Celgene Corporation (CELG) was up almost 3% after the company announced that the European Commission (EC) has granted approval to Otezla, an oral selective inhibitor of phosphodiesterase 4 (PDE4), for two therapeutic indications. Otezla gained approval for the treatment of moderate-to-severe chronic plaque psoriasis in adults who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen, and ultraviolet-A light (PUVA).
The EC also approved Otezla for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy – either as a monotherapy or in combination with DMARDs.
The EU approval of Otezla did not come as a surprise as the company had received a positive opinion on Otezla in Nov 2014 from the European Medicines Agency's Committee for Medicinal Products for Human Use for use in both the above mentioned indications.
We note that Otezla is already available in the U.S. The FDA has cleared the drug for the treatment of adult patients with active psoriatic arthritis (Mar 2014) and for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (Sep 2014). On its third quarter 2014 conference call, the company stated that Otezla has generated revenues of $18 million in the U.S.
Celgene carries a Zacks Rank #1 (Strong Buy). Other well-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG), Alexion Pharmaceuticals, Inc. (ALXN) and AbbVie Inc. (ABBV). While AMAG and Alexion carry the same rank as Celgene, AbbVie carries a Zacks Rank #2 (Buy).
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