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| |  EULAR: New Data Presented On Enbrel (Etanercept), Only Fully-Human TNF Soluble Receptor, Demonstrates Sustained Efficacy And Tolerability Up To 5 Years Ongoing Study Supports Benefit of Early, Aggressive Treatment of Rheumatoid Arthritis 58% of Patients Treated With 25 mg of Enbrel Have No Radiographic Progression Through 3 Years STOCKHOLM, SWEDEN -- June 14, 2002 -- Immunex Corporation today announced that data supporting the efficacy, tolerability and science of Enbrel® (etanercept) will be discussed at the 3rd Annual European League Against Rheumatism Meeting this week in approximately 35 oral and poster presentations. Data on Enbrel, the only fully human, TNF soluble receptor, will include the longest study to date of patients on a continuous therapy to inhibit tumor necrosis factor (TNF) in rheumatoid arthritis (RA). "What we have seen over time is a consistent and sustained response to this RA therapy, with more than 70% of patients responding," said Daniel Burge, M.D., Immunex vice president of clinical development. "Consistent response, defined as having achieved an ACR 20 response, has been seen when Enbrel is used as monotherapy (without other disease modifying anti-rheumatic drugs), whether patients are young or old, whether patients have long-standing disease or are newly diagnosed with moderate to severe disease." Data was presented from an ongoing study of 629 patients using Enbrel (etanercept) as monotherapy and who had failed other DMARDs (disease-modifying anti-rheumatic agents). These patients were observed in an open-label follow up study. The following data were presented for 119 patients who have now completed five years of therapy with Enbrel: -- 71% patients achieved the ACR 20 "In addition to seeing sustained efficacy through five years of follow up, Enbrel has demonstrated a consistent tolerability profile," said Dr. Burge. "In short-term studies of people being treated with Enbrel, the serious infection rate was comparable to those receiving placebo, and did not change with long-term experience. In addition, post-marketing reports of serious infections including tuberculosis, occur at rates comparable to the expected U.S. background incidence." Enbrel was generally well tolerated over the five years of this study. In the study, no significant differences in the type or rate of adverse events were seen in patients treated with Enbrel over time. Serious adverse events occurred at a rate of 0.14 per patient-year in this long-term study compared to 0.13 in the patients treated with Enbrel and 0.20 in placebo patients in the previous controlled studies. Likewise, serious infection (associated with hospitalization or IV antibiotics) occurred at a rate of 0.04 per patient year in the long-term study, compared to 0.04 per patient year in the patients treated with Enbrel and 0.05 in placebo patients in the controlled studies. The number of malignancies reported in patients treated with Enbrel was similar to the expected number calculated from the National Cancer Institute SEER database (30 observed vs. 31 predicted). No opportunistic infections have been observed in patients treated with Enbrel in the long-term study. Treatment with Enbrel (etanercept) is Effective for Patients with Early Erosive Rheumatoid Arthritis (ERA) -- Three Year Study Demonstrating 58% of Patients Receiving 25 mg. of Enbrel Demonstrated no Radiographic Progression A second study, conducted by Joan Bathon, M.D., John Hopkins University, assessed 161 ERA patients treated with Enbrel as part of an ongoing open-label extension study (three years of etanercept therapy total). "The study underscores the importance of the treating RA as early as possible with medicine that has been shown to inhibit the progression of structural damage," said Barry Labinger, Immunex senior vice president and general manager, commercial operations. "Over a three year period in this study, a majority (58%) of patients receiving 25 mg of Enbrel twice weekly, showed no radiographic progression of their RA, as measured by a total Sharp score." Patients in the open-label study had previously participated in a 2-year, multicenter study of ERA patients assessing the efficacy of Enbrel or methotrexate. The open-label study includes those patients randomized to receive Enbrel 25 mg twice weekly in the original study who continued this dose (n=161), and 143 patients previously receiving methotrexate who chose to receive Enbrel. The results for the 161 patients receiving Enbrel continuously for three years were: -- 77% of patients achieved an ACR 20 In this study, there was no increase of serious infections (requiring hospitalization or IV antibiotics), malignancies, or significant adverse events in the Enbrel group compared to the methotrexate group from the original controlled study. ABOUT Enbrel Enbrel is the only TNF receptor on the market. It 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 RA and psoriatic arthritis. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Enbrel is the only TNF inhibitor approved by the U.S. Food and Drug Administration to treat newly diagnosed RA patients with moderate to severe disease. Important Treatment Considerations 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 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 (etanercept). 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 RA 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%). Of these, only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%). Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical trials. Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth, market Enbrel in North America. Other Wyeth 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 Web site at (http://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. 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, supply capabilities and reliance on third-party manufacturers, product commercialization, competition, litigation and the other risk factors listed from time to time in reports filed by Immunex with the Securities and Exchange Commission, including but not limited to risks described under the caption "Important Factors That May Affect Our Business, Our Results of Operation and Our Stock Price" within its most recently filed Form 10-K. The forward-looking statements contained in this news release represent judgments of the management of Immunex as of the date of this release. Immunex undertakes no obligation to publicly update any forward-looking statements.
SOURCE: Immunex Corporation
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