R&D Briefing Highlights 30 Research Programs with More Than Half Discussed
for the First Time
Company Highlights Torcetrapib/Atorvastatin and Cholesterol Ester Transfer
Protein Research as Most Important New Development in Cardiovascular
Medicine in Years
Pfizer Now Projecting Adjusted Diluted EPS(1) for 2006 to be at Least $2.05
Per Share Compared to Previous Estimate of About $2.00 Per Share; Continues
to Target Average Annual Adjusted Diluted EPS(1) Growth in High Single
Digits Over 2007 and 2008 from the Higher Base of $2.05; Company Now
Projects Reported Diluted EPS for 2006 to Be At Least $1.68 Per Share
GROTON, Conn., Nov. 30 /PRNewswire-FirstCall/ -- Pfizer Inc said today
that its broad and diverse pipeline of new medicines, together with an
aggressive business development and licensing strategy, will drive a
significant stream of new products for a wide variety of therapeutic areas
starting in 2010.
"Our fundamental objective is to create a broad and very diversified
stream of new products that will, year after year, drive Pfizer's growth
and enhance the value of our shareholders' investment," said Jeffrey B.
Kindler, Pfizer's Chief Executive Officer. "We are developing new products
for a broad cross-section of therapeutic and specialty areas with strong
growth potential. The depth of our mid-stage pipeline gives us confidence
that we can generate a steady stream of new products that will address
significant unmet medical needs."
At today's meeting, Pfizer will review the largest pipeline in the
company's history. It now has more candidates, more trials, and more
programs than it has ever had, a total of 242 programs spanning 11
therapeutic areas. Pfizer scientists will describe 30 programs, with more
than half being discussed for the first time at this meeting.
Dr. John LaMattina, President of Pfizer Global Research and
Development, said, "We have momentum, very aggressive targets and
breakthrough science virtually across the board. We have important research
programs underway in atherosclerosis, oncology, diabetes, obesity,
rheumatoid arthritis, HIV, schizophrenia, liver disease and Alzheimer's
among others. I firmly believe that our outstanding progress is directly
related to changes we have made in how we work to streamline and improve
productivity. As a result, the company's portfolio of new molecular
entities has almost tripled since the beginning of the decade.
"We now expect that our Phase 3 portfolio will grow dramatically and
may even triple from 2006 to 2009. This will give us a steady stream of new
and important products from our internal development pipeline. We are
targeting four a year -- starting in 2011." Areas of concentration include:
-- A cardiovascular, metabolic and endocrine disease portfolio whose five
main areas of focus -- atherosclerosis, obesity, diabetes, bone and
muscle health, and thrombosis -- cover markets that are over $100
billion in total. Pfizer is building on its traditional strengths in
cardiovascular research and is expanding in metabolic and endocrine
diseases. Candidates in late stage development include CP-945,598, a
potential new treatment for obesity now in Phase III studies.
-- Pfizer's emerging oncology portfolio, where the company has several
potential first-in-class agents. Pfizer has made a major investment in
oncology and is moving quickly to build on the success of its launch of
Sutent earlier this year with an impressive array of novel agents. The
company is conducting extensive research in a wide variety of tumors,
building on new insights from molecular genetics.
Late-stage development projects include the monoclonal antibody CP-
675,206 in Phase III trials against metastatic melanoma and axitinib,
an anti-angiogenesis drug candidate expected to advance to Phase III
development in 2007 for breast, thyroid and lung cancers.
-- Pfizer's neuroscience portfolio, where the company has an industry-
leading track record and a portfolio of new drug targets in areas of
critical medical need, including Alzheimer's disease, pain, cognition
and ADHD, depression and anxiety, and sleep.
During the meeting, Pfizer will present new data on Lyrica, the
company's new medicine for neuropathic pain, which is being studied for
the treatment of fibromyalgia.
"Fibromyalgia is characterized by chronic, widespread pain that affects
tens of millions of people worldwide with a prevalence of approximately
two percent of the general population," said Martin Mackay, Ph.D.,
Senior Vice President, Worldwide Research and Technology. "We believe
that Lyrica has the potential to be a real breakthrough for treating
fibromyalgia."
