Celgene Corporation (CELG) received encouraging news from Europe when the EC cleared its cancer drug, Abraxane, for an additional indication. Abraxane was approved by the EC 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 news on Abraxane impacted the stock positively. Celgene intends to launch Abraxane in the EU for the indication in the coming months.
Approval for the new indication was gained on the basis of encouraging data from a phase III study (MPACT: n=861). The EC decision does not surprise us as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended Abraxane’s approval for the metastatic pancreatic cancer indication in Nov 2013. We remind investors that Abraxane in combination with Gemzar was approved by the U.S. Food and Drug Administration (FDA) for the same 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, in 2012, 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.
EU approval of Abraxane for treating metastatic pancreatic cancer will boost the drug’s sales potential significantly as the incidence of the disease is on the rise. Moreover, the EU pancreatic cancer market is characterized by significant unmet medical need. The EC decision on Abraxane marks the first approval of a drug for treating metastatic pancreatic cancer in the EU in approximately seven years.
Celgene carries a Zacks Rank #3 (Hold). Better-ranked stocks include Forest Laboratories Inc. (FRX) and Jazz Pharmaceuticals (JAZZ). While Forest Laboratories carries a Zacks Rank #1 (Strong Buy), Jazz Pharma holds a Zacks Rank # 2 (Buy).
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