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Affymax, Inc. Message Board

  • dinepat203 dinepat203 Feb 27, 2013 1:50 PM Flag

    FDA statement - Omontys is SAFE

    Despite these precautions, FDA stated, results of the pivotal trials “showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter."

    In developing Omontys, Affymax and Takeda sought to offer an anemia alternative to epoetin, a three-times-weekly drug sold under the brand name Epogen (epoetin alfa) by its developer Amgen, as well as by Amgen licensee Johnson & Johnson under the brand name Procrit (epoetin alfa). However, Omontys racked up only $34.6 million in sales for Takeda last year, disappointing analysts who expected much better results from the drug. Piper Jaffray analyst Ian Somaiya last year told Bloomberg he predicted sales of Omontys would reach $700 million by 2017

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