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Biopharmaceuticals Regulatory

 News Release - June 7, 2006

Abbott's HUMIRA(R) (Adalimumab) Approved in the European Union for Treatment of Severe Ankylosing Spondylitis

EU Approval Marks Third for HUMIRA in Treating Autoimmune Diseases

ABBOTT PARK, Ill., June 7 (HSMN NewsFeed) -- Abbott announced that it has received approval from the European Commission to market HUMIRA® (adalimumab) as a treatment for severe, active ankylosing spondylitis (AS) in Europe. AS is a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pain and stiffness, but is also associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation. It is estimated that nearly three million people in Europe are affected by a spinal arthritic disease such as AS.

This is the third in a series of autoimmune diseases targeted for HUMIRA therapy. HUMIRA also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis. This approval follows a positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Abbott's application for HUMIRA for AS in the United States is currently under review.

"This approval of HUMIRA in the European Union is important in the treatment of ankylosing spondylitis, a debilitating disease that strikes young, mostly male patients in their thirties and forties," said Desiree van der Heijde, M.D., co-lead investigator of the ATLAS Phase III clinical trial and Professor of Rheumatology at the Maastricht University, The Netherlands. "Treatments like HUMIRA are changing how we can treat AS. The data in the clinical trial showed that treatment with HUMIRA significantly reduced the pain and inflammation caused by AS, and in some patients, led to partial remission."

HUMIRA will be available immediately to patients with ankylosing spondylitis in several EU countries, including Germany, Spain, Finland and Denmark. Availability in other EU countries will occur in subsequent months as each country adopts pricing and reimbursement policies.

Unlike many other rheumatic conditions, AS affects mostly young men, and commonly begins before the age of 35. AS is difficult to diagnose in its early stages and is the most overlooked cause of persistent back pain in young adults.

Clinical Trial Results

The approval of HUMIRA for the treatment of AS is based on data from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) trial. ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in Europe and the United States. Results showed that HUMIRA was successful in reducing pain and inflammation in patients with AS -- the study's primary endpoint. Other findings demonstrated the efficacy of HUMIRA in many patients in reducing disease activity, inducing partial remission, improving physical function and improving physical quality of life.

"Today's approval of HUMIRA as a treatment for severe, active ankylosing spondylitis marks another milestone for Abbott, and more importantly for patients, in providing new treatment options for this potentially debilitating autoimmune disease," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "Tens of thousands of Europeans with rheumatoid arthritis and psoriatic arthritis have been prescribed HUMIRA. Now thousands of Europeans with AS have the option of HUMIRA as well."

A similar rate of treatment emergent adverse events leading to discontinuation of study drug was observed among placebo-treated (1.9 percent) and HUMIRA-treated (1.4 percent) patients. The overall incidence of adverse events reported by patients treated with HUMIRA was higher than the placebo treatment patients. The most common adverse events included nasopharyngitis, injection site reactions and headache.

About Ankylosing Spondylitis

Ankylosing spondylitis (AS), or arthritis of the spine, is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha, has been suggested to play a role in the disease development. AS is a form of arthritis known as spondyloarthritis, which is a group of closely linked rheumatic diseases that can cause pain in the spine and joints as well as ligaments and tendons, and also can cause inflammation that predisposes patients to spinal vertebrae fractures. AS is a chronic disease that primarily affects the spine causing back stiffness and deformity over time.

AS is associated with a number of extra-axial manifestations including peripheral arthritis and enthesitis (inflammation of the muscle-bone insertion). Other associated affected organ systems may include the eyes, intestines and skin.

Important Safety Information

Common adverse events (occurring in 1-10%) at least possibly related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), urinary tract infection, herpetic viral infection (including simplex and zoster), influenza, superficial fungal infections (including skin, nail and foot), lymphopenia, anemia, headache, dizziness, paraesthesias, hypertension, cough, nasopharyngeal pain, nasal congestion, nausea, abdominal pain, diarrhea, dyspepsia, mouth ulceration, rash erythematous, rash pruritic, hair loss, arthritis, fatigue (including asthenia and malaise), influenza like illness, hepatic enzymes increased (including alanine aminotransferase and aspartate aminotransferase), rash and pruritis. Upper respiratory infection and injection site reaction (including pain, swelling, redness or pruritis) were reported by more than 10% of patients.

Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until their infection is controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.

Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.

About HUMIRA

Rheumatoid Arthritis: HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate as well as for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment of methotrexate is inappropriate.

HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Psoriatic Arthritis: HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

Ankylosing Spondylitis: HUMIRA is indicated for the treatment of adults with severe, active ankylosing spondylitis, who have had inadequate response to conventional therapy.

To date, HUMIRA has been approved in 65 countries and prescribed to more than 150,000 patients worldwide. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

About Abbott

Abbott (NYSE: ABT ) 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 .


Source: Abbott

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