Abbott Laboratories Receives Positive Opinion for HUMIRA(R) Rheumatoid Arthritis Label Extension From European Medicines Evaluation Agency - Extension to Incorporate Reduction in the Rate of Joint Damage Progression and Improvement in Physical Function in Adults With RA - ABBOTT PARK, Ill., May 6 /PRNewswire-FirstCall/ -- Abbott Laboratories today announced that the European Medicines Evaluation Agency (EMEA) has granted a positive opinion for HUMIRA(R) (adalimumab) label extension for reducing the rate of progression of joint damage as measured by X-ray and improving physical function in adults with rheumatoid arthritis (RA), when given in combination with methotrexate. This positive opinion comes seven months after European Commission approval to market HUMIRA and provides new information for physicians and patients as they consider options for treating RA. In the United States, HUMIRA was approved Dec. 31, 2002, for both reducing signs and symptoms of RA and inhibiting the progression of structural damage. In October 2003, Abbott submitted a supplemental Biologics Licensing Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of HUMIRA to improve physical function in patients with moderately to severely active RA. The positive opinion from EMEA is based on clinical data from one study with RA patients with a mean disease duration of approximately 11 years that showed a statistically significant difference for change in modified total Sharp score, which assesses bone erosion and joint-space narrowing by looking at patient X-rays. This score was measured at six months, and was maintained at 12 months for patients in the study treated with HUMIRA 40 mg every other week and methotrexate. Improvements were maintained through two years of HUMIRA treatment. Patients receiving HUMIRA and methotrexate demonstrated less radiographic progression at one year than patients receiving methotrexate alone. Improvements in physical function and quality of life, as measured by a patient's ability to perform normal daily activities, such as getting dressed, walking and climbing stairs, were established and maintained with HUMIRA through two years of HUMIRA treatment in this study. RA patients who received HUMIRA and methotrexate saw less bone erosion and joint-space narrowing at six and 12 months than patients taking only methotrexate. Researchers assessed bone erosion and joint-space narrowing using Sharp scores. "One important measure of an RA treatment's success is its ability to slow the devastating joint and bone damage that occurs in so many RA patients. This destruction has a direct impact on long-term quality of life for patients," said Ferdinand C. Breedveld, M.D., a professor of rheumatology at Leiden University, Leiden, Netherlands, and chairman of the department of medicine at the Leiden University Medical Center. Abbott originally received a positive opinion from the EMEA in May 2003 for the treatment of adult RA and was granted European Union approval to market HUMIRA in September 2003. To date, HUMIRA has been approved in 41 countries and launched in 26. Clinical trials are also underway evaluating the potential of HUMIRA in early RA, juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease. "The positive opinion provides further validation of HUMIRA's ability to help physicians and RA patients battle this debilitating, life-long disease," said Holger Liepmann, senior vice president, international operations, Abbott Laboratories. "Strong patient acceptance is making HUMIRA the most successful global launch in Abbott's history," Liepmann said. Abbott expects worldwide HUMIRA sales to reach more than $700 million in 2004 and more than $1.2 billion in 2005. HUMIRA is the first fully human monoclonal antibody available in Europe for RA, and the first tumor necrosis factor alpha (TNF-alpha) antagonist approved in Europe with an indication for use with methotrexate or as monotherapy. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha, a protein that plays a central role in the inflammatory responses of autoimmune diseases such as RA. In the European Union, 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. The EMEA's positive opinion will be reviewed by the European Commission, which is expected to approve the label extension for HUMIRA for use in the treatment of adult RA patients for reducing the rate of progression of joint damage and to improve physical function. Authorizations generally occur approximately 90 days after the issuance of the EMEA opinion. To ensure maximum efficacy, HUMIRA is given in combination with methotrexate. In Europe, HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. The recommended dose of HUMIRA is 40 mg every other week by subcutaneous injection (a shot beneath the skin). Abbott offers 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. About RA More than 5 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 surrounding bone. The long-term prognosis for patients with RA can be poor, and as a result, many patients face increased disability and premature death. Important Safety Information Common adverse events (>1/100 and less than or equal to 1/10) at least possibly causally related to HUMIRA include headache, dizziness, respiratory tract and urinary tract infection, nausea, diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis and anemia. Injection site pain was reported by >1/10 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 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. Abbott's Commitment to Immunology Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. Founded in 1989, the Abbott Bioresearch Center in Worcester, Mass., is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. Abbott Laboratories 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 55,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web sites at http://www.abbott.com/ or at http://www.abbottimmunology.com/ . DATASOURCE: Abbott Laboratories CONTACT: International Media, Brian Kyhos, +1-847-936-7988, U.S. Media, Kelly Morrison, +1-847-937-3802, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott Laboratories Web site: http://www.abbott.com/ http://www.abbottimmunology.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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