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 Registry 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.:
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:
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
This news release contains forward-looking statements that are based on management'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 our business. Unless otherwise noted, Amgen is providing this information as of Oct. 16, 2009 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate 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 scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
CONTACT: Amgen Sonia Fiorenza, 805-447-1604 (media) Arvind Sood, 805-447-1060 (investors) Pfizer Danielle Halstrom, 484-865-2020 (media) Claire Ball, 973-660-6411 (investors)
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