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Leading the
Way to a
Healthier     Annual Review 2006
World
Financial Highlights

Year Ended December 31,
                                                                                                                       2005
                                                                                   2006
(In thousands except per share amounts)

Net Revenue                                                                                                 $18,755,790
                                                                        $20,350,655

Net Income                                                                                                      3,656,298
                                                                           4,196,706

Diluted Earnings per Share                                                                                             2.70
                                                                                   3.08

Dividends per Common Share                                                                                             0.94
                                                                                   1.01

Total Assets                                                                                                   35,841,126
                                                                          36,478,715

Stockholders’ Equity                                                                                           11,994,369
                                                                          14,652,755



                                                Wyeth at a Glance

Wyeth is one of the world’s largest                           medicines and animal health care products
research-based pharmaceutical and health                      that improve the quality of life for people
care products companies. It is a leader in                    worldwide. The Company’s major divisions
the discovery, development, manufacturing                     include Wyeth Pharmaceuticals, Wyeth
and marketing of pharmaceuticals, biotech-                    Consumer Healthcare and Fort Dodge
nology products, vaccines, non-prescription                   Animal Health.



                                                   A Special Report
            On the Cover                        on Alzheimer’s Disease                              Contents

Motivational life coach Meredith          Millions of people around the              1    Chairman’s Report to Stockholders
Froemke takes Enbrel for her              world are coming face to face
                                                                                     7    Wyeth’s Pipeline for Innovation
rheumatoid arthritis. “Within six         with Alzheimer’s disease, a
weeks of therapy, I felt like a new       neurodegenerative disorder that            8    An Expanding and Promising
human being,” she marvels. “It’s          robs sufferers of their memories,               Near-Term Pipeline
given me back my mobility and my          their identities and, ultimately,
                                                                                    12 The War on Alzheimer’s
life.” Her daughter, Lauren, also         their lives. Wyeth is at the forefront
has benefited from an innovative           of an extraordinary effort to             32 Selected Products from Wyeth
Wyeth medicine after being                find new and better medicines to
vaccinated with Prevnar to help           control this disease’s symptoms           33 Directors and Officers
prevent invasive pneumococcal             and, potentially, to halt or even
                                                                                    34 Financial Review
disease. Wyeth is a leader in             reverse its progression. A special
innovation through use of                 report beginning on page 12               36 Corporate Data
pharmaceutical, biotech and               takes an in-depth look at Wyeth’s
                                                                                    IBC Mission, Vision and Values
vaccine technologies.                     war on Alzheimer’s.
Chairman’s Report to Stockholders
                                   Robert Essner, Chairman and Chief Executive Officer


    am pleased to report that          “We once again delivered on our                 • Revenue from all of our

I   2006 was an excellent year                                                           biotechnology products in
                                           commitment to expand our
    for Wyeth. Building on our                                                           2006 reached $5.7 billion,
                                        growth, strengthen our position
strong performance in 2005,                                                              representing about a third
we once again delivered on our                                                           of Wyeth Pharmaceuticals’
                                        for the future and lead the way
commitment to expand our                                                                 total revenue and making
                                               to a healthier world.”
growth, strengthen our posi-                                                             Wyeth the fourth largest
tion for the future and lead                                                             biotechnology company in
the way to a healthier world.                                                            the world.
Driven by the steady growth of our key products, Wyeth      • In January 2007, we received an approvable letter
reported record revenue. We filed four New Drug Appli-         from the U.S. Food and Drug Administration (FDA)
cations (NDA) for new products, demonstrating solid           for Pristiq, a serotonin-norepinephrine reuptake
productivity from our research and development (R&D)          inhibitor for the treatment of major depressive disor-
efforts. Overall, our new product pipeline significantly       der, which will be launched with a specific focus
expanded and advanced. By maximizing productivity,            on women.
controlling costs and delivering high value, we helped      • Wyeth Consumer Healthcare provided an important
position Wyeth to address the economic realities of a         revenue contribution and positioned itself for future
changing health care environment. And, as we have             growth through the introduction of innovative new
done every year, during 2006 we continued to listen to        products such as Advil PM.
our stakeholders, to learn from them and to apply those     • Sales for Fort Dodge Animal Health rose 6 percent,
lessons to our business.                                      driven by increased revenue from its companion
    Highlighted below are some of Wyeth’s significant          animal and livestock products. The division’s robust
achievements during 2006 and in early 2007. These             new product pipeline is expected to continue as a
demonstrate the success of our efforts and our potential      source of strong growth.
to build upon them:                                         • We increased our dividend to stockholders for the
• Wyeth’s 2006 net revenue increased 9 percent to             second consecutive year, demonstrating the confi-
  nearly $20.4 billion, a record high for the Company.        dence we have in our Company’s future and in the
  Pro forma earnings grew 14 percent, the second              strength of its financial resources.
  consecutive year of double-digit growth. An in-depth          In the section that follows this report, you will
  review of our 2006 performance is provided in             read about how we’re striving to improve world health
  Wyeth’s 2006 Financial Report, the companion piece        and sustain our growth through a near-term pipeline
  to this Annual Review.                                    of innovative products. And in a special feature story
• We achieved annual sales of more than $1 billion for      on an area of enormous unmet need – Alzheimer’s
  each of six core product franchises: Effexor, Prevnar,    disease – you will read about how Wyeth researchers
  Protonix, Enbrel, Wyeth Nutrition and the Premarin        are seeking critical breakthroughs for patients, their
  family – demonstrating the breadth and diversity          caregivers and society.
  of our portfolio.
                                                                                                                   1
Wyeth Pharmaceuticals                 “Our pharmaceutical business                          Worldwide net sales
                                                                                       for Enbrel, the number
                                     delivered outstanding results by
         ur pharmaceutical

O                                                                                      one biotechnology product
          business delivered
                                   extending the reach of our products                 in its category in North
         outstanding results by
                                                                                       America, grew 20 percent
                                      and enhancing their potential
extending the reach of our
                                                                                       to more than $4.4 billion.
products and enhancing their               for further growth.”                        This includes sales in the
potential for further growth.
                                                                                       United States and Canada
At the same time, Wyeth
                                                                                       that are recorded by our
Pharmaceuticals took signifi-
                                                           marketing partner Amgen Inc. While all regions con-
cant steps to increase the efficiency and responsiveness
                                                           tributed to growth, strongest results came from Europe,
of its sales organization and to expand a variety of
                                                           where sales increased 33 percent, making Enbrel
educational efforts for patients.
                                                           the number one ranked biotechnology product there.
     Effexor and Effexor XR continued as the world’s
                                                                Wyeth Nutrition is a world leader in the develop-
number one antidepressant franchise. Sales reached
                                                           ment, manufacture and distribution of scientifically
$3.7 billion in 2006, an increase of 8 percent. An
                                                           based nutritional products for infants and toddlers.
additional indication for use of Effexor XR in panic
                                                           Wyeth Nutrition continued to grow at double-digit
disorder contributed to growth while the results of
                                                           rates in 2006. Global sales grew to $1.2 billion, an
the PREVENT study provided further evidence of the
                                                           increase of 15 percent over 2005. The two regions
sustained efficacy of Effexor XR in treating major
                                                           enjoying the fastest growth were Asia/Pacific, which
depressive disorder.
                                                           comprised nearly 60 percent of global nutritional sales
     Prevnar (Prevenar outside the United States) was
                                                           and grew 23 percent, and Latin America, which made
the number one selling vaccine in the world, with
                                                           up 16 percent of global sales and grew 15 percent.
42 million doses manufactured and net sales of nearly
                                                               Having recently celebrated its 90th anniversary,
$2 billion, an increase of 30 percent over 2005. Strong
                                                           Wyeth Nutrition has evolved into a significant interna-
global usage of Prevenar accelerated in 2006 as nine
                                                           tional player with 60 affiliates selling our products
more countries, including Germany, Mexico and
                                                           around the world. The Company markets its premium
the United Kingdom, added Prevenar to their National
                                                           product line under the Gold banner and, in late 2006,
Immunization Programs (NIP). In total, 16 countries
                                                           was first to market with an innovative new product
have incorporated Prevenar into their NIPs, and
                                                           called Gold with lutein, which seeks to protect the eyes
growing evidence of the vaccine’s high value creates
                                                           of infants. To meet increasing demand for providing
opportunities for further expansion.
                                                           infants and toddlers with high-value products like the
     Protonix, for erosive acid reflux disease, grew
                                                           Gold line, Wyeth Nutrition increased its manufacturing
7 percent to approximately $1.8 billion. During the
                                                           capacity in Mexico and began construction of an
year, RENEW, an innovative patient educational
                                                           expanded facility in the Philippines.
program for Protonix, was launched, providing sample
starter medications and educational materials to
facilitate discussions between patients and their physi-
cians and to help ensure patient compliance over the
longer term.




2
Wyeth remained a global leader in hormone                  Three growth drivers – Advil, Centrum and
therapies and was the U.S. market leader as sales of the   Caltrate – benefited significantly from this strategy.
Premarin family of products increased 16 percent           The Advil franchise grew 7 percent around the world,
globally and 21 percent in the United States. New data     largely fueled by new marketing efforts. In Canada,
published in 2006 helped to further clarify the benefits    Advil increased its market share and became the leader
and risks of hormone therapy for women, and Wyeth          in the analgesic category for the first time. The Cen-
currently is working with physicians and their patients    trum family of vitamin products achieved 4 percent
to appropriately address patient needs based on the        sales growth, driven by innovations in Europe and
emerging data.                                             growth in the age 50+ population. Centrum Advantage
    Zosyn (Tazocin outside the United States) contin-      was launched in the Canadian market in 2006.
ued to be the largest selling I.V. antibiotic worldwide    Caltrate grew 3 percent largely due to international
with global net sales of $972 million, a 9 percent         expansion.
increase over 2005. The success of Zosyn is attributa-         Overall, international sales increased 2 percent
ble to its clinical efficacy and its ability to help        while U.S. sales declined 3 percent. The decline in
hospitals control the emergence of resistant bacteria.     the United States primarily resulted from the ongoing
Tygacil, our new antibiotic product, also delivered net    impact of legislative restrictions on sales of pseu-
sales growth during the year. Since its launch in 2005,    doephedrine-containing cough/cold formulations. In
it has gained 55 worldwide regulatory approvals            response to these restrictions, Wyeth Consumer
and now is available in 33 markets. Tygacil is particu-    Healthcare transitioned most of its products to an
larly important in hospitals for patients infected         alternative active ingredient. This reformulation is
with common as well as more dangerous resistant            expected to impact sales favorably in 2007. Outside
infectious pathogens in complicated skin/skin-             the United States, a number of major international
structure and intra-abdominal infections.                  markets enjoyed double-digit growth, including
    All these products require the right selling model     Canada, China, Colombia, Mexico, Portugal, Taiwan,
for a changing health care environment. We’re pleased      Thailand and Venezuela.
to report that the new primary care selling model we           Wyeth Consumer Healthcare was particularly
implemented in the United States last year is working      successful in achieving operating efficiencies to fund
well. In 2006, we jumped from No. 8 to No. 1 in the        new investments and increase net income. Innovation
Health Strategies Group’s annual primary care physi-       also was a key contributor to growth, highlighted by
cian audit, which demonstrates physicians’ initial         the successful launch of Advil PM. Opportunities
satisfaction with our new structure.                       for future growth now are being developed, including
                                                           an innovative Caltrate food-grade line in China, the
                                                           start of a consumer health care business in Russia,
Wyeth Consumer Healthcare
                                                           and an intense research and development effort to
      xcluding the impact of revenue from Solgar

E                                                          deliver new forms of Advil.
       Vitamin and Herb, which was divested in 2005,
       sales for Wyeth Consumer Healthcare increased
1 percent to more than $2.5 billion in 2006, spurred
largely by a strong focus on supporting our core
global brands.




