RE: ABBOTT LABORATORIES ANNOUNCES STUDY TO MAKE D2E7(ADALIMUMAB)AVAILABLE TO RHEUMATOID ARTHRITIS (RA) PATIENTS IN NEED

[Guest guest]

Hi a,

My chest has been better. I haven’t had an episode in about 3 plus weeks.

Hooray! The Remicade is working, but I’m getting a little better than a 20%

response, where I was hoping for a 70% response! I would say my flares are

shorter and the pain a little less intense, and it helps my fatigue. I’m

just greedy. I want more.

Love and hugs,

Carol

[ ] ABBOTT LABORATORIES ANNOUNCES STUDY TO MAKE D2E7

> (ADALIMUMAB)AVAILABLE TO RHEUMATOID ARTHRITIS (RA) PATIENTS IN NEED

>

> 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

>

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