IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`AMERICAN CYANAMID COMPANY
`
`(now, by change of name, Wyeth
`Holdings Corporation),
`
`Opposer,
`
`_ v.
`
`WALGREEN co.,
`
`Applicant.
`
`
`Opposition No. 91151771
`
`_ NOTICE OF DEPOSITION
`
`‘PLEASE TAKE NOTICE that, pursuant to Rule 30 (b) (c) of the Federal Rules of Civil
`
`Procedure and Rule 2.120 of the Trademark Rules of Practice, Opposer will take the trial
`
`testimony of Robert Amo, Senior Product Manager, Wyeth Holdings Corporation, upon oral
`
`examination at Wyeth, Five Giralda Farms, Madison, New Jersey 07940, commencing at 2:00 in
`
`the afternoon of October 19, 2004.
`
`You are invited to attend and exercise your right to cross examination.
`
`Dated: New York, New York
`October 13, 2004
`'
`
`Respectfully submitted,
`.
`FROSS ZELNICK LEHRMAN &
`
`ZISSU, P.C.
`
`By: mmu 1’. M
`
`. Marie V. Driscol
`
`,
`
`Attorney for Opposer
`866 United Nations Plaza
`New York, NY 10017
`(212)813-5900
`
`IN THE UNITED sTATEs PATENT AND TRADEMARK OFFICE
`BEFOR THE TRADEMARK TRIAL AND APPEAL 3 ARD
`
`AMERICAN cvANAM1o COMPANY (now. by
`change ofname, Wyeth Holdings Corporation).
`Opposer.
`-v-
`WALGREEN co,
`
`o .N .9us171
`'
`W °
`Applicant.
`OPPOSER DEPOSITION EHX.
`
`I
`
`

`
`0
`
`CERTIFICATE OF MAILING
`
`The undersigned hereby certifies that the Notice of Deposition is being served by
`
`facsimile and first class mail postpaid this 13”‘ day of October 2004, on App1icant’s attorney,
`
`Robert R. Delaney, Jr., Esq., Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015.
`
`Z1/Lfl':Ltl/(%’VL:JC&(:£”
`
`Marie V. Driscoll
`
`- I:\mdrisco|l\a.hpc\Wyeth v. Walgrecn\Notice of Deposition - A THRU Z - 04101.2-pz.doc
`
`

`
`
`
`Annual Report 2003
`
`IN THE UNITED STATES PA'I‘EN'I' AND TRADEMARK UH<'I(.‘E
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`AMERICAN CYANAMID COMPANY (now, by
`change ofname, Wyeth Holdings Cmporation).
`Opposer.
`.V _
`WALGREEN CO..
`
`Opp. No. 9! I5l77I
`
`Applicant.
`OPPOSER DEPOSITION EI-IX, 2
`
`In Ehg ]Lab@mm1r’y
`
`

`
`
`
`Contents
`
`On the Cover
`
`1 Message to Stockholders
`In the Marketplace
`5 Growth and Innovation
`In the Laboratory
`14 Growth and Innovation
`..
`c
`'
`'
`_.
`22 Wyeth’s Pipeline for Growth
`24 P“-“Cllml Prodllcts
`25 Financial Review
`73 Directors and Officers
`74 Corporate Dam
`Il.’>C Mission,Vision and Values
`
`i
`
`'
`
`Aienc White and her daughter
`’\"-"*"“_*'j‘P"“"’f""P*‘“°‘“—*"€3f“"“S
`'lwm'”'”"5"lpmplc W°rld“”de
`,ll_Hf_
`,,,
`_
`“ M Km I mm Wlerhs “mom
`rive products. David A. Roth, M.D.,
`is the Therapeutic Area Director
`for Hemophilia Clinical Research
`and Development in Cambridge,
`I\"l1ISS11ClIl|SCtl'S. He is one of the
`
`("O00 Wyeth Scientist‘ "ml Ieclml‘
`
`cians who work to bring new,
`innovative products to the market.
`
` .1»)!
`
`i~4.5%,!.:1.|.,wi*.\ %J
`
`..._.I... .
`
`—
`
`.
`
`,
`
`Wyeth at a Glance
`
`Wyeth is one of the world’s largest research—driven
`pharmaceutical and health care products companies. It is
`a leader in the discovery, development, manufacturing
`and marketing of pharmaceuticals, biotechnology products,
`vaccines and non—prescription medicines that improve
`the quality of life for people worldwide. The Company’s
`major divisions include Wyeth Pharmaceuticals, Wyeth
`Consumer Healthcare and Fort Dodge Animal Health.
`
`Financial Highlights
`
`Year Ended December 31,
`(In thousands except pershare amounts)
`
`Net Revenue
`
`$15,850,632
`
`Net Income before Certain Significant Items"‘
`
`3,258,937
`
`Diluted Earnings per Share
`before Certain Significant Items"‘
`
`Net Income
`
`Diluted Earnings per Share
`
`Dividends per Common Share
`
`Total Assets
`
`Stockholders’ Equity
`
`2.44
`
`2,051,192
`
`1.54
`
`0.92
`
`31,031,922
`
`9,294,381
`
`$14,584,035
`
`2,962,581
`
`2.22
`
`4,447,205
`
`3.33
`
`0.92
`
`26,042,592
`
`8,155,912
`
`“‘ For izI'c'/Itifiaztioiz (If-(‘(16/.7 azrmizz sigzzificmzr irenz occ//Wing i1120()3(md 2002, I'cfl’r to “.2003. 2002 am‘! 200/ Siglzi/ii‘i7III II('n2.<“ on /mgr’ ()3 wit/Jin ll/Imzagwnonts
`l)iscr15sionmza' Analysis o/'Fim1m‘inl Conditkm and Rcsulls of Opcmtimrs.
`
`I
`I
`
`I
`I
`
`4
`
`
`
`
`
`