                                                                                                                3
Fort Dodge Animal Health                                     capture, and the simplification of clinical trial material
                                                             shipments and processes through a strategic alliance
        ales of our Fort Dodge Animal Health products

S                                                            with a leading, worldwide logistics provider.
         moved closer to $1 billion, reaching $936 million
                                                                  We continued to realize solid results from our
         and increasing 6 percent over the prior year. In
                                                             R&D organization, drawing upon our expertise in three
2006, Fort Dodge received pan-European regulatory
                                                             distinct discovery platforms: small molecules, biologics
approval to market ProMeris/ProMeris Duo, products
                                                             and vaccines. In 2006, Wyeth filed NDAs for Viviant,
offering flea and tick protection for dogs and flea protec-
                                                             for prevention of postmenopausal osteoporosis; Pristiq,
tion for cats. Approval in the United States is expected
                                                             for non-hormonal treatment of moderate to severe
in the first half of 2007. Another key achievement was
                                                             vasomotor symptoms associated with menopause;
the U.S. launch of Suvaxyn PCV2 One-Dose, a vaccine
                                                             Torisel, for patients with advanced renal cell carcinoma,
for the prevention of porcine circovirus, a disease that
                                                             which received priority review status; and bifeprunox –
leads to a wasting syndrome in pigs. In the face of global
                                                             filed with our partner Solvay Pharmaceuticals – for the
concerns over avian influenza, Fort Dodge received
                                                             treatment of schizophrenia. In addition, we submitted
approval for Poulvac Flufend, a new inactivated reverse
                                                             regulatory applications for a reformulation of BeneFIX,
genetics vaccine for poultry that addresses the potential
                                                             one of our hemophilia agents, as well as for a new adult
pandemic strain of the avian influenza virus.
                                                             granule-dose formulation of Protonix, and we received
                                                             regulatory approval for new dosing recommendations
Research and Development
                                                             for Rapamune in high-risk renal transplant patients.
         ur greatest challenge at Wyeth is to create

O
                                                             Wyeth also is seeking to expand its presence in the con-
          breakthrough medicines that serve the needs        traceptive market with Lybrel, currently awaiting final
         of patients in an increasingly competitive envi-    FDA approval. Lybrel is a novel, continuous-use oral
ronment. From a research and development standpoint,         contraceptive that is designed to provide significant
that challenge requires thinking and acting differently      benefits in terms of menstrual-cycle regulation.
in discovering and advancing to market potentially                During the year, we successfully advanced 15 new
important compounds. That is why we have instituted a        molecular entities and two new vaccine constructs
new Learn and Confirm paradigm for drug development           from discovery into development. In total, over the past
– a two-phase approach to streamlining the traditional       six years, 75 new drug candidates were placed into devel-
multiple phases of development. This effort places           opment, the majority having potential to be first- or
greater emphasis on high-performing teams, rapid             best-in-class therapies. That has made Wyeth a leading
decision making and improved clinical trial designs.         company within our industry peer group in discovering
Other accomplishments include the creation of a global       novel molecules and advancing them rapidly into clinical
network of 10 early clinical development centers to          development. We also believe that our pipeline is among
optimize our global patient mix, the streamlining of         the most robust in the industry. Others share our positive
clinical data collection processes using electronic data     views. For example, early in 2007, R&D Directions
                                                             magazine recognized Wyeth as the company with the best
                                                             central nervous system product pipeline in the industry.




4
In 2007, we expect to            “We continued to realize solid results                   Success will come not
submit several important                                                                  just in the laboratory
                                                     from our R&D
filings, including Viviant, for                                                            but also on the regulatory
                                            organization, drawing upon
the treatment of osteoporosis;                                                            front and through the
Aprela, for the treatment                                                                 development of strong part-
                                                 our expertise in three
of menopausal symptoms and                                                                nerships with patient
                                          distinct discovery platforms …”
prevention of postmenopausal                                                              groups, government, regula-
osteoporosis; methylnaltrex-                                                              tory agencies, and scientists
one subcutaneous, for opioid-                                                             in industry and academia.
induced constipation in advanced medical illness;            We must encourage additional research, accelerated and
methylnaltrexone I.V., for post-operative ileus; and         informed new drug reviews, and more aid to caregivers
Tygacil, for use in community-acquired pneumonia and         who bear the brunt of this health scourge. You will read
hospital-acquired pneumonia.                                 about some of the patients and their caregivers in this
                                                             report. These family members are courageous beyond
                                                             measure in doing everything in their power to try to care
A Special Report on Alzheimer’s Disease Research
                                                             for their loved ones at home.
     believe that Alzheimer’s disease is the biggest health

I    care issue of my generation. More than 4.5 million
                                                             The People of Wyeth
     Americans suffer today, and, as the baby boomer
generation ages, it is expected that this number will                ur Company has exhibited a track record of

                                                               O
grow substantially. Add to that millions more affected                 consistency, performance and responsibility.
by the disease – the families and caregivers of Alzheimer’s            The people of Wyeth know that to continue
patients – and the billions of dollars in health care costs  on this path, we must maintain a relentless focus
borne by society, and the nature of the challenge and        on improving our Company and running it even more
the critical importance of doing everything we can to        efficiently. Our people understand that we have an
overcome it become clear. Clinical research in this field     imperative to change Wyeth fundamentally in order
is complex and expensive with outcomes uncertain,            to succeed in the years ahead. At its core, this effort is
but the impact of success would be enormous.                 based on two simple ideas. First, every year we will
      We’re proud that Wyeth is at the cutting edge in       aim to grow our revenue through the quality of our
seeking new drugs not only to treat Alzheimer’s disease      products and their value to the people we serve. And
symptoms better than currently available therapies but       second, every year we will aim to grow our profit at
potentially to stop or even reverse the course of this       a faster rate than our revenue by running our Company
crippling and ultimately fatal disease. Our goal is to turn  more efficiently and productively. These goals drive
the corner on this terrible illness and provide new hope.    our results and determine how they are evaluated and
                                                             how we plan to improve upon them in the future.




Wyeth Research and Development Expenses                        Wyeth’s New Product Pipeline
($ in billions)
                                                               2001: 49 projects             2006: 77 projects
’06                                                     3.11
                                                                                                       LCM
                                                 2.75
’05                                                                       LCM                          22%
                                                                 NME      45%
’04                                                              55%
                                          2.46
                                                                                                 NME
                                                                                                 78%
’03                                2.09

                                                               NME = New molecular entity
                                                               LCM = Life cycle management



                                                                                                                      5
Changes in Management                                             valued at $160 million, to 250,000 Americans who
                                                                  were without adequate prescription drug coverage or
    am pleased that we have continued to strengthen the

I                                                                 insurance. Outside the United States, we worked to sup-
    leadership of our organization in a variety of ways.
                                                                  port maternal health care, ensure access to reproductive
    In October 2006, we welcomed Raymond J. McGuire
                                                                  and child health resources, and develop a new treatment
to our Company’s Board of Directors. Mr. McGuire is
                                                                  option for river blindness. We are working with the
a Managing Director and Co-Head, Global Investment
                                                                  Global Alliance for Vaccines and Immunization to find
Banking, for Citigroup Global Markets Inc. I know he
                                                                  an affordable and sustainable way to bring vaccines to
will provide important perspectives on our business oper-
                                                                  children in the developing world. We also are working
ations and strategy. In January 2007, Bernard Poussot
                                                                  hard to help protect and enrich the environment in
was elected Chief Oper-
                                                                  the communities where we live and work by steadily
ating Officer of Wyeth
                                                                  reducing environmental emissions and ensuring the
and joined the Com-
                                                                  safety of employees at all of our facilities.
pany’s Board of Direc-
tors. Earlier in 2006, he
                                                                  Looking to the Future
was promoted to Presi-
dent and Vice Chairman                                                    s we look to the future, we know that we will

                                                                  A
of Wyeth. In his more                                                       be operating in a tough environment around
than 20 years with our                                                       the world. To compete, we will continue
Company, Mr. Poussot’s                                            to attract, retain and engage a diverse workforce that
leadership has helped us                                          broadens our perspectives, enhances our customer
transform our organiza-                                           connections and increases our creativity. The more pro-
tion and set it on a                                              ductive and innovative we are in our operations, the
course for continual                                              better we will be in addressing concerns about pricing
growth. Also in 2006,                                             and access to our medicines.
Kenneth J. Martin was                                                 We have made important progress in a relatively short
promoted to Chief                                                 time as part of a longer-term effort to find new and more
                            Kenneth J. Martin, Chief Financial
Financial Officer and                                              efficient ways to meet the challenges of the 21st century.
                            Officer and Vice Chairman, left, and
Vice Chairman of                                                  The momentum we now have can be accelerated. We
                            Bernard Poussot, President, Chief
Wyeth. In addition to                                             will continue to foster a high-performance culture where
                            Operating Officer and Vice Chairman.
heading our finance                                                every person has a role, every person takes responsibility
organization, Mr. Martin took on responsibility for our           and every person acts to make a difference. We will
infrastructure initiative, which is critical to our operating     continue to execute against aggressive plans and develop
efficiency and, therefore, to our future success. Further          systems to help ensure both success and compliance with
supporting our management team, Joseph M. Mahady                  the highest legal and ethical standards around the world.
was named President – Global Business for Wyeth Phar-             And we will foster innovation through our creativity,
maceuticals and continues as a Senior Vice President of           challenging what we do every day and seeking improve-
Wyeth. In his new role, Mr. Mahady assumes operational            ments and opportunities for the years ahead. Our goal,
responsibility for Wyeth’s global pharmaceutical business.        over the next decade, is to make Wyeth a stronger
With this expanded responsibility, I am certain he will           company with an even higher value portfolio of prod-
bring significant insights to our worldwide business and           ucts to fuel growth.
commercial portfolio. In addition, Geno J. Germano was                I want to take this opportunity to thank the people
named President and General Manager, Wyeth Pharma-                of Wyeth for making a difference for our Company
ceuticals – United States and Wyeth Pharmaceutical                and those we serve. Thanks to their efforts, our growth
Business Unit. Robert E. Landry, Jr., was elected Treasurer       has accelerated, our pipeline never has been stronger and
of Wyeth.                                                         we are on the path to deliver important new medicines
                                                                  to a world in great need.
Corporate Social Responsibility
            yeth recognizes its significant responsibilities

W           as a global corporate citizen. One of the most
                                                                  Robert Essner
           important actions we can take in this regard
                                                                  Chairman and Chief Executive Officer
is to expand access to our medicines. Our patient assis-
                                                                  February 26, 2007
tance programs in 2006 provided free Wyeth medicines,

6
Wyeth’s Pipeline for Innovation
Since 2004, Wyeth has submitted 11 New Drug Applications (NDA) in the United States, delivering on our goal of
filing two NDAs for new molecular entities a year. And, over the past six years, 75 new drug candidates were placed
into development, the majority having potential to be first- or best-in-class therapies. This chart presents a snap-
shot of new drugs from Wyeth that currently are in human trials or are being reviewed by regulatory agencies.




