Enbrel(R) (etanercept) Data to be Presented at the 2009 American College of Rheumatology Scientific Meeting
New Data Contribute to Existing Body of Knowledge About ENBREL
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Oct. 16 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) and Pfizer (NYSE: PFE), today announced new scientific data about ENBREL being presented at the 2009 American College of Rheumatology (ACR) Scientific Meeting in Philadelphia, Pa., from Oct. 17-21, 2009. These presentations contribute to data generated through 17 years of collective clinical experience.
"The clinical data being presented at ACR expand on the breadth of rheumatologists' knowledge and contribute to the continued understanding of treating the rheumatic conditions for which ENBREL is approved in the U.S.," said Sean Harper, M.D., senior vice president and chief medical officer, Amgen. "New data from an established therapy such as ENBREL continue to inform the medical and scientific community with the goal of advancing patient care."
These studies include a broad range of patients with moderate to severe rheumatoid arthritis and psoriatic arthritis. See Indications and Important Safety Information below.
A comprehensive list of ACR abstracts is available online at http://acr.confex.com/acr/2009/schedule/index.cgi. Identified below are some abstracts of interest on ENBREL data.
-- Sustainability of Clinical Remission with Etanercept and Methotrexate,
in Combination or as Monotherapy, in Early Active Rheumatoid Arthritis
Lead author: Emery, P.
Abstract No. 1656 (Tuesday, Oct. 20, 2009)
-- Etanercept Benefits Skin, Joint, and Entheseal Symptoms in Patients
with Psoriasis and Psoriatic Arthritis: The PRESTA Trial
Lead author: Kirkham, B.
Abstract No. 523 (Sunday, Oct. 18, 2009)
-- Safety Profiles of Disease-Modifying Anti-Rheumatic Drugs and Biologics
in Patients with Rheumatoid Arthritis: Observations from the RADIUS
Lead author: Gibofsky, A.
Abstract No. 1593 (Sunday, Oct. 18, 2009)
-- Identifying Clinical Features of Disseminated Histoplasmosis in
Patients Receiving TNF Inhibitors
Lead author: McCroskery, P.
Abstract No. 999 (Monday, Oct. 19, 2009)
Gary L. Stiles, M.D., executive vice president, Pfizer, added, "Amgen and Pfizer are committed to ongoing research of ENBREL to grow the overall amount of information available about ENBREL and its safety and efficacy profile."
ABOUT RHEUMATOID ARTHRITIS
According to the Arthritis Foundation, approximately 1.3 million Americans are affected by rheumatoid arthritis (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 17 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
-- 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 is the most important information I should know about ENBREL?
ENBREL is a medicine that affects your immune system. ENBREL can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ENBREL. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before you take ENBREL and monitor you closely for TB while on ENBREL.
Before starting ENBREL, tell your doctor if you:
-- Think you have, are being treated for, have signs of, or are prone to
infection. You should not start taking ENBREL if you have any kind of
-- Have any open cuts or sores
-- Have diabetes or an immune system problem
-- Have TB or have been in close contact with someone who has had TB
-- Were born in, lived in, or traveled to countries where there is more
risk for getting TB. Ask your doctor if you are not sure.
-- Live or have lived in certain parts of the country (such as, the Ohio
and Mississippi River valleys, or the Southwest) where there is a
greater risk for certain kinds of fungal infections, such as
histoplasmosis. These infections may develop or become more severe if
you take ENBREL. If you don't know if histoplasmosis or other fungal
infections are common in the areas where you live or have lived, ask
-- Have or have had hepatitis B
-- Have heart failure
-- Develop symptoms such as persistent fever, bruising, bleeding, or
paleness while taking ENBREL
-- Use the medicine Kineret® (anakinra)
-- Have or develop a serious nervous disorder, seizures, any numbness or
tingling, or a disease that affects your nervous system such as multiple
-- Are scheduled to have surgery
-- Are scheduled for any vaccines. All vaccines should be brought
up-to-date before starting ENBREL. Patients taking ENBREL should not
receive live vaccines.
-- Are allergic to rubber or latex
-- Are pregnant, planning to become pregnant, or breastfeeding
After starting ENBREL, call you doctor right away if you have any sign of infection, including a fever, cough, flu-like symptoms, or have any open sores on your body. ENBREL can make you more likely to get infections or make any infection you have worse.
Possible side effects of ENBREL
Serious side effects include: serious infections including TB; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; rare reports of serious blood problems (some fatal); heart failure, including new heart failure or worsening of heart failure you already have; allergic reactions; immune reactions, including a lupus-like syndrome and lymphoma (a type of cancer). People with rheumatoid arthritis and psoriasis may have a higher chance for getting lymphoma.
Common side effects include: Injection site reaction, upper respiratory infections (including sinus infection), and headaches.
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 www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Prescribing Information and Medication Guide.
About Amgen and Pfizer
Amgen and Pfizer market ENBREL in North America. Pfizer 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 www.amgen.com.
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com
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Amgen Forward-Looking Statement
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