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2025'01.24.Fri
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2007'10.03.Wed
Abbott's HUMIRA(R) (adalimumab) Honored With Prestigious Galen Prize for Innovation in Patient Care
September 28, 2007


Prix Galien USA Names HUMIRA Best Biotechnology Product

    ABBOTT PARK, Ill., Sept. 28 /Xinhua-PRNewswire/ --
Abbott (NYSE: ABT), a leader in the treatment of autoimmune
diseases, has received the 2007 Galen Prize for Best
Biotechnology Product for HUMIRA (R) (adalimumab), the
first approved fully human antibody.  HUMIRA is approved
for use in the treatment of moderate to severe rheumatoid
arthritis, psoriatic arthritis, ankylosing spondylitis and
moderate to severe Crohn's disease.  The Galen Prize,
considered an equivalent to the Nobel Prize and awarded by
Prix Galien USA, is one of the highest accolades in the
pharmaceutical and biomedical industry recognizing
excellence in medical and scientific research and
innovation.  

    This is the first year in which the award, founded in
France in 1970 and recognized as an international research
honor, has been expanded to recognize scientific innovation
from U.S. pharmaceutical and biotechnology companies
specifically.  Abbott won the prestigious Prix Galien
international award in 1999 for developing one of the first
protease inhibitors for the treatment of HIV.

    "Abbott is extremely honored to be a Galen Prize
recipient, as it recognizes our diligence in the discovery
and development of innovative treatments for immunologic
diseases," said John Leonard, M.D., vice president,
Global Medical and Scientific Affairs, Abbott. 
"HUMIRA has become an important treatment option for
many patients dealing with these diseases."  

    HUMIRA resembles antibodies normally found in the body
and works by specifically blocking tumor necrosis factor
alpha (TNF-alpha), a protein that when produced in excess,
plays a central role in the inflammation associated with
autoimmune diseases.  HUMIRA is a fully-human
self-administered biologic and 190,000 patients worldwide
are currently being treated.  

    "HUMIRA represents years of dedicated research as
part of our commitment to improve the human
condition," said Jochen Salfeld, Ph.D., divisional
vice president, Biologics Research, Abbott Bioresearch
Center, who played an instrumental role in the development
of HUMIRA.  "We believe that the potential exists for
HUMIRA to be effective in other diseases that have
significant unmet needs and we're continuing to pursue that
research in hopes of providing relief to patients
worldwide."

    About Prix Galien USA

    Founded in 1970 by French pharmacist Roland Mehl to
recognize his country's  outstanding medical
accomplishments, the award, named in honor of Galen, the
Greek father of medicine and pharmacology, has evolved into
Europe's leading honor for medical research and development
achievement and is considered an equivalent to the Nobel
Prize.  With the addition of the United States award, Prix
Galien is now in 11 countries.  Consistent with the
tradition of its founders, national judging panels must
include top scientists who are undisputed in their clinical
achievements and ability to evaluate cutting-edge medicine. 


    Important Safety Information About HUMIRA 

    Serious infections, sepsis, tuberculosis (TB) and
opportunistic infections, including fatalities, have been
reported with the use of TNF-blocking agents, including
HUMIRA.  Many of these serious infections have occurred in
patients also taking other immunosuppressive agents that,
in addition to their underlying disease, could predispose
them to infections.  Infections have also been reported in
patients receiving HUMIRA alone.  Treatment with HUMIRA
should not be initiated in patients with active infections.
 TNF-blocking agents, including HUMIRA, have been associated
with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus.  Some cases have been
fatal.  Patients at risk for HBV infections should be
evaluated for prior evidence of HBV infections before
initiating HUMIRA.  The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not
receive live vaccines.

    More cases of malignancies have been observed among
patients receiving TNF blockers, including HUMIRA, compared
to control patients in clinical trials.  These malignancies,
other than lymphoma and non-melanoma skin cancer, were
similar in type and number to what would be expected in the
general population.  

