Celgene to reveal data on blood cancer drug
Analysts expect pomalidomide will win US approval in February, adding a potential blockbuster treatment to the biotech's drug lineup.
Celgene's (CELG) stock jumped more than 25% over the past 12 months in part because of the big biotech company's drug pipeline. And investors are set to find out more details about one of Celgene's promising new product, pomalidomide, a follow-up treatment for the blood cancer multiple myeloma.
Top-line results for a clinical study of pomalidomide will be presented Tuesday 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 U.S. approval of pomalidomide in combination with the steroid dexamethasone to treat relapsed or refractory multiple myeloma.
Celgene's drug Abraxane has also gotten much 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 to be 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 U.S. and Europe who have failed at least one prior therapy, according to numbers provided by William Blair analyst John Sonnier.
At least 45,000 U.S. and European patients have failed at least two previous treatments, says Sonnier, who rates Celgene a "buy."
In July, Onyx Pharmaceuticals (ONXX) multiple myeloma drug Kyprolis was approved for sale in the U.S. to treat patients who received at least two prior therapies.
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.
Shares of Celgene closed 2.3% higher at $80.50 Monday.
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