) 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
) Gleevec (imatinib) and Tasigna (nilotinib) and
) 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
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,
) currently looks attractive with a Zacks Rank #2 (Buy).
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