`
`
`
`company. That’s an ambitious goal,
`
`and, in 2003, we made steady
`
`progress toward mal<ing this vision
`
`a reality. Through strong execution
`
`and a focus on opportunity through
`
`innovation, we achieved record
`
`sales and enhanced our potential for
`
`future growth.
`
`Being the best means delivering solid growth for the
`products that serve our patients and customers. This year,
`global net revenue reached an all—time high, and four of
`our pharmaceutical products — Effexor, Enbrel, Premarin
`and Protonix — each exceeded $1 billion in annual sales.
`At the same time, our consumer and animal health care
`businesses grew at double-digit rates.
`Being the best means producing first-in—class and
`best—in—class therapies that address significant unmet med-
`ical needs around the world. In 2003, we moved 12 novel
`compounds from the laboratory into the clinic. We also
`initiated late—stage clinical trials for three therapies that
`have the potential to be first in their class.
`Being the best means having values that endure and
`living those values every day. In 2003, we relied on the
`values that are Wyeth’s foundation: quality, integrity,
`respect for people, leadership and collaboration.
`
`Robert Essner, Chairman, President and
`Chief Executive Officer
`
`'
`
`We recognize that diet drug litigation remains a
`significant issue for our Company. We will continue to
`press for the appropriate handling of valid claims
`within the national settlement while rooting out any
`fraud and abuse.
`
`We have responded on many fronts to support our
`Premarin franchise. Our education efforts are helping to
`inform physicians and patients about the appropriate role
`of hormonal therapy, and the new, low—dose products we
`introduced in 2003 have offered new treatment options.
`We’re proud of our accomplishments in 2003. Our
`core products grew strongly, our people performed excep~
`tionally and we invested heavily in research to ensure an
`enduring future.
`
`Results of Gperations
`
`Wyeth’s worldwide net revenue in 2003 grew 9 percent
`to nearly $15.9 billion. Net income and diluted earnings
`per share increased 10 percent to $3.3 billion and $2.44,
`respectively, before certain significant items in both 2002
`and 2003. After taking these items, which are described
`below, into account, net income and diluted earnings per
`share decreased to $2.1 billion and $1.54, respectively,
`compared with $4.4 billion and $3.33, respectively, in the
`prior year.
`
`Message to Stockholders
`
`t Wyeth, our vision is to be the
`
`world’s best pharmaceutical
`
`