-- A strong program in infectious diseases, where Pfizer is targeting key
bacterial agents and key viral diseases. The most advanced new drug
candidate in this therapeutic area is maraviroc, a CCR5 inhibitor that
Pfizer plans to file next month for use in treatment-experienced HIV
patients. The company will review groundbreaking research to develop
PF-3,491,390, an anti-fibrotic agent for treatment of chronic liver
disease. A Phase III study is planned for 2007.
-- CP-690,550, a compound that targets Janus Kinase 3, associated with
immunosuppression. The oral agent is in Phase II studies for the
treatment of rheumatoid arthritis and data indicates that it may have
superior response rates, compared to the monoclonal antibody Humira.
"The results are very impressive," said Dr. Mackay. "These were
patients who did not respond to either Humira or methotrexate. We see
great potential for oral treatments in this devastating disease."
Commenting on torcetrapib/atorvastatin (T/A), Dr. LaMattina said, "We
are first-in-class and we intend to remain best-in-class in a category that
has the potential to change the face of cardiovascular medicine. T/A raises
HDL and lowers LDL. We believe that the net benefits of the drug --
characterized by significant HDL elevation and LDL lowering vs. the small
elevation in blood pressure -- will greatly benefit patients with CV risk.
"The development of T/A has required tremendous innovation on our part
from the earliest stages of discovery through one of the most cutting-edge
development programs ever carried out anywhere. At the end of this
comprehensive program, we expect to have a medicine with unparalleled
efficacy in raising HDL, lowering LDL and with an anti-atherosclerosis
indication.
"We will learn of the top-line results of the three pivotal imaging
trials during the first quarter of 2007. During this same period, we will
also receive the results of some additional Phase III lipid studies. To
obtain a reliable picture of the overall safety and efficacy profile of
T/A, the results of all these studies will need to be analyzed and reviewed
together, and this will happen in the context of the American College of
Cardiology Meeting in March, 2007."
Business Development and Licensing to Aggressively Pursue External New
Products and Technologies
"Pfizer's core capabilities in science and medicine underscore our new
Business Development and Licensing strategy," said Pfizer Vice-Chairman
David Shedlarz. "The first part of our new strategy is a focus on
complementing our current pharmaceutical portfolio by both addressing gaps
in our existing portfolio as well as quickly seizing potential
opportunistic investments. To ensure we are successful in this effort,
teams of business development colleagues will be aligned with our
therapeutic area teams. Specific near term focus areas here include
diabetes, neurology, infectious disease, and oncology that combined have a
worldwide market potential significantly in excess of $200 billion.
"The second component of the strategy is focused on acquiring
synergistic products and services which either help amplify the value of
our current and future products or enhance our ability to demonstrate the
value of our products and capabilities. Potential opportunities in the area
include everything from drug delivery systems such as the Exubera inhaler,
to evidence-based medicine tools and diagnostics. The last component of our
strategy focuses on investment in novel healthcare products. Our
acquisition of PowderMed Ltd.'s vaccine delivery technology, announced in
October, is an example of this."
The company expects this strategy to contribute two new
externally-sourced products per year starting in 2010. These new products
are expected to be significant contributors to Pfizer's future revenue
growth.
"We recognize that many great ideas and insights arise in laboratories
and clinics around the world," said Shedlarz. "We are determined to be a
magnet for those ideas, and to apply our resources prudently to turn them
into valuable and innovative healthcare solutions. We will accelerate our
business development and licensing activity while ensuring appropriate
operational and financial discipline."
Increasing Focus on Scientific Collaborations and Partnerships
Pfizer emphasized in its presentations throughout the meeting that the
company is open to pursuing new and different approaches on many fronts to
maximize the potential of its research and development activities.
The company announced a groundbreaking, five-year research
collaboration with The Scripps Research Institute to advance scientific
knowledge of uncured diseases and novel ways to treat them. Under the terms
of the agreement, scientists from Pfizer and Scripps will work together in
collaborative teams to study and evaluate possible therapeutic approaches
for diseases such as cancer, diabetes and mental illness. The collaboration
will involve the development of new tests to rapidly validate approaches as
possible novel treatment options for patients.
