HUMIRA(R) (Adalimumab) Receives FDA Approval for Treatment of Psoriatic Arthritis

Abbott (NYSE: ABT)
announced today that the U.S. Food and Drug Administration (FDA) approved
HUMIRA(R) (adalimumab) for reducing signs and symptoms of active arthritis in
patients with psoriatic arthritis, a chronic disease that combines the
symptoms of arthritis, including joint pain and inflammation, with those of
psoriatic skin disease, such as dry, scaly skin. Psoriatic arthritis (PsA) is
a serious autoimmune disease and few available treatment options address the
potentially devastating combination of symptoms affecting both the skin and
joints. Psoriatic arthritis is the first new disease indication for HUMIRA
beyond rheumatoid arthritis (RA) and is one of the five autoimmune diseases
Abbott is studying for HUMIRA therapy.
"The pain of psoriatic arthritis combined with the social stigma of its
visible symptoms places a huge burden on people living with this disease,"
said Gail M. Zimmerman, president and chief executive officer of the National
Psoriasis Foundation. "The symptoms can be debilitating and some patients
experience diminished quality of life that may leave them feeling depressed
and socially isolated. The HUMIRA approval brings another effective treatment
option and hope for patients with this potentially devastating disease."

HUMIRA in Psoriatic Arthritis
The HUMIRA approval is based on results of the Adalimumab Effectiveness in
Psoriatic Arthritis Trial (ADEPT), which is the largest biologic trial in PsA.
ADEPT studied 313 adult patients with moderately to severely active PsA who
had an inadequate response to NSAID (non-steroidal anti-inflammatory drug)
therapy. HUMIRA patients experienced significantly greater improvement in
both joint and skin disease symptoms than placebo-treated patients at
24 weeks. Improvements in both skin lesions and joint symptoms were seen as
early as two weeks after initiation of treatment and continued to improve over
time.
Patients' arthritic symptoms also responded to HUMIRA, with nearly 60
percent of patients achieving ACR20 at week 12, one of the study's primary
endpoints, and with a sustained response through week 24. ACR70, a more
stringent response criterion, was achieved by nearly 25 percent of patients
treated with HUMIRA vs. 1 percent of patients treated with placebo at week 24.
American College of Rheumatology (ACR) scores measure the percentage of
improvement in tender and swollen joint count and several other clinical
measures.
"Clinical improvement in arthritic symptoms that can lead to disability as
well as the pain and stiffness that keeps patients from functioning normally
was rapid and significant with HUMIRA," said rheumatologist Philip Mease,
M.D., Swedish Medical Center and University of Washington School of Medicine,
Seattle, and lead investigator of the ADEPT study.
Clinical trial data from ADEPT showed the ability of HUMIRA to improve
both the skin and joint symptoms associated with psoriatic arthritis. Among
the 69 patients in the trial who had skin lesions involving greater than
3 percent body surface area (the palm of an adult hand represents
approximately 1 percent of the body's skin surface) who were treated with
HUMIRA, three out of four achieved PASI 50 (75 percent), three out of five
achieved a PASI 75 (59 percent) and two out of five (42 percent) achieved a
PASI 90 response at 24 weeks, which reflects at least 50, 75 or 90 percent
improvement in skin symptoms assessed by the Psoriasis Area and Severity Index
(PASI).
"The skin symptoms of psoriatic arthritis can severely affect patients'
day-to-day lives," said Dermatologist Kenneth Gordon, M.D., incoming
co-director of Dermatology, Evanston Northwestern Healthcare. "The approval
of HUMIRA gives patients access to a medication that can significantly impact
skin symptoms and allow them to engage in everyday activities again, such as
shaking hands when closing a business deal or going to a public pool."
"After taking HUMIRA, my skin improved for the first time in years," said
Annie Escalona, a native of Seattle and hiking enthusiast. "My joint pain
kept getting better and my skin was much clearer. I can now wear a backpack,
swim and enjoy activities I would have never dreamed of doing just a few years
ago."
The recommended dose of HUMIRA for psoriatic arthritis is 40 mg every
other week by subcutaneous injection (a shot beneath the skin), the usual dose
used for HUMIRA in the treatment of moderate to severe RA.
The rates of adverse events and serious adverse events in the ADEPT trial
were comparable with other HUMIRA RA clinical trials. Among patients taking
HUMIRA, the most common adverse events (those affecting at least 5 percent of
patients) were upper respiratory infection, nasopharyngitis, injection site
reaction, headache and hypertension. The safety profile of HUMIRA in the
ADEPT clinical trial was similar to that observed in the HUMIRA RA clinical
trials.
Abbott simultaneously submitted applications with the FDA and the European
Medicines Agency seeking approval to market HUMIRA to treat psoriatic
arthritis and early moderate to severe RA in December 2004. Abbott also
announced today FDA approval for HUMIRA for moderate to severe early RA and
received European approval for psoriatic arthritis and early severe RA on
Aug. 8, 2005.

About Psoriatic Arthritis
Psoriatic arthritis combines skin symptoms, such as dry, scaly skin and
patches of red, raised skin known as plaques, with arthritis symptoms
including joint pain and inflammation. Common symptoms of psoriatic arthritis
include varying degrees of skin involvement along with stiffness, pain,
swelling and tenderness of the joints that can lead to a reduced range of
motion and potential severe joint destruction.
Left untreated, psoriatic arthritis can be a progressively disabling
disease. The arthritic manifestations often include debilitating disease of
the hands and feet, as seen in rheumatoid arthritis, as well as painful
inflammation of the tendon insertions and arthritis of the spine. Psoriatic
arthritis is most often found in patients who suffer from psoriasis, a chronic
skin disease that affects nearly 3 percent of the world's population. It is
estimated that up to 30 percent of people with psoriasis also develop
psoriatic arthritis.
Like RA, psoriatic arthritis is an autoimmune disorder in which a human
protein, tumor necrosis factor-alpha (TNF-alpha), has been suggested to play a
role in disease development. HUMIRA, which is a fully human monoclonal
antibody that resembles antibodies normally found in the body, works by
specifically blocking TNF-alpha.

Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving
HUMIRA. Serious infections and sepsis, including fatalities, have been
reported with the use of TNF-blocking agents, including HUMIRA. Many of these
infections occurred in patients also taking other immunosuppressive agents
that in addition to their underlying disease could predispose them to
infections. Treatment with HUMIRA should not be initiated in patients with
active infections. The combination of HUMIRA and anakinra is not recommended.
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. 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 four 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.
The most frequent adverse events seen in the placebo-controlled clinical
trials in 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.
The safety profile for patients with psoriatic arthritis treated with
HUMIRA in the clinical trials has been similar to the safety profile seen in
patients with RA.

About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for
reducing the signs and symptoms, inducing major clinical response, inhibiting
the progression of structural damage, and improving physical function in
adults with moderately to severely active rheumatoid arthritis (RA). HUMIRA
can be used alone or in combination with methotrexate or other DMARDs.
Clinical trials are currently underway evaluating the potential of HUMIRA
in other autoimmune 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 committed to finding new treatments for autoimmune
diseases. More information about Abbott Immunology and HUMIRA, including full
prescribing information, is available on the Web sites http://www.rxabbott.com
and 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 more than 60,000 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.

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