Regular FirstWord Pharma PLUS readers may not be surprised to hear that a leading pharmaceutical equity analyst – International Strategy & Investment's Mark Schoenebaum – has suggested that Gilead Sciences' hepatitis C treatment Sovaldi could generate global sales of $5 billion in 2014, its first year on the market.
A number of Physician Views polls run by FirstWord in the latter months of 2013 indicated that anticipated usage of Sovaldi could be sufficiently high to drive a notable above-consensus sale performance for the drug over the next 12 months.
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If Schoenebaum's forecast is anywhere near being correct, then Sovaldi will become the fastest new drug launch of all time by an even more significant margin than previously anticipated. Current consensus estimates anticipate 2014 sales of around $2.5 billion versus the $1.6 billion that Vertex Pharmaceuticals' hepatitis C treatment Incivek generated during its first four full quarters of availability.
Analysts at Bloomberg Industries recently suggested that a current run rate of approximately 1500 prescriptions per week (achieved by Sovaldi during its fifth week of availability) would be sufficient alone to achieve US sales of $2.2 billion in 2014 (i.e. assuming no additional growth). By comparison, prescriptions of Incivek peaked at approximately 1000 per week, a rate that took Vertex's drug some 14 weeks to achieve.
Schoenebaum suggests that the Incivek launch remains the best model by which to project the outlook for Sovaldi and noted to investors on Wednesday that he was "having a very hard time getting to a number for 2014 that is below $5 billion."
A number of additional market dynamics will impact the development of the hepatitis C market in 2014, although the most significant of these is likely to be the launch of Gilead's Sovaldi + ledipasvir fixed-dose combination late in the year; a catalyst that is expected to actually boost sales momentum.
A number of physician polls run by FirstWord in the months leading up to the US launch of Sovaldi suggested key trends conducive to an above-consensus sales performance in 2014. These included notable patient warehousing, stronger-than-anticipated uptake across all patient genotypes for Sovaldi prior to the launch of Gilead's fixed-dose combination and potentially high use in the large genotype 1 population (which in most cases would require co-administration with interferon).
Unsurprisingly, Gilead indicated last week that most Sovaldi use to date has occurred in genotype 2 and 3 patients, but will be expected to provide further clarity when it unveils its Q4 results.
The FDA's willingness to approve usage of Sovaldi in genotype 1 patients co-administered only with ribavirin over 24 weeks (in interferon 'intolerant' patients) is another intriguing potential means of upside - Physician Views Poll Results – No wonder payers are concerned; physicians enthused by labelling that allows Gilead Sciences' sofosbuvir/ribavirin combo to be administered to GT1 patients.
Schoenebaum's call on Wednesday was bold – just as was Gilead's decision to acquire Pharmasset for $11 billion in order to secure Sovaldi two years ago – is it a precursor to further analyst upgrades?
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