Pfizer moved a step closer to getting EU a green light for its chronic myelogenous leukaemia (CML) drug bosutinib last week after it was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP).
The CHMP, which is part of the European Medicines Agency, lent its support for the drug’s use as a treatment for adults with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive CML who have previously been treated with tyrosine kinase inhibitor drugs such as Novartis’ Glivec/Gleevec (imatinib).
Bosutinib should also only be given to patients for whom imatinib, Novartis’ Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib) are not appropriate treatment options, said the committee.
Tyrosine kinase inhibitors have had a dramatic impact on CML over the last decade or more, but resistance to drug therapy and side effects remain a problem, so there is a need for additional lines of treatment.
“We believe many doctors and CML patients will find this treatment, if approved, to be a welcome addition, offering a distinct adverse event profile and a convenient once-daily dosing regimen,” commented Mace Rothenberg, Pfizer’s senior vice president of clinical development and medical affairs.
Bosutinib was approved in the US for CML last September under the Bosulif trade name, and analysts have predicted it could make sales of $300m or more within the next three to five years despite its second-line use.
Other drug candidates for CML are also coming through the pipeline, notably Ariad’s ponatinib which has been submitted for approval in the US and EU and has a different mechanism of action to the current crop of CML therapies.
Pfizer creates IPO for animal health business Zoetis
Meanwhile, Pfizer has started the ball rolling on its planned spin-out of animal health business Zoetis with an initial public offering of 86.1m shares scheduled for later this month that could raise up to $2.2bn.
The $22-$25-per-share minority share offering values the entire business at around $12bn. Pfizer said last year it intended to spin its animal health operations into a standalone business by July 2013.