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|New Findings Show Enbrel(R) (etanercept) Significantly Reduced Levels of C-Reactive Protein, a Marker of Inflammation, in Patients with Moderate to Severe Plaque Psoriasis|
SAN ANTONIO, Texas--(BUSINESS WIRE)--Feb. 1, 2008--Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced findings from a retrospective analysis, which demonstrated that ENBREL reduced C-reactive protein (CRP), a marker of inflammation, in patients with moderate to severe plaque psoriasis following 12 weeks of treatment. Median reduction in CRP levels was 10 times greater in the ENBREL treated group compared to the placebo treated group. These results will be presented today at the American Academy of Dermatology Scientific Meeting in San Antonio, Texas.
Psoriasis is a non-contagious, chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Approximately 80 percent of psoriasis patients have plaque psoriasis, which is characterized by painful and itchy, red, scaly patches.
Key findings of the analysis of moderate to severe plaque psoriasis patients without psoriatic arthritis (n=501) demonstrated:
-- Patients had intermediate to high baseline CRP levels,
indicating that psoriasis is a systemic inflammatory disease.
"The finding that patients with moderate to severe plaque psoriasis had increased inflammation, as exhibited by elevated CRP levels, reinforces that psoriasis is not only a skin disease, but in some patients may be a serious medical condition," said Bruce Strober, M.D., Ph.D., study investigator, co-director of the Psoriasis and Psoriatic Arthritis Center of New York University Medical Center. "The results from this study are encouraging because they show that ENBREL not only improved the symptoms of patients with moderate to severe psoriasis, but reduced their levels of CRP as well. However, further research is needed to better understand whether reducing CRP levels lowers the risk for developing conditions such as cardiovascular disease that may derive from increased systemic inflammation."
The analysis also evaluated the relationship between CRP levels and body mass index (BMI), an indicator of body fat, in people with psoriasis without psoriatic arthritis. Notably, obesity is common among patients with psoriasis. Findings showed:
-- Heavier patients with higher BMIs tended to have higher CRP
The 24-week registrational study was originally designed to test the efficacy and safety of ENBREL therapy in patients with moderate to severe plaque psoriasis, the results of which have previously been reported in The New England Journal of Medicine. The primary objective of this retrospective analysis was to evaluate the effectiveness of ENBREL in reducing levels of CRP in psoriasis patients with and without psoriatic arthritis from baseline to week 12 compared to placebo. Secondary objectives were to assess CRP values at baseline, and to assess the relationship between CRP levels and patient characteristics, such as BMI, use of statin drugs, and Psoriasis Area and Severity Index (PASI). During the double-blind portion of the analysis, patients were randomly assigned to receive either placebo or ENBREL injections (25 mg once weekly, 25 mg twice weekly or 50 mg twice weekly) for 12 weeks. During the subsequent 12 weeks, patients who initially received ENBREL continued to receive treatment with ENBREL at the same dose, while patients in the placebo group switched to ENBREL 25 mg twice weekly.
ABOUT C-REACTIVE PROTEIN
CRP is a blood protein that is a marker for a number of inflammatory conditions and is an indicator of risk for cardiovascular disease. The development of a high sensitivity CRP assay (hs-CRP) has enabled detection of low levels of CRP previously undetectable by traditional CRP evaluations. Even low levels of CRP (i.e., less than 3 mg/L), as measured by this high sensitivity test, are associated with increased cardiovascular risk; however it is not clear that CRP plays a causal role in the development of cardiovascular disease. The safety and efficacy of ENBREL have not been established for decreasing cardiovascular risk.
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.
ENBREL indications in the U.S.:
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:
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 Feb. 1, 2008 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