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Top 20 Pharmaceutical Companies Report

Our annual look at the 20 biggest players in the pharmaceutical marketplace

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By: Tim Wright

Editor-in-Chief, Contract Pharma

 
 

Rank Company
1 Pfizer, Inc.
2 GlaxoSmithKline, plc
3 Merck & Co.
4 AstraZeneca, plc
5 Bristol-Myers Squibb Co.
6
 Aventis
7
 Johnson & Johnson
8
 Novartis
9
 Pharmacia
10
 Wyeth
11
 Eli Lilly & Co.
12
 Abbott Laboratories
13
 F. Hoffman-La Roche
14
 Schering-Plough
15
 Takeda Chemical Industries
16
 Sanofi-Synthelabo
17
 Bayer AG
18
 Boehringer-Ingelheim
19
 Sankyo Co.
20
 Shionogi & Co.
For profiles of companies 6-20, please refer to the print edition of Contract Pharma.

1. Pfizer, Inc.

235 E. 42nd St.
New York, NY 10017-5755
Tel: (212) 573-2323 • Fax: (212) 573-7851
www.pfizer.com

Headcount 90,000  
Year Established 2000  
Pharmaceutical Revenues $25,518 13%
Total Revenues $32,259 10%
Net Income $7,788 109%
R&D Budget $4,847 9%


Drugs Approved/Launched

Drug Indication
Geodon antipsychotic/oral dosage
Zithromax middle ear infection
Bextra COX-2 inhibitor
Zyrtec-D 12 hour allergy
Zoloft post-traumatic stress
Vfend antifungal
Estrostep moderate acne in women


Drugs Pending

Drug Indication
Zoloft pediatric depression
Spiriva COPD
Zyrtec pediatric
Neurontin neuropathic pain
Relpax migraine
Cardura XL enlarged prostate


Drugs in Phase IIb and Beyond

Drug Indication
darifenacin overactive bladder
pregabalin neuropathic pain, epilepsy, GAD
Viagra female sexual arousal disorder
Zoloft dysthymia/social anxiety
Aricept vascular dementia
Geodon mania
capravirine HIV
lasofoxifene osteoporosis


Early Research Projects


Drug Indication
CP-529,414 cholesterol
UK-338,003 enlarged prostate
UK-369,003 erectile dysfunction
CP-526,555 smoking cessation
CP-122,721 antidepressant


Top Selling Drugs


Drug Indication $ (+/- %)
Lipitor cholesterol $6,449 28%
Norvasc antihypertensive $3,582 7%
Zithromax antibiotic $1,506 9%
Diflucan antifungal $1,066 5%
Zoloft antidepressant $2,366 11%
Neurontin epilepsy $1,751 31%
Viagra erectile dysfunction $1,518 13%
Zyrtec allergy $990 42%
Celebrex* rheumatoid arthritis $1,379 19%
Aricept* Alzheimer’s disease    
* Listed as Alliance Revenue, shared with Pharmacia and Eisai, respectively.
Account for 81% of total pharma sales, up from 77% in 2000.


Pfizer chairman and chief executive officer Henry A. McKinnell, Ph.D.
Key Personnel

Henry A. McKinnell, Ph.D.
chairman, chief executive officer

John F. Niblack, Ph.D.
vice chairman, president – Pfizer Global R&D

Karen L. Katen
executive vice president, president – Pfizer Pharmaceuticals Group, president – U.S. Pharmaceuticals

David L. Shedlarz
executive vice president, chief financial officer

Peter B. Corr, Ph.D.
senior vice president, executive vice president – Pfizer Global R&D, president – Worldwide Development

Jeffrey B. Kindler
senior vice president, general counsel

George M. Milne, Jr., Ph.D.
senior vice president, executive vice president – Pfizer Global R&D, president – worldwide strategic and operations management

Peter C. Brandt
vice president, senior vice president, finance, planning, business development and Pfizer Health Solutions – Pfizer Pharmaceuticals Group

Joseph M. Feczko, M.D.
vice president, senior vice president, Medical and Regulatory Operations – Pfizer Pharmaceuticals Group

Gary N. Jortner
vice president, senior vice president, product development – Pfizer Pharmaceuticals Group

J. Patrick Kelly
vice president, senior vice president, worldwide marketing – Pfizer Pharmaceuticals Group

John L. LaMattina, Ph.D.
vice president, executive vice president, Pfizer Global R&D, president – worldwide research

John W. Mitchell
vice president, president – Pfizer Global Manufacturing


Highlights

Congratulations are due to Pfizer for moving past Glaxo-SmithKline to reach the #1 spot in this year’s Top Companies, in addition to placing Lipitor in the top spot for worldwide sales. After integrating with Warner-Lambert in one of 2000’s major mergers, Pfizer posted revenue growth of 13% to hit $25.5 billion in pharmaceutical sales in 2001. Sales were driven by an astounding 28% increase in Lipitor sales, reaching nearly $6.5 billion. In total, the company had seven drugs earn more than $1.0 billion in sales last year, with Zyrtec right behind at $990 million. In addition, the company derived $1.4 billion in alliance revenue for Celebrex and Aricept.