                                                        Phase 3
                                              Phase 2




                                                                  Regulatory
                                                                     Review




                                                                                                                                      Phase 2



                                                                                                                                                        Phase 3



                                                                                                                                                                   Regulatory
                                                                                                                                                                      Review
Women’s Health and Bone                                                        Vaccines and
                                                                               Infectious Disease
Lybrel (levonorgestrel/EE)
      ™


Continuous contraception                                                       13-valent pneumococcal conjugate vaccine
Premenstrual dysphoric disorder                                                Prevention of pneumococcal disease in
Pristiq™ (desvenlafaxine succinate)                                              infants and children 6 months to 2 years
Vasomotor symptoms of menopause                                                Prevention of pneumococcal disease in
Viviant™ (bazedoxifene)                                                          high-risk individuals and adults > 50
Postmenopausal osteoporosis prevention                                         Tygacil® (tigecycline)
Postmenopausal osteoporosis treatment                                          Community-acquired pneumonia
Aprela™ (bazedoxifene/conjugated estrogens)                                    Hospital-acquired pneumonia
Postmenopausal osteoporosis                                                    Resistant pathogens
Vasomotor symptoms of menopause                                                HCV-796
Dibotermin alfa (rhBMP-2) injectable                                           Hepatitis C
Closed fractures                                                               Meningococcal B vaccine
                                                                               Prevention of meningococcal disease in
Neuroscience                                                                     adolescents
Bifeprunox
                                                                               Inflammatory Disease
Schizophrenia (U.S.)
Bipolar disorder                                                               TRU-015
Effexor XR® (venlafaxine HCl)                                                  Rheumatoid arthritis
Major depressive disorder (Japan)
Pristiq™ (desvenlafaxine succinate)                                            Oncology/Immunology/
Major depressive disorder
                                                                               Hemophilia
Fibromyalgia
                                                                               BeneFIX® (coagulation factor IX –
Neuropathic pain
                                                                                 recombinant)
Bapineuzumab (AAB-001)
                                                                               Reformulation – hemophilia B
Alzheimer’s disease
                                                                               Mylotarg® (gemtuzumab ozogamicin)
Lecozotan (SRA-333)
                                                                               Relapsed acute myeloid leukemia (EU)
Mild to moderate symptoms of
                                                                               Torisel™ (temsirolimus)
   Alzheimer’s disease
                                                                               Renal cell carcinoma
Vabicaserin (SCA-136)
                                                                               Mantle cell lymphoma
Schizophrenia
                                                                               Rapamune® (sirolimus)
                                                                               Conversion in liver transplant
Gastrointestinal/Metabolic
                                                                               ReFacto® AF (antihemophilic factor –
Protonix ® (pantoprazole sodium)                                                 recombinant)
Adult granules formulation                                                     Hemophilia A
Methylnaltrexone                                                               Bosutinib (SKI-606)
Subcutaneous for opioid-induced                                                Breast cancer, chronic myeloid leukemia,
   constipation in advanced medical illness                                      pancreatic cancer, non-small cell
I.V. for post-operative ileus                                                    lung cancer
Oral for opioid-induced constipation                                           HKI-272
PPM-204                                                                        Breast cancer, non-small cell lung cancer
Type 2 diabetes
                                                                               Phase 2                     Phase 3                              Regulatory Review
                                                                               Determination of safe       Determination of overall             Evaluation of safety
                                                                               and effective dosage for    benefit/risk ratio for an             and efficacy data
                                                                               an experimental medi-       experimental medicine,               by governmental
                                                                               cine, generally conducted   generally conducted in               regulatory agencies
                                                                               in hundreds of patients     thousands of patients

                                                                                                                                                                           7
Positioned for Growth:
             An Expanding and Promising Near-Term Pipeline
                      Important New Drugs Projected for Filing through 2007



                                Women’s Health Care

A
        t Wyeth, many
          important new
                                Viviant                                  Aprela
           drugs have           (bazedoxifene)                           (bazedoxifene/conjugated estrogens)
been filed with regulatory       Viviant, a selective estrogen receptor   During 2007, Wyeth is planning to
authorities or are in late-     modulator, is undergoing regulatory      file an NDA for Aprela for the treat-
                                review for the prevention of post-       ment of vasomotor symptoms and
stage clinical development,     menopausal osteoporosis while            vaginal atrophy and for the preven-
encompassing treatments         continuing in Phase 3 clinical trials    tion of osteoporosis, three major
                                for the treatment of postmenopausal      complications of menopause. Aprela
that span a variety of
                                osteoporosis. The National Osteo-        represents the first Tissue Selective
therapeutic areas, including    porosis Foundation estimates that        Estrogen Complex product and
                                approximately 8 million women in         seeks to provide the most compre-
women’s health care,
                                the United States                                             hensive therapy
neuroscience, cancer and        have osteoporosis                                             for menopause
                                and another 22 mil-                                           as well as a
infectious disease.
                                lion are at risk for                                          new paradigm
.                               developing this                                               for treatment
                                disease. Each year,                                           of osteoporosis.
                                osteoporotic frac-                                            The addition
                                tures cost the coun-                                          of conjugated
                                try’s health care                                             estrogens to
                                system an estimated                                           bazedoxifene
                                $18 billion.                                                  for the relief of
                                    In August 2006,                                           a wide range
                                the U.S. Food and                                             of menopausal
                                Drug Administration                                           symptoms
                                (FDA) accepted the                                            (including hot
                                Viviant New Drug                                              flushes) is
                                Application (NDA)                                             expected to add
                                for the prevention                                            significant value
                                of osteoporosis. In                                           for patients,
                                2007, Wyeth plans                                             potentially
                                to submit an additional NDA for          making the bazedoxifene family a
                                Viviant for the treatment of osteo-      comprehensive approach to treat-
                                porosis. If approved, Viviant will       ment of postmenopausal vasomotor
                                represent the first new agent in          symptoms and postmenopausal
                                its class in nearly 10 years and will    osteoporosis.
                                provide physicians with a new
                                option for patients at risk of osteo-
                                porosis and fracture.




8
Pristiq                                                                         Lybrel
(desvenlafaxine succinate)                                                      (levonorgestrel/ethinyl
                                                                                estradiol tablets)
Pristiq, a serotonin-norepinephrine
reuptake inhibitor, is being developed                                          Lybrel is an investigational oral
with a specific focus on women.                                                  contraceptive that contains a
The product will have two indica-                                               well-studied combination of low-
tions: the treatment of major                                                   dose levonorgestrel and ethinyl
depressive disorder and the relief                                                                     estradiol.
                                             Pristiq also has
of moderate to severe vasomotor                                                                        If approved,
                                         been studied for the
symptoms associated with                                                                               it is expected
                                         treatment of hot
menopause.                                                                                             to be the
                                         flushes associated with
   Pristiq is expected to improve                                                                      only combi-
                                         menopause, and
the balance of serotonin and norepi-                                                                   nation oral
                                         marketing applications
nephrine relative to that provided                                                                     contraceptive
                                         for this use were filed
by serotonin reuptake inhibitors                                                                       indicated for
                                         with the FDA and the
because of its pharmacologic profile                                                                    continuous
                                         European Medicines
as a dual reuptake inhibitor. This                                                                     usage, 365
                                         Agency in 2006. If
balance is thought to be important                                                                     days a year,
                                         approved, Pristiq
in depressed women who, when                                                                           without a
                                         will be the first non-
transitioning through menopause,                                                                       placebo phase
                                         hormonal treatment
often experience a fluctuation or                                                                       or a pill-free
                                         indicated for the
decline in estrogen that may directly                                                                  interval.
                                         relief of vasomotor
or indirectly diminish both serotonin                                                                  This product,
                                         symptoms.
and norepinephrine functioning.                                                                        when taken
                                            Additional clinical                                        consistently,
                                         trials now are under                                          is designed to
                                         way to evaluate the effectiveness      make it possible for many women
                                         and safety of Pristiq as a treatment   to eliminate the bleeding associated
                                         for fibromyalgia syndrome and           with the menstrual cycle while pro-
                                         diabetic neuropathic pain. NDA         viding effective contraception. In the
                                         filings for these two indications       United States, an approvable letter
                                         may occur as early as 2009.            for Lybrel was received from the
                                                                                FDA in June 2006, and, in the Euro-
                                                                                pean Union, the marketing applica-
                                                                                tion for Lybrel, under the trade
                                                                                name Anya, also is being reviewed.




                                                                                                                    9
Neuroscience                            Cancer
                                        Torisel
Bifeprunox                                                                        leukemia (CML). CML accounts for
                                        (temsirolimus)                            between 15 percent and 20 percent
                                                                                  of all adult leukemia cases in West-
An NDA for bifeprunox for the
                                        Torisel is a specific inhibitor of
                                                                                  ern populations.
treatment of schizophrenia was
                                        mTOR (mammalian target of
submitted to the FDA in October
                                        rapamycin), a signaling protein that
2006. Wyeth co-develops and co-
                                        regulates cell growth and new blood
promotes bifeprunox in the United
                                        vessel formation. U.S. and EU filings
States, Canada and Mexico with
                                        for Torisel were submitted in Octo-
Solvay Pharmaceuticals.
                                        ber 2006. It is undergoing priority
   The safety data for bifeprunox
                                        U.S. regulatory review and received
consistently have shown a favorable
                                        fast track status for the treatment of
weight and metabolic profile in
                                        advanced renal cell carcinoma
both short- and long-term studies.
                                        (RCC). Torisel currently is in clini-
Weight gain is a common and
                                        cal trials for several other cancers,
serious side effect of older atypical
                                        including mantle cell lymphoma.
antipsychotics and can cause
                                           RCC accounts for about 85 per-
patients to stop taking their medica-
                                        cent of all renal cancers. Patients
tion. While bifeprunox has been
                                        with the most advanced form of the
shown to have a smaller mean effect
                                        disease have a five-year survival rate
in acute psychosis when compared
                                        of less than 20 percent. Recently,
with older atypical antipsychotics,
                                        Wyeth reported data showing that
                                                                                     HKI-272, also in Phase 2, is a cell
it may be especially useful in
                                        patients who were treated with tem-
                                                                                  signaling inhibitor that focuses on
stabilized patients who need to be
                                        sirolimus alone experienced a 49
                                                                                  inhibiting tumor cell growth. This
maintained on therapy over the
                                        percent increase in median overall
                                                                                  agent targets a specific growth fac-
long term because of its favorable
                                        survival time compared with
                                                                                  tor receptor signaling molecule,
metabolic profile.
                                        patients treated with interferon-
                                                                                  HER-2, which is found on the sur-
                                        alpha alone. In addition to improv-
                                                                                  face of some breast cancer cells. It is
                                        ing overall survival, Torisel
                                                                                  being studied in advanced breast
                                        preserved a patient’s quality of life,
                                                                                  cancer patients who have failed
                                        potentially helping treated patients
                                                                                  standard therapy. Early clinical
                                        live longer and feel better.
                                                                                  data from these very early and very
                                                                                  small trials show encouraging
                                        Other Oncology Compounds
                                                                                  patient responses, including shrink-
                                        in Development
                                                                                  age of breast and lung tumors.
                                                                                     CMC-544 or inotuzumab,
                                        Wyeth’s pipeline contains several
                                                                                  currently in Phase 1, is using a novel
                                        innovative cancer compounds that
                                                                                  approach called antibody-targeted
                                        are in the middle stages of develop-
                                                                                  chemotherapy. Mylotarg, also from
                                        ment and are expected to advance to
                                                                                  Wyeth, uses similar technology
                                        larger clinical trials.
                                                                                  and currently is indicated for the
                                           SKI-606 or bosutinib, currently in
                                                                                  treatment of acute myelogenous
                                        Phase 2, is a cell signaling inhibitor
                                                                                  leukemia. CMC-544 initially is
                                        that targets critical growth path-
                                                                                  being developed for treatment of
                                        ways in cancer cells that allow cells
                                                                                  non-Hodgkin’s lymphoma.
                                        to divide. Clinical trial data thus far
                                        show activity in imatinib-resistant
                                        patients with chronic myelogenous


