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Biotech / Medical : Indevus Pharmaceuticals (NasdaqNM:IDEV)
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From: Arthur Radley1/23/2008 11:23:26 AM
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From January 22, 2008 UBS report:

N o PDUFA Delays for New Nebido Dosing
?? Results support an improved alternative treatment regimen of Nebido
IDEV released results of a 117-patient, Phase III trial of a new dosing regimen for
Nebido (initial injections of 750 mg, followed 4 wks later by another 750 mg, and
then 750 mg injection every 10 wks thereafter). The study met both primary
endpoints: 1) a responder analysis in which 94% had an average concentration of
testosterone within the normal range (same as in the 1000 mg dose every 12 wks,
and ahead of the 75% required by FDA), and 2) an outlier analysis in which no
patients exceeded maximum concentrations of testosterone.
?? New dosing regimen to be submitted instead of the original 1000 mg
IDEV plans to substitute the more optimal Nebido regimen for the initially
submitted 1000 mg regimen. The company met with the FDA, and a delay in the
action date was not expected. Use of the lower dose is believed to be safer as
fewer patients exceeded the Cmax limits established by the FDA. Steady state
results were reached within 4-14 wks vs. 24-36 wks for the original regimen.
?? Expectations are relatively positive around the June 27 PDUFA
Based on the trial meeting and exceeding FDA requirements for efficacy and
safety, we expect minimal interference to approval. Furthermore, the data are
backed by safety of the higher dose as well as years of experience with an
alternative dosing schedule in Europe. We continue to expect peak revenues of
over $200M by 2012.
?? Valuation: Buy; $12 PT
PT is based on an 18x multiple to our 2012 EPS estimate of $1.38, disc by 20%.
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