/FIRST ADD -- NYW043A -- Pfizer Inc Fourth-Quarter 2004 Performance Report/
/FIRST ADD -- NYW043A -- Pfizer Inc Fourth-Quarter 2004 Performance Report/
PFIZER INC
SUPPLEMENTAL INFORMATION
SHARES OUTSTANDING AND EPS INFORMATION:
FY04 FY03
Shares Outstanding (millions) - Basic EPS 7,530.6 7,212.8
Basic EPS $1.51 $.54
Adjusted Basic EPS* $2.14 $1.71
Shares Outstanding (millions)
- Diluted EPS 7,613.9 7,285.6
Diluted EPS $1.49 $.54
Adjusted Diluted EPS* $2.12 $1.69
4Q04 4Q03
Shares Outstanding (millions) - Basic EPS 7,461.2 7,585.6
Basic EPS $.38 $.08
Adjusted Basic EPS* $.58 $.51
Shares Outstanding (millions)
- Diluted EPS 7,510.6 7,668.3
Diluted EPS $.38 $.08
Adjusted Diluted EPS* $.58 $.50
* "Adjusted income," "adjusted basic earnings per share (EPS)," and
"adjusted diluted EPS" are defined as reported net income, reported
basic EPS, and reported diluted EPS excluding discontinued operations,
the cumulative effect of a change in accounting principle, significant
impacts of purchase accounting for acquisitions, merger-related costs,
and certain significant items. A reconciliation to reported net income
and reported diluted EPS is provided within this document.
QUESTIONS:
PRODUCT PERFORMANCE / NEW PRODUCT DEVELOPMENT
CARDIOVASCULAR / METABOLIC / ENDOCRINE
Q1) How is Lipitor performing?
A1) Worldwide sales of Lipitor totaled $3.264 billion in the fourth
quarter of 2004, reflecting growth of 23% compared to the same
period in 2003. It is the best-selling pharmaceutical product of
any kind in the world and the industry's first $10 billion product.
Lipitor continued to achieve double-digit unit growth worldwide. In
the U.S., November represented Lipitor's strongest month of
performance in two years, with new-prescription growth of 23%
(versus 27% market growth and 25% statin growth) and total-
prescription growth of 16%. This impressive performance can be
attributed to ground-breaking clinical data, more aggressive
treatment guidelines, and increased promotion within the category.
Lipitor has a growing body of evidence demonstrating benefit to
patients by impacting disease progression and by reducing heart
attacks and strokes (the ASCOT, CARDS, REVERSAL, PROVE-IT, and
ALLIANCE clinical trials). The safety profile and efficacy of
Lipitor have been demonstrated in more than 400 ongoing and
completed clinical trials involving more than 80,000 patients and in
more than 87 million patient years of therapy. These results
further support the outstanding record of Lipitor in cholesterol
reduction, proven cardiovascular (CV) outcomes benefit, and patient
safety across the full dosing range.
Two studies involving Lipitor were stopped early due to the benefits
seen in reducing CV outcomes. The Anglo-Scandinavian Cardiac
Outcomes Trial (ASCOT) showed that people with hypertension and
normal to mildly elevated cholesterol levels without a history of
coronary heart disease had 36% fewer fatal coronary events and
non-fatal heart attacks, 27% fewer fatal and non-fatal strokes, and
21% fewer cardiovascular events and procedures when taking Lipitor
than patients treated with placebo. The CARDS study, which was
presented at the American Diabetes Association meeting in 2004,
showed that treatment with Lipitor provided early and significant
benefits in prevention of coronary heart disease (37% reduction) and
stroke (48% reduction) in patients with diabetes and relatively low
LDL-cholesterol levels (median: 118 mg/dL).
Exploring atherosclerosis progression, REVERSing Atherosclerosis
with Aggressive Lipid Lowering (REVERSAL) is a major comparative
trial comparing the benefits of Lipitor 80 mg versus Pravachol 40
mg. Results from this trial were published in The Journal of the
American Medical Association in March 2004. In REVERSAL, Lipitor
halted the progression of atherosclerosis compared to Pravachol,
which only slowed the progression of disease. In addition, Lipitor
demonstrated a greater impact on atherosclerosis progression even
when the same LDL-cholesterol percentage reductions were achieved
compared to Pravachol.
The PROVE-IT trial, sponsored by Bristol-Myers Squibb, evaluated the
same treatment regimen as in REVERSAL on cardiovascular morbidity
and mortality in patients with acute coronary syndrome. The results
of this study showed that patients treated with Lipitor 80 mg
demonstrated early and significant protection against death and
major cardiovascular endpoints versus less intensive treatment with
Pravachol 40 mg. As in REVERSAL, the safety profiles of Lipitor 80
mg and Pravachol 40 mg were comparable. The results of PROVE-IT
were published in The New England Journal of Medicine. The outcomes
data from PROVE-IT complement the results from the REVERSAL trial.
Most recently, the January 6, 2005, issue of The New England Journal
of Medicine included the publication of a post-hoc analysis of the
REVERSAL trial and a pre-specified analysis of the PROVE-IT trial.
These analyses examine the effects of statin therapy and the roles
of LDL cholesterol and C-reactive protein (CRP) in disease
progression and CV outcomes. The results also provide the first
evidence to show that reductions in CRP may have clinical
importance. This evidence suggests that CV benefits of LIPITOR may
not be completely explained by aggressive LDL-cholesterol lowering
alone and that other mechanisms may also play a role. In REVERSAL
and PROVE-IT, greater reductions in CRP with Lipitor seem to
translate into slower disease progression and reduced CV events.