Commitment to Transparency
"During the past four months, I have repeatedly heard from investors
that they would like a broader picture of our pipeline and its potential,
as well as a realistic assessment of our opportunities and challenges,"
said Jeff Kindler. "The comprehensive pipeline and strategy review today,
along with the extensive discussion with our key scientists, address these
critically important points. We are providing more detail about the mid-
and earlier stages of our pipeline than we have before.
"As an example of our new approach, we plan to very shortly post our
pipeline -- front to back -- on our website, where investors, doctors,
patients and their families will be able to track our progress over time."
Kindler concluded, "Based on our pipeline, our ambition is to create a
company with a more diversified product portfolio with a heavy emphasis in
the therapeutic areas offering the greatest medical promise and commercial
potential. We recognize that our success depends on doing the hard work,
every day, to make our company as innovative and agile as it can be. We
have a wonderful set of opportunities and outstanding scientists, and we
won't lose sight of the importance of putting all of this to work on behalf
of patients and our shareholders."
Details on Financial Outlook
Pfizer is experiencing a favorable trend in revenues and lower costs in
the fourth quarter than it previously expected. The company now expects
2006 revenues to be slightly higher and costs to be slightly lower. Pfizer
is now projecting adjusted diluted EPS(1) for 2006 to be at least $2.05 per
share compared to its previous estimate of about $2.00 per share. The
company is now projecting reported diluted EPS for 2006 to be at least
$1.68, reflecting these revised expectations. Despite the higher EPS
forecast, Pfizer continues to target average annual adjusted diluted EPS(1)
growth in high single digits over 2007 and 2008 from the higher base of
$2.05.
For additional details, please see the attached supplemental financial
information and Disclosure Notice.
(1) "Adjusted income" and "adjusted diluted earnings per share (EPS)" are
defined as reported net income and reported diluted EPS excluding
purchase-accounting adjustments, merger-related costs, discontinued
operations, and certain significant items. As described under
Adjusted Income in the Management's Discussion and Analysis of
Financial Condition and Results of Operations section of Pfizer's Form
10-Q for the quarterly period ended October 1, 2006, management uses
adjusted income, among other factors, to set performance goals and to
measure the performance of the overall company. We believe that
investors' understanding of our performance is enhanced by disclosing
this measure. The adjusted income and adjusted diluted EPS measures
are not, and should not be viewed as, substitutes for U.S. GAAP net
income and diluted EPS.
PFIZER INC
SUPPLEMENTAL FINANCIAL INFORMATION
Reconciliation of Forecasted 2006 Adjusted Income(1) and Adjusted Diluted
EPS(1) to Forecasted 2006 Reported Net Income and Reported Diluted EPS
Full-Year 2006 Forecast
($ billions, except per-share amounts) Net Income(a) Diluted EPS(a)
Income/(Expense)
Forecasted Adjusted Income/ greater than greater than
Diluted EPS(1) or equal to $15.1 or equal to $2.05
Purchase Accounting Impacts,
Net of Tax (2.9) (0.39)
Adapting to Scale Costs, Net of Tax (1.1) (0.15)
Income From Discontinued Operations,
Net of Tax (b) 0.5 0.07
Equity Sales / Other 0.2 0.02
Tax Impact for the Repatriation of
Foreign Earnings 0.2 0.02
Resolution of Certain Tax Positions 0.4 0.06
Forecasted Reported Net Income/ greater than greater than
Diluted EPS or equal to $12.4 or equal to $1.68
(a) Forecasts in the table include our Consumer Healthcare business as
discontinued operations and exclude the effects of business-
development transactions not completed as of the end of the third
quarter of 2006 as well as the potential impact from a substantial
prospective gain on the divestiture of our Consumer Healthcare
business and costs related to our recently announced sales force
restructuring.
(b) Primarily reflects the reclassification of our Consumer Healthcare
business to discontinued operations.
