Recently, Pfizer Inc. (PFE) announced data from two studies, which evaluated its rheumatoid arthritis (RA) candidate tofacitinib.
Of the 2 studies from which detailed data were presented, one of them was a phase III study and the other a phase II study. The 12-month phase III study (ORAL Sync or A3921046: n= 792), evaluated tofacitinib (as a combination therapy) at two doses in patients suffering from moderate-to-severe active RA , who did not respond favorably to an existing therapy.
Data from the study revealed that treatment with tofacitinib brought down the symptoms of the disease and also resulted in improved mobility.
The other study (A3921109: n=111) evaluated the safety and efficacy of Lipitor against placebo in reducing LDL cholesterol (LDL-C) in patients suffering from moderate-to-severe active RA and undergoing tofacitinib therapy.
Data from the 12-week study revealed that the addition of Lipitor reduced the mean LDL-C by 35% as against a 5.8% increase in LDL-C observed in the placebo arm.
We note tofacitinib is an important pipeline candidate at Pfizer with filings in both the US and the EU expected by the end of the year. The year 2011 is expected to be a catalyst-filled year for the company.
Pfizer expects to present phase III data on several candidates including axitinib (renal cell carcinoma), Prevnar/Prevenar 13 (prevention of pneumococcal disease in adults) and Eliquis (stroke prevention in patients with atrial fibrillation) in 2011. Eliquis is being developed in collaboration with Bristol-Myers Squibb Company (BMY).
Pfizer also expects to present phase II data on crizotinib for non-small cell lung cancer. Pfizer remains on track to submit 15-20 regulatory applications in the period from 2010 to 2012 . Positive news related to its pipeline coupled with new approvals/launches will boost the stock.
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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