Further research is ongoing to explore vasculoprotective effects of
Lipitor beyond the benefit from aggressive LDL-cholesterol lowering.
There continues to be an opportunity for further growth of the
cholesterol-lowering market. Of the tens of millions of individuals
around the world that are in need of medical therapy for high
cholesterol, only about one third are actually receiving treatment.
Worldwide, millions of people with high cholesterol are not
diagnosed, are not treated, or are treated with a dose inadequate to
achieve their cholesterol goals. Evolving treatment guidelines
continue to encourage the broad use of statin therapy.
Q2) How is Caduet performing?
A2) Worldwide sales of Caduet totaled $15 million in the fourth quarter
of 2004. Although Caduet's performance to date has been modest, it
is slowly gaining traction due to increased product awareness and
acceptance. This is evident in its total prescriptions in the U.S.,
which were 65% higher in the fourth quarter than in the first six
months post-launch. We believe that Caduet is on its way to
becoming an extremely useful treatment option as physicians are
beginning to alter their longstanding practice of treating high
blood pressure and high cholesterol as two distinct conditions.
The FDA approved Caduet, the single-pill dual therapy of Lipitor
(atorvastatin calcium) and Norvasc (amlodipine besylate), on January
30, 2004, and Pfizer launched Caduet in the U.S. in May. The first
E.U. filing was submitted in France, the reference member state for
Caduet, in the fourth quarter of 2003. We will be pursuing E.U.
approvals for Caduet through the mutual recognition process.
Caduet provides an opportunity to simultaneously address two of the
most common risk factors of cardiovascular disease with the world's
most prescribed branded blood-pressure medication-Norvasc-and
lipid-lowering medication-Lipitor-in one pill. In September 2004,
the FDA approved changes to the prescribing information for Lipitor
and Caduet to include prevention of cardiovascular disease. The
results of the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid
Lowering Arm (ASCOT-LLA) bring a critical new insight into the
management of hypertensive patients-that hypertensive patients
benefit from Lipitor in addition to blood-pressure-lowering therapy.
On December 8, 2004, Pfizer announced that the independent ASCOT
steering committee had decided to stop the study in its entirety due
to favorable benefits being seen in patients receiving the
Norvasc-based treatment regimen. The fully analyzed results of the
study are anticipated in 2005.
By current estimates, each year 9 million deaths around the world,
equaling more than 75 million lost years of healthy life, may be
attributed to suboptimal blood-pressure or cholesterol levels.
Treatment guidelines advocate early and aggressive management of
multiple risk factors for patients at increased cardiovascular risk.
Q3) How is Norvasc performing?
A3) Worldwide sales of Norvasc in the fourth quarter of 2004 totaled
$1.253 billion, reflecting growth of 1% compared to the same period
in 2003. The slower rate of growth compared to earlier quarters is
attributable in part to patent expirations throughout the E.U.,
except for Italy, France, Sweden, and Switzerland. Norvasc
maintains exclusivity in many markets globally, including the U.S.,
Japan, Canada, and Australia. Norvasc's performance in the U.S.
throughout 2004 was strong, and prescription volumes reached a 52-
week high in October 2004.
Since its introduction in 1990, Norvasc has become the world's most-
prescribed branded antihypertensive therapy and the fourth-largest-
selling drug in the world. Its success has been driven by its
outstanding efficacy, once-daily dosing, consistent 24-hour control
of hypertension and angina, and excellent safety and tolerability.
Overall, Norvasc has been studied in more than 400,000 patients and
has been used in more than 30 billion patient days of therapy
worldwide.
Hypertension affects about 50 million Americans and one billion
people worldwide. Currently 69% of American adults diagnosed with
hypertension are not at their blood-pressure goal. Recent
guidelines call for early, aggressive blood-pressure management and
make clear that the majority of patients may require two or more
medications to reach their blood-pressure targets.
Recently reported randomized clinical trial results continue to
highlight the beneficial effects of Norvasc. In November 2004,
outcomes from the Pfizer-sponsored Comparison of Amlodipine versus
Enalapril to Limit Occurrences of Thrombosis (CAMELOT) trial were
published in The Journal of the American Medical Association. In the
two-year study of patients with coronary artery disease and normal
or well-controlled blood pressure, Norvasc-treated patients
experienced 42% fewer hospitalizations for chest pain and 27% fewer
coronary revascularization procedures, such as angioplasty and
coronary artery bypass surgery, compared to patients receiving
placebo. An intravascular ultrasound (IVUS) sub-study from the
CAMELOT trial demonstrated that patients who received Norvasc showed
no significant increase in the progression of plaque build-up in
coronary arteries. On December 8, 2004, Pfizer announced that early
indications from the landmark Anglo-Scandinavian Cardiac Outcomes
Trial (ASCOT) showed that patients receiving a treatment regimen
based on Norvasc experienced favorable cardiovascular benefits. As
a result of these findings, the independent ASCOT steering committee
decided to stop the trial early so that ASCOT investigators and
patients can discuss their optimum hypertension treatment moving
forward. Fully analyzed results of the study, involving nearly
20,000 patients with high blood pressure, are anticipated in 2005.
Q4) What is the status of Exubera?
A4) Exubera (inhaled insulin powder) is under development as a treatment
for both type 1 and type 2 diabetes through a collaboration between
Pfizer and Sanofi-Aventis. Pfizer is also collaborating with Nektar
Therapeutics, developer of the inhalation device and formulation
process for Exubera.
