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European Commission Grants Enbrel (Etanercept) Marketing Authorization For Psoriatic Arthritis

MADISON, NJ -- December 17, 2002 -- Wyeth (NYSE: WYE) today announced that the European Commission (EC) has approved the Company's Marketing Authorization Application (MAA) for EnbrelŪ (etanercept) for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel is the first biological therapy approved for the treatment of psoriatic arthritis in Europe.

"Unlike other types of arthritis, people with psoriatic arthritis often experience progressive joint pain and swelling, coupled with typical skin lesion of psoriasis," said Harold K. Marder, M.D., Senior Vice President, Global Medical Affairs, Medical Director, Wyeth Pharmaceuticals.

"There is a definite need for new therapies specifically approved to treat this disease. Current therapeutic approaches for psoriatic arthritis have largely been borrowed from other diseases " said Dr. Marder.

The EC marketing authorization was based on review of two randomized, double-blind, multicenter trials. A 24-week, multicenter, randomized, double-blind, placebo-controlled phase 3 study assessed the efficacy and tolerability of Enbrel (25mg twice-weekly subcutaneous injections) or placebo in 205 patients with psoriatic arthritis. The primary endpoint was measured by the proportion of patients who met the American College of Rheumatology preliminary criteria for improvement (ACR 20), which includes tender and swollen joint counts, a patient as well as a physician global assessment, patient assessment of pain, a disability index, and acute phase reactants. In addition, a subset of clinical study patients was evaluated by improvement in the psoriasis area and severity index (PASI), which measures improvement in both the amount and severity of psoriatic skin lesions.

* 59 percent of 101 patients receiving Enbrel achieved an ACR 20 response compared to 15 percent of 104 patients receiving placebo, after
12 weeks of treatment;
* 38 percent of 101 patients receiving Enbrel achieved an ACR 50 response compared to 4 percent of 104 patients receiving placebo after 12 weeks of treatment;
* 11 percent of 101 patients receiving Enbrel achieved an ACR 70 response compared to 0 percent receiving placebo, after 12 weeks of treatment;
* Similar results were seen at 24 weeks.

In a subset of patients with a pre-defined severity of psoriasis (greater than 3% body surface area involved), responses increased over time, and at 6 months, the proportions of patients achieving a 50% or 75% improvement in PASI were 47% and 23%, respectively, in the Enbrel group (n=66) compared to 18% and 3%, respectively, in the placebo group (n=62).

The results of this study were similar to those seen in an earlier, single-center, randomized, placebo-controlled study of 60 patients with psoriatic arthritis.

Adverse events in the psoriatic arthritis trial were similar to those reported in previous clinical trials of Enbrel in patients with rheumatoid arthritis (RA). There was no increase in the number of serious adverse events including serious infections occurring in psoriatic arthritis patients receiving Enbrel compared with those receiving placebo. The most common type of infection was upper respiratory infection (URI). Only the rate of injection site reactions (ISRs) in patients receiving Enbrel was statistically different compared to placebo (36 percent vs. 9 percent).

About Enbrel
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, and Wyeth Pharmaceuticals markets Enbrel outside of North America. The EC approval follows the January 2002 approval by the U.S. Food and Drug Administration (FDA) of the use of Enbrel in the treatment of psoriatic arthritis.

Enbrel is the only fully human, anti-TNF therapy approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel is the only biologic therapy that can be used alone. Enbrel is also approved to reduce the signs and symptoms of moderately to 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).

Rheumatologists have become familiar with the benefits and proven long- term tolerability profile of Enbrel, having treated over 129,000 patients worldwide in more than four years of post-marketing experience.

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.

Important Treatment Considerations
Since the product was first introduced, serious infections, some involving death, have been reported in patients using enbrel. Many of these infections occurred in patients who were prone to infections, such as those with advanced or poorly controlled diabetes. Rare cases of tuberculosis have also been reported. Enbrel should be discontinued in patients with serious infections. Do not start Enbrel if you have an infection of any type or if you have an allergy to Enbrel or its components. Enbrel should be used with caution in patients prone to infection. Contact your physician if you have any questions about Enbrel or infections.

There have been reports of serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Tell your doctor if you have ever had any of these disorders or if you develop them after starting Enbrel. There have also been rare reports of serious blood disorders, some involving death. Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if Enbrel has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using Enbrel.

The most frequent adverse events in placebo-controlled RA clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Of these, only the rate of ISR was higher than that of methotrexate. Patients have been observed in clinical trials for over
3 years. The incidence of malignancies has not increased with extended exposure to Enbrel and is similar to the projected background rate.

Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical trials.

In a study of 69 patients with JRA, infections (62%), headache (19%), abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in children. Serious adverse reactions reported rarely were chicken pox (3%), gastroenteritis (3%), serious infections (2%), depression/personality disorder (1%), skin ulcer (1%), inflammation in parts of the upper digestive tract (1%), and diabetes (1%).

About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.


SOURCE: Wyeth

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