Pfizer Inc. (PFE) recently announced that its oncology candidate, crizotinib, has been granted priority review status by the US Food and Drug Administration (FDA). The company is looking to get crizotinib approved for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer has also filed for approval in Japan, the second largest pharma market.
Pfizer had initiated the rolling submission for the new drug application on crizotinib in January 2011. Priority review status means that the NDA will be reviewed within a six-month period instead of the usual 10 months.
This means a response from the FDA regarding crizotinib’s approvability should be out later this year. Crizotinib enjoys orphan drug status in both the US and Japan.
The approval of crizotinib, potentially later this year, would be a major boost for Pfizer. With the company slated to face generics for Lipitor in the US from November 2011, any progress on the pipeline front is welcome news.
2011 should be a catalyst-filled year for the company. Pfizer, which reduced its R&D guidance earlier this year, expects to present phase III data on several candidates including tofacitinib (rheumatoid arthritis), axitinib (renal cell carcinoma), Prevnar/Prevenar 13 (prevention of pneumococcal disease in adults) and Eliquis (stroke prevention in patients with atrial fibrillation) in 2011.
Pfizer also expects to present phase II data on crizotinib for non-small cell lung cancer. Eliquis is being developed in collaboration with Bristol-Myers Squibb (BMY).
Pfizer remains on track to submit 15-20 regulatory applications in the 2010 to 2012 period. Regulatory filings for candidates including tofacitinib, in both the US and the EU, are scheduled to be submitted by the end of the year. Meanwhile, a response on Prevnar 13’s (adults) approvability should be out later this year.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term “Hold” rating). While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will be dependent on the success of drug development.
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