Exubera has been studied in more than 3,000 patients, some for up to
six years. As an effective alternative to insulin injections,
Exubera has also been shown in clinical trials to be preferred by
patients. This patient preference may encourage patient acceptance
of, and compliance with, insulin therapy, thereby improving the
health of diabetics and reducing the healthcare costs associated
with the disease. An estimated 177 million people worldwide suffer
from diabetes, now the fourth-leading cause of death in most
developed countries. Annual costs associated with the disease are
estimated at $186 billion worldwide.
In February 2004, Pfizer and Sanofi-Aventis submitted a regulatory
filing for Exubera in the E.U.
Q5) What is the status of Revatio?
A5) Revatio(TM) (the brand name for sildenafil citrate for pulmonary
arterial hypertension) was submitted to the FDA and regulatory
authorities in the Netherlands and Spain, the rapporteur and
co-rapporteur sponsors, the European Medicines Agency (EMEA) and
Health Canada in December 2004 as a treatment for pulmonary arterial
hypertension (PAH). Subsequent to the U.S. filing, the FDA approved
the company's request for an expedited review. Revatio has been
designated an orphan drug by the EMEA. Sildenafil is the same
active ingredient in Viagra(R), the world's leading
erectile-dysfunction medication, which has been used by more than 23
million men worldwide because of its unsurpassed efficacy and
safety. The Revatio dosing regimen is different from that for
Viagra, and, to avoid confusion, Revatio tablets will have a color
and shape different from those of Viagra tablets.
PAH is a rare, aggressive, and life-shortening vascular disease for
which new treatment options are desperately needed. Often referred
to as high blood pressure of the lungs, PAH affects approximately
200,000 people in North America and Europe. In a large
multinational clinical trial (SUPER 1), Revatio 20 mg taken three
times daily was found to be effective in treating PAH. Patients
treated with Revatio had improved physical functioning as
demonstrated by increased walking distance over a six-minute time
interval. Patients on Revatio also had a reduction in blood
pressure in arteries of the lungs and an increase in cardiac heart
output, both of which are critical in treatment of this disease.
Q6) What is the status of the torcetrapib/Lipitor program?
A6) A combination product of torcetrapib, a cholesteryl ester transfer
protein (CETP) inhibitor, and Lipitor is now in global Phase III
clinical trials for dyslipidemia that include 12,000 patients and
are enrolling 13,000 patients in mortality and morbidity trials.
The objective of the Phase III program is to demonstrate improved
efficacy and comparable safety of the combination product versus
Lipitor alone in a wide range of patients at cardiovascular risk
with and without clinically apparent disease and across a variety of
lipid abnormalities. The program is comprised of imaging trials
that include intravascular ultrasound and carotid ultrasound, as
well as a full range of blood-lipid efficacy studies. The program
is designed to provide conclusive evidence of the benefits of
raising HDL cholesterol through torcetrapib, in combination with the
powerful LDL-cholesterol lowering and established benefits of
Lipitor, beyond the well-demonstrated effects of Lipitor alone
across patients with all types of lipid abnormalities.
Demonstration of such benefit would provide support for use to
torcetrapib/Lipitor in patients currently being treated with Lipitor
and other statins. Additional scientific and mechanistic studies
are also underway to broaden our understanding of the effects of
CETP inhibition on lipid metabolism and atherosclerosis. These
studies represent a major commitment by Pfizer to significantly
advance our understanding of lipids and atherosclerosis to provide
an important new tool for patients and prescribers in preventing and
treating the global burden of cardiovascular disease.
Data from a study assessing torcetrapib's impact on atherosclerosis
in a rabbit animal model, recently reported at the American Heart
Association 2004 Scientific Session, supports its potential efficacy
for patients. Torcetrapib was found to inhibit CETP activity and
raise HDL cholesterol, which strongly correlated with reduction in
atherosclerosis in this rabbit model.
Q7) What is the status of varenicline?
A7) In 2000, it was estimated that there were 1.25 billion smokers
worldwide and that nearly 5 million premature deaths/year globally
were attributable to smoking. Seven out of ten smokers are
contemplating quitting or actively want to quit; however, only 3-5%
of patients can quit on their own. More effective treatments are
needed for smoking cessation than are provided by currently
available products. Varenicline is an innovative compound for
smoking cessation. Neither a nicotine derivative nor an
anti-depressant, varenicline was designed to selectively target the
alpha 4-beta 2 nicotine receptors in the brain that stimulate the
release of dopamine, which in turn results in the
rewarding/reinforcing effects of smoking and leads to nicotine
dependence. Varenicline is designed to have a unique dual benefit
for the smoker to reduce the craving for cigarettes and the related
withdrawal symptoms when quitting and to block the rewards from
smoking that perpetuate dependence. In an early Phase II trial,
almost half of smokers treated with varenicline stopped smoking. In
this same trial, only one out of three smokers treated with Zyban
stopped smoking. Varenicline complements Pfizer's leadership in
providing innovative products to treat cardiovascular risk factors
and the complications often associated with smoking. Varenicline is
currently in full Phase III development worldwide.
RESPIRATORY
Q8) How is Spiriva performing?
A8) Pfizer co-promotes Spiriva with the product's discoverer, Boehringer
Ingelheim. Sales of Spiriva continue to outpace the overall chronic
obstructive pulmonary disease (COPD) market. The product is
currently available in more than 45 countries and is the
best-selling COPD product in seven, including Germany and Australia.
It has been introduced in the U.S. (June 2004), Italy (July 2004),
and, most recently, Japan (December 2004).
