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Amgen files Enbrel plant sBLA

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Executive Summary

Amgen files sBLA Aug. 23 for Enbrel manufacturing facility in Rhode Island. Company expects to begin shipping from the plant immediately after approval, which is projected for first quarter 2003. Rhode Island plant will use same high-yield manufacturing process used at contract manufacturer Boehringer Ingelheim's facility (1"The Pink Sheet" April 29, p. 35). Etanercept shortage continues with 23,000 patients on waiting list as of July 24. Approximately 200,000 potential patients have signed up to receive information on rheumatoid arthritis through Amgen's "RA Access" unbranded TV ad campaign...

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