`
`
`
`In 2003, Wyeth recorded an after—tax charge of
`$1.3 billion to increase the reserve for diet drug litigation.
`The 2002 results included an after-tax charge of $910 mil-
`lion related to this litigation. In the first quarter of 2003,
`Wyeth recorded an after—tax gain of $559 million related
`to sales of the balance of our shares of Amgen Inc. that
`we received as a result of Amgen’s acquisition of Immunex
`Corporation in 2002.
`Wyeth’s 2002 financial
`results included after-tax
`
`sales by 39 percent to reach
`nearly $1.5 billion. Enbrel,
`the breakthrough biophar—
`maceutical for rheumatoid
`
`arthritis that Wyeth co-
`promotes in North America
`with Amgen and for which
`Wyeth has exclusive interna-
`tional rights, reached nearly
`$1.6 billion in sales. This
`
`represented a 70 percent increase compared with 2002,
`when supply constraints limited the availability of Enbrel
`to patients.
`Prevnar, our innovative vaccine for invasive pneumo-
`coccal disease, reached $946 million in sales, the largest
`annual volume ever recorded for a vaccine in the history
`of the pharmaceutical industry. Enhanced production
`capabilities led to this 46 percent increase, following
`a year in which sales decreased because of short—term
`manufacturing issues.
`Other highlights for Wyeth Pharmaceuticals:
`0 Zosyn (sold outside the United States as Tazocin), a
`broad—spectrum antibiotic used in more than 100
`countries to treat serious hospital—acquired infections,
`increased sales by 57 percent to $639 million.
`0 Altace, an anti—hypertensive that Wyeth co—promotes
`in the United States with King Pharmaceuticals, Inc.,
`delivered more than $200 million in alliance revenue.
`
`0 The CYPHER coronary stent generated $112 million in
`alliance revenue. This stent, made by a subsidiary of
`0 Johnson 56 Johnson, is coated with sirolimus, the active
`ingredient in Wyeth’s novel immunosuppressant,
`Rapamune. The device has been used to treat nearly
`500,000 patients in more than 80 countries.
`The Premarin family of hormone therapy products
`recorded sales of $1.3 billion, a decline from 2002. Also,
`the performance of FluMist was disappointing. Together
`with our partner Medlmmune, Inc., we are re—evaluating
`the future strategy for this product.
`
`Wyeth Research
`
`At Wyeth, we pride ourselves
`on many things. High on that
`list is our ability to discover,
`develop, manufacture and
`market medicines across three
`
`major areas: small molecules,
`the traditional source for most
`
`medicines today; biopharma—
`ceuticals, the products of
`genetic engineering that will
`
` i-up. my-«=-mu-«,
`
`
`
`
`gains of $2.6 billion related
`to sales of Amgen shares.
`In the fourth quarter
`of 2003, Wyeth recorded an
`after-tax special charge of
`$466 million to cover manu-
`
`facturing restructurings,
`asset impairments and costs
`related to the early extinguishment of debt. In 2002,
`Wyeth recorded an after-tax special charge of $234 million
`for restructuring and for other expenses related to cost-
`reduction programs.
`
`Wyeth Pharmaceuticals
`
`We’re fortunate at Wyeth. While other companies in the
`pharmaceutical industry are experiencing significant
`losses in sales and income from products at the end of their
`patent lives, most of our key products continue to enjoy
`patent protection. Among the major pharmaceutical com-
`panies, we have one of the lowest exposures to near—term
`patent expirations and generic competition.
`As a result, our core global brands continue to fuel our
`growth, ensure our stability and provide important
`resources for investing
`in our future. In 2003, nearly
`all of them performed
`strongly. We expanded the
`reach of these products,
`overcame several production
`issues and succeeded in
`
`,,«._-;.;;
`
`
`
`growing global net revenue
`for Wyeth Pharmaceuticals
`by 8 percent in 2003,
`exceeding $12.6 billion.
`Effexor, Wyeth’s novel antidepressant, achieved
`worldwide sales of $2.7 billion, an increase of 31 percent
`over 2002. Protonix, our proton pump inhibitor for the
`treatment of gastroesophageal reflux disease, increased
`
`

