Pfizer Aims For Top Slot After Millenium
November 11, 1998
Marketletter via NewsEdge Corporation : Pfizer is planning to launch three new drugs in
the next year, with a fourth launch scheduled in early 2000. The company provided an
update on its R&D pipeline at an analyst meeting held in New York, USA, this month.
William Steere, chairman and chief executive of the firm, told the meeting that Pfizer's
goal is to become the number one company in the drug industry early in the next
decade, and this will be fuelled by an acceleration in product launches. Pfizer is now
conducting clinical development programs that could potentially lead to the launches of
eight products in three years, he added. These positive sentiments were echoed by
analyst Carl Seiden at J P Morgan Securities, who told the Wall Street Journal that
Pfizer's pipeline " continues to be very impressive, very broad."
During 1998, Pfizer has already introduced two successful new products, namely
Trovan (trovafloxacin), a broad-spectrum quinolone antibiotic, and Viagra (sildenafil
citrate) for erectile dysfunction. Trovan is already among the top 10 most-prescribed
brand-name antibiotics, while Viagra, on the market for just six months, has already
surpassed every record for a successful launch of a new drug (Marketletters passim).
Pfizer noted that US sales of Viagra have now plateaued, and there have been some
reports of priapism (persistent painful erection) in a small number of users. A warning
about the risk of this effect will be added to the drug's labeling.
Near-Term Products Leading the pipeline are Celebrex (celecoxib) for arthritis, Tikosyn
(dofetilide) for atrial fibrillation and Relpax (eletriptan) for migraine, all of which are
under review by the US Food and Drug Administration, while following on is Zeldox
(ziprasidone) for psychotic disorders. Pfizer was issued a "not-approvable" letter by an
FDA advisory panel for ziprasidone earlier this year on the grounds that an effect on
cardiac function required further exploration, and has since withdrawn its application in
the European Union. The company now says it hopes to file an amended New Drug
Application in late 1999.
Pfizer highlighted Celebrex at the meeting, a drug which was discovered by GD Searle,
the pharmaceutical subsidiary of Monsanto, and to which it has copromotion rights
after approval. Celebrex is a cyclo-oxygenase 2 inhibitor for arthritis, which should offer
pain relief with significantly fewer gastrointestinal side effects than other analgesics.
Pfizer and Searle are also testing the drug against colon cancer and Alzheimer's disease,
while a follow-up compound with increased potency and selectivity is also in
development.
Celebrex will probably face competition from Merck & Co's COX-2 inhibitor Vioxx
(rofecoxib), which is following just a few months behind Celebrex in development
(Marketletters passim).
John Niblack, executive vice president of Pfizer, noted that another key aspect of Pfizer's
pipeline is its lack of exposure to generic competition. "With one exception, there are no
patent expirations for our major products until five or more years from now," he said.
In addition to adding new products, Pfizer is also pursuing a strategy of broadening the
existing product line by exploring new potential uses of each product., said Dr Niblack .
During the past year, the company received approval for the use of the antihistamine
Zyrtec (cetirizine) in children down to the age of two years. Meantime, filings are
pending for a liquid oral concentrate formulation of the selective serotonin reuptake
inhibitor antidepressant Zoloft (sertraline) for use in the elderly, as well as an indication
for the use of Zoloft in treating post-traumatic stress disorder. Clinical programs are
underway to support supplemental indications for several of the company's other
products, including Zithromax (azithromycin) in coronary artery disease, Viagra in
female sexual dysfunction and new indications for Norvasc (amlodipine), Trovan and
Zyrtec.
George Milne, president of Pfizer Central Research, gave a review of some of the key
elements in the group's research pipeline. Five New Chemical Entities are nearing the
end of clinical development, namely Alond (zopolrestat) for diabetic retinopathy, an
inhaled formulation of insulin for diabetes, the selective estrogen receptor modulator
droloxifene for breast cancer (and osteoporosis), darifenacin for urinary incontinence
and irritable bowel syndrome and the antifungal voriconazole. And behind these
late-stage candidates, there are 62 NCEs under active development, he added.