“Over the next three years, we project industry-leading earnings growth,” said Henry A. McKinnell, Ph.D., Pfizer’s chairman and chief executive officer. “We are confident of our ability to support a strong and expanding product portfolio that will sustain our position at the top of the global research-based pharmaceutical industry.” Dr. McKinnell replaced William C. Steere, Jr., as chairman, following Mr. Steere’s retirement in April 2001.

To achieve this pace, Pfizer plans to file 15 NDAs from 2001 to 2006. The company is already headed toward its next set of drugs with the May 2002 approval for Vfend, an antifungal drug that was first filed in late 2000. FDA rulings on Spiriva, a chronic obstructive pulmonary disease drug co-developed with Boehringer-Ingelheim, and Relpax, a new migraine drug, are also pending. In addition, Pfizer and Pharmacia received approval in 2001 for their co-marketed Bextra, a followup to the $2+ billion Celebrex.

Dr. McKinnell remarked, “Pfizer is in the enviable position of being able to sustain both an industry-leading research and development capability and the position of ‘partner of choice’ in the pharmaceutical business. We can drive growth through our own innovation and present a compelling case to those who seek alliances to develop, manufacture or market their products or services.”

Pfizer plans to maintain this status with an intensive R&D program. In June 2001, Pfizer opened the doors to the new headquarters of Pfizer Global R&D in New London, CT. The $294 million, 750,000-sq.-ft. site can house as many as 2,100 highly skilled employees. It also includes a child care facility; a cafeteria seating 550; a credit union; a fitness center; parking for 1,790 cars; a helipad; and a ferry dock for employees commuting between Pfizer’s Groton laboratories and the New London R&D headquarters.

In May 2002, PGRD followed up by opening a new research center in La Jolla, CA. Pfizer La Jolla includes eight buildings, which will eventually cover 800,000 square feet. Three buildings are already occupied and the others will the completed by 2004. In the last two years, Pfizer has invested $155 million in La Jolla.

More than 1,000 scientists will work at the site in a broad range of discovery disciplines including pharmaceutical sciences, analytical chemistry, medicinal chemistry, X-ray crystallography, high throughput screening, chromatography, pharmacology, pharmacokinetics, dynamics and metabolism and drug safety evaluation.

Pfizer does face some uncertainty in its R&D operations, since vice chairman John F. Niblack, president of PGRD, announced in June 2002 that he will retire on September 1. The company named three senior executives to oversee its global research, development and technology alliance efforts as part of a new organizational structure. Dr. Peter Corr has been named senior vice president of science and technology. In his new position, he will have overall responsibility for PGRD as well as the licensing and development and science policy functions.

Dr. John LaMattina has been named vice president, Pfizer Inc., executive vice president of PGRD, and president of Worldwide Research and Technology Alliances. He will assume the additional responsibility of managing the more than 500 external R&D alliances that Pfizer has with biotech companies, technology companies and universities.

Dr. Joe Feczko will become vice president, Pfizer Inc, executive vice president of PGRD and president of Worldwide Development, a new position that brings together all of the company’s major drug development activities. Both Dr. LaMattina and Dr. Feczko will report to Dr, Corr.

“This new PGRD leadership will give us industry-leading capabilities at every stage of the R&D process and beyond,” said Dr. McKinnell. John Niblack joined the company in 1967 as a molecular biologist. He managed the late-phase development and regulatory filings for many of the industry’s most successful medicines, including Norvasc, Zoloft, Zithromax, Diflucan, and Viagra.

Pfizer also has its share of legal issues to contend with. In addition to patent challenges on many of its best-selling drugs (Zoloft, Celebrex, Neurontin, Diflucan and Glucotrol XL, among others), the company is also facing a bevy of lawsuits connected to the marketing of diabetes drug Rezulin. Connected to more than 60 deaths in the U.S., the drug was pulled off the market in early 2000.

In December 2001, a Texas jury hit the pharma giant with a $43 million verdict, for a woman who claimed the drug destroyed her liver. In March 2002, an Oklahoma jury awarded $11.5 million to the family of a man who took Rezulin and died of liver failure. Pfizer has appealed both cases. Other suits were settled, and in some cases (Rockville, MD and Houston, TX), juries found the company not liable for some Rezulin users’ deaths.

