Baxter International Inc. (NYSE: BAX) announced publication in the June
12, 2008 issue of The New England Journal of Medicine (NEJM) of data
demonstrating Baxter's candidate avian influenza (H5N1) vaccine, CELVAPAN,
met Phase I/II trial endpoints for safety and immunogenicity (generating a
functional immune response). This is the first peer-reviewed publication of
study results for CELVAPAN, the first cell culture-derived avian influenza
vaccine to undergo clinical evaluation. The primary authors of the manuscript
are Hartmut J. Ehrlich, MD, vice president of global research and development
for Baxter's BioScience business, and Noel Barrett, vice president of
Baxter's vaccines research.
"Cell culture technology could represent the future of influenza vaccine
production," said John Oxford, professor of Virology, The Queen Mary School
of Medicine, London, United Kingdom. "Baxter has demonstrated the ability to
rapidly make large quantities of the vaccine that may protect people against
divergent H5N1 viruses."
Based on manufacturing processes, Vero cell technology may offer several
advantages versus conventional egg-based vaccine technology. Baxter's Vero
cell manufacturing process is more rapid due to its ability to use a "native"
virus that does not need to be modified to allow growth in chicken eggs,
therefore accelerating vaccine production.
"CELVAPAN combines innovative science and breakthrough production
technology with the aim of protecting people against an H5N1 pandemic flu
infection," said Hartmut J. Ehrlich, MD. "This is an immunogenic vaccine
without the need for an adjuvant to boost the immune response."
About CELVAPAN
CELVAPAN is manufactured in a cell culture-based system in Bohumil, Czech
Republic, at one of the largest cell culture vaccine production facilities in
the world. Vero cell technology uses a well-established cell line originally
derived from African green monkey kidneys in 1962. A continuous cell line has
been derived from these cells so that an unlimited supply of cells is
available without the requirement of generating additional cells from
animals.
Baxter's candidate avian flu vaccine is derived from the H5N1 strain
A/Vietnam/1203/2004. Its antigen composition and structure are identical to
the actual virus circulating in nature without the need to enhance an immune
response by including adjuvants, additives that may cause side effects. In
this Phase I/II study, CELVAPAN induced an immune response that is similar to
the body's defense against a natural virus infection. Earlier this year
CELVAPAN was accepted for licensure review by the Committee for Medicinal
Products for Human Use within the European Medicines Agency, making it the
first cell culture-based pandemic influenza vaccine to be reviewed by the
regulatory authority. The U.S. National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health, is also
conducting a trial with Baxter's CELVAPAN in the United States.
Phase I/II Clinical Trial Results
The randomized Phase I/II study enrolled 284 subjects in Austria and
Singapore (ages 18-45) and met its immunogenicity and safety endpoints. The
study mainly investigated the ability of the vaccine to induce substantial
levels of cross-immunity against divergent H5N1 strains.
The trial tested four different antigen concentrations ranging from 3.75
micrograms to 30 micrograms; 7.5 micrograms and 15 micrograms formulations
were studied with and without adjuvant (additive). Statistically, the
non-adjuvanted formulations induced the highest rates of subjects with a
titer (antibody concentration in the blood) more than 1:20 after the first
(40.5 percent and 39.5 percent for 7.5 micrograms and 15 micrograms) and
second (76.2 percent and 70.7 percent for 7.5 micrograms and 15 micrograms)
vaccinations, demonstrating this vaccine generates a robust immune response.
Regarding seroconversion (development of antibodies) or the percent of
subjects demonstrating a more than four-fold increase in titer after
immunization, the highest responses were again seen with the 7.5 micrograms
and 15 micrograms non-adjuvanted formulations, with 69.0 percent and 68.3
percent seroconversion, respectively.
High levels of cross-reactivity were demonstrated against the A/Hong Kong
strain with the 7.5 micrograms and 15 micrograms non-adjuvanted formulations
(76.2 percent and 78.0 percent, respectively, with neutralizing titer more
than 1:20). The responses against the clade 2 strain were somewhat lower
(45.2 percent and 36.6 percent with NT titers greater than or equal to 1:20
for the 7.5 micrograms and 15 micrograms non-adjuvanted formulations,
respectively). This demonstrates the ability of the vaccine to induce
cross-reactive immune responses against divergent H5N1 strains.
The most common side effects were injection site reactions, headaches and
fatigue, and the most common local reaction was pain at the injection site.
Baxter's Pre-Pandemic Planning Efforts
Baxter works closely with governments worldwide on pandemic preparation.
The company has delivered several million doses of CELVAPAN to various
governments around the world. 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. The company also delivered a stockpile of two million doses of
CELVAPAN to the U.K. Department of Health as part of an agreement announced
in February 2006. To improve access to treatment in developing countries,
Baxter also supports the World Health Organization's pandemic planning
programs through participation in a planned international stockpile program.
Baxter is also working with the NIAID in partnership with Fisher
BioServices Inc., and with the U.S. Department of Health and Human Services
in partnership with DynPort Vaccine Company LLC (DVC LLC), a Computer Science
Corporation Company, to further develop Vero cell culture-based candidate
pandemic and seasonal influenza vaccines. Baxter is working with the U.S.
Department of Health and Human Services, in partnership with DVC LLC, on a
seasonal Phase III clinical trial that is currently underway in the United
States and also plans to initiate a pandemic Phase I trial later this year in
the United States with an H5N1 reverse genetic reassorted (RG) Indonesia
strain vaccine. Baxter is also working with the NIAID in partnership with
Fisher BioServices Inc. on a Phase I trial in the United States using the
H5N1 Vietnam strain.
About Pandemic Flu
A pandemic is a global disease outbreak of a virus for which there is
little or no immunity in the human population, causing serious illness and
spreading easily person-to-person worldwide. Most cases of avian flu
infection in humans have resulted from direct or close contact with infected
poultry (e.g., domesticated chicken, ducks, and turkeys) or surfaces possibly
contaminated from feces of infected birds. Avian influenza infection follows
an unusually aggressive clinical course, with rapid deterioration and high
fatality. Primary viral pneumonia and multi-organ failure have been common
among people who have become ill with avian influenza.
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other indications. 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, licensures, 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: satisfaction of regulatory and other requirements
for timely commencement of additional clinical trials; 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 including additional experience
producing such vaccines at a large scale; 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
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