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Biopharmaceuticals Gastroenterology Regulatory

 News Release - June 7, 2007

Abbott's HUMIRA(R) (Adalimumab) Approved in the European Union for the Treatment of Crohn's Disease

HUMIRA is the First Self-Administered Biologic Treatment Offering Sustained Disease Remission in Severe Crohn's Disease

ABBOTT PARK, Ill., June 7 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today that it has received marketing authorization from the European Commission for the use of HUMIRA® (adalimumab) as a treatment for severe Crohn's disease. HUMIRA is the first self-administered biologic for the treatment of Crohn's disease and offers an effective and convenient treatment option that can help enable patients to maintain control of their disease. This announcement follows FDA approval for the Crohn's disease indication, which Abbott received in February, and is the fourth approved indication for HUMIRA in the United States and the European Union.

Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than 1 million people in North America and Europe. It affects people of all ages, but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease and few treatment options exist for patients suffering with this chronic condition.

"Crohn's can have a devastating impact on patients, many of whom are young and active, making it difficult to carry out normal day-to-day activities," said Rod Mitchell, chairman, European Federation of Crohn's & Ulcerative Colitis Associations. "The unpredictable nature of the disease can seriously impact their quality of life and self-esteem. For the half million people across Europe suffering from Crohn's, this approval offers hope to help them regain control of their disease."

Common symptoms of Crohn's 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, as many as 75 percent of patients with Crohn's disease will undergo surgery at least once for complications or disease resistant to treatment. Of those who undergo surgery to remove a portion of the intestines (resection), half will experience a relapse within five years.

"After I was diagnosed with Crohn's, the unpredictable symptoms made working and relationships difficult. I was afraid to leave the house," said Rocio Lopez, a HUMIRA clinical trial patient. "With HUMIRA, my Crohn's symptoms are under control and I have more freedom to live my life."

"The approval of HUMIRA in Crohn's disease means that an underserved patient population now has a clinically effective treatment option that they can administer themselves," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "For the thousands of people across Europe with Crohn's disease, HUMIRA represents a new, effective, and convenient treatment option."

HUMIRA for Crohn's Disease

The approval was based on data from three pivotal trials of HUMIRA in more than 1,400 adult patients with moderately to severely active Crohn's disease. The CLASSIC I, CHARM and GAIN trials supporting the indication for Crohn's disease evaluated the efficacy and safety of HUMIRA in a diverse group of moderate to severe adult Crohn's disease patients, from those who were naive to anti-tumor necrosis factor alpha (TNF-alpha) therapy, to patients who had previously lost response or were unable to tolerate infliximab, an anti-TNF agent for treatment of Crohn's disease.

In each trial, clinical remission was measured by 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, levels of general well being and other measures.

Key outcomes include:

-- The CLASSIC I induction trial evaluated HUMIRA for the induction of
clinical remission. Of 299 anti-TNF naive patients, 36 and 24 percent
of patients receiving HUMIRA (160 mg at week zero followed by 80 mg at
week two and 80 mg at week zero followed by 40 mg at week two,
respectively) achieved clinical remission at week four compared to
12 percent treated with placebo (p<0.001 for 160 mg/80 mg dose group
and p=0.06 for 80mg/40mg dose group).

-- The CHARM trial studied HUMIRA for the maintenance of clinical
remission. CHARM was a 56-week trial that enrolled 854 patients with
moderate to severe Crohn's disease. After a four-week open label
induction phase during which all subjects received 80 mg HUMIRA at week
zero followed by 40 mg HUMIRA at week two, 58 percent of patients
(n=499) demonstrated clinical response to HUMIRA (a CDAI decrease equal
to or greater than 70 from baseline). These patients were randomized
to receive either HUMIRA 40 mg every other week (eow), HUMIRA 40 mg
weekly, or placebo. Of those who continued on HUMIRA 40 mg every other
week (n=172), 40 percent were in clinical remission at week
26 (p<0.001) and 36 percent were in remission at week 56 (p<0.001),
versus 17 percent and 12 percent of patients in the placebo group,
respectively. For those who continued taking HUMIRA 40 mg weekly,
47 percent were in clinical remission at week 26 and 41 percent were in
remission at week 56 (p<0.001).

-- In GAIN, a four-week induction trial of 325 patients who lost response
or were intolerant to infliximab, three times as many patients taking
HUMIRA achieved clinical remission at week four versus placebo
(21 percent versus 7 percent, p less than or equal to 0.001).

The safety profile of HUMIRA in the Crohn's clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA). Adverse events reported by >5 percent of HUMIRA treated patients with a greater incidence than patients taking placebo include injection site irritation, injection site pain, injection site reaction, nausea, joint pain, inflammation of the nose and pharynx, abdominal pain, headache and fatigue.

In the EU, the recommended HUMIRA induction dose for adult patients with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2. If there is a need for a more rapid response to therapy, patients can take 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) followed by 80 mg at week 2, with the awareness that the risk for adverse events is higher during induction.

Important Safety Information

Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit

Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their RA could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.

The combination of HUMIRA and anakinra is not recommended.

TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.

More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded.

In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.

The most frequently reported adverse event (greater than or equal to 1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by greater than or equal to 1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, lymphopenia, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), infection, irritation or inflammation of the eye, cough, nasopharyngeal pain, diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, dermatitis and eczema, pruritus, hair loss, musculoskeletal pain, pyrexia, fatigue (including asthenia and malaise)


In addition to Crohn's disease, HUMIRA is approved for the treatment of RA, psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in Europe and the United States. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when produced in excess, plays a central role in the inflammatory responses of autoimmune diseases. To date, HUMIRA has been approved in 67 countries and more than 180,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.

In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX has been inadequate, and 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 with 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. Additionally, HUMIRA is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD-therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy.

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, diagnostics and devices. 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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