11/06 11:39 Innovation, Focus and New Drugs to Sustain Pfizer's Growth Into
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Innovation, Focus and New Drugs to Sustain Pfizer's Growth
Into the 21st Century, Steere Tells Analysts
Company Anticipates Initial Marketing Approval for Four New Chemical Entities
Over the Next Two Years
NEW YORK, Nov. 6 /PRNewswire/ -- By the end of the year, Pfizer will have
completed its evolution from a group of diverse businesses into a company
focused exclusively on prescription and self-medication pharmaceuticals for
humans and animals, William C. Steere, Jr., chairman and chief executive
officer of Pfizer Inc, said today.
"We've never been more clearly focused as a pharmaceutical company," Mr.
Steere told about 300 financial analysts, reporters and guests at a meeting
held at the company's headquarters, "and on our goal of becoming number one in
our industry." He noted that the Pfizer core businesses have never been
stronger, citing the "unrivaled strength of our current and ever-expanding
product line."
"Our product portfolio is young, strong and growing," he said. "Earlier
in the decade, we launched six products in six years. We are now conducting
clinical-development programs that could potentially lead to the launches of
eight products in three years -- - with more to come."
This year Pfizer introduced two new products: Trovan, a broad-spectrum
antibiotic, and Viagra, a treatment for erectile dysfunction. Trovan,
launched in February, is already among the top 10 most-prescribed brand-name
antibiotics. Viagra, on the market for 6 months, has surpassed every record
for a successful launch of a new drug.
"Today we stand on the threshold of a golden age of science," he
continued. "Thanks to genomic mapping and our increased understanding of the
way enzymes and proteins function, we're beginning to comprehend the process
of disease itself. Tremendous opportunities lie before us."
John F. Niblack, Ph.D., executive vice president of Pfizer and the
company's top scientist, reviewed the line-up of recently launched and near-
term research compounds.
"Our multifaceted approach to internal new-product R&D and external
collaborations has delivered an increasingly strong and diverse portfolio of
products," he said. "Of special significance is the fact that this product
line has many years of patent-protected market exclusivity ahead of it. With
one exception, there are no patent expirations for our major products until
five or more years from now."
Some of those products are: Norvasc, the world's top-selling
antihypertensive, Zithromax, most-prescribed brand-name antibiotic in the
U.S., Diflucan, the world's leading anti-fungal treatment, and Zoloft, the
world's second most widely used anti-depressant. Lipitor, a cholesterol-
lowering treatment, launched last year in partnership with Warner-Lambert
Company, and Aricept, a treatment for Alzheimer's disease also launched last
year in partnership with Eisai, continue to do extremely well.
On top of that portfolio of products, Dr. Niblack said, the company hopes
to add an additional four during the next two years: Celebrex for arthritis,
Tikosyn for atrial fibrillation and Relpax for migraine, all of which are
under review at the U.S. Food and Drug Administration; and Zeldox for
psychotic disorders, for which the company hopes to file an amended new drug
application in late 1999. Pfizer is participating in the expanded development
programs for Celebrex, which was discovered by G.D. Searle, the pharmaceutical
subsidiary of Monsanto, and will co-promote it after approval.
In addition to adding new products, Pfizer also pursues a strategy of
broadening the existing product line by broadening the potential uses of each
product.
"A key strategy for continued growth in our business is to maximize the
value of each approved drug," Dr. Niblack said. "We continue to invest
aggressively to add value to most of our other marketed products through
supplemental regulatory filings."
During the past year, he said, the company received approval for the use
of Zyrtec, an anti-histamine for seasonal and perennial allergies, in children
down to the age of two years. Filings are pending for Zoloft: a liquid oral
concentrate for use in the elderly, and an indication for the use of Zoloft in
treating post-traumatic stress disorder. Clinical programs are underway to
support supplemental indications for Zithromax, Lipitor, Norvasc, Zyrtec,
Viagra and Trovan.
