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Celgene Granted Priority Review Status for Revlimid

A study by research firm Decision Resources has forecast that Revlimid will generate $321 million in sales in 2009.Celgene (Nasdaq: CELG), headquartered in Summit, has been granted priority review status for its drug Revlimid by the Food and Drug Administration. This means a decision on whether or not to approve the drug will be made within six months.
The company is seeking approval for Revlimid for the treatment of myelodysplastic syndromes, which are cancers of the blood. About 300,000 people suffer from that group of malignancies worldwide.
Revlimid would be used to treat a subgroup of those patients who carry a chromosomal abnormality called “deletion 5q.” Celgene said that about 20% to 30% of all patients diagnosed with myelodysplastic syndromes suffer from this abnormality.
The FDA”s priority review status reduces the agency”s review time to six months from the standard 10. The status is granted to drugs that are believed to be able to provide significantly better treatment for a disease or disorder than those currently on the market.
Decision Resources, a research and advisory firm focusing on pharmaceutical and health care issues, has forecast that sales of Revlimid will generate $321 million in sales in 2009. According to the study, the anticipated approval of Revlimid for second-line therapy will considerably expand the multiple-myeloma drug market thanks to its oral formulation and favorable toxicity profile that will encourage significant off-label use in first-line and maintenance therapy.
At the close of trading Celgene shares were down $1.73 to $39.40.