Celgene's apremilast couldn't quite beat placebo in a late-stage trial on a rare and severe form of arthritis, imperiling a potential indication for a drug the company believes can break the blockbuster barrier.
Celgene picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of its blockbuster plan.
Celgene and most analysts have never met eye-to-eye on the future prospects of the psoriasis drug apremilast, which the biotech heavyweight expects could become a blockbuster seller. Yet at least one analyst argues that new data from a late-stage study of the oral treatment in patients with psoriatic arthritis could lift sales expectations for apremilast among his peers.
Celgene has put another brick in the wall of positive late-stage data for apremalist as a new therapy for psoriatic arthritis, building on its new drug application at the FDA.
Celgene executives highlight a blockbuster future for the oral psoriasis drug apremilast. But on Saturday, investigators rattled the company's die-hard enthusiasts, noting that new Phase III data fell short of an earlier round that had helped whip up high hopes.
In mapping out an aggressive plan for growth, Celgene executives have highlighted a blockbuster future for the oral psoriasis drug apremilast. But on Saturday investigators rattled the company's die hard enthusiasts, noting that Phase III data for the anti-inflammatory treatment fell short of an earlier round of mid-stage efficacy data which had helped whip up high hopes.
Celgene captured the center ring at the J.P. Morgan conference on its opening day Monday. Company CEO Bob Hugin boldly mapped out a 5-year plan to double sales and highlighted upbeat Phase III data on its psoriasis drug apremilast that he believes will set the stage for regulatory approval on both sides of the Atlantic.
Shares of Celgene surged yesterday as the company touted positive data from a pair of late-stage studies on apremilast, one of its top drug prospects now being prepped for FDA review.
Celgene says that its experimental drug apremilast aced the first of three late-stage studies, posting positive data for psoriatic arthritis.
At its R&D day yesterday, Celgene said that it expects to see $6 billion in revenue by 2015 from its three big blood cancer drugs Revlimid, Thalomid and Vidaza. But beyond its marketed products,