Celgene Corporation ( CELG ) presented encouraging data on its key growth driver, Revlimid, from a phase III study (FIRST/MM020: n=1,631) at the annual meeting of the American Society of Hematology. The study evaluated the safety and efficacy of Revlimid combined with low-dose dexamethasone versus the combination of melphalan, prednisone and thalidomide in newly diagnosed multiple myeloma (NDMM) patients who are not eligible for stem cell transplantation. Investors reacted positively to the news with the stock gaining 2.15% on Dec 9 to close the trading session at $170.01. We note that the combination of melphalan, prednisone and thalidomide represent the standard treatment for NDMM.
Data from the multicenter, open-label, phase III study supported the use of Revlimid as a long-term maintenance therapy for treating NDMM patients. Data revealed that continuous treatment with the combination of Revlimid and low-dose dexamethasone caused a significant improvement in progression free survival (the study's primary end point) compared to the standard therapy for NDMM. Data also showed an improvement in overall survival following treatment with the Revlimid containing regimen.
We note that in 2012, Celgene had withdrawn its marketing application on Revlimid as a maintenance therapy in the NDMM indication in the EU. The company intends to resubmit the application in the first quarter of 2014. Secondary primary malignancies, the primary cause of concern previously, was found be more or less identical across the arms of the study.
Positive data from the FIRST trial increases the probability of the drug gaining approval for the new indication in the EU. Revlimid is already approved for multiple indications in the U.S. while approval in the NDMM setting is expected to be sought by Mar 31, 2014. Approval of Revlimid for the new indication will further boost its sales potential apart from augmenting Celgene's top line.
Celgene, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. ( ALIOF ), Jazz Pharmaceuticals ( JAZZ ) and Vanda Pharmaceuticals Inc. ( VNDA ). All three stocks carry a Zacks Rank #1 (Strong Buy).