By early next week, AbbVie (ABBV) is widely expected to get approval for its hepatitis-c treatment, one that will compete with Gilead Sciences’ (GILD) Harvoni and Sovaldi. UBS analyst Marc Goodman says the only question is the treatment duration and the price:
Approval is not really a debate, in our view, given the quality of the data from the 6 Phase III trials with >2,300 patients. One potential opportunity to differentiate vs [Gilead's] Harvoni is the duration of therapy: if it is approved for 12 wks vs. 24wks for Harvoni, in GT-1b cirrhotic treatment-experienced patients. However, the FDA may require 24wks for all cirrhotics, since TURQUOISE-2 data for 12wks or 24wks resulted in SVR of 92% and 97%, respectively, vs. we understand to be the 95% bar for approval of new regimens. Within that, GT1b cirrhotics did well (99% SVR) based on a subgroup of 68 patients. Hence, it's possible the triple regimen is prescribed for 24wks in cirrhotics, with the option “to consider” 12wks in patients with low risk characteristics (well-compensated GT1b, non-null, non-TT). Our models assume this in the AbbVie label.
Goodman thinks AbbVie could trade at $72 in 12 months, assuming that it charges $76,000 for a 12-week regiment of its treatment and have about $1.5 billion in sales next year.
Shares of AbbVie have gained 1% to $67.24 at 1:10 p.m., while Gilead Sciences has jumped 2.5% to $104.96.
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