxter has received European Medicines Agency
(EMEA) approval for a mock-up pandemic vaccine called CELVAPAN, the brand name
for the company’s pandemic vaccine. The qualification, development and
manufacturing processes used in gaining mock-up licensure for CELVAPAN apply
as the company uses this new influenza A/H1N1 virus strain to produce a
pandemic vaccine. The CELVAPAN EMEA licensure supports fast track approval of
a pandemic vaccine containing the A/H1N1 virus strain. Baxter will submit the
A/H1N1 vaccine for approval upon completion of initial manufacturing runs.
Baxter’s research and development, manufacturing capabilities and pandemic
planning expertise allow the company to efficiently develop candidate vaccines
against potentially emerging influenza viruses. Baxter believes that its Vero
cell technology can be used to safely and reliably produce a vaccine in
response to this global public health issue. It is possible that Baxter’s Vero
cell technology may offer advantages, in that it may allow more rapid
production and delivery of pandemic vaccines.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures
and markets products that save and sustain the lives of people with
hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and
other chronic and acute medical conditions. As a global, diversified
healthcare company, Baxter applies a unique combination of expertise in
medical devices, pharmaceuticals and biotechnology to create products that
advance patient care worldwide.
This release includes forward-looking statements concerning the company’s
vaccines products, including with respect to potential delivery timelines. 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: continued success in advancing a new
technology through full-scale production, including with respect to steps
required for finishing and release; remaining regulatory approvals;
governments’ decisions with respect to orders; and other risks identified in
the company’s most recent filing on Form 10-K and other Securities and
Exchange Commission filings, all of which are available on the company's
website. The company does not undertake to update its forward-looking
statements.
Contact:
Baxter International Inc.
Media Contact:
Kym White, (847) 948-2304
or
Investor Contacts:
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085
Last Updated: June 12, 2009 15:00 EDT
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