Abbott Laboratories' HUMIRA(R) (Adalimumab) Marks Successful First Year Treating Patients With Rheumatoid Arthritis

ABBOTT PARK, Ill., Dec. 30 /PRNewswire-FirstCall/ -- HUMIRA(R) (adalimumab), the latest biologic therapy and first fully human monoclonal antibody for the treatment of rheumatoid arthritis (RA), was prescribed to more than 40,000 patients suffering from the potentially crippling joint disease during its first year on the market. Approved by the U.S. Food and Drug Administration (FDA) on December 31, 2002, HUMIRA is the most successful product launch in the Abbott's 115-year history.

"The success of HUMIRA in its first year confirms it is a treatment meeting an important need for patients and physicians," said Tim Walbert, divisional vice president and general manager, Abbott Immunology. "It is a reflection of Abbott's larger commitment to providing patients with the most innovative treatments science has to offer."

At the time of its regulatory submission, HUMIRA was the most studied biologic therapy for RA, with 23 clinical trials involving more than 2,400 patients. HUMIRA was FDA approved earlier than anticipated, just nine months after the company's regulatory submissions in the United States and Europe.

"The benefits of HUMIRA for my patients have been remarkable," said Charles A. Birbara, M.D., medical director of the Clinical Pharmacology Study Group at the University of Massachusetts City Campus, Worcester, Mass. "Before starting HUMIRA, some patients couldn't dress themselves or hold their children or grandchildren. HUMIRA has given them their lives back, with some patients responding as early as one week after their first dose."

HUMIRA offers convenient administration that is unmatched by available biologic medications. It is packaged in a pre-filled syringe specially designed for easy use at home by people with RA. The design, which has been tested with RA patients and received the Arthritis Foundation's Ease-of-Use Commendation seal, features unique plastic wings that are easy to hold and allows patients to self-administer their medication without having to mix or measure it. HUMIRA offers patients convenient dosing (typically every other week), with 75 percent fewer injections than another commonly prescribed self- injected RA treatment.

"I had my first injection on a Friday in mid-April," said Tecela Harris, HUMIRA patient. "After just five HUMIRA injections, I felt total improvement, physically and mentally. My knees and hands weren't swollen, and my watch and rings were loose. I wasn't stiff or hunched over when I woke up."

Key HUMIRA Milestones in 2003

Patient Access. In conjunction with the product launch in January, Abbott launched its Medicare Assistance Program, an unprecedented drug-access initiative that provides HUMIRA at no cost to Medicare-eligible seniors. Recently, Congress passed a new Medicare drug benefit, and -- as part of that legislation -- has included a two-year demonstration project that will allow for reimbursement of self-injectable drugs. Once the details of the demonstration project are determined, Abbott will help program participants transition to the project. Until then, Abbott will continue to offer HUMIRA free to eligible seniors through its Medicare Assistance Program.

RA Clinical Studies. Data presented at the European League Against Rheumatism (EULAR) meeting in June showed HUMIRA was effective in early RA; at the October American College of Rheumatology (ACR) annual meeting, studies showed that HUMIRA taken alone or in combination with methotrexate (MTX) exhibits sustained response for up to five years in adult patients with active RA. In addition, data showed that HUMIRA significantly improved the quality of life for people living with RA, including physical function, bodily pain and fatigue. It is the only biologic DMARD to demonstrate statistically significant reduction in fatigue in RA patients.

Additional Clinical Studies. In 2003, HUMIRA trials were announced in psoriatic arthritis, juvenile rheumatoid arthritis, psoriasis, and Crohn's. Phase III studies in ankylosing spondylitis will begin shortly.

Regulatory Milestones. The European Commission granted marketing authorization of HUMIRA in September for the treatment of adult RA. With E.U. marketing authorization, HUMIRA became the first human monoclonal antibody approved for RA in Europe and the first TNF antagonist approved with an indication for use with methotrexate or as monotherapy. In October, Abbott submitted to the FDA a supplemental Biologics Licensing Application (sBLA) seeking approval for the use of HUMIRA to improve physical function in patients with moderately to severely active RA.

Financial Performance. Abbott raised HUMIRA sales expectations twice during 2003. Abbott set its total 2003 sales expectations for HUMIRA at more $250 million worldwide. Also, HUMIRA became Abbott's most successful product launch in its 115-year history.

Awards. HUMIRA was named the Best New Medicine of 2003 by Med Ad News. In addition, HUMIRA was named one of Chicago's most innovative and successful products. One of 10 winners, HUMIRA was chosen among 130 submissions as a recipient of the 2003 Chicago Innovation Award, which honors local companies for their novel products and services. The award is sponsored by the Chicago Sun-Times and Kuczmarski & Associates.

About RA

RA is a chronic autoimmune disease that affects more than five million people worldwide, 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, often resulting in eventual destruction of the joint's interior and erosion of the surrounding bone. The long-term prognosis for RA patients can be poor, and many patients face disability and premature death. Quality of life is seriously affected as RA progresses. Many people with RA experience fatigue, which can be extreme and limit normal activity. Sufferers also endure pain that can interfere with daily function, missed workdays, and feelings of helplessness and depression.

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 injection site reactions (20 percent vs. 14 percent), 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.

About HUMIRA

HUMIRA is the first fully human monoclonal antibody approved by the 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. 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's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases, like RA. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., U.S., is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.

As part of its commitment to the research and treatment of immunological diseases, Abbott developed the Abbott Scholar Award, which provides funding to researchers in the early stages of their careers to promote career development and encourage continued research in rheumatology.

Additionally, Abbott and the ACR Research and Education Foundation are collaborating to develop new opportunities for medical residents interested in the field of rheumatology. This collaboration -- supported by a $4.5 million endowment from Abbott, the largest one-time gift that the Foundation has received to date -- is designed to ensure the continued recruitment of rheumatologists and rheumatology health professionals for years to come.

More information about Abbott Immunology and HUMIRA, including full prescribing information, is available on the Web sites www.abbottimmunology.com and www.HUMIRA.com , or in the United States by calling Abbott Medical Information at 1-800-633-9110. Patients interested in more information about RA can visit the Web site, www.RA.com .

About Abbott

Abbott Laboratories (NYSE: ABT) 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 more than 70,000 people and markets its products in more than 130 countries. In 2002, the company's sales were $17.7 billion.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com .

SOURCE  Abbott Laboratories
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