) recently announced that its renal cell cancer candidate,
axitinib, received a positive opinion from the Committee for Human
Medicinal Products (CHMP) of the European Medicines Agency (EMA).
Pfizer is seeking EU approval for the use of axitinib in
treatment-failed patients with advanced renal cell carcinoma.
With axitinib receiving a positive opinion from the CHMP, we
expect it to gain EU approval shortly.
Pfizer had announced the submission of its EU marketing
application for axitinib in June 2011. The regulatory filing was
based on phase III data from the AXIS 1032 trial. The AXIS 1032
trial, which was conducted in patients with previously treated
advanced renal cell carcinoma, showed that patients in the axitinib
arm experienced a significant improvement in progression free
survival (median of 6.7 months versus 4.7 months) compared to
patients being treated with
) Nexavar (sorafenib).
The approval of axitinib in the EU would provide advanced renal
cell carcinoma patients, especially previously-treated patients,
with an additional treatment option.
We note that axitinib gained approval earlier this year in the
US under the trade name Inlyta. Besides Inlyta, Pfizer has two
drugs approved for kidney cancer - Sutent and Torisel.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer, which
carries a Zacks #3 Rank (short-term 'Hold' rating). Pfizer is
facing a major patent cliff with Lipitor losing patent protection
in November 2011. Near-term earnings at Pfizer will be driven by
cost cutting efforts and share repurchases. Longer-term growth will
be dependent on the success of drug development.
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