Pfizer Announces Top-Line Results From A Phase 3 Long-Term Safety Study Of ALO-02:

  Pfizer Announces Top-Line Results From A Phase 3 Long-Term Safety Study Of
  ALO-02:

 An Investigational Agent Comprised Of Oxycodone Hydrochloride And Naltrexone
 Hydrochloride Extended-Release Capsules, In Subjects With Moderate-To-Severe
                           Chronic Non-cancer Pain

Business Wire

NEW YORK -- October 11, 2012

Pfizer Inc. (NYSE: PFE) announced top-line results today from a Phase 3
open-label long-term safety study of investigational agent ALO-02 (oxycodone
hydrochloride and naltrexone hydrochloride extended-release capsules) in
patients with moderate-to-severe chronic, non-cancer pain. The primary
objective of the study was to evaluate the safety of ALO-02 administered for
up to 12 months. The study showed that the adverse event profile was as
expected based on similar long-term safety studies with other extended-release
opioid formulations; the most common adverse events were nausea, constipation,
vomiting and headache. The study supports the safety profile of this
investigational analgesic.

ALO-02 uses technology designed to encourage use as intended. The technology
may discourage common methods of tampering associated with prescription opioid
misuse and abuse and consists of extended-release oxycodone pellets that
surround a sequestered core of naltrexone. When used as directed, the
naltrexone core remains sequestered and patients receive oxycodone in an
extended release manner. When the pellets are crushed, the naltrexone is
released and is designed to counteract the effects of oxycodone.

“These top-line data provide evidence of the long-term safety of ALO-02 in
patients with moderate-to-severe non-cancer pain regardless of prior
prescription opioid treatment,” said Steven J. Romano, M.D., senior vice
president, head, Medicines Development Group, Global Primary Care Business
Unit, Pfizer Inc.

Study ALO-02-10-3001 included adult patients with moderate-to-severe chronic
non-cancer pain lasting at least 3 months and requiring a continuous
around-the-clock opioid analgesic for an extended period of time. Before
enrolling in the study, subjects could be receiving a prescription opioid for
the management of chronic pain or could be opioid-naïve. The primary objective
of this single-arm, multicenter, safety study was to evaluate the long-term
safety of ALO-02 administered once or twice daily for up to 12 months. The
study enrolled 395 patients, the majority of whom – 77 percent – were
opioid-experienced. The majority of patients had chronic lower back pain (61
percent) and 18 percent had pain from osteoarthritis. Patients enrolled in the
study had pain for an average of nine years. A total of 193 (48.9%) patients
received ALO-02 for approximately 6 months and 105 (26.6%) patients for
approximately one year.

The most common treatment-emergent adverse events (>10%) while on ALO-02 were
nausea, constipation, vomiting and headache. The most common serious adverse
events were acute myocardial infarction, non-cardiac chest pain, pneumonia,
convulsion, and kidney stones, each of which occurred in 2 patients. A total
of 237 (60%) patients discontinued from the study over the one-year study
period, with 19 percent of patients reporting adverse events as the primary
reason for discontinuation. The adverse events that most commonly (>2%) lead
to discontinuation were nausea and constipation. The discontinuation rate was
within the expected range based on similar long-term safety studies with other
extended-release opioid formulations.

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world’s best-known consumer 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 the world’s
leading biopharmaceutical company, we also 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. To learn more
about our commitments, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of October
11, 2012. 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. Such risks and uncertainties include, among other things, the
uncertainties inherent in research and development; decisions by regulatory
authorities regarding whether and when to approve any drug applications that
may be filed for ALO-02 as well as their decisions regarding labeling and
other matters that could affect its availability or commercial potential; 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, 2011 and in
its reports on Form 10-Q and Form 8-K.

Contact:

Pfizer Inc.
MacKay Jimeson (media)
212-733-2324
Suzanne Harnett (investors)
212-733-8009
 
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