There has been a great deal of chatter and speculation over the widely anticipated results of a clinical trial of Xarelto, a forthcoming bloodthinner being developed by Bayer (OTCPK:BAYRY), which has a partnership deal with Johnson & Johnson (NYSE:JNJ). The Rocket-AF results were released over the weekend and showed that Xarelto met its primary goal of matching the efficacy of Warfarin, the standard treatment for decades.
Normally, this would be perceived as relatively good news, but consider the context. Boehringer Ingelheim is about to launch its own Pradaxa bloodthinner at the rich wholesale price of about $6.75 per pill a day. And the market for anti-clotting pills for stroke prevention is variously estimated to be worth anywhere from $15 billion to $20 billion. Stroke prevention in atrial fibrillation patients is the largest indication expected for Xarelto.
So merely being as effective as Warfarin is not good enough. The key question now is whether Xarelto was superior, since Pradaxa already demonstrated superiority. But reading the Bayer press release has left room for uncertainty.
“Some investors had hoped for superiority versus warfarin, despite a non-inferiority primary endpoint. (The) wording of the press release may suggest that superiority is not excluded,” writes Credit Suisse analyst Cathering Arnold in an investor note. “Xarelto’s efficacy could be superior and still satisfy ‘non-inferiority’ on the primary endpoint.”
But why is Bayer being so vague? Full results of the 14,000-plus patient study will be released on Nov. 15 at the American Heart Association meeting and Bayer is trying to obscure the fuller picture until then. The press release was “designed to satisfy minimal disclosures specifically related to financial regulatory requirements,” writes Leerink Swann analyst Seamus Fernandez in a note.
In yet another missive to investors, Wells Fargo analyst Larry Biegelsen points out the Rocket-AF release contained less info compared with a release for another study, Einstein DVT, in August because there was a backlash against Bayer for disclosing too much info ahead of a presentation and the AHA has stricter rules than the European Society for Cardiology for releasing topline results of a late-breaking trial. He also thinks J&J preferred not to release topline results at all, “so this may represent a compromise.”
He concludes by raising his 2014 forecast for US sales of Xarelto for J&J to $1.15 billion from $525 million because has “increased confidence in a positive outcome” for the Rocket-AF study.