AbbVie posts strong results for Hep C pill
pharmafile | December 11, 2013 | News story | Research and Development, Sales and Marketing | 3D, AbbVie, FDA, Gilead, hep C
AbbVie’s investigational hepatitis C pill cured 96% of difficult-to-treat patients in a late-stage clinical trial and looks set to muscle into the increasingly competitive marketplace.
Phase III results for its investigational three direct-acting-antiviral (3D) regimen was coupled with the older pill ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection.
In the 394-patient SAPPHIRE-II study, 96% of patients who previously failed both pegylated interferon and ribavirin treatment – including around half of whom had not responded to any treatment – achieved sustained virologic response at 12 weeks with AbbVie’s drug.
The majority of patients were GT1a, considered a difficult-to-treat subtype, according to the firm.
Scott Brun, VP of pharmaceutical development at AbbVie said: “Completion of the two placebo-controlled SAPPHIRE studies is an important step in AbbVie’s HCV clinical development programme.
“We look forward to the results of studies looking at AbbVie’s 3D regimen with and without ribavirin in different patients, as well as data from our dedicated study in patients with cirrhosis.”
Globally around 160 million people are chronically infected with hepatitis C and AbbVie is hoping to cash in on the lucrative market, which is expected to be worth more than $100 billion over the next decade, according to Bloomberg Industries.
Alex Arfaei, an analyst with BMO Capital Markets, said in a research note that AbbVie’s regimen ‘remains underappreciated’ and forecast sales of $1.6 billion in 2017.
Sales of Gilead’s Sovaldi (sofosbuvir) are expected to hit around $1.9 billion next year having already been approved in the US just this week, with the firm awaiting an EU approval in the coming months for the drug.
In late November the FDA also approved Janssen’s Olysio (simeprevir), another Hep C pill, as new oral treatments vie for a place in the once injectable-only market.
AbbVie, Bristol-Myers Squibb and Merck & Co are also seen as potential rivals to Gilead and Janssen with oral regimens that have shown impressive cure rates, whilst also cutting the current treatment duration to 12 weeks or less from the current 24- or 48-week treatment regimens.
Some analysts believe that because AbbVie’s regimen requires a larger number of pills to be taken compared to its rivals – this may hamper its competitiveness in the market.
Pricing war?
But despite this concern and that is not the first to market, AbbVie could still price out its rivals. Gilead announced that Sovaldi will cost $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000.
If AbbVie gains approval in the US and lowers its price by a significant margin, it may be able to gain the competitive edge over Gilead.
ISI Group analyst Mark Schoenebaum wrote in a note to clients: “A big price differential would likely be necessary to block Gilead’s regimen.
“In a two-player market (before other competitors reach the market), whether AbbVie would be willing to take a large price cut is not clear. Thus, the larger risk to price could be pushed out until 2017 when other competitors are able to reach the market.”
Ben Adams
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