Abbott Laboratories' HUMIRA (Adalimumab) Marks Successful First Year Treating Patients With RA

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Abbott Laboratories' HUMIRA® (Adalimumab) Marks Successful First Year

Treating Patients With Rheumatoid Arthritis

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ABBOTT PARK, Ill., Dec. 30 /PRNewswire-FirstCall/ -- HUMIRA®

(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

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 ,

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

http://www.abbottimmunology.com/ and http://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,

http://www.ra.com/ .

About Abbott

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 more than 70,000 people and markets

its products in more than 130 countries. In 2002, the company's sales

were $17.7 billion.

Web site:

http://www.abbott.com/http://www.abbottimmunology.com/http://www.humira.com/http\

://www.ra.com/