Press Release Template - Baxter

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Kym White, (847) 948-2304
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BAXTER RECEIVES EMEA POSITIVE OPINION FOR CELVAPAN H1N1
PANDEMIC INFLUENZA VACCINE
DEERFIELD, Ill., October 2, 2009 — Baxter International Inc. (NYSE: BAX)
today announced that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMEA) granted its “positive opinion” for CELVAPAN
H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion
confirms the acceptability of Baxter’s regulatory submission to obtain final marketing
authorization and licensure of the product.
Corporate News
Baxter International Inc.
One Baxter Parkway
Deerfield, IL 60015
CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted vaccine to
receive a positive opinion in the European Union. Initial quantities of vaccine have
already been delivered to a number of countries, including the UK and Ireland, for use in
their national vaccination programs, and are awaiting product release subject to final
marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of CELVAPAN
H1N1 in clinical trials. The company is conducting two randomized trials in 400 healthy
adults age 18 and over and in 400 children and adolescents to supplement the licensure
post-approval with appropriate clinical data. These trials are evaluating the safety and
immunogenicity of the vaccine at dose levels of 7.5µg and 3.75µg. Once countries
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BAXTER RECEIVES EMEA POSITIVE OPINION FOR CELVAPAN H1N1 PANDEMIC FLU VACCINE
VACCINE Page 2
initiate national vaccination programs using CELVAPAN H1N1, Baxter will also conduct
a large-scale observational study with CELVAPAN in 9,000 people of different age
groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well
tolerated in these age groups. The observed systemic and local reactions are similar to
those generally experienced after vaccination with licensed seasonal influenza
vaccines. Immunogenicity data from the first vaccination in adults are due later this
month. The current dosing schedule, as specified in the EMEA mock-up licensure for
CELVAPAN using another virus strain, calls for two 7.5 µg doses of vaccine to be given
21 days apart. Baxter expects the data from the trial of healthy adults to indicate
whether a single dose may be possible for CELVAPAN H1N1. This study will also
determine whether a lower dose, 3.75µg, is sufficient to induce the necessary immune
response.
"We are pleased that the regulatory submission and the preliminary clinical trial
data uphold the extensive work done by Baxter and the support received from key
Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D.,
vice president of global research and development for Baxter BioScience. “We are
looking forward to analyzing the immunogenicity data for our cell culture-derived, non-
adjuvanted vaccine to assess the potential of a one dose regimen.”
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Earlier this year, the EMEA granted mock-up licensure for CELVAPAN using a
different strain with pandemic potential, which was tested in five completed clinical trials
worldwide in more than 1,300 people. In addition, more than 3,500 people have been
vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure
is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004.
This pathway allows for the development, evaluation and licensure of a company’s

BAXTER RECEIVES EMEA POSITIVE OPINION FOR CELVAPAN H1N1 PANDEMIC FLU VACCINE
VACCINE Page 3
pandemic candidate vaccine using an available influenza strain that has the potential to
cause a pandemic. Once a pandemic is declared and the influenza virus strain causing
the pandemic is identified, the mock-up licensure allows for fast track approval of a
pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers
for Disease Control and Prevention (a WHO Collaborating Center) in early May. The
company then undertook pre-production testing and evaluation of the virus strain to
assess its growth characteristics in the company’s proprietary Vero cell culture
technology.
Baxter initiated commercial production in early June, and made its first
commercial product within 12 weeks of receipt of the virus. The company produces
bulk CELVAPAN H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech
Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and
finish before distribution. Baxter completed production of the first batches of
CELVAPAN H1N1 vaccine in late July and initiated its first delivery within two weeks.
The company continues to deliver vaccine on an ongoing basis to national public health
authorities.
Baxter initiated its license application for CELVAPAN H1N1 in July based on the
EMEA published guidelines for pandemic vaccine marketing authorization. The
company conducted rigorous testing of the H1N1 based vaccine and submitted
additional data for vaccine development, product quality and manufacturing processes
specific to that strain. Other non-E.U. countries may choose to evaluate the company’s
EMEA submission and licensure as the basis for their national health authority’s
authorization for use of the vaccine.
More information on CELVAPAN H1N1 clinical trials is available at
http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1

BAXTER RECEIVES EMEA POSITIVE OPINION FOR CELVAPAN H1N1 PANDEMIC FLU VACCINE
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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 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, release, shipment, and customer acceptance;
remaining regulatory approvals; governments’ continuing 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.
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