Shares of Celgene (CELG) tumbled nearly 12% on Thursday after the drug maker withdrew an application in Europe for its blood cancer drug Revlimid following a slew of questions from regulators.
The Summit, N.J.-based biopharmaceutical company said it would analyze the Committee for Medicinal Products for Human Use’s requests, and plans to re-submit the application with more mature data.
Celgene continues to seek approval for Revlimid for the treatment of multiple myeloma in Switzerland, Australia and other core markets. In the U.S., it is also re-evaluating the drug and plans to submit an application to the Food and Drug Administration in 2013.
The company is trying to get approval for the drug used in combination with low-dose dexamethasone as a potential treatment for relapsed multiple myeloma patients who have received at least two prior therapies and demonstrated disease progression on the last therapy.
Celgene’s new drug application had been based on data from a mid-stage study, the results of which were presented at the 2012 American Society of Clinical Oncology. A late-stage study is expected to complete enrollment in July, with data emerging by the end of the year.
Despite the drug woes, the Celgene reaffirmed its fiscal 2012 and long-term 2015 revenue and earnings guidance.
Celgene sees revenue in the range of $5.4 billion to $5.6 billion, with sales of its blockbuster Revlimid expected to be between $3.75 billion and $3.85 billion.
It forecasts non-GAAP earnings of $4.70 to $4.80 a share. Analysts in a Thomson Reuters poll are looking for full-year earnings of $4.79 on sales of $5.47 billion.
For 2015, Celgene sees earnings in the range of $8 to $9 a share on revenue of $8 billion to $9 billion.