10
Gastrointestinal
Infectious Disease                       and Metabolic                           Vaccines
                                         Methylnaltrexone
Tygacil                                                                          Prevnar 13
(tigecycline)                                                                    (13-valent pneumococcal
                                         Opioid analgesics, such as mor-
                                                                                 conjugate vaccine)
                                         phine, are among the most widely
Tygacil was launched on a global
                                         used medicines to treat patients with
basis in 2005 for the treatment
                                                                                 Since the introduction of Prevnar
                                         moderate to severe pain. However,
of complicated skin and abdominal
                                                                                 pneumococcal 7-valent conjugate
                                         their use often results in opioid-
infections. Developed as an
                                                                                 vaccine in the United States, the
                                         induced constipation or OIC, a
expanded, broad-spectrum antibi-
                                                                                 Centers for Disease Control and
                                         common and serious side effect that
otic for patients with acute infec-
                                                                                 Prevention estimates that invasive
                                         can be a barrier to effective pain
tions who are admitted to a
                                                                                 pneumococcal disease (IPD)
                                         management. The constipation can
hospital, it offers a high likelihood
                                                                                 addressed by the Prevnar serotypes
                                         be severe enough to require tempo-
of effective treatment when the
                                                                                 has been reduced 94 percent in
                                         rary discontinuation of the needed
pathogen causing an infection is
                                                                                 children and 55 percent in adults.
                                         opioids – thus leaving the patient
unknown and, more important,
                                                                                 In addition, the rate of antibiotic-
                                         with inadequate pain relief – or
when certain resistant pathogens
                                                                                 resistant IPD has decreased substan-
                                         surgical intervention. Every year, an
are suspected.
                                                                                 tially in infants and young children
                                         estimated 5 million patients suffer
   Tygacil also was developed to
                                                                                 and in adults over age 65.
                                         from OIC in the United States alone.
combat gram-positive resistant
                                         There currently is no approved
bacteria, including resistant Staphy-
                                         medication that specifically targets
lococcus aureus, and gram-negative
                                         the cause of OIC without interfering
bacteria, including ESBL-producing
                                         with pain relief.
Klebsiella pneumoniae. It represents
                                            Methylnaltrexone is a selective
a new weapon in the global battle
                                         opioid antagonist being studied as
against antibiotic resistance.
                                         a treatment to block the peripheral
   Wyeth is targeting an NDA
                                         side effects of opioid analgesics.
filing for Tygacil in 2007 to include
                                         The drug is designed to reverse OIC
community-acquired pneumonia,
                                         rapidly and consistently without
hospital-acquired pneumonia and
                                         reversing analgesic effects or
additional evidence of effectiveness
                                         inducing withdrawal symptoms.
in the treatment of infections caused
                                            Methylnaltrexone is being
by certain atypical pathogens.
                                         developed in subcutaneous and oral
Hospital-acquired pneumonias are
                                         dosage forms as first-in-class treat-
of particular importance because
                                                                                    Building on this significant
                                         ment platforms for OIC. It also is
of the relatively high rate of morbid-
                                                                                 advance in public health, Wyeth is
                                         being developed in an intravenous
ity and mortality associated with
                                                                                 developing Prevnar 13, a 13-valent
                                         (I.V.) form for post-operative ileus,
this condition. In addition, resistant
                                                                                 pneumococcal conjugate vaccine that
                                         a potentially serious impairment of
organisms are becoming more
                                                                                 targets 13 strains of S. pneumoniae.
                                         gastrointestinal function that can
prevalent in pneumonia, further
                                                                                 This new vaccine currently is under-
                                         delay surgical recovery and prolong
increasing the risk of mortality.
                                                                                 going worldwide Phase 3 trials in
                                         hospitalization.
                                                                                 both children and adults, with regu-
                                            Wyeth is developing methylnal-
                                                                                 latory submissions expected to begin
                                         trexone in collaboration with
                                                                                 in 2009. If approved, Prevnar 13
                                         Progenics Pharmaceuticals, Inc. The
                                                                                 would be the most complete vaccine
                                         companies plan to submit NDAs
                                                                                 available for the prevention of pneu-
                                         for subcutaneous methylnaltrexone
                                                                                 mococcal disease and otitis media in
                                         in early 2007, I.V. methylnaltrexone
                                                                                 young children. For adults, Prevnar
                                         in late 2007 or in early 2008 and
                                                                                 13 is expected to extend protection to
                                         oral methylnaltrexone in late 2008
                                                                                 persons age 50 and older and to pro-
                                         or early 2009.
                                                                                 vide them with long-term protection.
                                                                                                                    11
THE


    WAR     on Alzheimer’s
“       ach morning, for more years than I wish to     caregivers are added to the toll. Treatments cost

E       remember,” says Meryl Comer, a 62-year-        the U.S. health care system more than $100 billion
        old award-winning broadcast journalist,        annually. In the next 20 years, the number of
“I reintroduce myself to my husband, Harvey.           victims will increase sharply, with the potential to
I say, ‘Good morning, love. My name is Meryl.          bankrupt our health care system. “There are no
I am your wife. We’ve been married for 25 years.       cures, no remissions,” says former Speaker of
Don’t worry. This is your home. And you are            the U.S. House of Representatives and Center for
safe.’ His eyes are blank, and mine fill with tears.”   Health Transformation founder Newt Gingrich.
Dr. Harvey Gralnick, once a leading researcher         “You won’t meet an Alzheimer’s survivor because
at the National Institutes of Health, has had          there are none. The need for medical break-
Alzheimer’s disease for 12 years. Meryl, his           throughs never has been greater.”
caregiver, has been suffering for just as long.            Wyeth is on the leading edge of potential
    Dr. Gralnick is among 4.5 million Americans        breakthroughs, having declared an all-out war
with Alzheimer’s disease. In the United States, it     on the disease. This special report introduces
strikes one of every 10 people over age 65 and         the faces of Alzheimer’s, the weapons being
nearly half of those over age 85. About 18 million     developed and the battles that still need to be
people suffer worldwide – millions more when           waged – and won.
12
“Good morning, love.
 My name is Meryl.
 I am your wife …”




                   13
Understanding the Enemy
                                        A Primer on Alzheimer’s Disease

          ne hundred years                                                                           on ways to inhibit tangles,

O          after Alois                                                                               though many scientists
          Alzheimer, a                                                                               now believe that these
German psychiatrist and                                                                              form later in the disease
neuropathologist, first                                                                               process – perhaps driven
characterized the plaques                                                                            by the amyloid deposition.
and tangles in the autop-                                                                                 Symptoms of
sied brain of a victim                                                                               Alzheimer’s disease
of this crippling and ulti-                                                                          include loss of memory –
mately fatal degenerative                                                                            first short term and
disease, researchers                                                                                 eventually the ability to
still are not fully certain                                                                          remember the past or
what causes Alzheimer’s                                                                              create new memories;
                                This photomicrograph shows the outermost layer of the brain of
or exactly what the right                                                                            difficulty in speaking and
                                an Alzheimer’s disease sufferer. The red-colored accumulations are
                                beta-amyloid plaques.
strategy is to defeat it.                                                                            reading; disorientation;
      “Alzheimer’s disease                                                                           and, ultimately, loss of
was widely misunder-                                                                                 capacity to dress, bathe
                                secretase – cut this protein       insoluble in some people
stood for many years,”                                                                               or perform what com-
                                in certain ways, normal            after six decades of being
says Sid Gilman, M.D.,                                                                               monly are called activities
                                amyloid transforms into            fluid. The aggregation,
professor and Chair of                                                                               of daily living. Says
                                beta-amyloid peptide.              for whatever reason, leads
the Department of Neu-                                                                               Dr. Gandy: “Over time,
                                It becomes sticky and              to a misfolding of the
rology at the University of                                                                          all of the outside surface
                                aggregates together in the         protein. And once it takes
Michigan and Director of                                                                             of the brain, all of the
                                brain. Eventually, these           shape as what basically is
the Michigan Alzheimer’s                                                                             cerebral cortex – the part
                                aggregates accumulate              a bobby-pin-like structure,
Disease Research Center                                                                              that’s responsible for
                                between the nerve cells in         it becomes locked in that
there. “As people aged,                                                                              thinking – degenerates,
                                parts of the brain respon-         structure and accumulates,
it was widely believed                                                                               and patients die bed-
                                sible for memory and               forming amyloid plaques.
that they simply lost their                                                                          bound in a vegetative
                                judgment.                          As that happens, you see
memory. Today, some                                                                                  state.”
                                     Samuel Gandy, M.D.,           the characteristic lesions of
physicians still think                                                                                    Joel Ross, M.D., has
                                Ph.D., Chair of the                     Alzheimer’s disease.”
memory loss is normal as                                                                             been a practicing geriatri-
                                National Medical                                 The other
you grow older. That’s                                                                               cian and internist for the
                                and Scientific                                  abnormal pro-
not so. You should retain                                                                            past 20 years and has seen
                                Advisory                                         tein that
your memory until you                                                                                some 1,000 Alzheimer’s
                                Council of the                                    appears in
die. Alzheimer’s is a dis-                                                                           patients during that time.
                                Alzheimer’s                                        the disease is
ease process, and aging is                                                                           “Anger and depression
                                Association,                                        called tau,
just one risk factor.”                                                                               are common in early
                                notes, “The                                         which accu-
      What may be the                                                                                disease. Psychosis is not
                                amyloid                                             mulates in
primary culprit? Many                                                                                unusual in later disease.
                                peptide nor-                                       the cells
researchers believe it is the                                                                        And the wandering we
                                mally is found                                    themselves,
toxic form of a protein –                                                                            sometimes see is a func-
                                between nerve                                   leading to the
called amyloid precursor                                                                             tion of disorientation
                                cells in your                                 tangles that
protein – that appears                                                                               and lack of memory.”
                                blood or in your                           Dr. Alzheimer first
naturally in small quanti-
                                spinal fluid. The chal-               saw. The tangles develop
ties in our bodies. When
                                lenge is why it becomes            inside the nerve cells,
two enzymes – gamma                                                                                  Left: This CT scan of a brain
                                                                   eventually killing them.          shows the atrophy caused by
secretase and beta
                                                                   Some drugs are focusing           Alzheimer’s disease.

14
“I would do anything to keep him                                  Memory problems and confusion at his last job as a
                                                              chemical salesman contributed to his employment being
 just the way he is today.”                                   terminated in April 2005. Ted explains: “I made a lot of
                                                              my sales calls by phone, but I couldn’t remember exactly
                                                              what people had said to me after I hung up. I was taken
 June and Ted Roderick: They’re a Couple
                                                              out of sales and put in other jobs. Was it fair? It’s hard
                                                              to say.”
 J   une and Ted Roderick are at the leading edge of the          Ted finds humor a good defense mechanism. “Actu-
     baby boomer generation – a time when many think          ally, it’s a good excuse if I don’t want to do something
 about retirement, new hobbies, vacation plans, grand-        around the house. I can say, ‘I forgot.’ They’re the
 children. But June and Ted are too preoccupied for           two words I use most.” But sometimes it’s hard. “June
 that. Ted, age 63, has Alzheimer’s disease and has had       will arrive home and ask what I did during the day.
 it for at least six years.                                   I know I did things, but I don’t know what they were.
     “We’re fortunate because Ted continues to function       It’s frustrating.”
 at a high level,” his wife June says. “He’s still driving        June says, “You take every day and appreciate what
 and can read short articles in the newspapers and            you have. I would do anything to keep him just the
 magazines.”                                                  way he is today. We’ve been married 40 years. I hope
     Ted also can take apart a faucet and put it back         we can continue the way we are.
 together and make screens for storm windows. He says,            “We worry about losing each other,” she adds. “That’s
 “I feel more competent doing mechanical tasks than           why we keep fighting and trying to do everything we
 mental things. I just forget stuff.” And he speaks ration-   can to prevent the disease from getting worse. We won’t
 ally about his disease. “I can’t remember what I did         stop. We do everything together. You see, we’re a couple.
 an hour ago or yesterday. It’s annoying, but, for now,       And we want to stay a couple.”
 it’s not debilitating.”


