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Biotech / Medical : Avadel AVDL

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From: tom pope8/23/2007 9:16:16 PM
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Don't know if this adds anything. It's from Merrill, not from Ende, their Toronto office.

CASPER shows no compliance improvement with Coreg CR

An abstract containing the results of the CASPER study was published in the
Journal of Cardiac Failure, and will be presented at the Heart Failure Society of
America meeting September 16-19. The CASPER study included 405 heart
failure patients already taking carvedilol twice daily (Coreg IR). Patients were
randomized in a blinded fashion to continue on Coreg IR or switch to Coreg CR
(blinded; patients given Coreg CR in the morning and placebo as the second daily
dose). A third arm switched to Coreg CR once daily on an open-label basis. The
goal of the study had been to demonstrate that patients on Coreg CR were more
compliant with their dosing schedules than those taking Coreg IR twice daily.
However, there was no difference in drug taking compliance, adverse events,
quality of life (KCCQ), or patient satisfaction (TSQM). See Table 1 for details.

Outcome may make reimbursement more challenging
The general thesis around once-daily dosing is that simplifying the dosing
schedule should result in increased patient compliance, and potentially improved
outcomes. There was no such benefit seen in this heart failure population
because the blinded twice-daily dosing groups showed compliance rates of 87%
and 89% vs. the 75% compliance rate assumed in the study design. The high rate
of compliance in this population is likely due to the understanding amongst heart
failure patients of the risks of missed doses. The outcome of this study will likely
make improvements in formulary placement more difficult as generic versions of
Coreg IR reach the market (patent protection on Coreg IR expires on 5
September 2007).

Stock likely to remain weak as generic Coreg IR approaches
FLML stock has already begun to trade off as this news makes its way into the
market (there has been no press release), and is likely to remain weak pending
the entry of generic Coreg IR and the effects of GSK's additional sales force
efforts (2000 reps with Coreg CR in first position) on the product (no changes in
TRx growth rates thus far; see our Weekly TRx Tracker).
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