There are more than 2,300 legal claims currently filed against Pfizer because of Rezulin. Pfizer has successfully kept the lawsuits in California and West Virginia from reaching class action status.

Also, in December 2001, Pfizer received an FDA warning letter about its Terre Haute, IN, manufacturing facility. The site manufactures several aseptic products, including: Cefobid, Permapen Isojects, Pfizerpen G and Unasyn. Pfizer had no pending applications for new products to be manufactured at this facility.

The FDA letter made 31 specific observations at the facility. “Pfizer is taking this matter very seriously and we are providing a full and detailed response to all of the issues raised by the FDA,” said John Mitchell, Pfizer vice president and president of Pfizer global manufacturing. “We believe that we will be able to resolve these issues expeditiously and that they will not have any impact on current or anticipated new product filings.”


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2. GlaxoSmithKline, plc

Berkeley Ave.
Greenford, Middlesex
UB6 0NN,UK
Tel: (44) 020 8966 8000 • Fax: (44) 020 8966 8330
www.gsk.com

Headcount 100,000+  
Year Established 2000  
Pharmaceutical Revenues $24,775 5%(+9% based on UK currency)
Total Revenues $29,504 7% (+11% based on UK currency)
Net Income $4,405 -29% (-26% based on UK currency)
R&D Budget $3,817 1%

Drugs Approved/Launched

Drug Indication
Advair respiratory
Paxil generalized anxiety disorder
Coreg severe heart failure
Twinrix hepatitis A/B
Augmentin ES ear infections


Drugs Pending

Drug Indication
vardenafil erectile dysfunction
Compound 908 HIV
Ariflo chronic obstructive pulmonary disease
Lamictal bipolar disorder
Wellbutrin XL depression


Drugs in Phase IIb and Beyond

Drug Indication
Ziagen/Epivir HIV
Valtrex herpes
Natrecor acute heart failure
LAPDAP malaria
ibandronate postmenopausal osteoporosis
Imigran/Imitrex migraine
Hycamtin cancer


Early Research Projects

Drug Indication
SB281832 rheumatoid arthritis
SB408075 colorectal/pancreatic cancer
GW468816 smoking cessation
GI181771 obesity
SB207266 atrial fibrillation
SB249417 sepsis/septic shock


Top Selling Drugs


Drug Indication $ (+/- %)
Paxil CNS $2,670 11%
Augmentin antibacterial $2,050 8%
Flovent respiratory $1,320 2%
Seretide/Advair respiratory $1,220 new
Imitrex CNS $1,090 -1%
Avandia diabetes $1,020 45%
Wellbutrin CNS $932 36%
Serevent respiratory $929 -2%
Combivir antiviral $872 2%
Zofran oncology/emesis $865 16%
Account for 52% of total pharma sales, up from 45% in 2000.


Key Personnel
GlaxoSmithKline chairman Sir Richard Sykes (left) and chief executive officer J.P. Garnier

J.P. Garnier
chief executive officer

Sir Richard Sykes
chairman

Bob Ingram
chief operating officer, president pharmaceutical operations

Rupert Bondy
senior vice president, general counsel

John Coombe
chief financial officer

James Palmer
senior vice president, new product development, pharma R&D

Dan Phelan
senior vice president, HR

Howard Pien
president, pharmaceuticals international

David Stout
president, U.S. pharmaceuticals

Tim Tyson
president, global manufacturing &supply

Chris Viehbacher
president, pharmaceuticals Europe

Tachi Yamada
chairman, R&D

Jennie Younger
senior vice president, corporate communications

Jack Ziegler
president, consumer healthcare

Highlights
No big merger for GlaxoSmithKline in 2001, but don’t be surprised to find Bristol-Myers Squibb’s initials added to the alphabet soup of GSK. Rumor has it that the #2 pharmaceutical company (based on pharma revenues) is angling to snap up B-MS. I doubt that GSK would make the acquisition solely to regain that coveted top spot on the Contract Pharma list, but stranger things have happened in this industry. Just look at Martha Stewart . . .

In January 2001, GSK completed its acquisition of Block Drug Co., a consumer healthcare company best known for its Sensodyne toothpaste brand, for $1.2 billion. The acquisition is expected to add approximately $900 million to GSK’s over-the-counter business, placing it around $5 billion annually. Block Drug employed nearly 3,000 people in R&D, sales and marketing, manufacturing, and distribution. Chief executive officer Jean-Pierre Garnier commented, “The Block Drug acquisition will significantly enhance our consumer healthcare business, putting GSK among the top three consumer healthcare companies in the world, and number two in oral healthcare.”

