- Independent panel recommends study continues without changes
- Results expected in first half of next year, Lilly says
Eli Lilly & Co. fell in New York trading after a breast cancer treatment failed to meet interim efficacy criteria in a late-stage trial, possibly delaying its entry to market.
The shares were down 1.2 percent to $79.99 at 10:29 a.m. The stock had dropped 3.3 percent this year as of Tuesday’s close, underperforming the Standard & Poor’s 500 Health Care Index, which gained 3.7 percent during the period .
The drugmaker was evaluating the treatment of advanced breast cancer with its abemaciclib drug, given in combination with another medicine, fulvestrant. An independent panel recommended continuing the study without modification, and final results are expected in the first half of next year, Indianapolis-based Lilly said in a statement. The trial involves 669 patients whose disease had progressed following multiple treatments.
The results make it “unlikely that Lilly will be able to obtain a sufficiently competitive package” for regulatory approval in early 2017, Bloomberg Intelligence analyst Sam Fazeli wrote in a note. If the drug’s approval is delayed to 2018, abemaciclib would come third to market, behind Pfizer Inc.’s Ibrance and Novartis AG’s ribociclib.
Lilly’s abemaciclib is projected to generate more than $1 billion in sales by 2020, according to analysts’ estimates compiled by Bloomberg. The drug was granted breakthrough therapy status by U.S. Food and Drug Administration last year after early trials showed strong results. The status, attributed to drugs that showed early clinical signs of significant improvement over existing options for life-threatening diseases, means getting an expedited review by the FDA.
Breast cancer is the most common form of cancer in women, with almost 1.7 million new cases diagnosed in 2012 worldwide, according to World Cancer Research Fund International.