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European Union Approves Adalimumab for the Treatment of Adult Rheumatoid Arthritis

ABBOTT PARK, Ill., Sept. 10 /PRNewswire-FirstCall/ -- Abbott Laboratories (NYSE:ABT) announced today that it has received approval from the European Commission to market HUMIRA(R) (adalimumab), previously known as D2E7, for the treatment of adult rheumatoid arthritis (RA) in Europe.

"We are excited about the European Union approval of HUMIRA as it brings new hope to the approximately two-and-a-half million people in Europe who suffer from this debilitating condition," said Guillermo Herrera, senior vice president, International Operations, Abbott Laboratories.

HUMIRA will be available at pharmacies in Germany and the United Kingdom within five days. Availability in other European Union (E.U.) countries will occur in subsequent months as each country adopts pricing and reimbursement policies. In recent months, the drug has been made available in Europe through patient named basis programs or clinical study protocols. Abbott filed for E.U. approval in April 2002 and received a positive opinion from the European Medicines Evaluation Agency (EMEA) in May 2003. HUMIRA received approval from the U.S. Food and Drug Administration on December 31, 2002, and since then in nine additional countries. Also in May, as a result of the strong physician uptake and positive patient response in the U.S., Abbott raised the global sales expectations of HUMIRA for this year from more than $200 million to more than $250 million.

The E.U. approval for HUMIRA was based on data obtained in four controlled clinical trials. In all, 23 trials have been conducted with HUMIRA, involving more than 2,400 RA patients worldwide. The drug's effectiveness was evaluated by measuring patients' improvement in RA signs and symptoms response scores. Safety also was assessed in these trials, which included one of the largest prospective safety trials of a TNF-antagonist. Some patients in trials have been taking HUMIRA for more than five years.

"The European approval of HUMIRA gives European RA patients a new option to control their disease that has been shown by the clinical data to be effective, safe and patient-friendly," said Paul Emery, M.D., ARC professor of rheumatology, Leeds University and Leeds University Teaching Hospitals Trust, United Kingdom. "The administration of HUMIRA is also convenient, being self- administered usually once every other week."

HUMIRA is the first human monoclonal antibody available in Europefor RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. In the E.U., HUMIRA is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. To ensure maximum efficacy, HUMIRA is given in combination with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-a, a protein that plays a central role in the inflammatory responses of autoimmune diseases such as RA.

In the ARMADA (Anti-TNF Research Study Program of the Monoclonal Antibody D2E7 in Patients with Rheumatoid Arthritis) trial, some patients on 40 mg every other week treatment experienced an improvement in RA signs and symptoms as early as one week (22 percent, 14/63 patients). These studies used a leading measure, the American College of Rheumatology (ACR) scores, as evidence of patient response. After four years of treatment, 63 percent of patients receiving HUMIRA 40 mg every other week achieved an ACR 20 response, 50 percent achieved an ACR 50 response and nearly one in four (24 percent) achieved an ACR 70 response.

More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of hands, feet and wrists and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joint's interior and the surrounding bone. The long-term prognosis for patients with RA is poor, and as a result, many patients face increased disability and premature death.

The recommended dose of HUMIRA is 40 mg every other week by subcutaneous injection (a shot beneath the skin). Abbott will offer HUMIRA in specially designed pre-filled syringes so patients do not have to mix and measure the medicine, or leave their homes for treatment. The pre-filled syringe features handles and a plunger head designed for use by patients whose hands have been affected by their RA disease.

Important Safety Information
Common adverse events ( > 1/100 and 1/10 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 infections are 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.

HUMIRA should be used with caution in patients with mild heart failure, and is contraindicated in patients with moderate or severe heart failure. HUMIRA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.

Source: Abbott Laboratories

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