Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin Controlled-Release Formulation As Adjunctive Treatment

  Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin
  Controlled-Release Formulation As Adjunctive Treatment In Adult Patients
  With Partial Onset Seizures

Business Wire

NEW YORK -- November 16, 2012

Pfizer Inc. (NYSE: PFE) today announced top-line results of a double-blind,
placebo-controlled, Phase 3 study evaluating both the 165 mg dose and the 330
mg dose of pregabalin controlled-release (CR) formulation in adult patients
with partial onset seizures with epilepsy. These study results indicate
pregabalin CR did not meet its primary endpoint comparing the change in
seizure frequency to placebo, although both doses were well-tolerated.

This study is one of three Phase 3 studies of the pregabalin CR formulation,
which will ascertain the potential use of pregabalin as a once-a-day therapy.
The other two studies are evaluating the pregabalin CR formulation in
fibromyalgia and post-herpetic neuralgia. Pfizer will continue to further
analyze these top-line results as well as the top-line results of the other
two studies.

"While the study showed an observed improvement, it did not show a
statistically significant difference in seizure frequency, which we believe
may have been due to a higher-than-expected placebo response," said Steven J.
Romano, M.D., senior vice president, head, Medicines Development Group, Global
Primary Care Business Unit, Pfizer Inc. "Lyrica immediate-release has a proven
success record in patients with epilepsy, and we look forward to understanding
further the potential role of a once-a-day pregabalin formulation."

Epilepsy is a chronic disorder in which seizures occur intermittently. Partial
onset seizures (simple, complex, and secondarily generalized tonic-clonic) are
the most common. In the U.S., the immediate-release formulation – Lyrica^®
(pregabalin) capsules CV has been used as adjunctive therapy for partial onset
seizures since its approval in June 2005.

About the Study

The objective of the double-blind, randomized, parallel group, multi-center
study was to assess the efficacy and safety of pregabalin CR as adjunctive
treatment of partial onset seizures in adult patients with epilepsy.

The study was conducted in a total of 18 countries at 66 sites. The study
included four phases: Phase 1 - an 8 week baseline phase during which the
baseline seizure rate was recorded; Phase 2 - a 2 week double-blind dose
escalation phase; Phase 3 - a 12 week double blind maintenance phase where the
dosage of study medication was fixed; and Phase 4 - a 1 week taper phase at
the conclusion of the study. Treatment groups included pregabalin CR 165
mg/day, pregabalin CR 330 mg/day or placebo at a 1:1:1 ratio. These pregabalin
CR dose levels provided exposure similar to 150 mg and 300 mg daily doses of
currently available Lyrica (pregabalin) immediate-release formulations.

The primary endpoint was the log[e]-transformed 28 day seizure rate for all
partial onset seizures collected during the double-blind treatment phase
compared to the 8 week baseline (screening) seizure period.

The analysis of the primary endpoint, log[e ](28-days seizure rate + 1),
showed a non-significant result between pregabalin and placebo for the
pregabalin CR 330 mg group (p=0.0907). Responder rates, defined as the
percentage of patients with a ≥ 50% reduction in seizure frequency from
baseline, were 45.9%, 37.8% and 35.8% for the CR 330 mg, CR 165 mg, and
placebo groups, respectively, and highlight the high placebo response observed
in this study.

Both pregabalin CR 330 mg and pregabalin CR 165 mg were well tolerated in this
population. The tolerability and safety findings are consistent with past
pregabalin findings for patients with epilepsy, with dizziness, weight
increased and somnolence as the most frequently reported adverse events in the
study.

About Lyrica

Lyrica^® is currently approved for various indications in 120 countries and
regions globally. Since its first approval from the FDA in 2004, Lyrica has
been approved for five indications in the U.S., of which four are in the
therapeutic area of pain. These indications include neuropathic pain
associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain
after shingles), neuropathic pain associated with spinal cord injury,
fibromyalgia and partial onset seizures in adults with epilepsy who take one
or more drugs for seizures. Antiepileptic drugs (AEDs) including Lyrica
increase the risk of suicidal thoughts or behavior in patients taking AEDs for
any indication.

There have been post-marketing reports of angioedema and hypersensitivity with
Lyrica. Treatment with Lyrica may cause dizziness, somnolence, dry mouth,
edema and blurred vision. Other most common adverse reactions include weight
gain, constipation, euphoric mood, balance disorder, increased appetite and
thinking abnormal (primarily difficulty with concentration/attention).

For Lyrica prescribing information in the United States, please visit
www.lyrica.com.

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 November
16, 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 potential additional
indication for Lyrica as a once-a-day treatment, 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 supplemental drug applications that may be
filed for such additional indication 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.
Media:
MacKay Jimeson, 212-733-2324
or
Investors:
Suzanne Harnett, 212-733-8009
 
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