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European Committee Approves Etanercept for Ankylosing Spondylitis

MADISON, N.J., Sept. 25 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) , today announced that the Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Agency for the Evaluation of Medicinal Products (EMEA), has voted to recommend approval for ENBREL(R) (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.

This favorable opinion will be forwarded to the European Commission for endorsement before ENBREL receives final Marketing Authorization. If ENBREL is approved for this indication, ankylosing spondylitis will be the fifth indication for ENBREL in the European Community (EC). Currently it is approved in the EC for rheumatoid arthritis in adults with inadequate response to disease-modifying antirheumatic drugs, including methotrexate (MTX) (unless contraindicated), for rheumatoid arthritis in adults not previously treated with MTX, for adults with psoriatic arthritis, and for children with juvenile chronic arthritis.

"The potential for approval of ENBREL for the treatment of AS is truly exciting, offering many patients significant relief of symptoms such as back pain, morning stiffness, and fatigue as rapidly as two weeks after initiation of therapy. Also, for the first time, we see improvement in spinal mobility, which is a debilitating symptom of the disease," says Robert Power, President, International, Wyeth Pharmaceuticals.

Ankylosing spondylitis is a painful and potentially progressive inflammatory disease affecting 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. Unlike some other forms of arthritis, AS frequently strikes between the ages of 16 and 30, 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.

"We are pleased that the CPMP has recommended ENBREL for approval in the European Union for ankylosing spondylitis," says Dr. Peter Brock, Vice President of Global Medical Affairs and European Medical Director of Wyeth Pharmaceuticals. "ENBREL has a history of proven efficacy and tolerability in rheumatoid arthritis, 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 co-promote ENBREL in North America.

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 methotrextate (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.

Rheumatologists have become familiar with the benefits and proven long- term tolerability profile of ENBREL since it became commercially available nearly five years ago. More than 200,000 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.

Since the product was first introduced, serious infections, some involving death, have been reported in patients using ENBREL. ENBREL should be discontinued in patients with serious infections. Patients should not start ENBREL if they have an infection of any type or an allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to infection.

There have been reports of serious nervous-system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they ever have had any of these disorders or if they develop them after starting ENBREL. There also have been rare reports of serious blood disorders, some involving death.

Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous-system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using ENBREL.

The most frequent adverse events in clinical trials were injection-site reactions (ISRs) (37%), infections (35%), and headache (17%). Malignancies were rare. Only the rate of ISRs was higher than that of placebo.

Source: Wyeth

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