Amgen Will Launch Palifermin In Late January Under Brand Name Kepivance
This article was originally published in The Pink Sheet Daily
Executive Summary
The oral mucositis treatment clears FDA under priority review. Labeling includes the precaution that "Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro." Palifermin's safety and efficacy were assessed in two studies examining 381 patients.
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Amgen Kepivance Launch Under Way At Price Of $1,375 Per Dose
Mucositis therapy will have an initial market of less than $50 mil. for first approved indication, but potential for use in broader cancer market would be $3 bil. opportunity. Kepivance will help Amgen build on position as number one oncology company in U.S., although Amgen is cautioning investors to expect slower growth in 2005 in light of reimbursement climate.