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Abbott's Humira, one of 10 products to win 2003 Chicago Innovation Award
Abbott Park, Illinois | Saturday, October 11, 2003, 08:00 Hrs  [IST]

Abbott Laboratories' rheumatoid arthritis (RA) treatment, Humira, has been named one of Chicago's most innovative products as one of 10 recipients of the 2003 Chicago Innovation Awards. Humira was chosen among 130 submissions for the award, which recognizes unique products and services that fill an unmet need, change customer expectations and achieve market success.

"Abbott is committed to investing in research and scientific development that can improve people's lives," said Jeff M. Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories. "Abbott is pleased to be recognized for this innovation and prouder still that products like Humira make a difference in the lives of patients."

Now in their second year, the Chicago Innovation Awards are presented by Kuczmarski & Associates and sponsored by the William Wrigley, Jr., Company. Honorees from the winning companies will be recognized during a reception tonight in downtown Chicago.

"Innovation is the fuel that allows companies to succeed in the marketplace, but more importantly, products such as Humira demonstrate how innovation helps to enhance the lives of patients with debilitating diseases like RA," said Tom Kuczmarski, senior partner and president of Kuczmarski & Associates.

Humira, which received FDA approval on December 31, 2002, is the first human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more disease modifying antirheumatic drugs (DMARDS). Humira can be used alone or in combination with methotrexate (MTX) or other DMARDs. As a human monoclonal antibody, Humira resembles antibodies normally found in the body. It works by blocking a protein that causes joint inflammation.

Humira reduces the signs and symptoms in adults with moderately to severely active RA and slows the advance of the disease.

Rheumatoid arthritis is an incurable autoimmune disease that causes pain, stiffness and swelling around the joints, and can lead to disability and premature death. With RA, the immune system attacks healthy tissue, particularly those that line and cushion joints. More than two million Americans, and five million people worldwide, live with this crippling disease.

Humira is the first human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). Humira can be used alone or in combination with methotrexate (MTX) or other DMARDs.

Humira was created using phage display technology, resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1:K constant regions.

Clinical trials are also currently underway evaluating the potential of Humira in other autoimmune diseases.

Humira was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. Humira was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to Humira, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for Humira, and CAT will receive a royalty fee based on Humira sales.

Abbott received FDA approval to market Humira in the United States on December 31, 2002, and was granted approval from the European Commission to market Humira (adalimumab), previously known as D2E7, for the treatment of adult rheumatoid arthritis (RA), in Europe on September 10, 2003. Humira is the first human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. In Europe, 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.

RA is a chronic autoimmune disease that affects 2.1 million Americans, with women accounting for three out of four cases. RA causes pain, swelling and stiffness in the joints of hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the "wear and tear" joint condition and 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 many patients face disability and premature death.

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