Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug
Administration (FDA) Anesthetic and Analgesic Drug Products Advisory
Committee and Drug Safety and Risk Management Advisory Committee voted
(9 to 6) in favor of approval of ALO-02 (oxycodone hydrochloride and
naltrexone hydrochloride) extended-release capsules for its proposed
indication, “management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which alternative
treatment options are inadequate.”

The Committees recommended the inclusion of abuse-deterrent labeling for
intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They
voted against inclusion of abuse-deterrent labeling for the oral route
(6 to 9). The FDA will take the Committees’ recommendations into
consideration before taking action on the New Drug Application for
ALO-02.

“Pfizer believes the ALO-02 data support approval with abuse-deterrent
labeling and we look forward to ongoing discussions with the FDA,” said
Ken Verburg, PhD, Chief Development Officer, Neuroscience and Pain,
Pfizer Inc. “Abuse-deterrent opioids are an important part of a
multi-faceted approach to help address the growing abuse epidemic.”

About ALO-02 Technology

ALO-02 is the first investigational oxycodone formulated with
sequestered naltrexone technology designed to help deter oral and
non-oral abuse when crushed. ALO-02 extended-release capsules contain
pellets that consist of oxycodone hydrochloride, an opioid agonist,
which surround sequestered naltrexone hydrochloride, an opioid
antagonist. When taken as directed, the naltrexone is intended to remain
sequestered and patients receive oxycodone in an extended-release
manner. Studies demonstrate that when the pellets are crushed, up to 100
percent of the sequestered naltrexone is released and is available to
counteract the effects of oxycodone.

About 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 health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care 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 June 8, 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, ALO-02, 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, without limitation, the possibility of
unfavorable clinical trial results, including unfavorable new clinical
data and additional analyses of existing clinical data; whether and when
the FDA may approve the new drug application for ALO-02, which will
depend on the assessment by the FDA of the benefit-risk profile
suggested by the totality of the efficacy and safety information
submitted; decisions by regulatory authorities regarding labeling
(including whether the FDA will approve abuse-deterrent labeling) and
other matters that could affect the availability or commercial potential
of ALO-02; 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.

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