) announced encouraging top-line results from two pivotal phase
III studies from the Oral treatment Psoriasis Trials (OPT)
Program (OPT Pivotal #1 and OPT Pivotal #2) on Xeljanz
(tofacitinib:5mg and 10mg). Xeljanz, an oral Janus kinase (JAK)
inhibitor, is being developed for the treatment of
moderate-to-severe plaque psoriasis.
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Xeljanz showed statistically significant superiority at week 16
in the proportion of subjects achieving a Physician's Global
Assessment response of "clear" or "almost clear" over placebo.
The candidate also showed superiority in the proportion of
subjects achieving at least a 75% reduction in Psoriasis Area and
Severity Index over placebo. Psoriasis Area and Severity Index
are the two commonly used measures of efficacy in psoriasis.
In Oct 2013, Pfizer announced top-line data from the other two
phase III studies (OPT Compare and OPT Retreatment) under the OPT
Program evaluating Xeljanz (tofacitinib) for the treatment of
adults with moderate-to-severe chronic plaque psoriasis.
Results from the OPT Compare study were mixed with Xeljanz (10
mg) meeting the primary endpoint of non-inferiority to
) Enbrel but failing to meet the non-inferiority criteria to
Enbrel at the 5 mg dose. Results from the OPT Retreatment study
showed a higher number of patients who continued Xeljanz
treatment maintained their response during the treatment
withdrawal phase compared to patients who switched to placebo.
Based on the results from these four studies under the OPT
Program and a long-term extension study, Pfizer plans to make
regulatory submissions for Xeljanz in various countries for the
treatment of adults suffering from moderate-to-severe chronic
plaque psoriasis. Pfizer will filings a supplemental New Drug
Application (sNDA) for Xeljanz in the U.S. in early 2015.
Xeljanz is already available in the U.S. for the treatment of
moderate-to-severe active rheumatoid arthritis (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 JAK inhibitors. The
product represents a new treatment option for patients who
respond inadequately to or are unable to tolerate MTX. Xeljanz
sales were $114 million in 2013.
We are encouraged by Pfizer's progress with Xeljanz. Label
expansion of the drug will boost its sales potential.
Pfizer, a large-cap pharma stock, currently holds a Zacks Rank #3
(Hold). Some better-ranked stocks in the same sector include
Johnson & Johnson
). Both sport a Zacks Rank #2 (Buy).