An anticholinergic medication, Spiriva is the first inhaled COPD
treatment to provide significant and sustained improvements in lung
function with once-daily dosing. Clinical trials have shown that
patients with all stages of COPD, from mild to severe, can benefit
from taking Spiriva. Trials have also demonstrated that Spiriva
provided superior and sustained improvements in lung function,
breathlessness, health-related quality of life, and exercise
tolerance in COPD patients, and that the product provides sustained
and significant improvements in lung function compared to
ipratropium, the currently recommended first-line therapy outlined
in many treatment guidelines. Spiriva has also been shown to
significantly reduce COPD exacerbations and related health-resource
burden versus usual care.
New clinical data presented at the American College of Chest
Physicians meeting in October 2004 confirm the role of Spiriva as
first-line maintenance therapy in COPD. A double-blind,
placebo-controlled study examined patients' reported reasons for
stopping exercise in the setting of constant-work-rate bicycling.
As a result of Spiriva-induced reductions in exertional dyspnea,
patients are more likely to report leg discomfort rather than
breathing discomfort as the limiting factor for stopping exercise.
After six weeks, significantly fewer Spiriva-treated patients (28%)
than placebo-treated patients (42%) identified breathing discomfort
as the main reason for exercise limitation. Spiriva therapy also
shifted the relative magnitude of both breathing discomfort and leg
discomfort at the point of symptom limitation.
Q9) How is Zyrtec performing?
A9) Worldwide sales of Zyrtec totaled $349 million in the fourth quarter
of 2004, reflecting a decline of 3% compared to the same period in
2003. Zyrtec continues to be the most prescribed antihistamine
agent in a challenging market. The continued decline in new
prescriptions in the antihistamine market is largely due to the wide
availability of multiple, low-cost, over-the-counter branded and
private-label loratadine (Claritin) products since December 2002 and
continued aggressive cost shifting to consumers (such as through
higher co-pays) by regional managed-care plans.
Pfizer and UCB Pharma, who discovered Zyrtec, have substantial
published data demonstrating the superior performance of Zyrtec
versus Claritin, including two two-day environmental-exposure-unit
studies in which Zyrtec provided twice the overall symptom relief of
Claritin. More recently, new data demonstrating Zyrtec's superior
performance versus Allegra in a two-day environmental-exposure unit
were published in the January/February 2004 issue of Allergy and
Asthma Proceedings and presented at the American College of Allergy,
Asthma, and Immunology meeting in November 2004. Zyrtec has the
broadest range of formulations and treats the widest age range of
patients of any prescription antihistamine. Zyrtec is currently the
only prescription antihistamine available on the market with both
syrup and chewable forms.
Q10) What is the status of Daxas (the brand name for roflumilast)?
A10) Daxas is a phosphodiesterase-4 inhibitor, a class of compounds that
provides anti-inflammatory action for respiratory diseases. The
compound is currently being studied for both asthma and chronic
obstructive pulmonary disease (COPD), two respiratory diseases
associated with substantial morbidity and mortality. COPD affects
600 million people worldwide and kills more than 2.75 million people
each year, according to estimates by the World Health Organization.
The Global Burden of Disease Studies found that COPD was the
sixth-most-common cause of death worldwide in 1990 and predicted
that it would become the third-most-common cause of death by 2020.
In the U.S., COPD is currently the fourth-leading cause of death
(behind heart disease, cancer, and stroke), with death rates having
increased 22% in the last decade. Asthma affects more than 300
million people worldwide and kills 180,000 people each year. Pfizer
and our co-promotion partner Altana Pharma filed Daxas in the E.U.
in February 2004 for both asthma and COPD. For other markets, the
product is in late-stage development.
UROLOGY
Q11) How is Detrol/Detrol LA performing?
A11) Worldwide sales of Detrol totaled $285 million in the fourth quarter
of 2004, reflecting growth of 22% compared to the same period in
2003. Detrol's robust performance was due to successful launches of
the once-daily formulation in Latin America and Asia and strong
competitive positioning in the U.S. and E.U. It is the number-1
globally prescribed brand for overactive bladder (OAB), with more
than 8.5 million patients worldwide since launch and a 53% market
share.
Detrol/Detrol LA has proven 24-hour efficacy across OAB symptoms,
including urge incontinence, urgency, and frequency, resulting in
excellent patient-reported outcomes. Detrol/Detrol LA also offers
bladder selectivity with balanced receptor coverage, trusted
tolerability, and proven safety profile. OAB is a highly prevalent
condition, affecting 50-100 million people worldwide, with
approximately 16% prevalence in adults in the U.S. and E.U. The
market opportunity remains significant, as OAB is a vastly
underreported and undertreated condition.
As part of Pfizer's ongoing OAB research worldwide, the first
validated screener, called the OAB-V8TM screener, has been developed
and launched recently. OAB-V8TM screener is a simple-to-administer,
easy-to-score, eight-question instrument that has been studied in
1,260 patients and validated in more than 20 languages.
Q12) How is Viagra performing?
A12) Worldwide sales of Viagra totaled $469 million in the fourth quarter
of 2004, reflecting a decrease of 8% compared to the same period in
2003, due in large part to increased competition. Viagra maintains
a strong leadership position, with a 71% worldwide market share of
phosphodiesterase-5 inhibitors. Outside the U.S., where about half
of Viagra sales are generated, the fourth quarter marked a
competitive turning point, with 19% growth versus the third quarter
of 2004. It remains one of the world's most recognized
pharmaceutical brands.
