FRANKFURT: Bayer and Johnson and Johnson’s campaign to widen the market for its heart drug Xarelto hit a snag on Sunday when a study for a potential new patient subgroup failed to show a statistically reliant benefit.
The blockbuster clot prevention drug could not be shown to reduce the rate of dangerous blood clots in a certain group of high-risk patients after discharge from a hospital, the New England Journal of Medicine reported.
Participants in the so-called Mariner study had previously been admitted to hospital for a range of conditions that are associated with a higher risk of venous thromboembolism, such as heart failure, acute respiratory disease, ischemic stroke or infections.
Bayer reported 3.3 billion euros ($3.77 billion) in Xarelto revenues last year, mainly from stroke prevention in the elderly, and expects annual sales to rise above 5 billion euros.
A Bayer spokesman said that the latest results, also presented at the European Society of Cardiology congress in Munich, did not change its peak sales estimate or have any implications for other conditions that Xarelto is approved for.
It is a reversal of fortunes for Bayer, which in July won approval for additional Xarelto use in the potentially lucrative market for atherosclerosis patients.
Bayer has the marketing rights for the drug outside the United States while partner J&J sells Xarelto in the U.S., with Bayer being eligible for royalties on U.S. sales of 20-30 percent.