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New Data Show That Half of Patients with Active Early Rheumatoid Arthritis Achieved Clinical Remission at One Year When Treated with Enbrel(R) (etanercept) Plus Methotrexate Clinical Trial Data Demonstrate Benefits of Early Treatment in Patients with Moderate to Severe Rheumatoid Arthritis
BOSTON--(BUSINESS WIRE)--Nov. 7, 2007--Amgen (NASDAQ:AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced that data from a multicenter, randomized, double-blind trial of ENBREL plus methotrexate showed that 50 percent of patients with active early rheumatoid arthritis achieved clinical remission at one year. In contrast, 28 percent of patients achieved clinical remission who were treated with methotrexate alone. The population under study had less than two years (median seven months) of moderately to severely active disease. Results from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Boston, Massachusetts.
COMET marks the first major rheumatoid arthritis (RA) clinical trial with ENBREL to use clinical remission as a primary endpoint, as measured by disease activity score (DAS28 less than 2.6). DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a modified measure of the DAS44, which is a validated tool used in clinical trials and serves as the basis for the European League Against Rheumatism (EULAR) response criteria.
"Clinical remission, as measured by DAS28, is an important goal in clinical practice, and is perhaps the most relevant to patients' daily lives as they struggle with their symptoms," said Paul Emery, professor of Rheumatology, University of Leeds, UK. "We hope that both patients and physicians are encouraged by these findings as they set a new standard for earlier treatment of RA."
The COMET study's secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 scores at week 52 following treatment with ENBREL plus methotrexate, compared to methotrexate alone. The study showed 48 percent of patients receiving ENBREL plus methotrexate achieved an ACR 70 score, versus 28 percent of the methotrexate-only group. Additionally, 71 percent of patients receiving combination therapy achieved an ACR 50 score, versus 49 percent of patients treated with methotrexate alone. The percentage of patients who achieve an ACR 50 or ACR 70 score represent those who achieve a 50 percent or 70 percent improvement in select RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
More than 2 million Americans suffer from RA, which can cause stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is left untreated, patients can become disabled from irreversible joint damage caused by the disease, limiting their ability to function.
There were no differences in rates of serious infections or malignancies among patients in the ENBREL plus methotrexate group compared with the methotrexate-only group. No cases of TB or demyelinating disease were reported. No new safety signals were identified. In other RA clinical trials, the most common adverse events were injection site reaction, infection, and headache.
This study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with active early rheumatoid arthritis. Patients in this study had disease duration of less than or equal to 2 years, had not previously received methotrexate, and had active disease based on DAS28 (greater than or equal to 3.2) and elevation of erythrocyte sedimentation rate (greater than or equal to 28 mm/hr) or C-reactive protein (greater than or equal to 20 mg/L). Patients were randomized to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268). The primary endpoint was proportion of patients achieving DAS28 clinical remission (less than 2.6) at Week 52. Secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 at week 52. This double-blind, randomized, multicenter study consists of two 12-month periods. The data presented at ACR is from the first 12-month period (52 weeks).
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 and has since been used in more than 460,000 patients worldwide across indications.
ENBREL indications in the U.S.:
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
-- ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs.
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
-- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
What important information do I need to know about taking prescription Enbrel(R) (etanercept)?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:
-- Serious infections -- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes -- Some serious infections have been fatal -- Rare cases of tuberculosis have occurred -- What not to do -- Do not start ENBREL if you have an infection, such as an open sore or the flu, or are allergic to ENBREL or its components -- What to do -- Tell your doctor if you are prone to infection or have had hepatitis B -- Stop ENBREL if a serious infection occurs -- Contact your doctor if you have questions about ENBREL or develop an infection -- Tell your doctor if you have ever been treated for heart failure -- 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 -- In medical studies of all TNF blockers, including ENBREL, a higher rate of lymphoma (a type of cancer) was seen compared to the general population. The risk of lymphoma may be up to several-fold higher in rheumatoid arthritis and psoriasis patients -- The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown -- ENBREL can cause injection site reaction -- In a medical study of patients with JRA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults -- The kinds of infections reported were generally mild and similar to those usually seen in children -- Other serious adverse reactions were reported rarely, including serious infection (2 percent) and depression/personality disorder (1 percent)
If you have any questions about this information, be sure to discuss them with your doctor. Please visit www.enbrel.com or call 1-888-4ENBREL to request additional information, including the full U.S. Prescribing Information.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
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. To learn more, visit www.wyeth.com.
Amgen Forward-Looking Statement
This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of Nov. 7, 2007 and expressly disclaims any duty to update information contained in this news release.
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Wyeth Forward-Looking Statement
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
CONTACT: Amgen, Thousand Oaks
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