Recently, Celgene Corporation (CELG) presented data from a phase III study (CA-031) which evaluated its oncology candidate, Abraxane, as a first-line combination therapy in patients suffering from advanced non-small cell lung cancer (NSCLC). The data was presented at the 48th annual conference of the American Society of Clinical Oncology (ASCO).
Results from the multi-center, randomized study revealed that treatment with Abraxane prolonged overall survival compared to patients treated with Bristol-Myers Squibb’s (BMY) chemotherapy drug Taxol.
We remind investors that Celgene is seeking approval from the US Food and Drug Administration (FDA) for marketing Abraxane as a first-line therapy for treating NSCLC patients on the basis of data from the phase III study. A decision from the FDA is expected by October 12, 2012 (target date).We note that Abraxane is already available in the US as a second-line therapy for metastatic breast cancer. Approval of Abraxane for the additional indication would increase the sales potential of the drug.
Apart from the NSCLC indication, Celgene also presented data on Abraxane for the resectable pancreatic cancer indication at the ASCO. Data from the study (n=16), which evaluated Abraxane in combination with Eli Lilly’s (LLY) cancer drug Gemzar, revealed at least a 70% reduction in tumor-marker level in 50% patients on being treated with the combination therapy. Abraxane is also being evaluated for the pancreatic cancer indication in a larger study (MPACT), data from which is expected later in the year.
Our Recommendation
We have a Neutral recommendation on Celgene. We believe that Celgene, driven by its impressive oncology portfolio, expansion efforts, strong balance sheet and robust pipeline, will perform well in the coming quarters. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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