Celgene Nearing 52-week High on Abraxane Data, Upcoming PDUFA

Celgene (NASDAQ:CELG) moved closer today to securing another indication for its oncology drug, Abraxane, which is already approved as a second-line treatment for metastatic breast cancer. On Tuesday, Celgene announced that in a Phase III trial for metastatic melanoma, chemotherapy-naive patients treated with Abraxane showed a significant improvement in progression-free survival over those treated with dacarbazine, the only chemotherapy treatment currently approved for the skin cancer. If approved, analysts believe the added indication could become a billion dollar opportunity for Celgene, as melanoma is one of the most prevalent cancers in the U.S. and rates have been rising substantially in the last few decades.

Celgene acquired Abraxane in 2010 through the purchase of Abraxis BioScience, a $2.9B deal. Since its approval in 2005, Abraxane has had slow sales growth, but numbers are improving since Celgene took over. In 2011, the company’s first full year with the drug, it reported Abraxane revenue of $386M, and already in the first and second quarters of this year the drug provided $104M and $110M respectively, putting it on pace for 2012 revenues of well over $400M. Regardless, a bigger opportunity may lie in future indications for the drug, which is in a Phase III trial for pancreatic cancer, and the FDA will vote on October 12th whether to approve Abraxane as an advanced non small-cell lung cancer (NSCLC) treatment; the pancreatic cancer data is expected late this year. Although these catalysts have driven CELG up substantially over the last three months, there is still some room to gain. CELG is approaching its 52-week high of $80.42 and will likely find resistance there until the NSCLC decision next week prompts a break-out in one direction or the other. Following the decision, investors are likely to again rally ahead of the pancreatic data later this year. CELG is up 1.5% in the afternoon.