Guest guest Posted October 11, 2002 Report Share Posted October 11, 2002 ABBOTT LABORATORIES ANNOUNCES STUDY TO MAKE D2E7 (ADALIMUMAB) AVAILABLE TO RHEUMATOID ARTHRITIS (RA) PATIENTS IN NEED ‹U.S. ACCESS TO THERAPY (ACT) IN RA STUDY OPEN TO PATIENTS FAILING TRADITIONAL DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS)‹ Abbott Park, Illinois, October 9, 2002 ‹ Abbott Laboratories announced today the initiation of a study to make its investigational medication, D2E7 (adalimumab), available to rheumatoid arthritis (RA) patients in need of additional treatment options in several countries around the world. In the United States, the program is called the Access to Therapy (ACT) in RA study and it will allow patients with moderately to severely active RA who have failed treatment with one or more traditional disease-modifying anti-rheumatic drugs (DMARDs) to receive D2E7. Similar programs are being initiated in Europe. D2E7 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) following Abbott's simultaneous submissions earlier this year. " In my experience with RA patients, it is critically important to have multiple treatment options, " said Dr. Arthur Weaver, M.D, clinical professor of medicine, University of Nebraska Medical Center. " D2E7 has been extensively evaluated in clinical trials and the availability of D2E7 gives rheumatologists another option for patients who have had an inadequate response to available therapies or do not have access to certain medications. " In the United States, the ACT study is designed as an open-label, multi-center study for patients with moderately to severely active RA who have failed one or more traditional DMARDs. Patients will receive D2E7 via subcutaneous injection with or without other DMARDs and responses will be evaluated at defined intervals. Those who achieve at least a 20 percent improvement in RA signs and symptoms (as measured by a decrease in tender and/or swollen joint counts) will be able to remain in the study. " The ACT study is part of our commitment to help rheumatologists and RA patients fight this debilitating disease, " said Jeff Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, and chief scientific officer, Abbott Laboratories. " As we have done in other therapeutic areas, we remain committed to developing and making promising treatments available to patients in need. " Physicians and patients in the United States who are interested in this study can obtain more information by calling 1-800-553-1618 or visiting the Abbott Web site at www.abbottimmunology.com. Abbott is also working with regulatory agencies in countries around the world to initiate similar programs. Based on local regulatory requirements, study design and protocol may differ. Currently, D2E7 has been made available via patient named basis programs or study protocols to patients in Europe. About D2E7 D2E7 was developed as the first fully human monoclonal antibody for RA. D2E7 works by specifically blocking the activity of tumor necrosis factor alpha (TNF-alpha), which plays a central role in the inflammatory responses of autoimmune diseases such as RA. Regulatory submissions in the United States and Europe are based on data from 23 clinical trials involving more than 2,300 RA patients in North America, Europe and Australia. Clinical trials with D2E7 are also underway in juvenile rheumatoid arthritis (JRA) and Crohn's disease. D2E7 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. D2E7 was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to D2E7, including responsibility for manufacturing, clinical development, sales and marketing. Abbott will book all revenues for D2E7, and CAT will receive a royalty fee based on D2E7 sales. About RA 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. This joint destruction can be severely debilitating, potentially leading to deformities in the hands and the feet. 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. Abbott's Commitment to Immunology Abbott Laboratories is committed to the discovery and development of innovative treatments for immunologic diseases. Founded in 1989, the Abbott Bioresearch Center in Worcester, Massachusetts, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. Abbott Bioresearch Center employs leading-edge technologies, discovery and manufacturing processes, including proprietary phage antibody display technology, and mammalian cell expression systems to produce fully human monoclonal antibodies. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. http://abbott.com/news/press_release.cfm Quote Link to comment Share on other sites More sharing options...
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