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Celgene Corporation (CELG - Analyst Report) recently announced that its oncology drug, Abraxane, has performed well in a phase III study (CA033: n=529). The randomized, open-label, international study compared Abraxane with the standard chemotherapy treatment dacarbazine (DTIC) in chemotherapy-naïve patients suffering from metastatic melanoma, a form of skin cancer.

The encouraging pipeline related news had a positive impact on Celgene’s shares. Data from the study revealed that patients treated with Abraxane survived longer without the disease worsening compared to those in the DTIC arm. Abraxane, on being approved for this indication, would compete with drugs such as Roche’s (RHHBY - Analyst Report) Zelboraf, in the metastatic melanoma space.

We note that Abraxane is already available as a second-line therapy for metastatic breast cancer. The drug is being studied for many other indications.

Even though impressed by the positive news on Abraxane for the metastatic melanoma indication, we believe that investor focus will remain on the US approvability status of Abraxane in the advanced non-small cell lung cancer (NSCLC) indication. The US Food and Drug Administration (FDA) is expected to decide on Abraxane’s label expansion into the NSCLC indication later in the month (target date: October 12).

Moreover, the drug is being developed for other indications such as metastatic pancreatic cancer (phase III MPACT study, data expected by year-end/the first quarter of 2013). Positive news regarding Abraxane would further boost the stock.

Apart from news regarding the label expansion of Abraxane, another eagerly awaited event at Celgene concerns its other oncology candidate, pomalidomide. Celgene is seeking approval of the candidate in combination with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma patients, who have received at least two prior therapies. A final decision from the FDA is expected by February 10, 2013 (action date).

Our Recommendation

We currently have a Neutral recommendation on Celgene. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

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