"As we stack wave upon wave of major new chemical entities into our
product line, and maximize their value," he said, "it's obvious what we're
setting up: The potential for Pfizer to experience continued and vigorous
growth throughout the first decade of the next century."
George M. Milne, Jr., Ph.D., president, Pfizer Central Research, said,
"There are still five more NCEs targeted for delivery from the current wave -
Alond, Inhaled Insulin, droloxifene, darifenacin and voriconazole. And behind
these late-stage candidates, we have 62 new chemical entities under active
development. Including our supplemental filings for additional indications,
we have a total of 104 separate programs ongoing. The breadth and depth of
this portfolio as well as its momentum is unprecedented."
Dr. Milne outlined the company's efforts in cancer research, saying
"Alterations at the genetic level provide cancer cells with the ability to
grow unchecked, and then to generate their own blood supply, a process called
'angiogenesis.' These two characteristics not only promote the survival of
the cancer cells, but provide them with a competitive advantage when compared
to normal tissue."
In the cell, the "epidermal growth factor receptors" (EGFRs) control
growth. In cancer cells, EGFRs can be overproduced, thus leading to
unregulated growth. A compound called "CP-358,774" has just entered Phase II
clinical research as a potential agent to block EGFRs, thus preventing the
rapid, ungoverned growth of cancer cells.
Such tumor growth may also result from the ras oncogene being permanently
"switched on." Another compound (CP-609,754) has shown potential in pre-
clinical studies to block an enzyme that enables this process.
Two other compounds in pre-clinical development have shown promise in
inhibiting angiogenesis by blocking the activity of one of two of the enzymes
key to the growth of blood vessels in tumor cells.
A fifth compound with promise in the treatment of cancer patients is in
late Phase II clinical trials. Called ezlopitant, it reduces the incidence of
chemotherapy-induced emesis, thus helping patients better tolerate their anti-
cancer therapy.
"To summarize," Dr. Milne said, our efforts to discover new cancer
therapies leverage new scientific advances, allowing us to manage the whole
disease."
Other programs outlined by Dr. Milne include a search for drugs to combat
obesity, which places patients at an increased risk of hypertension, lipid
disorders, Type II diabetes, coronary artery disease, stroke, osteoarthritis
and certain cancers.
"Obesity-related disease is estimated to cost $100 billion each year in
the U.S. alone," he said. "We need agents that are both effective and safe to
treat this area of serious medical need." Pfizer has three candidates in pre-
clinical or early clinical development.
Dr. Milne described two selective estrogen receptor modulators (SERMs)
under development at Pfizer. One, droloxifene, has demonstrated efficacy in
treating breast cancer and lowers lipids by one-quarter. Furthermore, he
added, droloxifene has shown in clinical trials that it significantly
increases bone mass in both normal patients and those with osteoporosis. A
second SERM, CP-336,156, could prove to have even greater potential. One of
these two candidates will be chosen to enter Phase III clinical trials next
year.
Dr. Milne said that Pfizer has more than doubled the number of compounds
in Phase II clinical trials in the last year, and that the Discovery section
of Pfizer Central Research will post another record-breaking year of
productivity with 19 candidates entering development in 1998.
The company's R&D investment is anticipated to keep Pfizer on a strong
growth curve, Dr. Milne said. Construction is underway on nearly two and one-
half million square feet of new clinical and laboratory research space in
Connecticut, England, and Japan. In further R&D expansion, the company is
opening facilities in Cambridge, Massachusetts; and San Francisco, California;
to capitalize upon the biotechnology and academic expertise in those areas, he
said.
Additionally, Pfizer continues to seek out external alliances, Dr. Milne
said. Central Research added fourteen collaborations to its strategic
portfolio of research agreements, he said, and formed a partnership with the
University of Connecticut at Storrs, to establish a new center for vaccine
research for the company's Animal Health division.
"Pharmaceutical products for animals are an important part of our focus,"
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