Tuesday, November 19, 2013 2:07:29 PM
Results consistent with Phase II study and our expectations
ABBV reported top line results of the SAPPHIRE-I study, a Phase III trial of its latestage
all-oral HCV regimen in treatment-naïve GT1a/GT1b patients. Twelve weeks
of treatment with ABT-333+ribavirin+ABT-450/ritonavir+ABT-267 demonstrated
SVR rates (equivalent of cure) in 95% and 98% of patients in GT1a (more difficult to
treat subset) and GT1b patients, respectively. These results are positive and
confirmatory of the efficacy profile seen in the Phase II trials. However, the key data
will be the results with the ribavirin-free regimen, along with data in more difficult-totreat
subsets (e.g. cirrhotics). These additional Phase III study readouts (top line)
are expected in the coming months, with a comprehensive presentation of the
Phase III program likely at EASL (4/24/14-4/28/14). ABBV continues to anticipate
submitting global regulatory filings in 2Q14. For reference, we model ABBV
launching its late stage HCV regimen in early 2015, with peak sales of $1bn in
2019, implying ~7-10% share of the HCV market.
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