More than 130 clinical trials worldwide and more than six years of
real-world experience have shown that Viagra provides hard,
long-lasting erections that instill confidence in men, while
maximizing both patient and partner satisfaction. Studies have
shown that Viagra improves erections in up to 82% of men with
erectile dysfunction (ED). Men taking Viagra also report a 77%
improvement in their confidence to get and maintain an erection,
compared to only 18% taking placebo. After four years of treatment,
96% of Viagra users and 92% of their partners report being highly
satisfied with the product, with 95% of partners expressing a desire
for their men to continue with Viagra treatment. A recently
published study demonstrates that men taking Viagra under constant
visual sexual stimulation reported a hard erection lasting on
average for 33 minutes, compared to seven minutes for men on
placebo. No other ED therapy has been proven to work better or
faster than Viagra. Pfizer is confident that Viagra is uniquely
positioned to retain its leading position.
NEUROSCIENCE
Q13) How is Aricept performing?
A13) Aricept, approved for the treatment of symptoms of mild-to-moderate
Alzheimer's disease (AD), continues to lead the AD market with a 59%
worldwide market share and more than one billion cumulative patient
days of therapy. In its eighth year on the U.S. market, the product
continues to show strong new- and total-prescription growth, despite
the launch of a new competitor, and achieved revenue growth of 21%
in 2004. The product achieved record weekly new- and
total-prescription volume of more than 30,000 and 94,000,
respectively, in early December 2004. About 10% of people over 65
suffer from AD, including 4.5 million Americans.
Aricept's strong market leadership has been built on a large body of
clinical evidence supporting its excellent efficacy and tolerability
and a keen customer focus. Cognition is typically the first area
affected by AD. The benefits of early intervention with Aricept
were confirmed in a study published in December 2004 in the Archives
of Neurology. In this 24-week study of patients with early-stage or
mild AD, Aricept significantly improved cognitive performance
compared with placebo.
Q14) How is Geodon performing?
A14) Worldwide sales for Geodon totaled $143 million in the fourth
quarter of 2004, reflecting growth of 36% compared to the same
period in 2003. In the U.S., the product's new- and
total-prescription shares continue to grow, with Geodon achieving
its highest new-prescription share of 5.5% in October 2004. The
product's October new-prescription growth of 36% compares to 6%
growth of the overall U.S. antipsychotic market. Geodon is
available in both an oral capsule and a rapid-acting intramuscular
dosage form.
Approximately 1% of the population suffers from schizophrenia. In
the treatment of schizophrenia, clinical trials have demonstrated
Geodon to be as effective as risperidone (Risperdal) and olanzapine
(Zyprexa) in controlling both positive and negative symptoms, with a
lower incidence of extra-pyramidal side effects than risperidone and
significantly less weight gain and adverse changes in other
metabolic indices than olanzapine. In a recent head-to-head study
versus Zyprexa published in October 2004 in the American Journal of
Psychiatry, Geodon demonstrated efficacy equivalent to Zyprexa in
treating schizophrenia, while being associated with a lower
incidence of weight gain and more favorable effects on lipid profile
and other metabolic parameters. The Journal of Clinical Psychiatry
published a head-to-head study comparing Geodon to risperidone in
in-patients with schizophrenia or schizoaffective disorder. The
study found that Geodon improved psychotic symptoms, was generally
well tolerated, and demonstrated less effect on prolactin and weight
than risperidone.
Geodon is approved for acute bipolar mania in six countries,
including the U.S., where the new indication was launched in
November 2004. Pfizer filed for bipolar mania in the E.U. during
the fourth quarter of 2004. As much as 3.5% of the population
suffers from bipolar disorder, which, like schizophrenia, is a
life-long illness. The use of Geodon in bipolar disorder represents
a large and growing opportunity. In clinical trials for the
treatment of bipolar mania, Geodon has been shown to control manic
symptoms rapidly without inducing depression. A recent study
published in the American Journal of Psychiatry showed that Geodon
rapidly controls acute mania in as little as two days, with
sustained control throughout the study. Geodon was found to be safe
and well tolerated, with a low incidence of movement disorders.
Q15) How is Lyrica (the brand name for pregabalin) performing?
A15) Worldwide sales of Lyrica totaled $10 million in the fourth quarter
of 2004, its first full quarter on the market. Lyrica was approved
in July 2004 in the E.U. for treatment of peripheral neuropathic
pain and as adjunctive therapy for partial epilepsy. The subsequent
launches in Germany and the U.K. represent the most successful
introductions of any neuropathic-pain or adjunctive-epilepsy product
to date in those markets. Strong initial adoption is attributable
to the significant unmet medical need in both conditions, the
compelling clinical evidence supported by the Lyrica clinical
program (the largest ever for a neuroscience compound, with more
than 9,000 patients in clinical trials), and the positive initial
results experienced by patients and physicians.
Lyrica offers outstanding efficacy-demonstrated by rapid and robust
pain reduction across its entire dose range of 150-600 mg-and
favorable tolerability. New evidence-based guidelines for treatment
of post-herpetic neuralgia from the American Academy of Neurology,
published in the September 2004 issue of Neurology, endorsed Lyrica
as a recommended first-line treatment. Another study, published in
the December 2004 issue of Neurology, demonstrated Lyrica's efficacy
in diabetic peripheral neuropathy.
Lyrica was approved in Mexico in September 2004 for neuropathic pain
and as adjunctive therapy for partial seizures. In the U.S., Lyrica
was approved on December 30, 2004, and is the first FDA-approved
product for the treatment of neuropathic pain associated with
diabetic peripheral neuropathy and post-herpetic neuralgia. The
product will be available to patients and physicians in the near
future. In September 2004, Pfizer also received an approvable
letter for Lyrica as adjunctive therapy in the treatment of partial
seizures in adults and a non-approvable letter for the treatment of
generalized anxiety disorder. Pfizer is working closely with the
FDA to resolve open issues for both indications.
