Pfizer Inc. PFE announced findings from two pivotal phase III studies – AD-301 and AD-302 – on non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor, crisaborole topical ointment 2%. Crisaborole is being developed for the treatment of patients with mild-to-moderate atopic dermatitis (AD).
Detailed data from the studies revealed that crisaborole achieved statistical significance on both primary and secondary endpoints in the treatment of AD in children (aged two years and above) and adults, compared to vehicle ointment alone. Adverse events related to the treatment were infrequent, mild to moderate in severity and similar to vehicle ointment. These findings were published in the online issue of the Journal of the American Academy of Dermatology.
We note that crisaborole was added to Pfizer’s portfolio following its acquisition of Anacor Pharmaceuticals, Inc. in Jun 2016.
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Crisaborole is currently under review in the U.S. for the treatment of mild-to-moderate AD. A response from the FDA is expected by Jan 7, 2017.
According to information provided by the company in its press release, AD affects about 18–25 million people in the U.S. including 8–18% of infants and children. In the U.S., about 80–90% of all AD patients have mild or moderate disease.
Since no new therapies have been approved for AD in the last 15 years, crisaborole could gain market share quite rapidly on commercialization.
Meanwhile, Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY are also looking to get their candidate, dupilumab, approved for the treatment of adult patients with inadequately controlled moderate-to-severe AD. A regulatory application in the U.S. is planned for the third quarter of 2016. Dupilumab enjoys Breakthrough Therapy status in the U.S. for the treatment of AD.
Pfizer currently carries a Zacks Rank #2 (Buy). Another favorably placed stock in the health care sector is GW Pharmaceuticals plc GWPH, sporting a Zacks Rank #1 (Strong Buy).
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