Still, 2001 was essentially a rebuilding (or, better yet, consolidating) year for GSK, as it worked to organize its two major parts, GlaxoWellcome and SmithKlineBeecham. In March 2002, Sir Richard Sykes, GSK’s chairman, decided to retire from his post. Sir Christopher Hogg was named to replace him. Sir Richard said, “Having overseen the successful merger of GSK and as I approach my 60th birthday, I feel now is the time to depart. I wish to devote my time and energy to my role as Rector of Imperial Col-lege and leave GSK in great shape for the future.”

As for the future, GSK proposed a series of shutdowns and cutbacks at several of its sites, to facilitate the integration of the two businesses. The company is considering closing down a facility in Liverpool that manufactures CFC-containing asthma inhalers, laying off 500 workers. Also, some operations at the Barnard Castle site in County Durham have become redundant because of overlap. The company may fire as many as 400 workers in the next three years. GSK may sell off its Montrose, Angus site, which manufactures bulk actives and employs 720. Also, GSK plans to shut down several Block sites, firing approximately 550 people.

Tim Tyson, GSK’s president of global manufacturing and supply, remarked, “These proposals follow a detailed review that examined every aspect of our site network, and implementing them would significantly reshape and improve our manufacturing business.” Mr. Tyson added that GSK stood firmly by its UK employees, stating that one-quarter of the company’s total workforce was UK-based, with 40% of its R&D taking place in that country. “The UK remains a core location for the GlaxoSmithKline manufacturing network,” he said.

By next year, the company expects to deliver merger-related and pre-merger manufacturing restructuring savings of $2.6 billion. The company plans to put $365 million of that back into R&D, supplementing its 2001 R&D budget of $3.8 billion.

R&D spend is paying off for GSK, as the company is planning a series of regulatory filings for 2002, including an HIV drug, Ariflo for chronic obstructed pulmonary disease, ibdandronate for post-menopausal osteoporosis (to be filed by Roche), Lamictal for bipolar disorder, and Wellbutrin XL for depression. GSK Biological received approval for Twinrix, the first combination hepatitis A&B vaccine, in May 2001. But some analysts contend that the bulk of GSK’s pipeline remains in early development, and we all know how difficult it is to project regulatory approvals.

In fact, GSK and partner Corixa Corp. received a review letter from the FDA for their non-Hodgkin’s lymphoma drug Bexxar, requesting additional data before considering approval. The companies requested a formal meeting with the FDA to discuss the review, but haven’t commented on the results of that get-together. The companies had hoped for fast track review of the drug.

GSK’s biggest headlines recently have been made in the courtroom, where the company lost a major battle for the U.S. patent rights to Augmentin, its $2.0 billion antibiotic ($1.4 billion in U.S. sales). In May 2002, a federal district court ruled that GSK’s U.S. patents for the drug are invalid, and will expire in June, July and December of this year. GSK has argued that the patents should apply through 2017 and 2018.

The three companies challenging GSK are Geneva Pharmaceuticals, Teva Pharmaceuticals and Ranbaxy. A spokesman for Ranbaxy said, “Barring any unforeseen circumstances . . . we fully expect to launch in December 2002.” He added: “We are going to wait for the legal process to conclude.” The other companies in the case launch competing products earlier than that. Geneva already has U.S. approval for its generic form, and Israel-based Teva plans to get approval very soon.

The company is appealing the ruling, and plans to sue for lost damages if it wins the case after generic versions of Augmentin have reached the marketplace. Augmentin is already off patent in Europe, where cheap generic versions are available.

In 2001, GSK launched Augmentin ES, a pediatric version of the drug intended to treat antibiotic-resistant ear infections. The company also filed an sNDA for Augmentin XR, an extra-strength version of the drug for adults, but received a non-approval letter from the FDA in December 2001. GSK is working to provide more data demonstrating the bacteriologic efficacy of the drug in treatment of patients with respiratory tract infections of penicillin-resistant strep.

In recent years, court cases have nullified some patent protection for GSK antidepressant Wellbutrin, and the patents for the Paxil powerhouse have been challenged in court since 1998. Paxil’s patents begin expiring in 2006, although that remains a point of contention.

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3. Merck &Co.