                                                                                                                     15
William Utermohlen,
                                                                     an American artist
                                                                     living in London, chron-
                                                                     icled the progression
                                                                     of his Alzheimer’s
                                                                     disease in a series of
                                                                     self-portraits, several
     Changes in personality   Dr. Gandy says,                                                   a series of biomarkers,
                                                                     of which are shown
also can include anxiety      “the medicines                                                    or proteins, whose pres-
                                                                     here. The top painting,
and apathy or even suspi-     we have today                                                     ence in the blood or spinal
                                                                     completed shortly after
                                                                     he learned he had the
ciousness, agitation or       wear off and                                                      fluid may indicate the
                                                                     disease, is followed by
delusion. With the passing    aren’t effective.                                                 disease already is at work.
                                                                     others he created as
of time, victims may lose     They don’t                                                             “I would advocate
                                                                     the disease pro-
their ability to swallow      appreciably slow                                                  starting a therapy when
                                                                     gressed and affected
                                                                     his abilities and per-
and eat solid foods or        the progression                                                   amyloid is just beginning
                                                                     ceptions. Today, Mr.
become incontinent.           of the disease                                                    to be deposited – before
                                                                     Utermohlen resides in
Often they die from the       and don’t attack                                                  significant symptoms
                                                                     a nursing home and
consequences of being         the underlying                                                    occur,” adds Ronald Black,
                                                                     no longer paints.
bedridden or sustaining       pathology.”                                                       M.D., Senior Director,
a physical injury, like a     Most researchers                                                  Neuroscience Clinical
broken hip. Many don’t        now believe                                                       Development at Wyeth.
                                                                      at risk factors
recover, in part, because     toxic amyloid                                                     “That is the promise
                                                                      and treat at least a
they can’t remember they      and tau begin                                                     of prevention. It parallels
                                                                      decade in advance
are sick or had an accident   forming years                                                     treatment of breast
                                                                      of cognitive decline.
and can’t understand          before symptoms                                                   cancer: Detect and treat
                                                                      The reason for
directions for therapies      appear. So even                                                   at an early stage.”
                                                                      that length of time
to help them get better.      as researchers                                                         Wyeth is participating
                                                                      is because Mother
     “We believe there is     begin to seek                                                     in the Alzheimer’s Disease
                                                                      Nature is very
a genetic basis for this      new treatments                                                    Neuroimaging Initiative,
                                                                      careful. There is so
disease,” says Dr. Gilman.    for Alzheimer’s,                                                  a five-year public/private
                                                                      much redundancy
Having the gene called        they are focusing                                                 partnership that has
                                                                      in the brain that
Apolipoprotein E4 puts        on how to diag-                                                   brought together industry,
                                                                      one has to lose
one at greatest risk, often   nose the disease                                                  academia and the National
                                                                      huge numbers of
predisposing a person to      at its earliest                                                   Institutes of Health to
                                                                      nerve cells before
develop the disease sooner    possible stages.                                                  validate biomarkers and
                                                              symptoms develop.”
rather than later. “If you         The basic principle,                                         develop new neuroimag-
                                                                   Standard psychologi-
look at the universe of       Dr. Gandy notes, “is to                                           ing tools.
                                                              cal testing, coupled with
Alzheimer’s patients,” he     target the disease before                                              How do physicians
                                                              imaging, is about 80 per-
adds, “50 percent have        permanent damage                                                  help patients when so few
                                                              cent to 90 percent accurate
the ApoE4 gene.”              to neurons occurs. Part                                           therapies are available?
                                                              in diagnosing the disease
     Included among           of the reason to target                                           Among other things,
                                                              and staging it – from mild
known physical aspects        amyloid is that it is felt                                        “We encourage them to
                                                              to moderate to severe.
of the disease is the loss    to accumulate early in                                            participate in our clinical
                                                              Diagnosis also includes
of nerve cells that use the   the disease cascade. Once                                         trials for their own sake
                                                              ruling out other possible
neurotransmitter acetyl-      there is an effective ther-                                       and for the sake of others
                                                              physical or psychological
choline, a chemical that      apy that treats early stages                                      afflicted with this devastat-
                                                              causes that may be more
these cells use to commu-     of the disease, the field                                          ing disease,” Dr. Gilman
                                                              treatable, such as severe
nicate with each other.       will try to identify patients                                     says. “I tell them what
                                                              depression, alcoholism,
Nearly all the currently      earlier and earlier. We                                           they can expect next.
                                                              thyroid malfunction,
approved medicines target     hope this information will                                        I prepare them as best I
                                                              brain traumas or stroke.
this aspect of the disease.   lead to prevention of                                             can. At least today, we
                                                              Scientists are making
However, as Alzheimer’s       Alzheimer’s by identifying                                        have great hope for better
                                                              progress toward develop-
progresses and nerve          patients most at risk.”                                           treatments – more than
                                                              ing simpler tests for the
cells become impaired to           Dr. Gilman agrees:                                           ever before. This is the
                                                              disease by identifying
the point of degenerating,    “It would be ideal to look                                        dawn of a new age.”
16
wyeth 2006 Annual Review
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wyeth 2006 Annual Review