Q16) How is Neurontin performing?
A16) Worldwide sales for Neurontin totaled $481 million in the fourth
quarter of 2004, reflecting a decline of 39% compared to the same
period in 2003. This decline in sales is due to the at-risk launch
of generic gabapentin by Ivax, Alpharma, and Teva in the U.S.
Pfizer's Greenstone subsidiary followed suit by launching its own
generic version of gabapentin. Pfizer has sued these and other
companies for patent infringement, and if the court determines that
these companies have infringed Pfizer's Neurontin patent, Pfizer
will seek all available remedies and damages, including damages
based on Pfizer's lost profits.
Neurontin continues to be available in more than 100 countries and
has been prescribed by more than 12 million patients since its
initial approval in 1994. It is approved for adjunctive therapy in
epilepsy in more than 100 countries and for treatment of a range of
neuropathic-pain conditions in more than 60 countries.
Q17) How is Relpax performing?
A17) Worldwide sales of Relpax totaled $54 million in the fourth quarter
of 2004, reflecting growth of 91% compared to the same period in
2003. Launched in more than 25 countries, the product continues to
gain market share rapidly in the $2.3 billion global oral triptan
market. In the U.S., Relpax new-prescription volume has grown by
73% versus December 2003, achieving 10.8% new-prescription share.
Relpax has become the number-2 triptan in both switch prescriptions
and new-to-market prescriptions, second only to sumatriptan. Relpax
was launched in Canada, the fifth largest triptan market, in
November 2004.
Published data demonstrate that Relpax 40 mg provides better and
more sustained relief from the symptoms of migraine than the market
leader, sumatriptan (Imitrex), even if patients wait to treat and
the pain is more intense. Relpax 40 mg also provides significantly
more sustained relief than zolmitriptan (Zomig) or naratriptan
(Amerge) based on two controlled studies. In addition, Relpax 40
mg has demonstrated efficacy in patients who have previously failed
to obtain adequate relief with other prescription or with
over-the-counter migraine medications, such as Imitrex, Maxalt,
Excedrin Migraine, non-steroidal anti-inflammatory drugs, and
Fiorinal/Fioricet. Recent data presented at the European Federation
of Neurological Societies and the Migraine Trust International
Symposium show that treating a migraine attack early with Relpax
provides greater efficacy for migraine sufferers than waiting until
the pain becomes more severe. The highest two-hour pain-free rates
were seen among patients with mild pain taking Relpax 40 mg within
30 minutes of pain onset, and sustained pain-free rates were higher
for patients treated with Relpax 40 mg when the pain was mild versus
moderate-to-severe.
The migraine market still represents a large untapped opportunity
and a significant opportunity for continued Relpax growth. The
prevalence of migraine is estimated to be 12% globally, with fewer
than 50% of these patients being diagnosed and fewer than 20%
receiving prescription medicine.
Q18) How is Zoloft performing?
A18) Worldwide sales of Zoloft totaled $959 million in the fourth quarter
of 2004, reflecting growth of 7% compared to the same period in
2003. This strong performance in the fourth quarter followed a 6%
decline in the U.S. in the third quarter, compared to the same
quarter in 2003, which resulted from proposed regulatory changes to
Zoloft's prescribing information and media coverage of the use of
antidepressants in children and adolescents.
Zoloft has been the number-one prescribed antidepressant in the U.S.
since 2000. Physicians have written approximately 250 million
Zoloft prescriptions for a variety of psychiatric disorders,
accounting for more than 13 billion patient days of therapy. A
large body of clinical data supports Zoloft's safety and
effectiveness in its indicated uses. Zoloft is approved for six
mood and anxiety disorders-major depression, panic disorder,
obsessive-compulsive disorder (OCD) in adults and children,
post-traumatic stress disorder, pre-menstrual dysphoric disorder
(PMDD), and social anxiety disorder. For each of these indications
except PMDD, Zoloft is approved for both acute and long-term use.
Regulatory agencies in the U.S. and U.K. recently examined the
safety of SSRIs in the treatment of depressed children and
adolescents. In the U.K., clinical data in the adult population was
also reviewed. The U.K. Medicines and Healthcare Products Regulatory
Authority (MHRA) mandated that all SSRIs and
serotonin/norepinephrine receptor inhibitors (SNRIs) except
fluoxetine (Prozac) be contraindicated in children and adolescents
with major depression. An advisory panel reaffirmed that Zoloft is
safe and effective in children and adolescents with OCD. In
December 2004, the MHRA proposed new prescribing information for
SSRIs and SNRIs on suicidality and withdrawal of treatment in
adults.
In the U.S., following the recommendations of an advisory panel, on
October 15, 2004, the FDA directed the makers of 33 currently
marketed antidepressants, including both SSRIs and non-SSRI
antidepressants, to include a black-box warning that antidepressants
may increase the risk of suicidal behavior in children and
adolescents. In the nine completed clinical trials of Zoloft in
pediatric and adolescent patients, which included studies of Zoloft
in children diagnosed with depression, OCD, or both, no suicides
occurred. The trials found no statistically significant differences
between Zoloft-treated patients and placebo controls in their rates
of suicide attempts or ideation.
Q19) What is the status of indiplon?
