Prix Galien USA Names HUMIRA Best Biotechnology Product
ABBOTT PARK, Ill., Sept. 27 /CNW/ -- 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
"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
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
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
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
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
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.
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
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.
For further information:
For further information: U.S. Media, Liz Shea, +1-847-935-2211, or
International Media, Tracy Sorrentino, +1-847-937-8712, or Financial, John
Thomas, +1-847-938-2655, all of Abbott Web Site: http://www.abbott.com