Guest guest Posted April 17, 2001 Report Share Posted April 17, 2001 ENBREL Enrollment Program Expands: ENBREL® (etanercept) Now Available to New Patients Enrolled in Queue System As of March 31, 2001 Headlines Last Change 04/11 12:59 New Patients Interested in Joining the Enrollment Program Are Encouraged To Call 888-4-ENBREL SEATTLE, April 11 /PRNewswire/ -- The maker of ENBREL® (etanercept) announced today that approximately 2,500 new patients are being offered " active " status in the ENBREL Enrollment Program. Patients are offered active status when they have completed their application and supply is available. " This is good news for thousands of patients who have been waiting to try ENBREL, " said Mark Booth, general manager for ENBREL at Immunex Corporation (Nasdaq: IMNX). The ENBREL Enrollment program was launched in November 2000 to identify and enroll current users of the highly prescribed tumor necrosis factor (TNF) inhibitor ENBREL because growing demand was projected to exceed the current supply. Immunex and Wyeth-Ayerst Laboratories (a division of American Home Products Corporation, (NYSE: AHP)), the companies that market ENBREL in the United States, initiated the program so that patients already using ENBREL could continue to receive therapy. In an extraordinary response to the program, more than 77,000 patients have joined the ENBREL Enrollment Program, with approximately 67,000 patients having at least one ENBREL prescription filled since January. The companies established a queue system for new patients, to manage demand and available supply. " Because we now better understand the ordering and utilization patterns of current users in the program, we are very pleased that we can now make ENBREL available to a number of new patients, " said Booth. " We anticipate activating more new patients who are waiting to use ENBREL as usage patterns and available supply allows. " New patients interested in using ENBREL can call 888-4ENBREL to enroll in the program and will join the patient queue. As the companies have previously announced, supplies of ENBREL will be limited until mid-2002, when a manufacturing facility expansion is expected to be completed. The new facility in Rhode Island is one part of a strategic program to increase manufacturing supply of ENBREL. The program also includes development of another manufacturing facility in Ireland, which is expected to produce ENBREL for the commercial market by 2005. ABOUT ENBREL ENBREL is currently approved for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active RA. The FDA originally approved ENBREL on November 2, 1998, to reduce signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more DMARDs. ENBREL is the only TNF inhibitor that can be used both with methotrexate or alone. ENBREL acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in normal immune function and the cascade of reactions that cause the inflammatory process of RA. ENBREL competitively inhibits binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT ENBREL OR INFECTIONS. There have been rare reports of 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. There have also been rare reports of serious blood disorders, some involving death. Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using ENBREL. The most frequent adverse events in placebo-controlled clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%). Immunex Corporation and Wyeth-Ayerst Laboratories market ENBREL in North America. Other AHP affiliates market ENBREL outside of North America. Immunex manufactures ENBREL. Additional information about ENBREL, including full prescribing information, can be found on the company-sponsored website at (www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735). Immunex Corporation is a leading biopharmaceutical company dedicated to improving lives through immune system science innovations. American Home Products Corporation's Wyeth-Ayerst division is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products and generic pharmaceuticals. American Home Products Corporation is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It also is a global leader in vaccines, biotechnology and animal health care. NOTE: Except for the historical information contained herein, this news release contains forward-looking statements that involve substantial risks and uncertainties. Among the factors that could cause actual results or timelines to differ materially are risks associated with research and clinical development, regulatory approvals, our supply capabilities and reliance on third-party manufacturers, product commercialization, competition, litigation and other risk factors listed from time to time in reports filed by Immunex with the SEC, including but not limited to risks described under the caption " Important Factors That May Affect Our Business, Our Results of Operations and Our Stock Price " within our most recently filed Form 10-K. The forward-looking statements contained in this news release represent our judgment as of the date of this release. Immunex undertakes no obligation to publicly update any forward-looking statements. An electronic version of this news release -- as well as additional information about Immunex of interest to investors, customers, future employees and patients -- is available on the Immunex home page at www.immunex.com. Quote Link to comment Share on other sites More sharing options...
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