`
`
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`
`WCH’s sales outside
`the United States grew by
`22 percent in 2003, led by
`strong international sales of
`Advil and of the division’s
`
`two major nutritional sup-
`plement brands, Centrum
`and Caltrate. Worldwide,
`WCH ranked first in the
`
`nutritional supplement cate-
`gory, with sales exceeding $902 million in 2003. The
`Centrum family continued as the leading global brand
`in this category, with 2003 sales of approximately
`$546 million.
`
`Accelerating this pace of growth in the highly competi-
`tive OTC market requires expanding our portfolio. In
`addition to developing new proprietary products, we are
`increasing our international presence, creating novel
`product line extensions of leading brands such as the
`recently launched Robitussin Coug/oGels, and pursuing
`new Rx—to—OTC switch opportunities.
`
`Fort Dodge Animal Health
`Fort Dodge Animal Health has become an important
`contributor to Wyeth’s growth. In 2003, Fort Dodge
`increased its sales by 21 percent to $793 million, reversing
`two years of declines caused by weakness in the global
`animal health care market.
`1
`
`Fort Dodge is the number one veterinary vaccine man-
`ufacturer in the world. The division’s sales of vaccines and
`
`«*2
`
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`
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`
`other biological products exceeded $400 million in 2003.
`It also is a major
`manufacturer of animal
`parasiticides, such as its
`innovative ProHeart prod—
`ucts for the prevention of
`canine heartworm disease.
`Included among Fort
`Dodge’s key achievements
`during the year was the
`growth of its novel West
`Nile-Innovator vaccine, a
`first—in-class vaccine to aid in the prevention of West
`Nile disease in horses. The vaccine now has become
`
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`Fort Dodge’s largest selling product, with 2003 revenue
`increasing by 25 percent to $64 million. Continued strong
`growth is expected with the 2004 launch of extensions
`to the West Nile-Innovator product line that include pro-
`tection against other deadly equine diseases.
`
`give us the next wave of innovative therapies; and vaccines,
`which have become a subject of greater interest and grow-
`ing need in the past several years.
`Maintaining this diverse infrastructure requires a sig-
`nificant financial commitment. In 2003, Wyeth invested
`nearly $2.1 billion in research and development. These
`expenditures are critical and necessary for our future. They
`provide important tools to discover tomorrow’s break-
`throughs sooner and bring them to market faster. These
`investments are bearing fruit. Our pipeline is among the
`\
`strongest in the industry, our
`productivity in R&D keeps
`improving, and our strategy
`of developing first—in—class
`and best—in—class medicines
`'
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`.
`important therapies around
`the globe.
`In the past two years,
`36 new compounds have
`entered clinical development.
`Of these, nearly a third have advanced to Phase 2 clinical
`trials. And, in 2003, we filed 14 applications to begin
`clinical trials on therapies for
`Alzheimer’s disease, cancer,
`hepatitis C, neuropathic
`pain, thrombosis and other
`conditions.
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`I Wyeth Consumer
`I-Iealthcare
`
`One of Wyeth’s great assets
`is our global consumer
`health care business, which provides balance and diversity
`to our Company and important products to our cus-
`tomers. In 2003, Wyeth Consumer Healthcare (WCH)
`exhibited strong growth, delivering a sales increase of 11
`percent to $2.4 billion.
`Alavert, the first over—the—counter (OTC) competitor
`to Claritin®, was a significant contributor to that growth.
`In its first full year, Alavert captured 13 percent of the
`OTC market for non—sedating antihistamines, achieving
`sales of $82 million. In addition, the Advil family of
`ibuprofen—based products continued to grow steadily.
`The brand achieved global sales of $586 million in 2003,
`fueled by Advil Liqui—Gels, which grew 35 percent, and
`by Advil Allergy Sinus, which expanded the brand into
`the allergy segment of the OTC market.
`
`

