Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis

NEW YORK–(BUSINESS WIRE)– 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 care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer
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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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