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Biopharmaceuticals Gastroenterology FDA

 News Release - September 7, 2006

Abbott Submits U.S. and E.U. Regulatory Applications Seeking Approval for HUMIRA(R) (Adalimumab) as a Treatment for Crohn's Disease

Crohn's Disease Is the Fourth Autoimmune Disease for HUMIRA Submitted for Regulatory Approval in Both the U.S. and Europe

ABBOTT PARK, Ill., Sept. 7 (HSMN NewsFeed) -- Abbott announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe Crohn's disease. Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe combined. Currently, there is no cure for Crohn's disease, reinforcing the need for safe and effective treatment options that will help patients maintain control of their disease.

"HUMIRA may offer much-needed hope to physicians, as well as to people living with Crohn's disease, who have had limited, effective, long-term treatment options," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago.

The global filings are based on the results of three randomized, double- blind, placebo-controlled, multi-center trials of HUMIRA -- CLASSIC I (CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease), CHARM (Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance) and GAIN (Gauging Adalimumab effectiveness in Infliximab Nonresponders).

Clinical trials have been completed evaluating the efficacy and safety of HUMIRA in a range of moderate-to-severe Crohn's disease patients, from those who were naive to anti-TNF therapy to patients who had previously lost response or were unable to tolerate infliximab. In these trials, HUMIRA demonstrated statistical significance in inducing and maintaining clinical remission in patients with moderate-to-severe Crohn's disease. In the study evaluating the ability of HUMIRA to maintain remission, a proportion of patients in clinical remission were able to discontinue steroid use.

About HUMIRA Pivotal Crohn's Disease Clinical Trials

-- CLASSIC I was a study of 299 patients with moderate-to-severe Crohn's disease, which showed that initiating treatment with HUMIRA 160 mg followed by 80 mg at week 2 resulted in a statistically significant greater percentage of patients achieving clinical remission at four weeks compared to placebo. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being and other measures.

-- CHARM was a 56-week trial of patients with moderately-to-severely active Crohn's disease. The 499 patients who demonstrated clinical response to HUMIRA during a four-week open-label induction phase were randomized to receive either HUMIRA or placebo. A statistically significantly greater percentage of those who continued on HUMIRA maintained clinical remission through one year compared to placebo. In CHARM, the proportion of patients in clinical remission at week 26 and week 56 who were able to discontinue steroid use was evaluated. At week 56, 29 percent of patients taking 40 mg HUMIRA every other week and 23 percent of patients taking 40 mg HUMIRA weekly discontinued the use of steroids and maintained remission, compared to 6 percent of those receiving placebo (p< or = 0.008).

-- GAIN evaluated the efficacy of HUMIRA in moderately-to-severely active Crohn's disease patients who had previously lost response or were unable to tolerate infliximab, a group of patients currently without effective treatment options. Results from GAIN will be presented at the annual meeting of the American College of Gastroenterology (ACG) and at the United European Gastroenterology Week (UEGW) meeting, both in October.

The safety profile of HUMIRA in the Crohn's clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA).

"Based on our clinical studies, we believe HUMIRA offers promise for patients who suffer from Crohn's disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "Data from three pivotal studies in more than 1400 patients suggest the potential of HUMIRA to help many Crohn's disease patients meet their treatment goals of achieving and maintaining control of symptoms and improving quality of life."

About Crohn's Disease

Crohn's disease is a serious chronic, inflammatory disease of the GI tract that may affect more than one million people in North America and Europe combined and is typically diagnosed before age 40. It can have a devastating impact on the lifestyles of patients, many of whom are young and active. Common symptoms of the disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Complications include intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition. Over the course of their disease, at least 50 percent of patients with Crohn's will undergo surgery at least once for complications or disease refractory to treatment, and up to 70 percent of those patients may require a second surgery.

Abbott Initiates Additional Gastrointestinal Clinical Trials

Abbott has initiated a Treatment Protocol (CHOICE - Clinical study of the Human antibody adalimumab in CrOhn's patients who failed prior Infliximab: Collection of safety and Efficacy data) in the United States to evaluate the use of HUMIRA in patients who are no longer responding or are intolerant to infliximab, an approved therapy for Crohn's disease. Treatment protocols are used to facilitate the availability of promising new drugs under clinical investigation to patients with a serious or life-threatening disease who are not involved in the clinical trials and have no comparable or satisfactory alternative drug or therapy available, and to obtain additional data regarding use of the drug.

Additional information about HUMIRA clinical trials is available through Abbott Medical Information, 1-800-633-9110, and on the Abbott Web site, .

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.


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 (MTX) or other disease-modifying anti- rheumatic drugs (DMARDs).

In the U.S., HUMIRA is also 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. HUMIRA was also approved on July 28, 2006 for reducing signs and symptoms in patients with active ankylosing spondylitis.

In Europe, HUMIRA, in combination with MTX, is indicated for the treatment of moderate-to-severe, active RA in adult patients when the response to DMARDs including MTX has been inadequate. HUMIRA is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment of MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX.

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD-therapy has been inadequate. HUMIRA is also indicated for the treatment of adults with severe, active ankylosing spondylitis who have had an inadequate response to conventional therapy.

To date, HUMIRA has been approved in 67 countries, and more than 160,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune- mediated diseases.

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 or in the United States by calling Abbott Medical Information at 1-800-633-9110.

About Abbott

Abbott (NYSE: ABT ) 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 .

Source: Abbott

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