Top-line results for a clinical study of pomalidomide will be presented in the morning at the American Society of Hematology meeting in Atlanta. The study data will be revealed in a so-called late-breaking session, a designation usually reserved for breakthrough medical research.
Wall Street analysts expect pomalidomide will be approved by February 10, the deadline for Food and Drug Administration officials to decide on market clearance for the drug. Like Celgene?s biggest-selling cancer product, Revlimid, pomalidomide is a derivative of the once-banned drug thalidomide. In company studies, pomalidomide was shown to help lengthen lives of patients who were previously treated with other drugs. Celgene filed for US approval of pomalidomide in combination with the steroid dexamethasone to treat relapsed or refractory multiple myeloma.
Celgene?s drug Abraxane has gotten a lot of attention in recent weeks as that therapy shows potential to treat pancreatic cancer. But expectations also are high for pomalidomide. ?
Celgene CEO Robert Hugin previously predicted pomalidomide is a potential blockbuster product. Analysts say the study data released so far for the drug and the market potential seem to back up that assertion.
There are about 100,000 relapsed multiple myeloma patients in the US and Europe who have failed at least one prior therapy, according to numbers provided by William Blair analyst John Sonnier.
At least 45,000 US and European patients have failed at least two previous treatments, says Sonnier, who rates Celgene a buy. ??
In July, Onyx Pharmaceuticals (NASDAQ:ONXX) multiple myeloma drug Kyprolis was approved for sale in the US to treat patients who received at least two prior therapies.
The Celgene drug?s clinical success has been telegraphed in recent months but data presented at a major medical meeting is the most relevant and up-to-date information. New details can either hurt a stock or bolster it.
While the study results are under wraps, so far the signs are that the data is pretty good.
?Please be there on Tuesday morning because you will not be disappointed,? Jean-Pierre Bizzari, Celgene?s head of hematology and oncology clinical affairs, told investors at the medical conference Sunday night.
The presentation will take place at 7:30 ET Tuesday morning. ?
Shares of Celgene rose 2% to $80.21 in early afternoon trading Monday.
Twitter: @brettchase
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