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Etanercept Approved by European Union for the Treatment of Ankylosing Spondylitis

MADISON, N.J., Jan. 20, 2004 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the European Commission has approved ENBREL (etanercept) (25 mg twice weekly) for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

Ankylosing spondylitis is the fifth indication for ENBREL in the European Union (EU). It is also approved in the EU for rheumatoid arthritis in adults with inadequate response to methotrexate (MTX), for rheumatoid arthritis in adults not previously treated with MTX, for adults with psoriatic arthritis, and for children with juvenile chronic arthritis.

"We are pleased that ENBREL is now approved in the European Union for the treatment of ankylosing spondylitis," says Robert Power, President, International, Wyeth Pharmaceuticals. "Clinical studies showed that ENBREL offers many patients significant relief of symptoms such as back pain, morning stiffness, and fatigue as rapidly as two weeks after initiation of therapy."

Ankylosing spondylitis is a painful and potentially progressive inflammatory disease affecting the spine and the joints and ligaments that normally allow a person's back to move and flex. The disease most often occurs in the lower back but can affect the upper spine and neck. The spine can fuse, causing deformity and loss of motion. Ankylosing spondylitis may also involve other joints, such as the hips, shoulders, knees, and ankles. The disease frequently strikes people in their late teens and twenties, and tends to affect more men than women. It is estimated that there are more than 600,000 patients with AS in Europe and 350,000 in the United States.

"For the first time, with the use of ENBREL we see improvement in spinal mobility, the loss of which is a debilitating symptom of ankylosing spondylitis," said Dr. Peter Brock, Vice President of Global Medical Affairs and European Medical Director of Wyeth Pharmaceuticals. "ENBREL has proven to be an effective and generally well-tolerated treatment for a broad range of rheumatoid arthritis patients, which will be important to physicians introducing the therapy to a new group of patients."

In a pivotal phase III study (n=277), after 12 weeks 60 percent of patients treated with ENBREL (n=138) achieved a 20 percent improvement in the Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20), a composite measure that includes back pain, morning stiffness, global patient assessment, and physical function, compared with 27 percent of patients receiving placebo. At 24 weeks, 58 percent of patients treated with ENBREL achieved this significant reduction compared with 23 percent of the placebo patients.

Adverse events were similar to those reported in previous clinical trials of ENBREL, with injection site reactions occurring more frequently than in the placebo group. The most frequent adverse events in placebo-controlled rheumatoid arthritis (RA) clinical trials (n=349) were injection site reactions (ISRs) (37%), infections (35%), and headache (17%). Only the rate of ISRs was higher than that of placebo.

Wyeth Pharmaceuticals markets ENBREL outside North America. ENBREL was discovered by Immunex, now part of Amgen (Nasdaq: AMGN), and jointly developed with Wyeth Pharmaceuticals. The two companies copromote ENBREL in North America.

In Europe, ENBREL is the only fully human TNF-receptor therapy approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate and for the treatment of active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. ENBREL is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. In this population ENBREL has been shown to slow progression of disease-associated structural damage as measured by X-ray. ENBREL is also approved for the treatment of active polyarticular-course juvenile chronic arthritis in children aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

In the United States, ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone. ENBREL is indicated for reducing signs and symptoms of moderately and severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients 4 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ENBREL is indicated for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in patients with psoriatic arthritis. ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Rheumatologists have become familiar with the benefits and proven long-term tolerability profile of ENBREL since it became commercially available over five years ago. More than 215,000 patients have been treated worldwide across indications. ENBREL (etanercept) acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process of psoriatic arthritis and RA. The binding of ENBREL to TNF renders the bound TNF biologically inactive, which can result in significant reduction in inflammatory activity.

Source: Wyeth Pharmaceuticals

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