`
`
`
`Inside Wyeth
`
`A number of changes took place at Wyeth this year.
`We made the Company a better place for our employees,
`welcomed new colleagues and said goodbye to others.
`On October 17, 2003, Wyeth Pharmaceuticals offi-
`cially opened its new global headquarters in College ille,
`Pennsylvania. The move to Collegeville allows Wyeth
`Pharmaceuticals to have key research and business func-
`tions in one location. This will facilitate communication
`
`and increase productivity.
`In January 2004, Wyeth announced the election
`of Robert Langer, Sc.D., to the Company’s Board of
`Directors. This election increases the number of Board
`
`members from 10 to 1 1. Dr. Langer is the Kenneth J.
`Germeshausen Professor of Chemical and Biomedical
`Engineering at Massachusetts Institute of Technology,
`and he brings to our Board a wealth of experience in the
`medical and scientific fields.
`
`In July 2003, Lawrence V. Stein was elected Senior
`Vice President and General Counsel. Mr. Stein succeeds
`Louis L. Hoynes, Jr., Executive Vice President and General
`Counsel, who retired after leading the Company’s Law
`Department for more than 12 years. We deeply appreciate
`Mr. Hoynes’ outstanding service and wise counsel.
`Additionally, Egon E. Berg retired as Vice President —
`Intellectual Property and Associate General Counsel ln
`February 2004.
`Douglas A. Dworkin joined Wyeth as Vice President
`and Deputy General Counsel effective January 2004.
`Also in January 2004, Gary L. Stiles, M.D., joined
`Wyeth Pharmaceuticals as Executive Vice President and
`Chief Medical Officer. In March 2004, Eileen M. Lach
`was elected Vice President of Wyeth in addition to her
`current positions as Corporate Secretary and Associate
`General Counsel.
`
`Driving Growth and Innovation
`
`Wyeth’s performance in 2003 was strong and steady. We’re
`proud of what we achieved in a challenging environment.
`Throughout the year, Wyeth clearly demonstrated that we
`have what it takes to succeed and to win.
`
`2003 was a good year not just for the Company
`but also for senior citizens in the United States. The
`
`enactment of a Medicare prescription drug benefit
`is an important milestone for the future of our country.
`While the new law poses challenges for Wyeth and for
`the entire pharmaceutical industry, it delivers improved
`access to affordable medicines for America’s seniors,
`
`which is a monumental achievement. The legislation also
`helps ensure that the pharmaceutical industry will retain
`its ability to fund research to produce the next genera-
`tion of groundbreaking therapies.
`Looking ahead, we believe Wyeth can continue to drive
`short—term growth with the core group of novel products
`we have introduced in recent years. As for the long term,
`our growth will depend on the depth and breadth of our
`research capabilities, on our pipeline of new products in
`various stages of development, and on improvements we
`have made for moving those products through the pipeline
`faster and with a greater assurance of success.
`In the future, we aim to bring two novel medicines
`to market every year. When we do that, we will have
`accomplished a great deal, not only for our stockholders
`but also for our patients. These new drugs will target
`conditions that are not adequately addressed by current
`treatments. People who suffer from terrible diseases
`urgently require these therapies. We’re going to do our
`best to provide them.
`Our employees have been tested over the past several
`years, and they have shown they are capable of delivering
`remarkable achievements. In the months and years ahead,
`Wyeth will do even more, even better, for the people we
`serve and the people we help as we work to become the
`world’s best pharmaceutical company.
`
`/2sé%62a,/
`
`Robert Essner,
`Chairman, President and
`Chief Executive Officer
`
`March 4, 2004
`
`

`
`

`
`

`
`
`
`Continued Expansion: Sales of Effexor grew by nearly
`
`31 percent in 2003 to $2 7 billion In addition to its initial
`
`approval for the treatment of depression Effexol has
`
`been approved in numerous countries for the treatment of
`
`generalized anxiety disorder and social anxiety disorder
`
`yeth’s antidepres-
`sant, Effexor, is
`the Company’s
`largest selling product. In
`2003, Effexor recorded
`global sales of approxi-
`mately $2.7 billion, ranking
`it among the top 20 phar-
`maceutical products in the
`world. Although Effexor —
`a selective serotonin and
`
`norepinephrine reuptake
`inhibitor — has been on the
`
`market since 1994, it con-
`tinues to grow strongly,
`with total sales increasing by
`nearly 31 percent in 2003.
`In 2004, global sales for the
`Effexor family are expected
`to exceed $3 billion.
`
`In the United States,
`which accounts for about
`
`75 percent of worldwide
`antidepressant sales,
`Effexor XR is among the
`fastest growing antidepres-
`sants on the market. In
`
`many international mar-
`kets, Effexor XR is growing
`at a rate two—to-three times
`faster than that of the over-
`
`all antidepressant market.
`Effexor XR is the most
`prescribed antidepressant
`
`in the United Kingdom,
`Brazil, Portugal, Greece,
`Ireland and Denmark.
`It is the second most
`
`prescribed antidepressant
`in Germany, Canada,
`Sweden, Australia, Poland,
`the Netherlands and
`Colombia.
`
`Effexor affects the
`level of serotonin and nor-
`
`epinephrine in the brain.
`These two important
`neurochemical transmit-
`
`ters are thought to play a
`key role in depression and
`related conditions. Analyses
`of studies have shown
`
`that Effexor achieves and
`maintains remission of
`
`symptoms in depression,
`demonstrating a better
`response than major
`antidepressants that only
`affect serotonin. In addi-
`
`tion, compared with other
`antidepressants, it has the
`longest average length of
`therapy and the lowest
`discontinuation rate.
`
`Initially approved in
`the United States for the
`
`treatment of depression,
`Effexor XR subsequently
`received approval for the
`treatment of generalized
`
`anxiety disorder (GAD)
`and for the short—term
`
`treatment of social anxiety
`disorder (SAD). Similar
`approvals have been granted
`in many other countries
`around the world.
`
`GAD, a condition that
`often coexists with depres-
`sion, is characterized by
`constant, exaggerated
`and uncontrollable worry
`that lasts for at least six
`months and interferes
`
`with daily life. GAD is
`experienced by an esti-
`mated 8 million people in
`the United States each year.
`Effexor XR is the only
`antidepressant on the U.S.
`market that is approved for
`the short— and long—term
`treatment of GAD. The
`
`product has been shown to
`be effective in improving
`and virtually eliminating
`the symptoms of both
`
`GAD and depression in
`many patients.
`SAD, another common
`psychiatric disorder in the
`United States, affects more
`than 10 million people in
`any given year. People with
`SAD have an extreme,
`constant fear of everyday
`social situations that
`
`severely disrupts their day-
`to—day functioning. They
`may avoid social situations
`because of intense self-
`
`consciousness in public
`and unreasonable fear of
`embarrassment.
`
`Wyeth continues to
`research additional indica-
`
`tions for Effexor XR.
`Phase 3 clinical studies are
`
`under way for Effexor
`XR’s use as a therapy for
`panic disorder, and a sup-
`plemental submission for
`the long—term treatment of
`SAD has been filed.
`
`Geographic expansion also
`is anticipated, including the
`expected launch of Effexor
`XR in Japan in 2008. I
`
`