(1) "Adjusted income" and "adjusted diluted earnings per share (EPS)" are
defined as reported net income and reported diluted EPS excluding
purchase-accounting adjustments, merger-related costs, discontinued
operations, and certain significant items. As described under
Adjusted Income in the Management's Discussion and Analysis of
Financial Condition and Results of Operations section of Pfizer's
Form 10-Q for the quarterly period ended October 1, 2006, management
uses adjusted income, among other factors, to set performance goals
and to measure the performance of the overall company. We believe
that investors' understanding of our performance is enhanced by
disclosing this measure. The adjusted income and adjusted diluted
EPS measures are not, and should not be viewed as, substitutes for
U.S. GAAP net income and diluted EPS.
DISCLOSURE NOTICE: The information contained in this document and the
attachment is as of November 30, 2006. The Company assumes no obligation to
update any forward-looking statements as a result of new information or
future events or developments.
This document and the attachment contain forward-looking information
that involves substantial risks and uncertainties about the Company's
in-line products and product candidates, financial results and estimates,
and business prospects. Among other things, this document and the
attachment contains, in particular, forward-looking information that
involves substantial risks and uncertainties about improvements in the
Company's research and development productivity and about various products
in development and potential additional indications for various in-line
products, including their potential benefits and, in certain cases,
projections with respect to their advancement within the research and
development pipeline, regulatory authority filing and approval dates and
launch dates. You can identify these statements by the fact that they use
words such as "will," "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe," "target," "forecast" and other words and terms
of similar meaning. Among the factors that could cause actual results to
differ materially are the following: the uncertainties inherent in research
and development activities; decisions by regulatory authorities regarding
whether and when to approve drug applications and supplemental drug
applications that have been or may be filed for such products in
development and for such additional indications for in-line products as
well as their decisions regarding labeling and other matters that could
affect the availability or commercial potential of such products and such
additional indications; the speed with which regulatory authorizations,
pricing approvals and product launches may be achieved; competitive
developments, including with respect to competitor drugs and drug
candidates that treat diseases and conditions similar to those treated by
our drugs and drug candidates; the ability to successfully market both new
and existing products domestically and internationally; difficulties or
delays in manufacturing; trade buying patterns; the ability to meet generic
and branded competition after the loss of patent protection for our
products or competitor products; the impact of existing and future
regulatory provisions on product exclusivity; trends toward managed care
and health care cost containment; possible U.S. legislation or regulatory
action affecting, among other things, pharmaceutical pricing and
reimbursement, including under Medicaid and Medicare, the importation of
prescription drugs that are marketed outside the U.S. and sold at prices
that are regulated by governments of various foreign countries, and the
involuntary approval of prescription medicines for over-the-counter use;
the potential impact of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003; legislation or regulations in markets outside
the U.S. affecting product pricing, reimbursement or access; contingencies
related to actual or alleged environmental contamination; claims and
concerns that may arise regarding the safety or efficacy of in-line
products and product candidates; legal defense costs, insurance expenses,
settlement costs and the risk of an adverse decision or settlement related
to product liability, patent protection, governmental investigations,
ongoing efforts to explore various means for resolving asbestos litigation
and other legal proceedings; the Company's ability to protect its patents
and other intellectual property both domestically and internationally;
interest rate and foreign currency exchange rate fluctuations; governmental
laws and regulations affecting domestic and foreign operations, including
tax obligations; changes in generally accepted accounting principles; any
changes in business, political and economic conditions due to the threat of
future terrorist activity in the U. S. and other parts of the world, and
related U. S. military action overseas; growth in costs and expenses;
changes in our product, segment and geographic mix; and the impact of
acquisitions, divestitures, restructurings, product withdrawals and other
unusual items, including our ability to realize the projected benefits of
our Adapting to Scale multi-year productivity initiative, including the
benefits of the planned broadening of this initiative in 2007 and 2008, and
the ability of the Company and Johnson & Johnson to satisfy the conditions
to closing the sale of the Company's Consumer Healthcare business,
including receiving the required regulatory approvals A further list and
description of these risks, uncertainties and other matters can be found in
the Company's Annual Report on Form 10-K for the fiscal year ended December
31, 2005, and in its reports on Forms 10-Q and 8-K.
This document includes discussion of certain clinical studies relating
to various in-line products and product candidates. These studies typically
are part of a larger body of clinical data relating to such products or
product candidates, and the discussion in this webcast should be considered
in the context of the larger body of data.
SOURCE Pfizer Inc
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