One Merck Dr.
P.O. Box 100
Whitehouse Station, NJ 08889-0100
Tel: (908) 423-1000
www.merck.com

Headcount 78,100  
Year Established 1891  
Pharmaceutical Revenues $20,456 10%
Total Revenues $47,715 18%
Net Income $7,282 7%
R&D Budget $2,456 5%


Drugs Approved/Launched

Drug Indication
Cancidas antifungal
Invanz antibiotic


Drugs Pending

Drug Indication
Zetia cholesterol


Drugs in Phase IIb and Beyond

Drug Indication
Arcoxia COX-2 inhibitor
Singulair allergic rhinitis
rotavirus vaccine rotavirus
HPV vaccine HPV
KRP-297 diabetes
MK-869 chemotherapy-induced emesis


Early Research Projects

Drug Indication
HIV vaccine HIV


Drugs Coming Off Patent

Drug Date
Prilosec 2002?
Prinivil 2002
Prinzide 2001
Mevacor 2001
Vaseretic 2001


Top Selling Drugs

Drug Indication $ (+/- %)
Zocor cholesterol $6,700 26%
Vioxx osteoarthritis/ acute pain $2,600 18%
Cozaar/Hyzaar high blood pressure $1,900 12%
Fosamax postmenopausal osteoporosis $1,800 38%
Singulair asthma $1,400 63%
Account for 70% of total pharma sales, up from 61% in 2000.


Key Personnel
Merck chairman, president and chief executive officer Raymond V. Gilmartin

Raymond V. Gilmartin
chairman, president, chief executive officer

Judy C. Lewent
executive vice president, chief financial officer

David W. Anstice
president, Human Health – the Americas

Paul R. Bell
president, Human Health – Asia Pacific

Kenneth C. Frazier
senior vice president, general counsel

Edward M. Scolnick, M.D.
executive vice president, science and technology, president, Merck Research Laboratories

Bernard J. Kelley
Merck Manufacturing Division

Per Wold-Olsen
president, Human Health – Europe, Middle East, Africa

Bradley T. Sheares, Ph.D.
president, U.S. Human Health

Adel Mahmoud, M.D., Ph.D.
president, Merck Vaccines


Highlights

No company faced more critical patent expirations recently than Merck. In 2001, the company lost patent protection for Prilosec (for which it only has U.S. rights and otherwise supplies to AstraZeneca), Mevacor and Vaseretic, the latter of which it recently sold to Biovail. HIV drug Prinivil expired last month. In 2000, it lost Vasotec and Pepcid. So how has Merck gone about replacing these drugs and their diminishing revenues? The company planned on making a splash with a pair of new drugs, Cancidas (antifungal) and Invanz (antibiotic), as well as boosting sale for its COX-2 inhibitor, Vioxx. Given that Merck was in the midst of the most successful period in its history, with 17 new drugs introduced since 1995, the company had reason to be optimistic.

In addition to Invanz and Cancidas, the company is also hoping to receive FDA approval for Zetia, a cholesterol drug co-developed with Schering-Plough, and Singulair, a treatment for allergic rhinitis. In order to market these drugs, and enhance the positions of existing franchises, Merck added more than 1,000 sales reps in 2001, with plans to add 500 more this year.

However, the past year was not kind to Merck. The entire COX-2 class of drugs produced lower-than-expected revenues as questions began to arise about possible cardiovascular side effects.

In May 2002, the company announced that it was withdrawing the NDA for Arcoxia, its next-generation COX-2 drug. Merck has decided to add efficacy data to the application, as well as an additional indication for the drug, in hopes that this will position it more strongly in the growing COX-2 field, which is led by Pharmacia and Pfizer’s jointly marketed Celebrex and newly released Bextra. Arcoxia was already approved in the UK and is prescribed there for a number of indications.

Some suspect Merck of dissembling, claiming that the new indication the company seeks, ankylosing spondylitis, affects too small a percentage of the population to make a significant impact on Arcoxia’s results. Conjecture is that Merck is withholding the drug while it conducts trials to ascertain the cardiovascular risk associated with this class of drugs. The new application will likely be filed in the first half of 2003.

In addition to patent expirations and COX-2 woes, Merck also created waves with its January 2002 announcement that it will spin off its Merck-Medco pharmaceutical benefits management (PBM) business. The unit, acquired in 1993, has risen from $2.2 billion in revenues to $26.4 billion in that time (while its Internet division became the fist e-PBM to reach $1.0 billion in sales), but analysts contend that its thin margins left it contributing little to Merck’s bottom line.

In his announcement, chairman and chief executive officer Raymond V. Gilmartin, commented, “It is clear that Merck-Medco is a much different company than it was nine years ago, and the environment in which it operates has also changed dramatically. Given the evolution of the distinct and highly competitive environments in which Merck and Merck-Medco operate, we believe the best way to enhance the success of both businesses going forward is to enable each one to pursue independently its unique and focused strategy.”