`
`

`
`
`
`Accelerated Girowtlii: Global sales for Enbrel totaled nearly
`
`
`
`$1.6 billion in 2003, a 70 percent increase over 2002. Enbrel
`
`reduces the pain, swelling, joint stiffness and fatigue caused
`by rheumatoid arthritis, psoriatic arthritis and ankylosing
`
`spondylitis.
`
`
`
` patients in the United States
`
`are considered to have mod-
`
`these conditions and to stop
`further deterioration of the
`
`joints by blocking a type of
`protein called tumor necro-
`sis factor, a key trigger for
`the chain of events leading
`to inflammation.
`
`Regulatory approval
`was received in the United
`
`States during 2003 for a
`once—weekly dosing sched-
`ule. This new schedule will
`
`provide Enbrel patients with
`greater flexibility and dosing
`convenience. In addition, a
`regulatory application was
`submitted in the United
`
`erate to severe psoriasis.
`With the anticipated
`addition of the psoriasis
`indication, Enbrel sales are
`expected to accelerate over
`the next few years. The
`introduction of Erzbrel in
`
`Japan in 2004 also is
`expected to provide a
`substantial boost in sales
`
`performance. The comple-
`tion of Wyeth’s Grange
`Castle, Ireland, biopharma—
`ceutical manufacturing
`facility, scheduled for full
`operation in 2005, is
`expected to provide sub-
`stantial additional
`
`States and in the European
`Union for the use of Enbrel
`in the treatment of moderate
`
`manufacturing capacity to
`meet the growing global
`demand for Enbrel.
`
`to severe chronic plaque
`psoriasis. Approval of this
`application in the United
`States is anticipated in 2004.
`Psoriasis is an inflam-
`
`Wyeth co—promotes
`Enbrel in North America
`
`with Amgen and has exclu-
`sive international rights to
`the product. I
`
`matory disease affecting
`nearly 7 million people
`in the United States. It is
`
`characterized by chronic
`inflammation of the skin,
`which results in the forma-
`
`tion of red, itchy skin
`plaques that can be painful
`and disfiguring. An esti-
`mated 1 million psoriasis
`
`
`
`of their disease, 80 percent
`experienced no progression
`of joint damage and 51
`percent reported significant
`improvement in functional-
`ity after one year of therapy.
`This degree of response is
`remarkably better than the
`response typically seen in
`this field.
`
`Enbrel also is approved
`in the United States and
`
`Europe for the treatment
`of juvenile RA, psoriatic
`arthritis and ankylosing
`spondylitis, a type of
`arthritis of the spine. These
`diseases result when the
`
`body’s immune system
`attacks its own healthy
`cells, causing inflammation
`in the lining and connec-
`tive tissues of the joints.
`This leads to pain, swelling,
`stiffness and eventual joint
`damage. Enbrel helps to
`reduce the symptoms of
`
`nbrel recorded
`
`strong sales in 2003,
`following a year in
`which manufacturing limi-
`tations constrained supply.
`Through expanded pro-
`duction capacity, Enbrel
`achieved global sales of
`nearly $1.6 billion for the
`year, an increase of 70 per-
`cent compared with 2002.
`Enbrel treats moderate
`to severe rheumatoid
`
`arthritis (RA), a condition
`afflicting an estimated 6
`million people worldwide
`and about 2 million in the
`United States. Enbrel is
`
`indicated for reducing the
`signs and symptoms of
`the disease, inhibiting the
`progression of structural
`damage in the joints of
`early stage RA patients and
`improving physical func-
`tion in patients with
`moderately to severely
`active RA.
`
`A recent study of
`RA patients who received
`the combination of Enbrel
`
`plus methotrexate, another
`drug used to treat RA,
`showed dramatic results.
`
`Thirty—seven percent of
`the patients in this study
`achieved clinical remission
`
`

