Positive CHMP Opinion Sends Celgene Soaring


Shares of Celgene Corporation (CELG) hit a 52-week high of $164.00 on Nov 22, 2013 buoyed by the positive opinion of the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) on the company’s cancer drug, Abraxane, for an additional indication.

The CHMP recommended the approval of Abraxane as a first-line therapy in patients suffering from metastatic adenocarcinoma of the pancreas in combination with Eli Lilly and Company’s (LLY) Gemzar. The positive opinion by the CHMP will be reviewed by the European Commission (EC). A final decision from the EC should be out in the next two to three months.

The CHMP’s positive opinion for the new indication came on the basis of encouraging data from a phase III study (MPACT: n=861). We remind investors that Abraxane in combination with Gemzar was approved by the U.S. Food and Drug Administration (:FDA) for the metastatic pancreatic cancer indication in Sep 2013.

We note that Abraxane is already available in the EU as a monotherapy for treating adults suffering from metastatic breast cancer. The patients have failed first-line therapy for metastatic disease. Moreover, standard, anthracycline containing treatment is not indicated in those patients. We note that Abraxane is approved in more than 40 countries across the globe for the metastatic breast cancer indication.

Furthermore, last year, the drug was cleared by the FDA as a first-line combination therapy for treating patients suffering from locally advanced or metastatic non-small cell lung cancer.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. (ALIOF) and Vanda Pharmaceuticals Inc. (VNDA). While Actelion carries a Zacks Rank #1 (Strong Buy), Vanda holds a Zacks Rank #2 (Buy).

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