He added, “This transaction will allow Merck to focus more fully on its priorities of turning cutting-edge science into breakthrough medicines and supporting them through targeted and well-executed marketing. In addition to investing behind our internal pipeline, our efforts also will include a continuing, intense focus on the entire spectrum of product licensing—from early- to late-stage opportunities—as well as targeted acquisitions. We also believe that providing investors with ‘pure plays’ in the pharmaceutical and PBM businesses, respectively, will allow full valuation of both businesses.”

Merck has stuck to its guns with its strategy of avoiding Big Pharma mergers. While others have been bandied about as potential suitors for Bristol-Myers Squibb and Wyeth, Merck’s name has avoided the rumor mills. The company’s main acquisition in 2001 was Kirkland, WA-based Rosetta Inpharmatics, an informational genomics company. The company contends that Rosetta’s technology and research capabilities will enhance both basic discovery and preclinical screening.

At a recent shareholder meeting, Mr. Gilmartin remarked, “By focusing on the long-term growth of the business, rather than short-term fixes, we expect to deliver double-digit earnings per share growth in the core pharmaceutical business in 2003 and top-tier performance over the longer term,” perhaps taking a dig at some of his competitors who contemplate yet another major acquisition as a means of enhancing a thin drug pipeline.

Enhancing its position as an R&D stronghold, Merck broke ground in October 2001 on its new drug discovery facility in Boston. The site, scheduled to open in 2004, will house 300 scientists in close proximity to a number of major research institutions.

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4. AstraZeneca, plc

15 Stanhope Gate
London W1K 1LN
UK
Tel: (44) 00 7304 5000 • Fax: (44) 020 7304 5151
www.astrazeneca.com


Headcount 54,000  
Year Established 1999  
Pharmaceutical Revenues $16,480 4%
Total Revenues $16,480 -9% *
Net Income $2,484 54%
R&D Budget $2,700 4%
* 2001 revenues excludes agro, fine chemicals


Drugs Approved/Launched

Drug Indication
Casodex prostate cancer


Drugs Pending

Drug Indication
Crestor cholesterol
Arimidex breast cancer
Faslodex breast cancer


Drugs in Phase IIb and Beyond

Drug Indication
Exanta thrombosis
Merrem anti-infection
Atacanda hypertension
Iressa solid tumors


Early Research Projects

Drug Indication
AR-H047108 peptic ulcer, acid reflux
AZD7545 diabetes
ZD9331 solid tumors
D5522 rhinitis
AZD9056 rheumatoid arthritis
NAD-299 anxiety/depression


Top Selling Drugs

Drug Indication $ (+/- %)
Losec/Prilosec peptic ulcer/acid reflux $5,684 -9%
Zestril hypertension $1,097 -8%
Pulmicort asthma $775 10%
Zoladex oncology $728 -1%
Seloken hypertension $722 25%
Seroquel anti-psychotic $700 65%
Nolvadex breast cancer $630 9%
Nexium peptic ulcer/ acid reflux $580 first full year
Casodex prostate cancer $569 31%
Account for 72% of total pharma sales, up from 71% in 2000.


Key Personnel

Tom McKillop
chief executive officer

Bruno Angelici
executive vice president, international sales and marketing

David Brennan
executive vice president, North America and president and chief executive officer, AstraZeneca LP

John Patterson
executive vice president, product strategy and licensing;

Barrie Thorpe
executive vice president, operations

Tony Bloxham
executive vice president, human resources


Highlights
A recent Datamonitor study (New Generation of Blockbusters: Pipeline Potential 2002-2008) contends that AstraZeneca is leading the way in Big Pharma R&D, with potential for $7.2 billion in sales by 2008 from three currently unapproved products. This is great news for AZ, which is battling to retain some form of patent protection for its biggest seller, Prilosec. Considering that Prilosec was also the top selling drug in the world in 2000, the stakes are high.

Prilosec’s status will be decided in court, possibly by the end of the summer. Two companies claiming generic rights have actually been awarded “co-exclusivity” to sell a generic version of Prilosec. However, AZ has mounted a legal challenge to one of the patents, and neither generic company is willing to risk the losses they would incur were they to begin selling generic Prilosec and then lose the technical patent case. If AZ wins the pending case, it can hold onto Prilosec exclusively for another five years.

A new twist entered the Prilosec case this June, when Procter &Gamble asked an FDA panel to move Prilosec to over-the-counter status. If P&G wins out, AZ would gain royalties from OTC sales. OTC Prilosec would be cheaper than AZ’s version or that of a generic, but the volume of OTC sales could make it a less damaging move to AZ’s bottom line.