`
`

`
`
`
`Reflux ifiieliieii: Sales of Proton/"X, indicated for the treatment
`
`of gastroesophageal reflux disorder, grew 39 percent in 2003
`to nearly $1.5 billion. The efficacy of Protonix for nighttime
`
`GERD, which prevents many patients from getting a good
`
`night's sleep, has played an important role in its rapid growth.
`
`of a competitive PPI in
`2003 may impact the sales
`of branded prescription
`PPIs in the future, Protonix
`is expected to remain a
`growth product in 2004
`and beyond.
`Protonix works by
`blocking the production
`of stomach acid. It is indi-
`cated for the treatment
`and maintenance of heal-
`
`ing of erosive esophagitis
`and associated symptoms
`of gastroesophageal reflux
`disease (GERD). GERD
`occurs when the muscle
`between the stomach and
`
`esophagus is weakened
`or is too relaxed. This
`allows stomach acid to
`
`move up into the esopha-
`gus, a condition called acid
`reflux. Over time, acid '
`reflux can damage the lin-
`ing of the esophagus and
`cause sores, a development
`called erosive esophagitis
`or erosive GERD. If left
`
`rotonix, a proton
`pump inhibitor
`(PPI), is one of the
`fastest growing products in
`the highly competitive PPI
`market. In 2003, Protonix
`reached nearly $1.5 billion
`in sales ~ an increase of 39
`
`percent over the previous
`year. Launched by Wyeth
`in 2000 under license from
`
`ALTANA AG, Protonix
`surpassed $1 billion in
`sales after just three years
`on the market. This strong
`performance is ranked
`among the 10 most success-
`ful pharmaceutical launches
`of all time.
`
`Protonix is the only
`PPI available in both oral
`and intravenous formula-
`
`tions, a feature that has
`made it the leading PPI in
`the hospital market. In
`addition, Protonix has
`maintained a price advan-
`tage over other branded
`PPIs since its launch, giving
`the product a strong posi-
`tion in many managed
`care formularies. Although
`the launch of generic and
`over—the—counter versions
`
`,
`"“"“"> ///A4’//// .
`4%
`’-‘ '9*l//.'///////zv.;,/
`Gem-_—,y
`
`
`
`continued taking Protonix.
`In that study, 93 percent
`of people with erosive
`esophagitis were healed
`completely after taking
`Protonix for eight weeks.
`Another study among
`healed erosive GERD
`
`patients demonstrated that
`a large majority of these
`patients maintained heal-
`ing for a full year when
`they continued taking
`Protonix.
`Protonix also has
`
`been approved in the
`United States for the treat-
`
`ment of pathological
`hypersecretory conditions,
`including Zollinger—Ellison
`syndrome. These condi-
`tions are characterized by
`an oversecretion of stom-
`ach acid and can cause
`
`severe esophagitis. I
`
`untreated, erosive GERD
`can cause significant tissue
`damage.
`The persistent heart-
`burn and acid reflux
`associated with GERD
`
`can be very uncomfort-
`able, particularly at night.
`These symptoms may
`disrupt sleep and thus
`impair daytime alertness.
`The approved labeling
`for Protonix specifically
`describes its benefits for
`
`nighttime symptoms,
`and independent market
`research has shown that
`
`a majority of gastroen-
`terologists prefer Protonix
`to treat nighttime GERD.
`Medical studies have
`demonstrated the benefits
`
`of Protonix for daytime
`relief as well.
`
`In an eight—week clini-
`cal study among patients
`with erosive GERD, eight
`out of 10 people found that
`their nighttime heartburn
`disappeared and did not
`return as long as they
`
`
`
`11
`
`

