Celgene ($CELG) seemed to be sprinting toward a big win for its multiple myeloma drug Revlimid. European regulators were expected to bless broader use of the drug as a maintenance therapy. But a big hurdle popped up in its path: Europe's Committee for Medicinal Products for Human Use asked for "more mature" data.
So, under the non-committal headline "Celegene Provides Regulatory Update," the company said it had pulled the European application, planning to resubmit later. And it's "re-evaluating" a similar submission to the FDA, planning to file next year.
The company affirmed its financial guidance for the year--including Revlimid sales of $3.75 billion to $3.85 billion--but next year's goals might be another story. Celgene had been counting on stepped-up growth for Revlimid to drive its results. Company officials should be eating their words now, Bernstein analyst Geoffrey Porges told Forbes' Matthew Herper. "Owning this stock is like Bill Murray in 'Groundhog Day' ... the same bad experiences over and over again."
It's quite a turnabout. Based on previous analyst expectations, Revlimid was expected to be the second-biggest oncology product in the world by 2018, according to EvaluatePharma, with $6.751 billion in sales. And based on Revlimid growth, plus its near-term pipeline products, Celgene itself was pegged to be the second-biggest player in the oncology market at $9.286 billion in cancer-drug revenues. Both of those predictions could still prove true, but perhaps not as quickly as Celgene had hoped.