ENBREL is the First Biologic to Publish Data Showing Safety and Sustained Efficacy for up to Nine Years in Patients with Moderate-to-Severe Rheumatoid Arthritis.THOUSAND OAKS, Calif. -- Amgen (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMGN) today announced that Enbrel([R]) (etanercept) is the first biologic with published data to show improvements in multiple measures of efficacy that were sustained in rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. (RA) patients completing up to nine years of therapy. These new data are being presented at the American College of Rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. (ACR See riser card. ) Scientific Meeting in Washington, D.C. "The current data in Rheumatoid Arthritis suggest that Enbrel is both effective and safe in long-term use," said Mark Genovese, M.D., Stanford University Medical Center Stanford University Medical Center (Stanford Hospital & Clinics) is one of four hospitals affiliated with Stanford University and Stanford University School of Medicine, along with the Lucile Packard Children's Hospital, the Veteran's Administration Hospital in Palo Alto, and Santa , Palo Alto, California “Palo Alto” redirects here. For other uses, see Palo Alto (disambiguation). Palo Alto (IPA: /ˌpæloʊˈʔæltoʊ/, from Spanish: palo: "stick" and alto: "high", i.e. . "These findings are significant because they provide a degree of reassurance to both the patient and the physician that unexpected safety concerns do not appear to be developing after nine years of use." ENBREL continues to have a strong safety profile for extended periods of use. In the studies presented at ACR, rates of serious adverse events and serious infections remained low and were consistent with controlled portions from the double-blind phases of the studies. The overall number of observed malignancies (excluding nonmelanoma skin cancers) were similar in type and number to what would be expected in the general population. Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA LRA Lord's Resistance Army (rebel group in Uganda) LRA Louisiana Recovery Authority LRA Local Registration Authority LRA Local Redevelopment Authority ) patients who completed ENBREL treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed ENBREL treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate Erythrocyte Sedimentation Rate Definition The erythrocyte sedimentation rate (ESR), or sedimentation rate (sed rate), is a measure of the settling of red blood cells in a tube of blood during one hour. . Data being presented at ACR showed that ENBREL provided sustained improvement in the signs and symptoms of RA, in those patients who continued in the study, regardless of duration of disease. Following eight years of ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA patients achieved ACR 20; 60 percent of ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent of LRA patients achieved ACR 70. Further, for those patients with LRA who received ENBREL treatment for nine years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70. The ability to perform daily activities is an important goal for many people with RA, and data presented at ACR showed that treatment with ENBREL may help them achieve this goal. Through eight years of treatment with ENBREL, data showed that 73 to 85 percent of patients with ERA and 53 to 72 percent of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire (HAQ HAQ Health Assessment Questionnaire HAQ Harvard Asia Quarterly ) score, a patient questionnaire that measures disability. A clinically significant improvement in HAQ was defined as at least a 0.22 improvement from baseline. "Before I was diagnosed with RA, the pain, stiffness and fatigue stopped me from doing many of the activities I enjoyed," said Gloria Treece, a participant in the study. "Since starting ENBREL treatment approximately nine years ago, I'm now able to take part in many activities with my family." These studies were designed to assess the safety and long-term efficacy of ENBREL in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug disease-modifying antirheumatic drug DMARD Rheumatology Any agent–eg, azathioprine, gold, cyclophosphamide, hydroxychloroquin, and MTX–which slows the rate of joint destruction in rheumatoid arthritis , and adult patients with ERA (defined as less than or equal to three years of disease duration). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies (LRA, N=644; ERA, N=207). ABOUT RA More than two 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 joint damage caused by the disease, limiting their ability to function. ABOUT ENBREL ENBREL is a fully human soluble TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f receptor. ENBREL has more than 14 years of collective clinical experience. 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 methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. or used alone. * reducing signs and symptoms of moderate to severe polyarticular-course juvenile rheumatoid arthritis juvenile rheumatoid arthritis n. Abbr. JRA Chronic inflammatory arthritis that begins in childhood, characterized by swelling, tenderness, and pain in one or more joints and by lymph node and splenic enlargement. in patients who have failed one or more disease modifying anti-rheumatic drugs Disease Modifying Anti-Rheumatic Drugs (DMARDs) A class of antirheumatic drugs, including chloroquine, methotrexate, cyclosporine, and gold compounds, that influence the disease process itself and do not only treat its symptoms. Mentioned in: Antirheumatic Drugs (DMARDs). * reducing signs and symptoms, keeping joint damage of active arthritis from getting worse, and improving physical function in patients with psoriatic arthritis Psoriatic Arthritis Definition Psoriatic arthritis is a form of arthritic joint disease associated with the chronic skin scaling and fingernail changes seen in psoriasis. . ENBREL can be used with methotrexate in patients who do not respond adequately to methotrexate alone. * reducing signs and symptoms in patients with active ankylosing spondylitis Ankylosing Spondylitis Definition Ankylosing spondylitis (AS) refers to inflammation of the joints in the spine. AS is also known as rheumatoid spondylitis or Marie-Strümpell disease (among other names). . * the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy systemic therapy Therapeutics Any therapy that reaches target tissues via the systemic circulation or phototherapy Phototherapy Definition Phototherapy, or light therapy, is the administration of doses of bright light in order to normalize the body's internal clock and/or relieve depression. . ENBREL is a type of protein called a tumor necrosis factor tumor necrosis factor n. Abbr. TNF A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. (TNF) blocker that blocks the action of a substance your body's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. 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 Side effects Effects of a proposed project on other parts of the firm. , 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
-- 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 reactions
-- In a medical study of patients with JRA, infections, headaches,
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 infections (2%) and depression/personality
disorder (1%)
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 Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. 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 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 Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , rheumatoid arthritis, and other serious illnesses. With a broad and deep 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 Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care, cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , 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. Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q Form 10-Q See 10-Q. and Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. . Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. 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 risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting , the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, 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." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion