Celgene Corporation (CELG - Analyst Report) recently announced that its oncology drug, Abraxane, has performed well in a phase III study (MPACT: n=861). The study evaluated the combination of Abraxane and Eli Lilly’s (LLY - Analyst Report) Gemzar as a first-line therapy in patients suffering from advanced pancreatic cancer.
Data from the study revealed that there was significant improvement in overall survival in patients treated with Abraxane and Gemzar compared with those treated with Gemzar alone. Data also revealed a 31% decline in the risk of disease progression or death of patients treated with the combination of Abraxane and Gemzar as opposed to those in the Gemzar arm. Moreover, median progression-free survival of 5.5 months was observed in the Abraxane plus Gemzar arm compared with 3.7 months for patients in the Gemzar arm.
Based on encouraging data from the MPACT study, Celgene intends to seek approval of Abraxane for the new indication in the US and EU in the first half of 2013. Approval in other markets is expected to be sought in the second half of 2013.
We note that Abraxane is already available in the US as a second-line therapy for metastatic breast cancer. The label of the drug was expanded in Oct 2012 when the US Food and Drug Administration (FDA) approved Abraxane as a first-line combination therapy for treating patients suffering from locally advanced or metastatic non-small cell lung cancer. Curative surgery or radiation therapy is not applicable for those patients. The FDA approval of Abraxane for the additional indication was based on positive results from a phase III study (CA-031).
If Celgene is successful in expanding Abraxane’s label into the advanced pancreatic cancer indication, the drug’s sales potential would be boosted further. Celgene boasts of a strong pipeline. The company has multiple pipeline events lined up in the coming quarters. Positive pipeline related news would boost the stock.
Celgene carries a Zacks Rank #2 (Buy) in the short run. Pharma stocks, which appear to be more favorably placed, include Valeant Pharma (VRX - Analyst Report) and Medivation, Inc. (MDVN - Analyst Report). Both the companies carry a Zacks Rank #1 (Strong Buy).