R&D Briefing Highlights 30 Research Programs with More Than
Half Discussed for the First Time 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. DATASOURCE: Pfizer Inc CONTACT: Media -
Andy McCormick, +1-212-733-5469, or Paul Fitzhenry,
+1-212-733-4637, Investors - Ron Aldridge, +1-212-573-3685, or
Carol Schimmelpfenneg, +1-212-573-2718 Web site:
http://www.pfizer.com/ Company News On-Call: Pfizer's press
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