    There was an approximately 3.5 fold higher rate of
lymphoma in combined controlled and uncontrolled open-label
portions of HUMIRA clinical trials.  The potential role of
TNF-blocking therapy in the development of malignancies is
not known. TNF-blocking agents, including HUMIRA, have been
associated in rare cases with demyelinating disease and
severe allergic reactions.  Infrequent reports of serious
blood disorders have been reported with TNF-blocking
agents.  

    Worsening congestive heart failure (CHF) has been
observed with TNF-blocking agents, including HUMIRA, and
new onset CHF has been reported with TNF-blocking agents. 
Treatment with HUMIRA may result in the formation of
autoantibodies and rarely, in development of a lupus-like
syndrome.

    The most frequent adverse events seen in the
placebo-controlled clinical trials in adults with
rheumatoid arthritis (HUMIRA vs. placebo) were injection
site reactions (20 percent vs. 14 percent), upper
respiratory infection (17 percent vs. 13 percent),
injection site pain (12 percent vs. 12 percent), headache
(12 percent vs. 8 percent), rash (12 percent vs. 6 percent)
and sinusitis (11 percent vs. 9 percent).  Discontinuations
due to adverse events were 7 percent for HUMIRA and 4
percent for placebo.  As with any treatment program, the
benefits and risks of HUMIRA should be carefully considered
before initiating therapy.

    In HUMIRA clinical trials for ankylosing spondylitis,
psoriatic arthritis and Crohn's disease, the safety profile
for adult patients treated with HUMIRA was similar to the
safety profile seen in adult patients with rheumatoid
arthritis.
 
    About HUMIRA

    In the United States, HUMIRA is approved by the Food
and Drug Administration (FDA) for reducing signs and
symptoms, inducing major clinical response, inhibiting the
progression of structural damage, and improving physical
function in adult patients with moderately to severely
active rheumatoid arthritis.  

    HUMIRA is indicated for reducing the signs and symptoms
of active arthritis, inhibiting the progression of
structural damage and improving physical function in
patients with psoriatic arthritis.  HUMIRA can be used
alone or in combination with methotrexate or other
disease-modifying anti-rheumatic drugs (DMARDs).  

    HUMIRA is also approved for reducing signs and symptoms
in patients with active ankylosing spondylitis. 

    Earlier this year, HUMIRA was approved for reducing the
signs and symptoms and inducing and maintaining clinical
remission in adults with moderately to severely active
Crohn's disease who have had an inadequate response to
conventional therapy, and reducing the signs and symptoms
and inducing clinical remission in these patients if they
have also lost response to or are intolerant to
infliximab.

    Clinical trials are currently under way evaluating the
potential of HUMIRA in other immune-mediated diseases.

    Abbott's Commitment to Immunology 

    Abbott is focused on the discovery and development of
innovative treatments for immunologic diseases.  The Abbott
Bioresearch Center, founded in 1989 in Worcester, Mass.,
United States, is a world-class discovery and basic
research facility supporting research and development of
biologic treatments.  Abbott Biotechnology Limited, which
opened earlier this year in Barceloneta, Puerto Rico,
United States, is the main production facility for Abbott's
anti-TNF treatment and one of the world's largest centers
for production of monoclonal antibodies. 

    More information about HUMIRA, including full
prescribing information, is available on the web site
http://www.HUMIRA.com or in the United States by calling
Abbott Medical Information at 1-800-633-9110.

    About Abbott 

    Abbott is a global, broad-based health care company
devoted to the discovery, development, manufacture and
marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics.  The
company employs 65,000 people and markets its products in
more than 130 countries. 

    Abbott's news releases and other information are
available on the company's Web site at
http://www.abbott.com. 


    For more information, please contact:

    Abbott

     U.S. Media, Liz Shea
     Phone: +1-847-935-2211

     International Media, Tracy Sorrentino
     Phone: +1-847-937-8712

     Financial, John Thomas
     Phone: +1-847-938-2655
PR
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