Amgen and Wyeth Pharmaceuticals today announced the presentation of additional data that showed that the safety profile of Enbrel(R) (etanercept) was maintained with long-term use in patients with moderate-to-severe juvenile rheumatoid arthritis (JRA) who completed up to eight years of therapy
THOUSAND OAKS, CA, USA and COLLEGEVILLE, PA, USA | June 13, 2007 | Amgen (NASDAQ:AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced the presentation of additional data that showed that the safety profile of Enbrel(R) (etanercept) was maintained with long-term use in patients with moderate-to-severe juvenile rheumatoid arthritis (JRA) who completed up to eight years of therapy. JRA is a chronic autoimmune disease of childhood that is sometimes difficult to diagnose. ENBREL is the only biologic medicine currently approved to treat the signs and symptoms of JRA in patients who have previously tried a traditional disease modifying antirheumatic drug (DMARD). The study results will be presented at the European League Against Rheumatism (EULAR) Annual Congress, an international rheumatology meeting, in Barcelona, Spain.
Approximately 50,000 children in the United States have JRA. Symptoms of JRA include fatigue, joint pain and stiffness following sleep or inactivity, fever and associated muscle weakness. There are differing presentations of the signs and symptoms of JRA and there is no specific test for diagnosis.
"Early diagnosis and treatment are crucial to managing symptoms of JRA," says Andreas O. Reiff, M.D., head of Rheumatology and Rehabilitation at Children’s Hospital Los Angeles and study investigator, who will be presenting the data at EULAR. "The ENBREL data are important for both physicians and parents because they demonstrate the safety profile has remained consistent after long-term use in this patient population."
The study, which was designed to assess the long-term safety of ENBREL in people with JRA, found that the overall rate of serious adverse events did not increase with long-term use of ENBREL. No deaths, lymphomas or other malignancies, tuberculosis or other opportunistic infections were reported. Sixty-one percent of patients studied (n=42) entered their fourth year of continuous ENBREL treatment. Further, 38 percent (n=26) of patients studied entered their eighth year of continuous ENBREL treatment and experienced a similar safety profile.
Patients with JRA who participated previously in a double-blind, randomized controlled trial of ENBREL (n=69) were eligible to enroll in this multicenter open-label extension study (n=58). Safety assessments included the incidence of serious adverse events, deaths, lymphomas, malignancies, opportunistic infections and medically important infections.
About ENBREL
ENBREL is a fully human soluble TNF receptor. ENBREL has more than 14 years of collective clinical experience.
ENBREL Indications:
— 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 DMARDs.
— 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, 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%) and depression/personality disorder (1%)
If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information at www.enbrel.com or call 1-888-4ENBREL.
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. Additional information about ENBREL, including the full U.S. Prescribing Information, can be found on the Web site sponsored by the companies at www.enbrel.com or by calling, in the U.S., 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, 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.
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This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2006, and in our periodic reports on Form 10-Q and Form 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.
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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.
SOURCE: Amgen
