CHMP in Favor of Pfizer's Axitinib

Pfizer (PFE - Analyst Report) 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 Bayer/Onyx Pharma’s (BAYRY - Analyst Report)/(ONXX - Analyst Report) 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.