Focus On Cancer Dr Milne spent some time looking at Pfizer's activities in the area of
cancer. He emphasized the company's efforts in the development of angiogenesis
inhibitors, and took the unusual step of revealing some compounds in preclinical
development at the group.
Epidermal growth factor receptors are involved in the control of cell growth, and in
cancer cells, overexpression of EGFRs can lead to unregulated growth. An EGFR
blocker, CP-358,774, has just entered Phase II clinical trials against solid tumors. Pfizer is
developing this agent with OSI Pharmaceuticals. Other compounds in the
antiangiogenesis program include CP-471,358, a metalloproteinase inhibitor, and
CS-564,959, which blocks the enzyme tyrosine kinase.
Another approach being investigated by Pfizer is the inhibition of the enzyme farnesyl
transferase (which is involved in the control of the ras oncogene). Pfizer's lead FT
blocker, CP-609,754, has reduced the size of tumors in mice for long periods, and Phase I
trials are now planned.
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 anticancer therapy.
Other programs outlined by Dr Milne included a search for drugs to combat obesity,
which places patients at an increased risk of hypertension, lipid disorders, type 2
diabetes, coronary artery disease, stroke and osteoarthritis. Pfizer has three candidates
for the treatment of obesity in preclinical or early clinical development, including an
appetite suppressant, CP-644,673 (licensed from Phytopharm of the UK), which is
currently in Phase II trials.
Droloxifene Dr Milne also noted that two SERMs are under development at Pfizer.
Droloxifene has now demonstrated efficacy in clinical trials in breast cancer patients,
and has also been shown to have a favorable effect on lipids. Furthermore, he added,
droloxifene has shown in clinical trials that it significantly increases bone mass in both
normal patients and those with osteoporosis. The product will be a competitor to Eli
Lilly's Evista (raloxifene), already approved for postmenopausal osteoporosis, and has
also been shown to reduce the incidence of newly-diagnosed breast cancer in clinical
trials.
A second SERM, CP-336,156, could prove to have even greater potential, he noted and
either droloxifene or this latter agent will be chosen to enter Phase III clinical trials in
osteoporosis next year. Meanwhile, Pfizer is also developing an agent which promotes
the production of insulin-like growth factor- 1, called CP-424,391, which may have a role
in increasing bone and muscle mass in the elderly.
Dr Milne said that Pfizer has more than doubled the number of compounds in Phase II
clinical trials in the last year, with 19 candidates entering development in 1998.
Construction is underway on nearly 2.5 million square feet of new clinical and
laboratory research space in the USA, UK, and Japan.
In addition, Pfizer, like almost all other companies in the drug industry, has recognized
the importance of signing external R&D alliances, and Pfizer Central Research has
recently added 14 collaborations to its strategic portfolio of research agreements, said
Dr Milne. Most recently, the firm has formed a partnership with the University of
Connecticut at Storrs in the USA 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," Dr Milne noted, adding that "we currently have 43 animal
health candidates in development."
Corporate "Evolution" Nears Completion 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 human and animals.
David Shedlarz, Pfizer senior vice president and chief financial officer, noted that the
company's increased focus on pharmaceuticals allows strong diversification across a
broad portfolio of therapeutic areas as well as geographic diversification.
"In 1990, essentially all of our pharmaceutical revenue growth was accounted for by just
two products. Today, eight products are strong contributors to revenue growth," he
noted. Pfizer is now the third-largest drug company in the world in terms of prescription
drug sales, having leapfrogged from ninth place at the start of the decade.
He also pointed to the company's increased profitability, noting that "the results of our
decade-long effort to improve margins through divestitures, the impact of new products
and productivity initiatives can be seen in the strong improvement in our profitability."
Mr Shedlarz added that: "in spite of increased investment to support the introductions
and marketing of our new products and heightened R&D spending, net income before
taxes and other deductions increased from one of the lowest in the industry (16.5% of
total revenues) in 1990 to one of the highest - 29% for the first nine months of this
year."
<<Marketletter -- 11-16-98>> |