  • 1. Leading the Way to a Healthier Annual Review 2006 World
  • 2. Financial Highlights Year Ended December 31, 2005 2006 (In thousands except per share amounts) Net Revenue $18,755,790 $20,350,655 Net Income 3,656,298 4,196,706 Diluted Earnings per Share 2.70 3.08 Dividends per Common Share 0.94 1.01 Total Assets 35,841,126 36,478,715 Stockholders’ Equity 11,994,369 14,652,755 Wyeth at a Glance Wyeth is one of the world’s largest medicines and animal health care products research-based pharmaceutical and health that improve the quality of life for people care products companies. It is a leader in worldwide. The Company’s major divisions the discovery, development, manufacturing include Wyeth Pharmaceuticals, Wyeth and marketing of pharmaceuticals, biotech- Consumer Healthcare and Fort Dodge nology products, vaccines, non-prescription Animal Health. A Special Report On the Cover on Alzheimer’s Disease Contents Motivational life coach Meredith Millions of people around the 1 Chairman’s Report to Stockholders Froemke takes Enbrel for her world are coming face to face 7 Wyeth’s Pipeline for Innovation rheumatoid arthritis. “Within six with Alzheimer’s disease, a weeks of therapy, I felt like a new neurodegenerative disorder that 8 An Expanding and Promising human being,” she marvels. “It’s robs sufferers of their memories, Near-Term Pipeline given me back my mobility and my their identities and, ultimately, 12 The War on Alzheimer’s life.” Her daughter, Lauren, also their lives. Wyeth is at the forefront has benefited from an innovative of an extraordinary effort to 32 Selected Products from Wyeth Wyeth medicine after being find new and better medicines to vaccinated with Prevnar to help control this disease’s symptoms 33 Directors and Officers prevent invasive pneumococcal and, potentially, to halt or even 34 Financial Review disease. Wyeth is a leader in reverse its progression. A special innovation through use of report beginning on page 12 36 Corporate Data pharmaceutical, biotech and takes an in-depth look at Wyeth’s IBC Mission, Vision and Values vaccine technologies. war on Alzheimer’s.
  • 3. Chairman’s Report to Stockholders Robert Essner, Chairman and Chief Executive Officer am pleased to report that “We once again delivered on our • Revenue from all of our I 2006 was an excellent year biotechnology products in commitment to expand our for Wyeth. Building on our 2006 reached $5.7 billion, growth, strengthen our position strong performance in 2005, representing about a third we once again delivered on our of Wyeth Pharmaceuticals’ for the future and lead the way commitment to expand our total revenue and making to a healthier world.” growth, strengthen our posi- Wyeth the fourth largest tion for the future and lead biotechnology company in the way to a healthier world. the world. Driven by the steady growth of our key products, Wyeth • In January 2007, we received an approvable letter reported record revenue. We filed four New Drug Appli- from the U.S. Food and Drug Administration (FDA) cations (NDA) for new products, demonstrating solid for Pristiq, a serotonin-norepinephrine reuptake productivity from our research and development (R&D) inhibitor for the treatment of major depressive disor- efforts. Overall, our new product pipeline significantly der, which will be launched with a specific focus expanded and advanced. By maximizing productivity, on women. controlling costs and delivering high value, we helped • Wyeth Consumer Healthcare provided an important position Wyeth to address the economic realities of a revenue contribution and positioned itself for future changing health care environment. And, as we have growth through the introduction of innovative new done every year, during 2006 we continued to listen to products such as Advil PM. our stakeholders, to learn from them and to apply those • Sales for Fort Dodge Animal Health rose 6 percent, lessons to our business. driven by increased revenue from its companion Highlighted below are some of Wyeth’s significant animal and livestock products. The division’s robust achievements during 2006 and in early 2007. These new product pipeline is expected to continue as a demonstrate the success of our efforts and our potential source of strong growth. to build upon them: • We increased our dividend to stockholders for the • Wyeth’s 2006 net revenue increased 9 percent to second consecutive year, demonstrating the confi- nearly $20.4 billion, a record high for the Company. dence we have in our Company’s future and in the Pro forma earnings grew 14 percent, the second strength of its financial resources. consecutive year of double-digit growth. An in-depth In the section that follows this report, you will review of our 2006 performance is provided in read about how we’re striving to improve world health Wyeth’s 2006 Financial Report, the companion piece and sustain our growth through a near-term pipeline to this Annual Review. of innovative products. And in a special feature story • We achieved annual sales of more than $1 billion for on an area of enormous unmet need – Alzheimer’s each of six core product franchises: Effexor, Prevnar, disease – you will read about how Wyeth researchers Protonix, Enbrel, Wyeth Nutrition and the Premarin are seeking critical breakthroughs for patients, their family – demonstrating the breadth and diversity caregivers and society. of our portfolio. 1
  • 4. Wyeth Pharmaceuticals “Our pharmaceutical business Worldwide net sales for Enbrel, the number delivered outstanding results by ur pharmaceutical O one biotechnology product business delivered extending the reach of our products in its category in North outstanding results by America, grew 20 percent and enhancing their potential extending the reach of our to more than $4.4 billion. products and enhancing their for further growth.” This includes sales in the potential for further growth. United States and Canada At the same time, Wyeth that are recorded by our Pharmaceuticals took signifi- marketing partner Amgen Inc. While all regions con- cant steps to increase the efficiency and responsiveness tributed to growth, strongest results came from Europe, of its sales organization and to expand a variety of where sales increased 33 percent, making Enbrel educational efforts for patients. the number one ranked biotechnology product there. Effexor and Effexor XR continued as the world’s Wyeth Nutrition is a world leader in the develop- number one antidepressant franchise. Sales reached ment, manufacture and distribution of scientifically $3.7 billion in 2006, an increase of 8 percent. An based nutritional products for infants and toddlers. additional indication for use of Effexor XR in panic Wyeth Nutrition continued to grow at double-digit disorder contributed to growth while the results of rates in 2006. Global sales grew to $1.2 billion, an the PREVENT study provided further evidence of the increase of 15 percent over 2005. The two regions sustained efficacy of Effexor XR in treating major enjoying the fastest growth were Asia/Pacific, which depressive disorder. comprised nearly 60 percent of global nutritional sales Prevnar (Prevenar outside the United States) was and grew 23 percent, and Latin America, which made the number one selling vaccine in the world, with up 16 percent of global sales and grew 15 percent. 42 million doses manufactured and net sales of nearly Having recently celebrated its 90th anniversary, $2 billion, an increase of 30 percent over 2005. Strong Wyeth Nutrition has evolved into a significant interna- global usage of Prevenar accelerated in 2006 as nine tional player with 60 affiliates selling our products more countries, including Germany, Mexico and around the world. The Company markets its premium the United Kingdom, added Prevenar to their National product line under the Gold banner and, in late 2006, Immunization Programs (NIP). In total, 16 countries was first to market with an innovative new product have incorporated Prevenar into their NIPs, and called Gold with lutein, which seeks to protect the eyes growing evidence of the vaccine’s high value creates of infants. To meet increasing demand for providing opportunities for further expansion. infants and toddlers with high-value products like the Protonix, for erosive acid reflux disease, grew Gold line, Wyeth Nutrition increased its manufacturing 7 percent to approximately $1.8 billion. During the capacity in Mexico and began construction of an year, RENEW, an innovative patient educational expanded facility in the Philippines. program for Protonix, was launched, providing sample starter medications and educational materials to facilitate discussions between patients and their physi- cians and to help ensure patient compliance over the longer term. 2
  • 5. Wyeth remained a global leader in hormone Three growth drivers – Advil, Centrum and therapies and was the U.S. market leader as sales of the Caltrate – benefited significantly from this strategy. Premarin family of products increased 16 percent The Advil franchise grew 7 percent around the world, globally and 21 percent in the United States. New data largely fueled by new marketing efforts. In Canada, published in 2006 helped to further clarify the benefits Advil increased its market share and became the leader and risks of hormone therapy for women, and Wyeth in the analgesic category for the first time. The Cen- currently is working with physicians and their patients trum family of vitamin products achieved 4 percent to appropriately address patient needs based on the sales growth, driven by innovations in Europe and emerging data. growth in the age 50+ population. Centrum Advantage Zosyn (Tazocin outside the United States) contin- was launched in the Canadian market in 2006. ued to be the largest selling I.V. antibiotic worldwide Caltrate grew 3 percent largely due to international with global net sales of $972 million, a 9 percent expansion. increase over 2005. The success of Zosyn is attributa- Overall, international sales increased 2 percent ble to its clinical efficacy and its ability to help while U.S. sales declined 3 percent. The decline in hospitals control the emergence of resistant bacteria. the United States primarily resulted from the ongoing Tygacil, our new antibiotic product, also delivered net impact of legislative restrictions on sales of pseu- sales growth during the year. Since its launch in 2005, doephedrine-containing cough/cold formulations. In it has gained 55 worldwide regulatory approvals response to these restrictions, Wyeth Consumer and now is available in 33 markets. Tygacil is particu- Healthcare transitioned most of its products to an larly important in hospitals for patients infected alternative active ingredient. This reformulation is with common as well as more dangerous resistant expected to impact sales favorably in 2007. Outside infectious pathogens in complicated skin/skin- the United States, a number of major international structure and intra-abdominal infections. markets enjoyed double-digit growth, including All these products require the right selling model Canada, China, Colombia, Mexico, Portugal, Taiwan, for a changing health care environment. We’re pleased Thailand and Venezuela. to report that the new primary care selling model we Wyeth Consumer Healthcare was particularly implemented in the United States last year is working successful in achieving operating efficiencies to fund well. In 2006, we jumped from No. 8 to No. 1 in the new investments and increase net income. Innovation Health Strategies Group’s annual primary care physi- also was a key contributor to growth, highlighted by cian audit, which demonstrates physicians’ initial the successful launch of Advil PM. Opportunities satisfaction with our new structure. for future growth now are being developed, including an innovative Caltrate food-grade line in China, the start of a consumer health care business in Russia, Wyeth Consumer Healthcare and an intense research and development effort to xcluding the impact of revenue from Solgar E deliver new forms of Advil. Vitamin and Herb, which was divested in 2005, sales for Wyeth Consumer Healthcare increased 1 percent to more than $2.5 billion in 2006, spurred largely by a strong focus on supporting our core global brands. 3
  • 6. Fort Dodge Animal Health capture, and the simplification of clinical trial material shipments and processes through a strategic alliance ales of our Fort Dodge Animal Health products S with a leading, worldwide logistics provider. moved closer to $1 billion, reaching $936 million We continued to realize solid results from our and increasing 6 percent over the prior year. In R&D organization, drawing upon our expertise in three 2006, Fort Dodge received pan-European regulatory distinct discovery platforms: small molecules, biologics approval to market ProMeris/ProMeris Duo, products and vaccines. In 2006, Wyeth filed NDAs for Viviant, offering flea and tick protection for dogs and flea protec- for prevention of postmenopausal osteoporosis; Pristiq, tion for cats. Approval in the United States is expected for non-hormonal treatment of moderate to severe in the first half of 2007. Another key achievement was vasomotor symptoms associated with menopause; the U.S. launch of Suvaxyn PCV2 One-Dose, a vaccine Torisel, for patients with advanced renal cell carcinoma, for the prevention of porcine circovirus, a disease that which received priority review status; and bifeprunox – leads to a wasting syndrome in pigs. In the face of global filed with our partner Solvay Pharmaceuticals – for the concerns over avian influenza, Fort Dodge received treatment of schizophrenia. In addition, we submitted approval for Poulvac Flufend, a new inactivated reverse regulatory applications for a reformulation of BeneFIX, genetics vaccine for poultry that addresses the potential one of our hemophilia agents, as well as for a new adult pandemic strain of the avian influenza virus. granule-dose formulation of Protonix, and we received regulatory approval for new dosing recommendations Research and Development for Rapamune in high-risk renal transplant patients. ur greatest challenge at Wyeth is to create O Wyeth also is seeking to expand its presence in the con- breakthrough medicines that serve the needs traceptive market with Lybrel, currently awaiting final of patients in an increasingly competitive envi- FDA approval. Lybrel is a novel, continuous-use oral ronment. From a research and development standpoint, contraceptive that is designed to provide significant that challenge requires thinking and acting differently benefits in terms of menstrual-cycle regulation. in discovering and advancing to market potentially During the year, we successfully advanced 15 new important compounds. That is why we have instituted a molecular entities and two new vaccine constructs new Learn and Confirm paradigm for drug development from discovery into development. In total, over the past – a two-phase approach to streamlining the traditional six years, 75 new drug candidates were placed into devel- multiple phases of development. This effort places opment, the majority having potential to be first- or greater emphasis on high-performing teams, rapid best-in-class therapies. That has made Wyeth a leading decision making and improved clinical trial designs. company within our industry peer group in discovering Other accomplishments include the creation of a global novel molecules and advancing them rapidly into clinical network of 10 early clinical development centers to development. We also believe that our pipeline is among optimize our global patient mix, the streamlining of the most robust in the industry. Others share our positive clinical data collection processes using electronic data views. For example, early in 2007, R&D Directions magazine recognized Wyeth as the company with the best central nervous system product pipeline in the industry. 4
