Pfizer Inc. (PFE) recently released encouraging top-line results from a randomized, placebo-controlled trial, CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) on pneumonia vaccine Prevenar 13.
Prevenar 13 was approved by the U.S. Food and Drug Administration (FDA) under an accelerated approval process.
As part of its regulatory commitments under the FDA’s accelerated approval program, Pfizer conducted the CAPiTA study to verify the clinical benefit of Prevenar 13 for adults.
The trial evaluated the efficacy of Prevenar 13 in preventing the first episode of community-acquired pneumonia (CAP) caused by the serotypes contained in the vaccine. The trial met its primary endpoint.
The CAPiTA study met both the secondary endpoints as well – efficacy against a first episode of non-bacteremic/non-invasive vaccine-type CAP and a first episode of vaccine-type invasive pneumococcal disease (IPD). Pfizer expects to provide detailed results in Mar 2014.
We remind investors that in Feb 2012, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) indicated that it will defer voting on a recommendation for the routine use of Prevenar 13 in adults 50 years of age and older until the results of CAPiTA are out. The ACIP also needs data on the impact of pediatricuse of Prevenar 13 on the disease burden and serotype distribution among adults for a favorable recommendation.
The encouraging results from the CAPiTA study will be instrumental in gaining a positive recommendation from the ACIP.
Meanwhile, the FDA approved Pfizer’s supplemental New Drug Application (sNDA) for rheumatoid arthritis (RA) drug, Xeljanz.
The approval updates the current label of Xeljanz 5 mg tablets to include encouraging radiographic data from two phase III studies, ORAL Scan and ORAL Start. The results from both the studies showed a reduction of radiographic progression.
We note that Xeljanz was approved in the U.S. in early Nov 2012 for the treatment of moderately to severely active RA in adult patients who have not responded adequately to or cannot tolerate methotrexate (MTX). Xeljanz is the first oral treatment to gain approval in a new class of medicines known as Janus kinase (JAK) inhibitors.
We are encouraged by the recent bout of positive news from Pfizer. Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the sector include Alexion Pharmaceuticals, Inc. (ALXN), Biogen Idec Inc. (BIIB) and Actelion Ltd. (ALIOF). While Alexion and Biogen hold a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).
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