October 27, 2008
Enbrel(R) (Etanercept) Is the First Biologic With Published Efficacy and Safety Data for Up to a Decade of Continuous Use for the Treatment of Moderate to Severe Rheumatoid Arthritis
SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ -- Amgen and Wyeth Pharmaceuticals, a division of Wyeth , today announced that ENBREL is the first biologic with published clinical trial data to show sustained improvements in multiple measures of efficacy in moderate to severe rheumatoid arthritis (RA) patients completing up to 10 years of therapy. In this analysis, the safety profile remained consistent with continuous ENBREL use for up to 10 years. These new data are being presented at the American College of Rheumatology (ACR) Scientific Meeting in San Francisco. (Abstract 1007; Poster Board 268)
"The long-term evaluation of medications for the treatment of RA is important because this is a chronic, progressive disease that requires continuous treatment to inhibit the progression of further joint damage," said Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, California. "These 10-year data demonstrate that improvements in disease activity measures were maintained and the safety profile was consistent over time. Rheumatologists may find this long-term data helpful when prescribing ENBREL for clinically appropriate patients."Data from two long-term, open-label extension studies presented at ACR showed that ENBREL provided improvement in the signs and symptoms of RA that was maintained for up to 10 years in adult patients with early rheumatoid arthritis (ERA) or long-standing RA (LRA). Approximately one-third of patients who started either study continued on ENBREL throughout the decade of use.
Of the proportion of patients evaluated for efficacy and still on therapy for up to 10 years, 56 percent achieved an ACR 50 response. Further 39 percent and 31 percent (ERA and LRA, respectively) achieved an ACR 70 response. These scores represent a 50 percent or 70 percent improvement in RA outcome measures that include joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation.
"RA may pose serious challenges to remaining physically active and participating in the normal daily activities, such as grocery shopping or walking up a flight of stairs, that many people take for granted," said Genovese. "The study findings showed that in addition to managing the symptoms of RA, treatment with ENBREL helped patients to remain active up to 10 years."
Additional data demonstrated sustained improvement in physical function in the subset of patients studied for efficacy. Yearly snapshots of the Health Assessment Questionnaire (HAQ) score showed that 73-86 percent of patients with ERA and 64-72 percent of patients with LRA achieved a clinically significant improvement in HAQ Disability Index. HAQ scores measure a patient's self-reported ability to perform activities of daily living such as dressing, walking, and grooming. A clinically significant reduction in HAQ was defined as at least a 0.22 improvement from baseline.
The data being presented at ACR also showed that the rates and types of serious adverse events and serious infections reported in patients treated with ENBREL for up to 10 years have remained consistent with what was reported in the control populations during the double-blind phases of the studies. Important safety information for ENBREL is provided below.
The studies were designed to assess the long-term safety and efficacy of ENBREL in adult patients with ERA (defined as less than or equal to three years of disease duration), as well as adult patients with LRA (defined as failure to respond to at least one disease-modifying antirheumatic-drug). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies. Safety data were analyzed for all patients who received at least one dose of ENBREL (ERA, N=558; LRA, N=714). Efficacy endpoints were analyzed in patients who received ENBREL 25 mg twice weekly in ERA (baseline: N=207, 10-year: N=79) and LRA studies (baseline: N=644, 10-year: N=255).
ABOUT RHEUMATOID ARTHRITIS
According to the Arthritis Foundation, approximately 1.3 million Americans have been diagnosed with RA, which can cause pain, stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is left untreated, joint damage caused by the disease can impair function, disabling some patients.
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has 16 years of collective clinical experience with an established safety profile. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe plaque psoriasis in adults.
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 the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children ages 2 and older. -- 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. Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
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, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active 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.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you: -- Think you have, are being treated for, have signs of, or are prone to infection -- Have any open sores -- Have or have had TB or hepatitis B -- Have ever been treated for heart failure -- Have ever had or develop a serious nervous system disorder -- Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, 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, including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please visit http://www.enbrel.com/ or call 1-888-4ENBREL to request additional information, including the U.S. Prescribing Information and Medication Guide.
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, manufactures 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 http://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 http://www.wyeth.com/.
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The statements in this press release that are not historical facts are forward-looking statements that 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, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and 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; emerging data on our products and pipeline 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" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. 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.
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CONTACT: Sonia Fiorenza (media), +1-805-447-1604, Arvind Sood(investors), +1-805-447-1060, both of Amgen; or Danielle Halstrom, (media),+1-484-865-2020, or Justin Victoria (investors), +1-973-660-5340, both ofWyeth
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