  • 7. In 2007, we expect to “We continued to realize solid results Success will come not submit several important just in the laboratory from our R&D filings, including Viviant, for but also on the regulatory organization, drawing upon the treatment of osteoporosis; front and through the Aprela, for the treatment development of strong part- our expertise in three of menopausal symptoms and nerships with patient distinct discovery platforms …” prevention of postmenopausal groups, government, regula- osteoporosis; methylnaltrex- tory agencies, and scientists one subcutaneous, for opioid- in industry and academia. induced constipation in advanced medical illness; We must encourage additional research, accelerated and methylnaltrexone I.V., for post-operative ileus; and informed new drug reviews, and more aid to caregivers Tygacil, for use in community-acquired pneumonia and who bear the brunt of this health scourge. You will read hospital-acquired pneumonia. about some of the patients and their caregivers in this report. These family members are courageous beyond measure in doing everything in their power to try to care A Special Report on Alzheimer’s Disease Research for their loved ones at home. believe that Alzheimer’s disease is the biggest health I care issue of my generation. More than 4.5 million The People of Wyeth Americans suffer today, and, as the baby boomer generation ages, it is expected that this number will ur Company has exhibited a track record of O grow substantially. Add to that millions more affected consistency, performance and responsibility. by the disease – the families and caregivers of Alzheimer’s The people of Wyeth know that to continue patients – and the billions of dollars in health care costs on this path, we must maintain a relentless focus borne by society, and the nature of the challenge and on improving our Company and running it even more the critical importance of doing everything we can to efficiently. Our people understand that we have an overcome it become clear. Clinical research in this field imperative to change Wyeth fundamentally in order is complex and expensive with outcomes uncertain, to succeed in the years ahead. At its core, this effort is but the impact of success would be enormous. based on two simple ideas. First, every year we will We’re proud that Wyeth is at the cutting edge in aim to grow our revenue through the quality of our seeking new drugs not only to treat Alzheimer’s disease products and their value to the people we serve. And symptoms better than currently available therapies but second, every year we will aim to grow our profit at potentially to stop or even reverse the course of this a faster rate than our revenue by running our Company crippling and ultimately fatal disease. Our goal is to turn more efficiently and productively. These goals drive the corner on this terrible illness and provide new hope. our results and determine how they are evaluated and how we plan to improve upon them in the future. Wyeth Research and Development Expenses Wyeth’s New Product Pipeline ($ in billions) 2001: 49 projects 2006: 77 projects ’06 3.11 LCM 2.75 ’05 LCM 22% NME 45% ’04 55% 2.46 NME 78% ’03 2.09 NME = New molecular entity LCM = Life cycle management 5
  • 8. Changes in Management valued at $160 million, to 250,000 Americans who were without adequate prescription drug coverage or am pleased that we have continued to strengthen the I insurance. Outside the United States, we worked to sup- leadership of our organization in a variety of ways. port maternal health care, ensure access to reproductive In October 2006, we welcomed Raymond J. McGuire and child health resources, and develop a new treatment to our Company’s Board of Directors. Mr. McGuire is option for river blindness. We are working with the a Managing Director and Co-Head, Global Investment Global Alliance for Vaccines and Immunization to find Banking, for Citigroup Global Markets Inc. I know he an affordable and sustainable way to bring vaccines to will provide important perspectives on our business oper- children in the developing world. We also are working ations and strategy. In January 2007, Bernard Poussot hard to help protect and enrich the environment in was elected Chief Oper- the communities where we live and work by steadily ating Officer of Wyeth reducing environmental emissions and ensuring the and joined the Com- safety of employees at all of our facilities. pany’s Board of Direc- tors. Earlier in 2006, he Looking to the Future was promoted to Presi- dent and Vice Chairman s we look to the future, we know that we will A of Wyeth. In his more be operating in a tough environment around than 20 years with our the world. To compete, we will continue Company, Mr. Poussot’s to attract, retain and engage a diverse workforce that leadership has helped us broadens our perspectives, enhances our customer transform our organiza- connections and increases our creativity. The more pro- tion and set it on a ductive and innovative we are in our operations, the course for continual better we will be in addressing concerns about pricing growth. Also in 2006, and access to our medicines. Kenneth J. Martin was We have made important progress in a relatively short promoted to Chief time as part of a longer-term effort to find new and more Kenneth J. Martin, Chief Financial Financial Officer and efficient ways to meet the challenges of the 21st century. Officer and Vice Chairman, left, and Vice Chairman of The momentum we now have can be accelerated. We Bernard Poussot, President, Chief Wyeth. In addition to will continue to foster a high-performance culture where Operating Officer and Vice Chairman. heading our finance every person has a role, every person takes responsibility organization, Mr. Martin took on responsibility for our and every person acts to make a difference. We will infrastructure initiative, which is critical to our operating continue to execute against aggressive plans and develop efficiency and, therefore, to our future success. Further systems to help ensure both success and compliance with supporting our management team, Joseph M. Mahady the highest legal and ethical standards around the world. was named President – Global Business for Wyeth Phar- And we will foster innovation through our creativity, maceuticals and continues as a Senior Vice President of challenging what we do every day and seeking improve- Wyeth. In his new role, Mr. Mahady assumes operational ments and opportunities for the years ahead. Our goal, responsibility for Wyeth’s global pharmaceutical business. over the next decade, is to make Wyeth a stronger With this expanded responsibility, I am certain he will company with an even higher value portfolio of prod- bring significant insights to our worldwide business and ucts to fuel growth. commercial portfolio. In addition, Geno J. Germano was I want to take this opportunity to thank the people named President and General Manager, Wyeth Pharma- of Wyeth for making a difference for our Company ceuticals – United States and Wyeth Pharmaceutical and those we serve. Thanks to their efforts, our growth Business Unit. Robert E. Landry, Jr., was elected Treasurer has accelerated, our pipeline never has been stronger and of Wyeth. we are on the path to deliver important new medicines to a world in great need. Corporate Social Responsibility yeth recognizes its significant responsibilities W as a global corporate citizen. One of the most Robert Essner important actions we can take in this regard Chairman and Chief Executive Officer is to expand access to our medicines. Our patient assis- February 26, 2007 tance programs in 2006 provided free Wyeth medicines, 6
  • 9. Wyeth’s Pipeline for Innovation Since 2004, Wyeth has submitted 11 New Drug Applications (NDA) in the United States, delivering on our goal of filing two NDAs for new molecular entities a year. And, over the past six years, 75 new drug candidates were placed into development, the majority having potential to be first- or best-in-class therapies. This chart presents a snap- shot of new drugs from Wyeth that currently are in human trials or are being reviewed by regulatory agencies. Phase 3 Phase 2 Regulatory Review Phase 2 Phase 3 Regulatory Review Women’s Health and Bone Vaccines and Infectious Disease Lybrel (levonorgestrel/EE) ™ Continuous contraception 13-valent pneumococcal conjugate vaccine Premenstrual dysphoric disorder Prevention of pneumococcal disease in Pristiq™ (desvenlafaxine succinate) infants and children 6 months to 2 years Vasomotor symptoms of menopause Prevention of pneumococcal disease in Viviant™ (bazedoxifene) high-risk individuals and adults > 50 Postmenopausal osteoporosis prevention Tygacil® (tigecycline) Postmenopausal osteoporosis treatment Community-acquired pneumonia Aprela™ (bazedoxifene/conjugated estrogens) Hospital-acquired pneumonia Postmenopausal osteoporosis Resistant pathogens Vasomotor symptoms of menopause HCV-796 Dibotermin alfa (rhBMP-2) injectable Hepatitis C Closed fractures Meningococcal B vaccine Prevention of meningococcal disease in Neuroscience adolescents Bifeprunox Inflammatory Disease Schizophrenia (U.S.) Bipolar disorder TRU-015 Effexor XR® (venlafaxine HCl) Rheumatoid arthritis Major depressive disorder (Japan) Pristiq™ (desvenlafaxine succinate) Oncology/Immunology/ Major depressive disorder Hemophilia Fibromyalgia BeneFIX® (coagulation factor IX – Neuropathic pain recombinant) Bapineuzumab (AAB-001) Reformulation – hemophilia B Alzheimer’s disease Mylotarg® (gemtuzumab ozogamicin) Lecozotan (SRA-333) Relapsed acute myeloid leukemia (EU) Mild to moderate symptoms of Torisel™ (temsirolimus) Alzheimer’s disease Renal cell carcinoma Vabicaserin (SCA-136) Mantle cell lymphoma Schizophrenia Rapamune® (sirolimus) Conversion in liver transplant Gastrointestinal/Metabolic ReFacto® AF (antihemophilic factor – Protonix ® (pantoprazole sodium) recombinant) Adult granules formulation Hemophilia A Methylnaltrexone Bosutinib (SKI-606) Subcutaneous for opioid-induced Breast cancer, chronic myeloid leukemia, constipation in advanced medical illness pancreatic cancer, non-small cell I.V. for post-operative ileus lung cancer Oral for opioid-induced constipation HKI-272 PPM-204 Breast cancer, non-small cell lung cancer Type 2 diabetes Phase 2 Phase 3 Regulatory Review Determination of safe Determination of overall Evaluation of safety and effective dosage for benefit/risk ratio for an and efficacy data an experimental medi- experimental medicine, by governmental cine, generally conducted generally conducted in regulatory agencies in hundreds of patients thousands of patients 7
  • 10. Positioned for Growth: An Expanding and Promising Near-Term Pipeline Important New Drugs Projected for Filing through 2007 Women’s Health Care A t Wyeth, many important new Viviant Aprela drugs have (bazedoxifene) (bazedoxifene/conjugated estrogens) been filed with regulatory Viviant, a selective estrogen receptor During 2007, Wyeth is planning to authorities or are in late- modulator, is undergoing regulatory file an NDA for Aprela for the treat- review for the prevention of post- ment of vasomotor symptoms and stage clinical development, menopausal osteoporosis while vaginal atrophy and for the preven- encompassing treatments continuing in Phase 3 clinical trials tion of osteoporosis, three major for the treatment of postmenopausal complications of menopause. Aprela that span a variety of osteoporosis. The National Osteo- represents the first Tissue Selective therapeutic areas, including porosis Foundation estimates that Estrogen Complex product and approximately 8 million women in seeks to provide the most compre- women’s health care, the United States hensive therapy neuroscience, cancer and have osteoporosis for menopause and another 22 mil- as well as a infectious disease. lion are at risk for new paradigm . developing this for treatment disease. Each year, of osteoporosis. osteoporotic frac- The addition tures cost the coun- of conjugated try’s health care estrogens to system an estimated bazedoxifene $18 billion. for the relief of In August 2006, a wide range the U.S. Food and of menopausal Drug Administration symptoms (FDA) accepted the (including hot Viviant New Drug flushes) is Application (NDA) expected to add for the prevention significant value of osteoporosis. In for patients, 2007, Wyeth plans potentially to submit an additional NDA for making the bazedoxifene family a Viviant for the treatment of osteo- comprehensive approach to treat- porosis. If approved, Viviant will ment of postmenopausal vasomotor represent the first new agent in symptoms and postmenopausal its class in nearly 10 years and will osteoporosis. provide physicians with a new option for patients at risk of osteo- porosis and fracture. 8
  • 11. Pristiq Lybrel (desvenlafaxine succinate) (levonorgestrel/ethinyl estradiol tablets) Pristiq, a serotonin-norepinephrine reuptake inhibitor, is being developed Lybrel is an investigational oral with a specific focus on women. contraceptive that contains a The product will have two indica- well-studied combination of low- tions: the treatment of major dose levonorgestrel and ethinyl depressive disorder and the relief estradiol. Pristiq also has of moderate to severe vasomotor If approved, been studied for the symptoms associated with it is expected treatment of hot menopause. to be the flushes associated with Pristiq is expected to improve only combi- menopause, and the balance of serotonin and norepi- nation oral marketing applications nephrine relative to that provided contraceptive for this use were filed by serotonin reuptake inhibitors indicated for with the FDA and the because of its pharmacologic profile continuous European Medicines as a dual reuptake inhibitor. This usage, 365 Agency in 2006. If balance is thought to be important days a year, approved, Pristiq in depressed women who, when without a will be the first non- transitioning through menopause, placebo phase hormonal treatment often experience a fluctuation or or a pill-free indicated for the decline in estrogen that may directly interval. relief of vasomotor or indirectly diminish both serotonin This product, symptoms. and norepinephrine functioning. when taken Additional clinical consistently, trials now are under is designed to way to evaluate the effectiveness make it possible for many women and safety of Pristiq as a treatment to eliminate the bleeding associated for fibromyalgia syndrome and with the menstrual cycle while pro- diabetic neuropathic pain. NDA viding effective contraception. In the filings for these two indications United States, an approvable letter may occur as early as 2009. for Lybrel was received from the FDA in June 2006, and, in the Euro- pean Union, the marketing applica- tion for Lybrel, under the trade name Anya, also is being reviewed. 9
  • 12. Neuroscience Cancer Torisel Bifeprunox leukemia (CML). CML accounts for (temsirolimus) between 15 percent and 20 percent of all adult leukemia cases in West- An NDA for bifeprunox for the Torisel is a specific inhibitor of ern populations. treatment of schizophrenia was mTOR (mammalian target of submitted to the FDA in October rapamycin), a signaling protein that 2006. Wyeth co-develops and co- regulates cell growth and new blood promotes bifeprunox in the United vessel formation. U.S. and EU filings States, Canada and Mexico with for Torisel were submitted in Octo- Solvay Pharmaceuticals. ber 2006. It is undergoing priority The safety data for bifeprunox U.S. regulatory review and received consistently have shown a favorable fast track status for the treatment of weight and metabolic profile in advanced renal cell carcinoma both short- and long-term studies. (RCC). Torisel currently is in clini- Weight gain is a common and cal trials for several other cancers, serious side effect of older atypical including mantle cell lymphoma. antipsychotics and can cause RCC accounts for about 85 per- patients to stop taking their medica- cent of all renal cancers. Patients tion. While bifeprunox has been with the most advanced form of the shown to have a smaller mean effect disease have a five-year survival rate in acute psychosis when compared of less than 20 percent. Recently, with older atypical antipsychotics, Wyeth reported data showing that HKI-272, also in Phase 2, is a cell it may be especially useful in patients who were treated with tem- signaling inhibitor that focuses on stabilized patients who need to be sirolimus alone experienced a 49 inhibiting tumor cell growth. This maintained on therapy over the percent increase in median overall agent targets a specific growth fac- long term because of its favorable survival time compared with tor receptor signaling molecule, metabolic profile. patients treated with interferon- HER-2, which is found on the sur- alpha alone. In addition to improv- face of some breast cancer cells. It is ing overall survival, Torisel being studied in advanced breast preserved a patient’s quality of life, cancer patients who have failed potentially helping treated patients standard therapy. Early clinical live longer and feel better. data from these very early and very small trials show encouraging Other Oncology Compounds patient responses, including shrink- in Development age of breast and lung tumors. CMC-544 or inotuzumab, Wyeth’s pipeline contains several currently in Phase 1, is using a novel innovative cancer compounds that approach called antibody-targeted are in the middle stages of develop- chemotherapy. Mylotarg, also from ment and are expected to advance to Wyeth, uses similar technology larger clinical trials. and currently is indicated for the SKI-606 or bosutinib, currently in treatment of acute myelogenous Phase 2, is a cell signaling inhibitor leukemia. CMC-544 initially is that targets critical growth path- being developed for treatment of ways in cancer cells that allow cells non-Hodgkin’s lymphoma. to divide. Clinical trial data thus far show activity in imatinib-resistant patients with chronic myelogenous 10
