Study To Compare ENBREL Benefits With Standard Treatments
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., and COLLEGEVILLE, Pa., July 9, 2003 - Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that rheumatologists at more than 400 study sites have completed enrollment of 5,000 patients in the second phase of the RADIUS (Rheumatoid Arthritis DMARD Intervention and Utilization Study) program, making it the largest clinical trial to date to evaluate the impact of a Tumor Necrosis Factor (TNF) inhibitor in patients with rheumatoid arthritis (RA) in the United States. This milestone brings the total number of patients enrolled in the RADIUS program to 10,000.
For at least five years, the second phase of the RADIUS program will compare the tolerability, efficacy and treatment patterns of ENBREL® (etanercept) in 5,000 RA patients with that of 5,000 patients treated with a variety of disease modifying anti-rheumatic drugs (DMARDs).
"We are pleased with the overwhelming response to enrollment," said Dr. Jonathan Leff, Amgen's senior director of medical affairs. "This study is expected to enrich the wealth of information we have about ENBREL and its potential benefits for long-term use in patients with this chronic and progressive disease."
RADIUS will evaluate patients who meet American College of Rheumatology (ACR) criteria for diagnosis of RA, and who require a change or addition of a new DMARD. ENBREL will be used in eligible patients either as a monotherapy or in addition to the patient's current DMARD treatment.
"This is exciting for physicians and patients because the RADIUS program offers a unique opportunity to longitudinally analyze real-world patient outcomes, the durability and safety of our best therapies, and apply these findings to improve patient care," said Dr. John Cush, chief of rheumatology at Presbyterian Hospital of Dallas and clinical professor of internal medicine at the University of Texas Southwestern Medical Center.
"The RADIUS program will provide physicians with a valuable look at how various therapies are used by community physicians in patients with RA," said Dr. Victoria Kusiak, vice president of global medical affairs and North American medical director of Wyeth Pharmaceuticals. "This broad database should provide physicians with important real-world clinical and safety information from which their patients will benefit."
ENBREL is the only fully human anti-TNF receptor approved for use to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. ENBREL is the only biologic therapy approved to treat newly diagnosed RA patients, and can be used alone. It is also approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to disease-modifying medicines.
Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 180,000 patients worldwide across all indications since becoming commercially available five years ago.
ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process of psoriatic arthritis and RA. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
Individual results may vary. In medical studies, ENBREL worked for about two out of three adults with RA.
Since the product was first introduced, the following have been reported in patients using ENBREL:
• Serious Infections
- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
- Some serious infections were fatal
- Rare cases of tuberculosis
• What to do/Not do
- Do not start ENBREL if you have an infection or are allergic to ENBREL or its components
- 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
• 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
• The incidence of cancer has not increased with extended exposure to ENBREL and is similar to the expected rate.
• ENBREL can also 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%)
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary 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 (NASDAQ: AMGN) is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth (NYSE: WYE) 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 nonprescription 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.
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 for the year ended December 31, 2002, and in Amgen's 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.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing its products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of Amgen's products are affected by 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 Amgen's products. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify side effects or manufacturing problems with its products after they are on the market. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while Amgen routinely obtain patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors.
Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third party suppliers.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, and commercialization, and economic conditions, including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patents, and other risks and uncertainties, including those detailed from time to time in Wyeth's periodic reports, including quarterly reports on Form 10-Q and the Annual Report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. Wyeth assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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