Celgene beats Street, expects Thalomid approval delay

CELG's third quarter EPS beat Street estimates, but the stock dropped $4.17 to $58.22 on 3.9 million shares, in part due to uncertainty about what action FDA would take on the upcoming PDUFA date for Thalomid thalidomide for multiple myeloma. CELG commented on the possible outcomes of its sNDA, which has a PDUFA date of Oct. 23. While the company has received no guidance from FDA, President and COO Sol Barer noted that one possibility is that the agency might want the final data from the ECOG study in newly diagnosed MM patients, which are now available. The sNDA included interim data from that study. If that is the case, CELG could have those data ready for submission in early 2005, which would restart a six-month approval clock and put potential approval out about nine months from now. Another possibility would be full approval. Barer also said that the company could be asked to make a commitment to complete its own ongoing Phase III trial in newly diagnosed MM patients. Both that trial and the ECOG study compare Thalomid plus dexamethasone to dexamethasone alone. Thursday's BioCentury Extra misstated the potential FDA actions.

For the third quarter, CELG reported EPS of $0.24, up 383% from the same period last year and beating the Street estimate of $0.20. Revenues were up 37% for the quarter to $101.5 million from $74.3 million in the same period last year, but this quarter's revenues missed Street estimates of $105.5 million. Sales of Thalomid were up 36.7% quarter over quarter to $78.7 million. Thalomid is approved for erythema nodosum leprosum but gets most of its sales from off-label use for MM. ...