  • 13. Gastrointestinal Infectious Disease and Metabolic Vaccines Methylnaltrexone Tygacil Prevnar 13 (tigecycline) (13-valent pneumococcal Opioid analgesics, such as mor- conjugate vaccine) phine, are among the most widely Tygacil was launched on a global used medicines to treat patients with basis in 2005 for the treatment Since the introduction of Prevnar moderate to severe pain. However, of complicated skin and abdominal pneumococcal 7-valent conjugate their use often results in opioid- infections. Developed as an vaccine in the United States, the induced constipation or OIC, a expanded, broad-spectrum antibi- Centers for Disease Control and common and serious side effect that otic for patients with acute infec- Prevention estimates that invasive can be a barrier to effective pain tions who are admitted to a pneumococcal disease (IPD) management. The constipation can hospital, it offers a high likelihood addressed by the Prevnar serotypes be severe enough to require tempo- of effective treatment when the has been reduced 94 percent in rary discontinuation of the needed pathogen causing an infection is children and 55 percent in adults. opioids – thus leaving the patient unknown and, more important, In addition, the rate of antibiotic- with inadequate pain relief – or when certain resistant pathogens resistant IPD has decreased substan- surgical intervention. Every year, an are suspected. tially in infants and young children estimated 5 million patients suffer Tygacil also was developed to and in adults over age 65. from OIC in the United States alone. combat gram-positive resistant There currently is no approved bacteria, including resistant Staphy- medication that specifically targets lococcus aureus, and gram-negative the cause of OIC without interfering bacteria, including ESBL-producing with pain relief. Klebsiella pneumoniae. It represents Methylnaltrexone is a selective a new weapon in the global battle opioid antagonist being studied as against antibiotic resistance. a treatment to block the peripheral Wyeth is targeting an NDA side effects of opioid analgesics. filing for Tygacil in 2007 to include The drug is designed to reverse OIC community-acquired pneumonia, rapidly and consistently without hospital-acquired pneumonia and reversing analgesic effects or additional evidence of effectiveness inducing withdrawal symptoms. in the treatment of infections caused Methylnaltrexone is being by certain atypical pathogens. developed in subcutaneous and oral Hospital-acquired pneumonias are dosage forms as first-in-class treat- of particular importance because Building on this significant ment platforms for OIC. It also is of the relatively high rate of morbid- advance in public health, Wyeth is being developed in an intravenous ity and mortality associated with developing Prevnar 13, a 13-valent (I.V.) form for post-operative ileus, this condition. In addition, resistant pneumococcal conjugate vaccine that a potentially serious impairment of organisms are becoming more targets 13 strains of S. pneumoniae. gastrointestinal function that can prevalent in pneumonia, further This new vaccine currently is under- delay surgical recovery and prolong increasing the risk of mortality. going worldwide Phase 3 trials in hospitalization. both children and adults, with regu- Wyeth is developing methylnal- latory submissions expected to begin trexone in collaboration with in 2009. If approved, Prevnar 13 Progenics Pharmaceuticals, Inc. The would be the most complete vaccine companies plan to submit NDAs available for the prevention of pneu- for subcutaneous methylnaltrexone mococcal disease and otitis media in in early 2007, I.V. methylnaltrexone young children. For adults, Prevnar in late 2007 or in early 2008 and 13 is expected to extend protection to oral methylnaltrexone in late 2008 persons age 50 and older and to pro- or early 2009. vide them with long-term protection. 11
  • 14. THE WAR on Alzheimer’s “ ach morning, for more years than I wish to caregivers are added to the toll. Treatments cost E remember,” says Meryl Comer, a 62-year- the U.S. health care system more than $100 billion old award-winning broadcast journalist, annually. In the next 20 years, the number of “I reintroduce myself to my husband, Harvey. victims will increase sharply, with the potential to I say, ‘Good morning, love. My name is Meryl. bankrupt our health care system. “There are no I am your wife. We’ve been married for 25 years. cures, no remissions,” says former Speaker of Don’t worry. This is your home. And you are the U.S. House of Representatives and Center for safe.’ His eyes are blank, and mine fill with tears.” Health Transformation founder Newt Gingrich. Dr. Harvey Gralnick, once a leading researcher “You won’t meet an Alzheimer’s survivor because at the National Institutes of Health, has had there are none. The need for medical break- Alzheimer’s disease for 12 years. Meryl, his throughs never has been greater.” caregiver, has been suffering for just as long. Wyeth is on the leading edge of potential Dr. Gralnick is among 4.5 million Americans breakthroughs, having declared an all-out war with Alzheimer’s disease. In the United States, it on the disease. This special report introduces strikes one of every 10 people over age 65 and the faces of Alzheimer’s, the weapons being nearly half of those over age 85. About 18 million developed and the battles that still need to be people suffer worldwide – millions more when waged – and won. 12
  • 15. “Good morning, love. My name is Meryl. I am your wife …” 13
  • 16. Understanding the Enemy A Primer on Alzheimer’s Disease ne hundred years on ways to inhibit tangles, O after Alois though many scientists Alzheimer, a now believe that these German psychiatrist and form later in the disease neuropathologist, first process – perhaps driven characterized the plaques by the amyloid deposition. and tangles in the autop- Symptoms of sied brain of a victim Alzheimer’s disease of this crippling and ulti- include loss of memory – mately fatal degenerative first short term and disease, researchers eventually the ability to still are not fully certain remember the past or what causes Alzheimer’s create new memories; This photomicrograph shows the outermost layer of the brain of or exactly what the right difficulty in speaking and an Alzheimer’s disease sufferer. The red-colored accumulations are beta-amyloid plaques. strategy is to defeat it. reading; disorientation; “Alzheimer’s disease and, ultimately, loss of was widely misunder- capacity to dress, bathe secretase – cut this protein insoluble in some people stood for many years,” or perform what com- in certain ways, normal after six decades of being says Sid Gilman, M.D., monly are called activities amyloid transforms into fluid. The aggregation, professor and Chair of of daily living. Says beta-amyloid peptide. for whatever reason, leads the Department of Neu- Dr. Gandy: “Over time, It becomes sticky and to a misfolding of the rology at the University of all of the outside surface aggregates together in the protein. And once it takes Michigan and Director of of the brain, all of the brain. Eventually, these shape as what basically is the Michigan Alzheimer’s cerebral cortex – the part aggregates accumulate a bobby-pin-like structure, Disease Research Center that’s responsible for between the nerve cells in it becomes locked in that there. “As people aged, thinking – degenerates, parts of the brain respon- structure and accumulates, it was widely believed and patients die bed- sible for memory and forming amyloid plaques. that they simply lost their bound in a vegetative judgment. As that happens, you see memory. Today, some state.” Samuel Gandy, M.D., the characteristic lesions of physicians still think Joel Ross, M.D., has Ph.D., Chair of the Alzheimer’s disease.” memory loss is normal as been a practicing geriatri- National Medical The other you grow older. That’s cian and internist for the and Scientific abnormal pro- not so. You should retain past 20 years and has seen Advisory tein that your memory until you some 1,000 Alzheimer’s Council of the appears in die. Alzheimer’s is a dis- patients during that time. Alzheimer’s the disease is ease process, and aging is “Anger and depression Association, called tau, just one risk factor.” are common in early notes, “The which accu- What may be the disease. Psychosis is not amyloid mulates in primary culprit? Many unusual in later disease. peptide nor- the cells researchers believe it is the And the wandering we mally is found themselves, toxic form of a protein – sometimes see is a func- between nerve leading to the called amyloid precursor tion of disorientation cells in your tangles that protein – that appears and lack of memory.” blood or in your Dr. Alzheimer first naturally in small quanti- spinal fluid. The chal- saw. The tangles develop ties in our bodies. When lenge is why it becomes inside the nerve cells, two enzymes – gamma Left: This CT scan of a brain eventually killing them. shows the atrophy caused by secretase and beta Some drugs are focusing Alzheimer’s disease. 14
  • 17. “I would do anything to keep him Memory problems and confusion at his last job as a chemical salesman contributed to his employment being just the way he is today.” terminated in April 2005. Ted explains: “I made a lot of my sales calls by phone, but I couldn’t remember exactly what people had said to me after I hung up. I was taken June and Ted Roderick: They’re a Couple out of sales and put in other jobs. Was it fair? It’s hard to say.” J une and Ted Roderick are at the leading edge of the Ted finds humor a good defense mechanism. “Actu- baby boomer generation – a time when many think ally, it’s a good excuse if I don’t want to do something about retirement, new hobbies, vacation plans, grand- around the house. I can say, ‘I forgot.’ They’re the children. But June and Ted are too preoccupied for two words I use most.” But sometimes it’s hard. “June that. Ted, age 63, has Alzheimer’s disease and has had will arrive home and ask what I did during the day. it for at least six years. I know I did things, but I don’t know what they were. “We’re fortunate because Ted continues to function It’s frustrating.” at a high level,” his wife June says. “He’s still driving June says, “You take every day and appreciate what and can read short articles in the newspapers and you have. I would do anything to keep him just the magazines.” way he is today. We’ve been married 40 years. I hope Ted also can take apart a faucet and put it back we can continue the way we are. together and make screens for storm windows. He says, “We worry about losing each other,” she adds. “That’s “I feel more competent doing mechanical tasks than why we keep fighting and trying to do everything we mental things. I just forget stuff.” And he speaks ration- can to prevent the disease from getting worse. We won’t ally about his disease. “I can’t remember what I did stop. We do everything together. You see, we’re a couple. an hour ago or yesterday. It’s annoying, but, for now, And we want to stay a couple.” it’s not debilitating.” 15
  • 18. William Utermohlen, an American artist living in London, chron- icled the progression of his Alzheimer’s disease in a series of self-portraits, several Changes in personality Dr. Gandy says, a series of biomarkers, of which are shown also can include anxiety “the medicines or proteins, whose pres- here. The top painting, and apathy or even suspi- we have today ence in the blood or spinal completed shortly after he learned he had the ciousness, agitation or wear off and fluid may indicate the disease, is followed by delusion. With the passing aren’t effective. disease already is at work. others he created as of time, victims may lose They don’t “I would advocate the disease pro- their ability to swallow appreciably slow starting a therapy when gressed and affected his abilities and per- and eat solid foods or the progression amyloid is just beginning ceptions. Today, Mr. become incontinent. of the disease to be deposited – before Utermohlen resides in Often they die from the and don’t attack significant symptoms a nursing home and consequences of being the underlying occur,” adds Ronald Black, no longer paints. bedridden or sustaining pathology.” M.D., Senior Director, a physical injury, like a Most researchers Neuroscience Clinical broken hip. Many don’t now believe Development at Wyeth. at risk factors recover, in part, because toxic amyloid “That is the promise and treat at least a they can’t remember they and tau begin of prevention. It parallels decade in advance are sick or had an accident forming years treatment of breast of cognitive decline. and can’t understand before symptoms cancer: Detect and treat The reason for directions for therapies appear. So even at an early stage.” that length of time to help them get better. as researchers Wyeth is participating is because Mother “We believe there is begin to seek in the Alzheimer’s Disease Nature is very a genetic basis for this new treatments Neuroimaging Initiative, careful. There is so disease,” says Dr. Gilman. for Alzheimer’s, a five-year public/private much redundancy Having the gene called they are focusing partnership that has in the brain that Apolipoprotein E4 puts on how to diag- brought together industry, one has to lose one at greatest risk, often nose the disease academia and the National huge numbers of predisposing a person to at its earliest Institutes of Health to nerve cells before develop the disease sooner possible stages. validate biomarkers and symptoms develop.” rather than later. “If you The basic principle, develop new neuroimag- Standard psychologi- look at the universe of Dr. Gandy notes, “is to ing tools. cal testing, coupled with Alzheimer’s patients,” he target the disease before How do physicians imaging, is about 80 per- adds, “50 percent have permanent damage help patients when so few cent to 90 percent accurate the ApoE4 gene.” to neurons occurs. Part therapies are available? in diagnosing the disease Included among of the reason to target Among other things, and staging it – from mild known physical aspects amyloid is that it is felt “We encourage them to to moderate to severe. of the disease is the loss to accumulate early in participate in our clinical Diagnosis also includes of nerve cells that use the the disease cascade. Once trials for their own sake ruling out other possible neurotransmitter acetyl- there is an effective ther- and for the sake of others physical or psychological choline, a chemical that apy that treats early stages afflicted with this devastat- causes that may be more these cells use to commu- of the disease, the field ing disease,” Dr. Gilman treatable, such as severe nicate with each other. will try to identify patients says. “I tell them what depression, alcoholism, Nearly all the currently earlier and earlier. We they can expect next. thyroid malfunction, approved medicines target hope this information will I prepare them as best I brain traumas or stroke. this aspect of the disease. lead to prevention of can. At least today, we Scientists are making However, as Alzheimer’s Alzheimer’s by identifying have great hope for better progress toward develop- progresses and nerve patients most at risk.” treatments – more than ing simpler tests for the cells become impaired to Dr. Gilman agrees: ever before. This is the disease by identifying the point of degenerating, “It would be ideal to look dawn of a new age.” 16