In addition, the company’s #2 drug, Zestril, is also facing patent expiration. The FDA granted AZ an additional six months of patent protection for Zestril in December 2001, following the company’s submission of pediatric trial data relating to the drug. (We’re not sure why the FDA wants children to take a drug to treat hypertension, but that’s their business . . .)

Anticipating the loss of Prilosec, AZ began pushing its next-generation proton pump inhibitor, Nexium, last year. In its first full year, Nexium reached $580 million in sales and received 16% of new prescriptions in its market. Another recent release, Symbicort, reached $83 million in sales in limited release.

AZ’s top prospect for blunting the loss of Prilosec’s revenue is Crestor, a cholesterol drug that is projected to reach nearly $3 billion in sales by 2005 (or $6 billion by 2006, according to one optimistic analyst). In June 2002, AZ received an approvable letter from the FDA for Crestor, but didn’t publish the details of it. This led to some panic among analysts and shareholders that the FDA would only approve a limited dosage form (5 mg, possibly) for the drug.

“It’s good news that Crestor is approvable. But what we don’t know is whether it’s fairly good news or very good news,” said Peter Cartwright, an analyst at Williams de Broe. AZ contended that Crestor may still be launched in the U.S. by the end of the year.

The late-stage pipeline is strong for AZ, but that doesn’t mean there aren’t more hurdles ahead. In June 2002, AZ received a ‘not approvable letter’ from the FDA for its sNDA for Casodex (150mg) for the treatment of non-metastatic prostate cancer. The letter doesn’t impact the current use and approval of Casodex’s 50mg formulation for advanced prostate cancer treatment.

“Having failed to reach consensus with the FDA as to the most appropriate use of this potential new therapy, we are reviewing a number of options including requesting an advisory committee meeting,” says Dr. Gerard T. Kennealey, vice president of oncology research at AZ. “In addition, the FDA has suggested that we request a public hearing to review the data and discuss the findings in an open forum. AZ firmly believes that Casodex 150 mg addresses a current unmet medical need, and we will continue to work with the FDA to bring this treatment option to patients.”

Also, in June 2001, AZ cancelled development of Viozan, a COPD drug that was completing Phase III trials. At the same time, AZ discontinued development of AR-C89855, a compound similar to Viozan. AZ also discontinued the development of remacemide, a potential treatment for Huntington’s chorea and Parkinson’s disease, during 2001 for failure to meet target efficacy criteria. The LTA (sodium channel blocker) program in analgesia in AZ’s pain control therapeutic area was also discontinued during the year for failure to meet target criteria.

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5. Bristol-Myers Squibb Co.

345 Park Ave.
New York, NY 10154-0037
Tel: (212) 546-4000
www.bms.com


Headcount 46,000  
Year Established 1887  
Pharmaceutical Revenues $16,285 13%
Total Revenues $19,423 7% *
Net Income $5,245 11%
R&D Budget $5,003 158% **
* not including sales from discontinued operations
** (includes $2.7 billion in R&D expenses from DuPont Pharma and ImClone transactions


Drugs Approved/Launched

Drug Indication
Tequin bronchitis


Drugs Pending

Drug Indication
Aripiprazole schizophrenia
Vanlev hypertension
Plavix acute coronary syndrome


Drugs in Phase IIb and Beyond

Drug Indication
Erbitux colorectal cancer
Atazanavir HIV/AIDS
Garenoxacin antibiotic
NNRTI HIV/AIDS
Farnesyltransferase cancer inhibitor
Dual PPAR alpha/ gamma agonist diabetes
“Superstatin” cholesterol
Epothilone cancer
CTLA4-lg rheumatoid arthritis
LEA29Y transplantation
Entecavir hepatitis B
Factor Xa inhibitor deep-vein thrombosis


Early Research Projects

Drug Indication
CRF1 antagonist antidepressant
DPP4 inhibitors diabetes
HIV entry blocker HIV/AIDS
CDK2 cell cycle inhibitor cancer


Drugs Coming Off Patent

Drug Date
Monopril 2002
Serzone 2003
Paraplatin 2004
Glucophage XR 2003
Glucovance 2003


Top Selling Drugs

Drug Indication $ (+/- %)
Pravachol cholesterol $2,173 20%
Glucophage diabetes $2,049 18%
Plavix platelet inhibitor $1,350 50%
Taxol cancer $1,197 -25%
Paraplatin ovarian cancer $702 2%
Zerit HIV $546 -12%
Avapro hypertension $510 34%

Account for 52% of total pharma sales, down from 54% in 2000.


