Vertex said it stands ready to market hepatitis C drug telaprevir, under the brand name Incivek, and its approval could come as early as this month.
The Boston company, which is handling US marketing for the drug, said about 200 field-based employees have been hired to support a potential launch, including a sales team of 115 therapeutic specialists and others, according to a statement. Telaprevir's PDUFA date is May 23. In March, the firm launched a YouTube channel, HepC.tv, and posted the second in a series of animated educational videos this week.
In April, an FDA advisory committee voted 18-0 to recommend FDA approval. A rival hepatitis C drug from Merck, Victrelis (boceprevir), saw the same positive vote a day earlier. Analysts predict both drugs will reach market and have blockbuster potential.
Which one are physicians more likely to adopt? Market share may depend on the side effect profiles. Telaprevir is more efficacious than boceprevir but may aggravate patients who have skin sensitivities, while boceprevir is more notorious for anemia.
Citing these differences, the Sanford C. Bernstein analyst Tim Anderson wrote in a recent research report that “investor consensus has consistently been that Victrelis may capture ~25% of the hepatitis C market, with telaprevir capturing the remainder.”
Vertex's co-development partner, Johnson & Johnson unit Janssen-Cilag International, is also awaiting a decision from EU regulators. Vertex said it believes that Tibotec, a division of Janssen-Cilag, may receive a response in the second half of this year.
Merck executives said they also expect the FDA to approve Victrelis this month and will be ready to begin selling it immediately, and shortly thereafter in Europe. In a first-quarter earnings call with analysts, Merck declined to provide details on its launch strategy.