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|New Study Demonstrates Combination Therapy with Enbrel Inhibited Progression of Joint Damage and Offered Significant Symptom Relief for Rheumatoid Arthritis Patients|
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., and COLLEGEVILLE, Pa., June 16, 2003 - Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the positive results of a new study. The study assessed the efficacy, including impact on joint damage and disease activity, in rheumatoid arthritis (RA) patients following year-long treatment with a combination of ENBREL. (etanercept) plus methotrexate, compared with either treatment alone. Results of the study will be presented this week at a satellite symposium during the European League Against Rheumatism meeting in Lisbon, Portugal.
"The study is the first to compare a combination of ENBREL and methotrexate with either therapy alone in patients with rheumatoid arthritis," said primary investigator Dr. Lars Klareskog, professor of rheumatology at Karolinska Hospital in Stockholm, Sweden. "The results demonstrate a very favorable response with the combination on both the signs and symptoms and joint damage of RA."
The multi-center, double-blind, Phase 3 study randomized 682 patients with RA for a period of one year or longer (up to approximately 88 weeks) to receive ENBREL (25 mg twice weekly) plus methotrexate (mean dose of 17 mg once weekly), ENBREL (25 mg twice weekly) plus placebo capsules once weekly, or methotrexate (mean dose of 17 mg once weekly) plus placebo injections twice weekly.
Adverse events were similar to those reported in previous clinical trials of ENBREL in patients with RA.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. If left untreated or improperly treated, RA can produce serious destruction of one or more joints, which frequently leads to permanent disability, significantly impacting quality of life.
ENBREL is the only fully human, soluble TNF receptor approved to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. ENBREL is the only biologic therapy approved for first line treatment of RA patients. ENBREL can be used alone or in combination with methotrexate.
Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 150,000 patients worldwide since becoming commercially available four years ago.
ENBREL 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, resulting in significant reduction in inflammatory activity.
Since the product was first introduced, the following have been reported in patients using ENBREL:
• Serious Infections
- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
- Some serious infections were fatal
- Rare cases of tuberculosis
• What to do/Not do
- Do not start ENBREL if you have an infection or are allergic to ENBREL or its components
- Tell your doctor if you are prone to infection
- Stop ENBREL if a serious infection occurs
- Contact your doctor if you have questions about ENBREL or develop an infection
• 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.
• Rare reports of serious blood disorders (some fatal)
- Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness
• The incidence of cancer has not increased with extended exposure to ENBREL and is similar to the expected rate.
• ENBREL can also cause injection site reactions.
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL, including full Prescribing Information, can be found on the Web site sponsored by the companies at www.enbrel.com or by calling toll free 888-4ENBREL (888-436-2735).
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
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.
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