`
`

`
`
`
`
`
`rezmar, a novel
`7—valent vaccine,
`targets diseases
`caused by Streptococcus
`przeumoniae, a major
`source of serious childhood
`
`illnesses such as bacteremia,
`septicemia, bacterernic
`pneumonia and meningitis.
`Worldwide sales of
`
`Prezmar totaled $946 mil-
`
`lion in 2003, a 46 percent
`increase over 2002 and
`
`the highest sales volume
`ever recorded for a vaccine
`
`in one year. Increased
`manufacturing capacity
`allowed Prez/nar sales to
`
`grow strongly in 2003, and
`Wyeth continues to make
`enhancements at every
`stage of the vaccine’s pro-
`duction process to help
`Preunar achieve its full
`
`commercial potential.
`Prezmar is expected to
`exceed $1 billion in sales
`in 2004.
`Prezmar has been
`
`approved in 65 countries.
`It has attained widespread
`acceptance in several
`major markets, including
`
`France, Spain, Portugal
`and Canada. Continued
`
`strong growth in the inter-
`national use of the vaccine
`
`is expected over the next
`few years.
`Prer/nar was launched
`
`by Wyeth in the United
`States in 2000 and is
`included in the U.S.
`Recommended Childhood
`Immunization Schedule
`
`published by the Centers
`for Disease Control and
`Prevention. Millions of
`
`infants and children have
`been vaccinated with
`Prez/nar. It is estimated
`
`that vaccination coverage
`in the United States has
`
`exceeded 90 percent in the
`infant population.
`Prior to the introduc-
`tion of Prermar in the
`
`United States, there were
`approximately 1 7,000
`cases of invasive pneumo-
`coccal disease reported
`every year in children
`under the age of five.
`
`isease Prevention: Nearly 4 million infants each year
`
`are vaccinated with Prevnarfor protection against invasive
`
`pneumococcal diseases such as bacteremia, septicemia,
`
`bacteremic pneumonia and meningitis. Studies have shown
`that infant vaccinations with Prevnar have reduced the
`
`occurrence of pneumococcal diseases in adults as well.
`
`invasive pneumococcal dis-
`ease rates decreased by 32
`percent for those in the 20-
`to—39—year—old age group
`and by 18 percent among
`those 65 years of age and
`older in the year following
`the commercial launch of
`Prei/nar in the United States.
`
`Development is
`under way to increase the
`number of pneumococcal
`serotypes in the vaccine
`to include those that are
`
`more prevalent in the
`developing world. Invasive
`pneumococcal disease is
`a significant global health
`problem that kills an
`estimated 1.2 million peo-
`ple each year. In addition,
`Wyeth is conducting Phase
`2 clinical trials to evaluate
`
`the potential for Prezmar
`to reduce the incidence
`
`of invasive pneumococcal
`disease in other at~risk
`
`populations. I
`
`Studies have shown that
`
`Prez/nar has significantly
`reduced the incidence of
`
`invasive pneumococcal dis-
`ease caused by the seven
`serotypes contained in the
`vaccine by as much as 95
`percent in infants less than
`two years of age in the
`study populations. Recently
`updated surveillance data
`from Northern California
`Kaiser Permanente — a
`
`major U.S. health care
`provider — underscored
`the efficacy of Prez/nar.
`The data showed that
`the incidence of invasive
`
`pneumococcal disease
`per 100,000 person—years
`in children under two
`
`years of age fell from a
`range of 51 to 98 in the
`pre—Pre1/nar years to zero
`in 2002 and 2003 after
`
`the vaccine gained wide-
`spread use.
`Other studies have
`
`shown that the immuniza-
`tion of infants with Prezmar
`reduced the incidence of
`disease in unvaccinated
`
`populations. One such
`study from the Centers for
`Disease Control and
`
`Prevention was published
`in 2003. It reported that
`
`13
`
`

`
`

`
`
`
`Improving Research Productivity
`
`he pharmaceutical
`research programs at
`Wyeth are focused
`on creating first—in—class
`and best—in—class therapies
`that address significant
`unmet medical needs.
`
`0 Twelve new compounds
`moved into development, up
`from an annual average of
`three just a few years ago.
`Fourteen Investigational
`New Drug (IND) applica-
`tions were filed with the
`
`To sustain growth and
`innovation in the face of
`
`U.S. Food and Drug
`Administration in 2003.
`
`intense competition and high 0
`development costs, Wyeth
`is striving to become the
`most productive research
`and develo