A19) Indiplon is a unique GABA-receptor modulator for insomnia being
developed by Pfizer and Neurocrine Biosciences. Indiplon has been
developed in both immediate-release and modified-release forms to
address multiple aspects of insomnia. Neurocrine Biosciences has
announced that it will resubmit U.S. regulatory filings for both
forms, previously submitted in the fourth quarter of 2004, to update
the electronic formatting of the filings.
Q20) What is the status of asenapine?
A20) Asenapine is a novel psychotropic agent currently in Phase III
development in more than 3,000 patients for the treatment of the
acute symptoms and maintenance therapy of schizophrenia, as well as
for treatment of the acute manic episodes associated with bipolar
disorder. The compound is being developed in partnership with
Organon. Based on Phase II results, asenapine has demonstrated
strong efficacy and good toleration, with no clinically significant
side effects. If approved, asenapine will enter a global
antipsychotic market currently estimated at more than $13 billion in
annual sales and growing about 13%.
INFECTION
Q21) How is Vfend performing?
A21) Worldwide sales of the antifungal Vfend totaled $83 million in the
fourth quarter of 2004, reflecting growth of 35% compared to the
same period in 2003. Strong growth can be attributed to sustained
demand and global launches. Vfend has been launched in 51 countries,
including the U.S., and it is now the leading hospital antifungal
product in France and Germany.
Vfend is a new-generation azole antifungal with an extended spectrum
of activity against both yeasts and moulds. The risk of serious
fungal infections in hospitalized patients is growing. Fungal
infections, especially in immunocompromised patients, are associated
with high morbidity and mortality and require prompt and effective
treatment. Vfend is approved in the U.S. for primary treatment of
acute invasive aspergillosis, salvage therapy for rare but serious
fungal infections caused by the pathogens Scedosporium apiospermum
and Fusarium spp., and treatment of esophageal candidiasis. In
Europe, Vfend is also approved for the treatment of serious,
invasive, fluconazole-resistant Candida infections (including C.
krusei). Vfend is available in oral tablets, powder for oral
suspension, and intravenous forms and shows excellent
bioavailability. As a result, there is the potential that some
patients may be discharged from the hospital sooner, with orally
administered therapy continuing at home.
In the first quarter of 2004, Pfizer filed regulatory submissions in
the U.S. and E.U. for use of Vfend in treatment of candidemia. In
October 2004, European regulators issued a positive opinion on the
application. In December 2004, the FDA approved Vfend for treatment
of candidemia in non-neutropenic patients, for disseminated Candida
infections in the skin, and for Candida infections in the kidney,
abdomen, bladder wall, and wounds. Data presented at the American
Society of Hematology meeting in December 2004 demonstrated that
patients with invasive aspergillosis who were treated with Vfend as
primary therapy required fewer days of intensive care compared to
patients receiving standard treatment.
Q22) How is Zithromax performing?
A22) Worldwide sales of Zithromax, the world's largest-selling
antibiotic, totaled $675 million in the fourth quarter of 2004,
reflecting a decrease of 15% compared to the same period in 2003.
This sales performance in part reflects a 6.7% reduction in global
new-prescription demand for antibiotics. In the U.S., Zithromax
remains the number-one branded product in all key indications in the
respiratory-tract-infection market, with more than three times the
market share of the second-leading branded competitor. Zithromax
prescriptions in sinusitis, its newest indication in the U.S., grew
22% since launch and increased to 17.5% of all prescriptions for
this indication in 2004.
Zithromax is first-line therapy for a number of key indications,
including acute exacerbations of chronic bronchitis,
community-acquired pneumonia, sinusitis, and otitis media.
Zithromax has a proven track record of clinical efficacy across the
spectrum for mild/moderate RTI, unsurpassed safety, and a short
therapeutic course that contributes to patient compliance and is
cost effective.
A novel microsphere formulation of azithromycin has been developed
that allows for delayed release of drug in the small intestine
instead of the stomach, maintaining tolerability. This delayed
release, together with the long half-life of Zithromax microspheres,
allows delivery of two grams of the product as a single dose. Data
for this new formulation have been submitted to the FDA and other
regulatory authorities for review.
Zithromax is included among the Pfizer medicines being provided to
aid the victims of the earthquake and tsunami that struck Asia and
Africa on December 26, 2004.
Q23) How is Zyvox performing?
A23) Worldwide sales of Zyvox totaled $135 million in the fourth quarter
of 2004, reflecting growth of 73% compared to the same period in
2003. While days of therapy for all anti-staphylococcal products
have increased 14% worldwide in the past year, days of Zyvox therapy
have increased more than 50%. Zyvox is now marketed in 62
countries.
The clinical value of Zyvox is growing, due to the rising incidence
of infections caused by methicillin-resistant Staphylococcus aureus
(MRSA) and multi-drug-resistant enterococci and their associated
morbidity and mortality. Zyvox has proven efficacy in the treatment
of patients with pneumonia and skin and soft-tissue infections,
including diabetic foot infections, often caused by MRSA. The
product has a unique mechanism of action that stops the initial
stage of bacterial protein production, without which bacteria cannot
multiply. This results in no cross-resistance with other
antibiotics. Zyvox is available in intravenous and oral
formulations. This allows for earlier discharge for some patients,
who can switch from the intravenous Zyvox in the hospital to the
oral form at home and thereby reduce their hospital costs. Zyvox is
also approved for pediatric use.
