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Adalimumab Clinical Trial Program Expanded To Include Crohn's Disease

ABBOTT PARK, Ill., Sept. 29 /PRNewswire/ -- Abbott Laboratories announced today the expansion of its immunology clinical trials program to include an additional Phase III study evaluating the potential of HUMIRA® (adalimumab) in Crohn's disease. Crohn's disease is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), has been suggested to play a role in the disease development. Data from clinical studies suggest that treatments that inhibit TNF-a may be effective in these disease states. HUMIRA, which is a human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.

"Abbott is committed to exploring the full therapeutic potential of HUMIRA," said Jim Lefkowith, M.D., divisional vice president, Immunosciences Development, Abbott Laboratories. "Based on the recent approval of HUMIRA for rheumatoid arthritis, we're excited to be expanding programs that will help us understand the effect of HUMIRA in other autoimmune diseases, in addition to our continued programs in rheumatoid arthritis."

Crohn's Disease
A Phase III study has been initiated that will evaluate the safety and efficacy of HUMIRA in the induction and maintenance of clinical remission in subjects with moderately to severely active Crohn's disease. Patients in the trial will be randomized to receive HUMIRA or placebo and response to treatments will be measured according to the Crohn's Disease Activity Index (CDAI) score. The CDAI is a commonly used tool that measures factors such as weight loss and abdominal pain. This study is in addition to the Phase III Crohn's study initiated in 2002.

Crohn's disease is a chronic inflammatory disease of the gastrointestinal (GI) tract, usually beginning in late childhood or early adulthood. Common symptoms include diarrhea, abdominal pain, weight loss, fever, and in some cases rectal bleeding.

"Patients with Crohn's disease experience severe gastrointestinal symptoms because of an inflammatory response in the intestinal tract," said William Sandborn, M.D., professor of medicine, Mayo Medical School. "These patients have limited treatment options today. This trial is designed to assess the long-term effects of HUMIRA on disease activity."

More information about HUMIRA clinical trials can be obtained by calling Abbott Medical Information at 1-800-633-9110.

Important Safety Information
Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, 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 on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. The most frequent adverse events seen in the placebo-controlled clinical trials (HUMIRA vs. placebo) were 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.

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) and 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 juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis and early RA.

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.

Earlier this month, the European Commission granted marketing authorization to HUMIRA for the treatment of adult rheumatoid arthritis (RA). With E.U. marketing authorization, HUMIRA became 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. 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.

Source: Abbott Laboratories

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