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Biopharmaceuticals FDA Drug Delivery

 News Release - June 26, 2006

Abbott Receives FDA Approval for New HUMIRA(R) Delivery Device

HUMIRA Pen Offers Patients Easier, Less Painful Way to Self-Administer Medicine

ABBOTT PARK, Ill., June 26 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today that the U.S. Food and Drug Administration (FDA) approved the HUMIRA Pen, a new device for administering HUMIRA® (adalimumab), a treatment approved for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). With its one-touch activation and easy-to-grasp size and shape, the HUMIRA Pen offers improved ease of use for these patients, many of whom may have swelling or stiffness in the hands. The HUMIRA Pen has a needle that is not visible during the injection process, and this device provides a less painful experience for some patients. Patients place the HUMIRA Pen against the skin, press a button, and wait for the medicine to inject. The HUMIRA Pen will be available to U.S. patients beginning in August.

Currently, HUMIRA is taken as a subcutaneous injection (injection beneath the kin) via a specially designed prefilled syringe. HUMIRA is currently indicated for moderate to severe rheumatoid arthritis and for active arthritis in patients with psoriatic arthritis and is being studied as a possible treatment for other autoimmune diseases.

In results of the TOUCH (Trial Of Usability in Clinical settings of HUMIRA Autoinjector vs. Prefilled Syringe) study, which included 52 HUMIRA prefilled syringe patients, approximately nine out of 10 preferred the new HUMIRA Pen, rating it more convenient and easier to use, while approximately eight out of 10 found it to be less painful.

"Injectable medications are among the most effective treatments we have for RA and PsA, but nobody enjoys receiving an injection," said Alan Kivitz, M.D., practicing rheumatologist and founder of the Altoona (Pa.) Center for Clinical Research. "The HUMIRA Pen is an important advance because it offers people a convenient administration option to treat their disease."

The medicine used in the HUMIRA Pen will be identical to that used in the prefilled syringe and the standard dosing, 40 mg every other week, remains the same.

"With the approval of the HUMIRA Pen, Abbott furthers its goal of empowering patients to treat these potentially debilitating autoimmune diseases as conveniently as possible," said Rebecca Hoffman, divisional vice president, Immunology Development, Abbott.

The objective of the TOUCH study was to assess which method of delivery rheumatoid arthritis patients preferred: the HUMIRA prefilled syringe that they were already using, or the new HUMIRA Pen. This study included RA patients (N=52) who had prior experience with the HUMIRA prefilled syringe and tried the new HUMIRA Pen. Patients rated their injection preferences for several attributes, including overall preference, ease of use, convenience, time to complete injection and pain.

About Rheumatoid Arthritis

More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, potentially resulting in destruction of the joints' interior and the surrounding bone.

More information on RA and current treatment options can be found at http://www.RA.com.

About Psoriatic Arthritis

Psoriatic arthritis combines skin symptoms, such as dry, scaly skin and patches of red, raised skin known as plaques, with arthritis symptoms that include joint pain and inflammation. Common symptoms of psoriatic arthritis include varying degrees of skin involvement along with stiffness, pain, swelling and tenderness of the joints that can lead to a reduced range of motion and potentially severe joint destruction.

Important Safety Information

Cases of tuberculosis (TB) 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 also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (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.

The safety profile for patients with psoriatic arthritis treated with HUMIRA in the clinical trials has been similar to the safety profile seen in patients with RA.

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDs.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including full prescribing information, is available on the Web site http://www.rxabbott.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

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


Source: Abbott

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