Pfizer will present data on three investigational compounds that
represent potential new mechanisms for targeting pain and inflammation.
These data will highlight tanezumab, a molecule designed to target nerve
growth factor, a key pain mediator; CP-690,550, a JAK-inhibitor that
suppresses immune-related inflammatory response; and esreboxetine, a
highly-selective norepinephrine reuptake inhibitor which plays a role in
controlling the activity of this important neurotransmitter. These data
will be presented at the 2008 American College of Rheumatology
Scientific Meeting in San Francisco, California.
"Pfizer has an established track record of
bringing innovative therapies to patients suffering with pain and
inflammation,” said Martin Mackay, Ph.D.,
president, Pfizer Global Research and Development. "Data
to be presented at ACR confirm our clinical approaches in developing
these three compounds – CP-690,550,
esreboxetine and tanezumab – as potential new
medicines to provide relief from these serious medical conditions.”
Rheumatoid Arthritis
Data is being presented from several clinical trials studying
CP-690,550, an oral medication that inhibits the Janus Kinase enzyme
(JAK). This enzyme plays a major role in controlling the activation and
proliferation of white blood cells, key elements of the immune system,
which play a major role in rheumatoid arthritis (RA). CP-690,550 has
shown encouraging results for the treatment of rheumatoid arthritis at
doses that don’t appear to be associated with
excessive immune suppression.
Investigators will present interim results from a late-breaking Phase 2B
study evaluating the activity of CP-690,550 in combination with
methotrexate, the most commonly-used RA treatment. Approximately 60
percent of patients on doses at or above 3 mg of CP-690,550 responded to
treatment as compared to 37.7 percent on placebo. These data confirm and
extend the promising data seen in an earlier phase 2A study to this
longer, 12 week study, and to patients who are already taking
methotrexate to treat their rheumatoid arthritis.
Also being presented is a pharmacokinetic drug interaction study which
showed that CP-690,550 and methotrexate can be co-administered without
dose adjustment. In addition, preliminary results from an open label
extension study will be presented.
In these studies, the most commonly reported adverse events were nausea,
headache, dizziness, disorientation, hot flushes, urinary tract
infections, diarrhea and liver function tests.
Larger and longer phase 3 studies are expected to start in 2009 to help
further define the benefits and risks of CP-690,550 as a potential
treatment for rheumatoid arthritis.
According to the Arthritis Foundation, 1.3 million Americans live with
rheumatoid arthritis, a type of arthritis that can be severe,
debilitating, deforming and even shorten life.
Osteoarthritis Pain
Pfizer continues to research new ways of treating osteoarthritis pain.
Two studies to be presented highlight a new compound in development and
new data for Celebrex (celecoxib) in the treatment of osteoarthritis
pain.
Results from a Phase 2 study exploring the safety and efficacy of
tanezumab, a novel biologic designed to block nerve growth factor, show
that treatment once every eight weeks may significantly decrease pain in
patients suffering from moderate to severe osteoarthritis pain in the
knee. In the trial, approximately 75 percent of patients in both the
tanezumab 100 and 200 µg/kg treatment groups
experienced a 50 percent reduction in knee pain as compared to 26
percent of patients in the placebo group. In the study, the most common
adverse events associated with tanezumab include headache, upper
respiratory tract infection, paresthesia (abnormal sensations),
hypoesthesia (decreased sensations) and arthralgia (joint aches).
Another late-breaking study evaluated continuous use of daily Celebrex
treatment over a 22-week period compared to intermittent use of the
medicine in preventing spontaneous OA flares. The study showed that
continuous use resulted in 42 percent fewer OA flare episodes than the
intermittent use. The results from the study also demonstrated that
there were no significant differences in overall adverse events between
the intermittent and continuous use groups.
According to the Arthritis Foundation, osteoarthritis affects 27 million
Americans. Recent data show that one in two Americans are at risk for
knee osteoarthritis over their lifetime. Loss of joint function as a
result of osteoarthritis is a major cause of work disability.
Fibromyalgia
Pfizer is a pioneer in the study of fibromyalgia, investing many years
of research into treatment options for this complex pain condition. In
June 2007, Lyrica (pregabalin) CV became the first FDA-approved
treatment for the management of fibromyalgia. Data supporting that
approval showed Lyrica patients experienced significant reduction in
pain as early as week one in some patients.
While widespread pain is the cornerstone of fibromyalgia, the condition
is also characterized by other hallmark symptoms such as fatigue and
difficulty concentrating.
Data presented at ACR will highlight the results of a phase 2 proof of
concept study with esreboxetine, a highly selective norepinephrine
reuptake inhibitor in a fibromyalgia population.
Data from this study showed that esreboxetine may be effective in
relieving in key fibromyalgia symptoms, including pain, function and
fatigue and was generally well tolerated. In the study, 43 percent of
patients receiving esreboxetine reported their condition was much
improved or very much improved as compared to 23 percent of
placebo-treated patients.
The most common side effects compared to placebo were constipation,
insomnia, dry mouth, headache and nausea. The proportion of patients who
discontinued as a result of adverse events was 8.2 percent in the
esreboxetine group and 2.3 percent in the placebo treatment group.
Fibromyalgia has been recognized by the professional community for over
30 years as a common, chronic widespread pain condition and is now
thought to affect up to six million Americans. Recent evidence suggests
a neurological basis to fibromyalgia, as demonstrated by brain scans and
altered levels of certain neurotransmitters.
About Pfizer’s
Investor Briefing at ACR
On Tuesday, October 28 at 6:00 p.m. PCT, Pfizer will host a briefing for
analysts and investors to review data presented at the meeting on
candidates in Pfizer’s pain and inflammation
portfolio.
About Celebrex
CELEBREX is indicated for the relief of the signs and symptoms of
osteoarthritis, rheumatoid arthritis in adults and ankylosing
spondylitis, and for the management of acute pain in adults.
Cardiovascular Risk
All prescription NSAIDS, including CELEBREX, may cause an increased risk
of serious cardiovascular (CV) thrombotic events, myocardial infarction,
and stroke, which can be fatal. All NSAIDs may have a similar risk. This
risk may increase with duration of use. Patients with CV disease or risk
factors for CV disease may be at greater risk.
All prescription NSAIDs, including CELEBREX, are contraindicated for the
treatment of perioperative pain in coronary artery bypass graft surgery.
Gastrointestinal Risk
All prescription NSAIDs, including CELEBREX, cause an increased risk of
serious gastrointestinal adverse events including bleeding, ulceration,
and perforation of the stomach or intestines, which can be fatal. These
events can occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious gastrointestinal events.
About Lyrica
LYRICA is indicated for the management of Fibromyalgia, neuropathic pain
associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia,
and as adjunctive therapy for adults with Partial Onset Seizures. There
have been post-marketing reports of angioedema and hypersensitivity.
Treatment with Lyrica may cause dizziness, somnolence, peripheral edema
or blurred vision. Other most common adverse events include dry mouth,
weight gain, constipation, euphoric mood, balance disorder, increased
appetite and thinking abnormally.
For more information on Pfizer’s pipeline and
marketed medicines, including full prescribing information, please visit www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
October 25, 2008. Pfizer assumes no obligation to update any
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 the drug
candidates CP-690,550, tanezumab and esreboxetine, including their
potential benefits, which involve 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 any such drug candidates as well as
their decisions regarding labeling and other matters that could affect
the availability or commercial potential of any such drug candidates;
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, 2007 and in its reports on Form 10-Q and
Form 8-K.