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Conditional EU Approval for Pfizer's Bosulif

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Pfizer Inc. (PFE) recently announced it has gained conditional marketing authorization from the European Commission (EC) for its oncology product, Bosulif (bosutinib). Bosulif gained conditional EU approval  for the treatment of adults suffering from chronic, accelerated, and blast phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) that has been previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom treatments like Novartis’ (NVS) Gleevec (imatinib) and Tasigna (nilotinib) and Bristol-Myers Squibb’s (BMY) Sprycel (dasatinib) are not considered suitable.

The conditional approval was expected as, earlier this year, the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the conditional approval of Bosulif.

Conditional approval means that Pfizer will have to provide the EMA with additional efficacy and safety data on Bosulif. The approval is renewable on a yearly basis and could be converted into full marketing approval depending on the review of the additional data by the CHMP.

We note that Bosulif is already approved in the US. Pfizer gained US Food and Drug Administration (:FDA) approval in Sep 2012 for Bosulif for the treatment of chronic, accelerated, or blast phase Ph+ CML in adult patients who are resistant or intolerant to prior therapy. Bosulif enjoys orphan drug status in the US.

Pfizer currently carries a Zacks Rank #3 (Hold). While near-term earnings will be driven by cost cutting efforts and share repurchases, longer-term growth will depend on the success of drug development. Pfizer’s pipeline needs to deliver given the Lipitor loss of exclusivity and the upcoming loss of exclusivity on additional products in the next few years.

Among large-cap pharma companies, Novo Nordisk (NVO) currently looks attractive with a Zacks Rank #2 (Buy).

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