Phase 3 Data Published in the Journal of the
American Academy of Dermatology
Pfizer Inc. (NYSE:PFE) announced today the publication of
findings from two pivotal Phase 3 studies of investigational
crisaborole topical ointment 2% (formerly AN2728) in the online
issue of the Journal of the American Academy of Dermatology.
“Atopic dermatitis, or eczema, is a chronic, inflammatory skin
disease that affects millions of children and adults. There have
been no new therapies approved in the United States for people with
atopic dermatitis in the past 15 years,” said Amy
Paller, M.D., Walter J. Hamlin Professor and Chair of
Dermatology, Professor of Pediatrics, Northwestern University
Feinberg School of Medicine. “The results seen in these pivotal
Phase 3 studies demonstrate that crisaborole, if approved, could be
a meaningful treatment option for patients with mild to moderate
atopic dermatitis.”
The detailed results from the Pivotal Phase 3 studies (AD-301
and AD-302) showed that crisaborole achieved statistically
significant results on primary and secondary endpoints for the
treatment of atopic dermatitis (AD) in children two years of age
and up and adults versus vehicle ointment alone. Crisaborole
treatment-related adverse events were infrequent, mild to moderate
in severity, and similar to vehicle ointment.
“The addition of crisaborole to the Pfizer inflammation and
immunology portfolio as a potential treatment option for patients
with mild to moderate atopic dermatitis underscores our commitment
to deliver innovative medicines for patients with high unmet needs
in medical dermatology,” said Michael Corbo, Chief Development
Officer, Inflammation & Immunology, Pfizer Global Product
Development, “This publication highlights the quality of the Phase
3 clinical data with crisaborole, and we are excited to continue to
work with our Anacor colleagues and regulatory authorities in our
effort to bring this important medicine to patients.” Pfizer
recently completed the acquisition of Anacor Pharmaceuticals. If
approved, crisaborole would represent the first commercialized
product as a result of the combination with Anacor.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic condition characterized by
inflammation and itching.1,2,3 Lesions of AD are commonly red,
elevated patches and are often accompanied by pruritus
(itching).1,2,3 Based on available sources, approximately 18 to 25
million people in the United States suffer from AD,4 and 80% to 90%
have mild or moderate disease.5 AD most commonly appears in
childhood, with estimates that between 8% and 18% of all infants
and children in the United States are affected by the disease.6
About Crisaborole Topical Ointment, 2%
Crisaborole topical ointment, 2%, is an investigational
non-steroidal topical anti-inflammatory PDE4 inhibitor in
development for the potential treatment of mild to moderate AD.
Crisaborole is a boron-containing small molecule that inhibits PDE4
in target cells, which may reduce the production of
pro-inflammatory cytokines thought to cause the signs and symptoms
of AD.
Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
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expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
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DISCLOSURE NOTICE: The information contained in this
release is as of July 13, 2016. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about a
product candidate, crisaborole topical ointment 2%, including its
potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated trial commencement and completion dates and regulatory
submission dates, as well as the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
additional analyses of existing clinical data; whether and when any
applications for crisaborole may be filed with regulatory
authorities in any jurisdictions (other than the United States);
whether and when the U.S. Food and Drug Administration will approve
the pending application for crisaborole and whether and when
regulatory authorities in any other jurisdictions where
applications may be filed may approve such applications, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of crisaborole; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com
1 Bieber T. Atopic dermatitis. Ann Dermatol 2010;22:125-37.
2 Bieber T. Atopic dermatitis. N Engl J Med.
2008;358:1483-94.
3 Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care
for the management of atopic dermatitis: section 2. Management and
treatment of atopic dermatitis with topical therapies. J Am Acad
Dermatol. 2014;71:116-32.
4 Hanifin JM, Reed ML. A population-based survey of eczema in
the United States. Dermatitis. 2007;18(2):82-91.
5 Arkwright PD, Motala C, Subramanian H, Spergel J, Schneider
LC, Wollenberg A. Management of difficult-to-treat atopic
dermatitis. Journal of Allergy Clin Immunol Pract.
2013;1:142-51.
6 Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence
in the United States: Data from the 2003 National Survey of
Children’s Health. J Invest Dermatol. 2011;131(1):67-73.
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version on businesswire.com: http://www.businesswire.com/news/home/20160713005698/en/
Pfizer Inc.Media:Steven Danehy,
978-273-3946Steven.Danehy@pfizer.comorInvestor:Chuck Triano,
212-733-3901Charles.E.Triano@pfizer.com
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