Key Personnel

Peter R. Dolan
chairman, chief executive officer

Richard J. Lane
executive vice president, president, Worldwide Medicines Group

John L. McGoldrick
executive vice president

Donald J. Hayden, Jr.
executive vice president, Health Care Group

Peter S. Ringrose, Ph.D.
chief scientific officer, president, Pharmaceutical Research Institute

Andrew G. Bodnar, M.D.
senior vice president, medical and external affairs

Tamar D. Howson
senior vice president, corporate and business development

Andrew Bonfield
senior vice president, chief financial officer

Elliott Sigal, M.D., Ph.D.
senior vice president, global clinical and pharmaceutical development


Highlights

In November 2001, Bristol-Myers Squibb announced its plan to submit five NDAs for blockbuster drugs within one year and to accelerate its plans to release three new drugs each year. The company had just completed its $7.8 billion acquisition of DuPont Pharmaceuticals, adding such products as Sustiva, Coumadin and Cardiolite, as well as an intriguing R&D pipeline, with candidates for treating depression, deep vein thrombosis, breast cancer, inflammatory diseases and obesity.

By June 2002, B-MS was consulting with Goldman Sachs investing firm to discuss options for alleviating its pipeline woes, according to the Wall Street Journal, leading to speculation that B-MS was searching for a merger partner. The company’s stock, trading at $56.19 that day in November, was down to $25.15 by summer 2001.

How did it get to this point so quickly? Some observers chalk it up to the company’s flawed partnership with ImClone, but several other factors have also come into play during the fall of B-MS.

First, B-MS lost a series of patent suits, giving up protection for three major drugs, Glucophage, Taxol and BuSpar. Then, the company opened itself to charges of illegally blocking generic competition, after filing a secondary patent to protect BuSpar hours before generic versions were ready to ship. Twenty-nine states’ attorneys general are suing the company, and the Federal Trade Commission is investigating alleged anticompetitive actions. The company faces similar action for Taxol. Prudential Securities estimates that Bristol-Myers faces damages of more than $1 billion if found guilty in the Buspar case.

Meanwhile, BuSpar’s sales dropped from $708 million in 2000 to $338 million last year, and Taxol sales dropped 25% to $1.2 billion. And the patent problems don’t end there for B-MS. Protection for Plavix, which yielded $1.4 billion in sales in 2001, may also be challenged in court.

Then, the dream pipeline began to dry up. One of the drugs, ImClone’s Erbitux, is on hold pending a revised Phase III trial. Another, hypertension drug Vanlev, originally had its NDA withdrawn in April 2000, so treating it as though it was part of a new wave of drugs was somewhat disingenuous.

Some analysts fear that the company’s lack of buzz about Vanlev and schizophrenia drug Aripiprazole mean that neither drug is expected to be a big hit in its marketplace. According to Jim Jubak, MSN’s money markets editor, in an April 2002 column, “If B-MS had good news to take the attention off the current earnings problem, it certainly would have announced it, analysts figured. Preliminary clinical results on Vanlev already showed that the drug didn’t offer any particular improvement over a Merck drug already on the market. The lack of comment must have meant either that the prospects for sales of the two drugs were extremely modest or, worse, that there was something wrong with one or both of the new drugs. That may seem like a huge jump of logic—but it’s a reasonable one in this case.”

Finally, B-MS faces massive inventory writedowns, the result of aggressively selling its products to wholesalers. This has led to reduced sales, as wholesalers sell from their existing stock, rather than buying new product from B-MS.

Taken together, these problems led chairman and chief executive officer Peter R. Dolan to issue an earnings warning in April 2002, where he remarked, “The company’s current business performance is unacceptable and I am taking steps today, and may take additional actions in the future as necessary, to strengthen our organizational structure, focus our priorities and accelerate our future growth. I recognize that today’s announcement may have a negative impact on our results in the short term, but it is absolutely necessary that we take concrete steps today in order to position Bristol-Myers Squibb for the long term. We have a proud history as a leader in the pharmaceutical industry, and I will take necessary steps to assure that we maintain and build upon this heritage.”

That day, Mr. Dolan announced that he was assuming direct responsibility for B-MS’ global pharmaceuticals business, both at the level of strategic planning and in daily execution.

Not all the news has been terrible for B-MS. In early 2002, the company received approval for its once-a-day version of HIV drug Sustiva and its 80mg version of Pravachol. The latter drug also benefited strongly from the withdrawal of Bayer’s Baycol drug, as sales grew 20% to $2.2 billion 2001.

B-MS followed through on part of its pipeline promise, resubmitting Vanlev to the FDA, along with an EU Marketing Authorization Application (MAA) for atazanavir, an HIV drug. Still, most experts won’t be surprised if 2002 is the last year for Bristol-Myers Squibb as an independent firm on the Contract Pharma Top Companies list.

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