Incivek sales decline looks set to continue.
On January 29, Vertex Pharmaceuticals released disappointing Q4 2012 results that revealed a plummet in sales of Incivek (telaprevir), the company’s first-generation protease inhibitor used to treat chronic hepatitis C infection.
Sales of Incivek saw a year-on-year decrease of 51% in Q4 2012, with sales dropping to $222.8m from a high of $456.8m in Q4 2011.
Incivek showed strong initial uptake after its launch in May 2011, racking up full year sales of $951.0m. However, since then significant advancements in the pipeline and concerns over the safety and tolerability profile of the drug have led to a steep drop of sales in 2012. Indeed, in December 2012, Incivek was hit with a black-box warning of progressive and potentially fatal skin reactions in patients who receive the treatment. The drug is also plagued by side effects of rash and anemia and unpleasant co-administration with intravenous interferon.
Sales of Incivek are under threat from upcoming second-generation protease inhibitors which display substantial improvements in tolerability. Several developers, including Johnson & Johnson and Bristol-Myers Squibb, are attempting to incorporate these improved candidates into interferon-free combination regimens employing multiple mechanisms of action. Early data of these combinations suggest this new approach offers significant improvements over current treatment, leaving little incentive for physicians to prescribe Incivek in the future. Key opinion leaders interviewed by Datamonitor suggest first-generation protease inhibitors will be pushed out as promising data for new drugs continue to come in.
The anticipation of interferon-free regimens which demonstrate superior efficacy, tolerability, and convenience has led some physicians to advise their patients to delay treatment with Incivek until such regimens arrive. Vertex does have its own oral interferon-free regimen in the pipeline, but this is lagging well behind the potentially groundbreaking regimens from Gilead and Abbott, and Datamonitor expects that Vertex’s regimen will arrive too late to capitalize on patient warehousing.
Vertex is hoping that sales of Kalydeco (ivacaftor), its cystic fibrosis treatment approved in January 2012, will partially offset the large drop in Incivek sales, but the relative rarity of this condition compared to hepatitis C infection will lead to an inevitable overall reduction in sales revenue.