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Priority FDA Review for Celgene's Abraxane

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Celgene Corporation (CELG) recently announced that the US Food and Drug Administration (:FDA) will review the supplemental New Drug Application (sNDA) for cancer drug Abraxane on a priority basis.

We note that Abraxane is already available in many countries for the metastatic breast cancer indication. In Oct 2012, the FDA approved Abraxane as a first-line combination therapy for treating patients suffering from locally advanced or metastatic non-small cell lung cancer. Celgene is now seeking approval of Abraxane in combination with Eli Lilly and Company’s (LLY) Gemzar as a first-line therapy in patients suffering from advanced pancreatic cancer.

The sNDA was filed by Celgene in Mar 2013 on the basis of encouraging data from a phase III study (MPACT: n=861), which evaluated the combination of Abraxane and Gemzar in the indication. A response from the FDA is expected to be out by Sep 21, 2013 (target date).

We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission.

We note that Abraxane in combination with Gemzar is also under review in the EU for the advanced pancreatic cancer indication. Celgene intends to seek Abraxane approval for the new indication in other countries during the course of the year. Approval for the additional indication would boost Abraxane’s sales potential significantly.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Alexion Pharmaceuticals, Inc. (ALXN) and Cubist Pharmaceuticals, Inc. (CBST) look equally attractive in the biopharma space with a Zacks Rank #2 each.

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