Data showing advantages of Zyvox continue to emerge. In October
2003, important data were presented at the Infectious Diseases
Society of America meeting showing that Zyvox was more effective
than vancomycin in treating patients with complicated skin and
soft-tissue infections due to suspected or proven MRSA, with lower
costs compared with vancomycin due to shorter intravenous therapy
and reduced hospital stay. A post-hoc analysis of these MRSA
patients with surgical-site infections was published in the American
Journal of Surgery in December 2004. Patients treated with Zyvox
had microbiologic success rates of 87% compared to 48% for patients
on vancomycin.
Q24) What is the status of UK-427,857?
A24) UK-427,857 represents a novel mechanism of action, CCR-5 co-receptor
antagonism. CCR-5 co-receptor antagonists form a sub-class of a
broader group of HIV antiretrovirals known as entry inhibitors.
Unlike current antiretroviral agents that work by inhibiting HIV
replication within white blood cells, UK-427,857 works by blocking
the human chemokine co-receptor CCR-5, which is expressed on the
surface of human white blood cells, thereby preventing the virus
from entering host cells. UK-427,857 has been shown in vitro to be
effective against HIV strains resistant to the current classes of
HIV antiretroviral agents, potentially addressing a significant
unmet medical need in HIV therapy. Phase I studies have shown
UK-427,857 to be well tolerated across a range of potential doses,
and Phase II studies have shown UK-427,857's efficacy and safety as
monotherapy in HIV patients. A clinical program is now underway in
pursuit of an indication for the treatment of patients with HIV
infection in combination with other antiretroviral agents.
The global HIV/AIDS epidemic killed more than 3 million people in
2003. An estimated 5 million people acquired HIV during the year,
bringing to 38 million the number of people living with the virus
around the world (UNAIDS Report, July 2004). Pfizer is committed to
bringing meaningful improvement to the lives of people living with
HIV/AIDS and to those at risk around the world.
OPHTHALMOLOGY
Q25) How is Xalatan/Xalacom performing?
A25) Worldwide sales of Xalatan/Xalacom totaled $353 million in the
fourth quarter of 2004, reflecting growth of 23% compared to the
same period in 2003. Xalatan/Xalacom outpaced the growth of the
total anti-glaucoma market. Xalatan/Xalacom together hold
leadership of the glaucoma market in dollar sales. Worldwide annual
sales of Xalatan, the number 1 prescribed anti-glaucoma medication
in the world, achieved the $1 billion milestone in sales in 2004.
An estimated 67 million people suffer from glaucoma worldwide. Each
year, more than 100,000 people in the U.S. are diagnosed with
glaucoma, a group of eye diseases characterized by damage to the
optic nerve, visual-field loss, and/or elevated intraocular pressure
(IOP). Xalatan, a prostaglandin analogue used to lower the
intraocular pressure associated with glaucoma and ocular
hypertension, continues to lead the worldwide anti-glaucoma market
and has displaced beta blockers as the accepted gold standard. It
provides comprehensive IOP management by combining the benefits of
powerful efficacy, superior tolerability and patient persistency,
five-year safety data, and physician preference so physicians can
achieve the outcome of preventing or delaying optic-nerve damage
that can lead to blindness. Xalacom, a combination of Xalatan and
the beta-blocker timolol, provides incremental efficacy for patients
who have an insufficient response to monotherapy while maintaining
the simplicity of a single daily dose.
Future opportunity exists as, in the U.S., approximately one third
of the diagnosed glaucoma patients are untreated and only 10-15% of
the ocular hypertensive patients received treatment.
An article published in the September 2004 issue of the American
Journal of Ophthalmology compared the nocturnal effects of the
once-daily beta-blocker timolol and Xalatan on IOP in patients with
ocular hypertension or early glaucomatous changes. Although both
treatments were effective in lowering IOP during the day, only
Xalatan reduced IOP at night. These results provide support in our
efforts to accelerate share gain from the large, remaining
beta-blocker segment.
The article "Risk Assessment in the Management of Patients with
Ocular Hypertension," published in the September 2004 issue of the
American Journal of Ophthalmology, addresses physicians' decisions
about when to treat an ocular-hypertensive patient. The article
establishes the concept of global risk assessment and translates the
findings from the Ocular Hypertension Treatment Study into practical
guidelines for initiation of treatment in ocular-hypertensive
patients. As in cardiovascular disease, the concept of global risk
assessment, when applied to glaucoma, may enable ophthalmologists to
identify and treat patients earlier in the disease continuum to
prevent the onset of glaucoma, further irreversible damage to the
optic nerve, and loss of visual function.
Q26) What is the status of Macugen?
A26) Pfizer and Eyetech Pharmaceuticals, Inc., the discoverer of Macugen,
are jointly developing and will jointly commercialize the product.
Macugen is an aptamer that selectively binds to, and neutralizes,
vascular endothelial growth factor for the treatment of age-related
macular degeneration (AMD). The FDA approved Macugen for the
treatment of neovascular (wet) age-related macular degeneration in
December 2004. The product has been filed in the E.U., Canada,
Australia, and Brazil. AMD is the leading cause of irreversible
vision loss among Americans over 55 and occurs in both wet and dry
forms. In wet AMD, blood vessels grow abnormally into the area
beneath the retina. The wet form accounts for approximately 200,000
new cases annually, with a prevalence of 1.2 million cases in the
U.S. alone. Positive Phase III results for Macugen in AMD,
announced at the American Academy of Ophthalmology meeting in 2003,
demonstrated benefit to a broad group of wet AMD patients
irrespective of lesion subtype or size, unlike existing therapies.
PRNewswire-FirstCall -- Jan. 19
SECOND AND FINAL ADD -- Q&A CONTINUES -- TO FOLLOW
Source: Pfizer Inc
Web site: http://www.pfizer.com/
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