Pfizer Will Build on Current Strengths for Future Success, Steere Tells Shareholders
In-Line Products to Fund Record-Setting Research Program
NEW YORK, April 23 /PRNewswire/ -- Pfizer Inc (NYSE: PFE - news) expects to spend more than $2 billion on research and development this year to fund more than 170 R&D projects, both company records, William C. Steere, Jr., chairman and chief executive officer told the Annual Meeting of Shareholders today.
''Nineteen-ninety-seven was a terrific year for the 10 pharmaceutical products we introduced in the last decade,'' Mr. Steere said. ''They continued to perform strongly, with their sales growing by 18 percent. Building on these strengths, we're forging ahead with an ambitious R&D program. This year, we have budgeted our R&D budget at well over $2 billion -- more than almost any other health care company in the world.''
Mr. Steere said that he was particularly gratified by the acceptance of the company's two newest products, Trovan and Viagra, both launched this year. ''The preliminary response has been extraordinary,'' he said, adding that the company, as is its practice, will include sales figures with its quarterly earnings report.
Mr. Steere said that the company's complementary strengths in R&D, marketing and sales have made it the partner of choice for many companies around the world. Pfizer co-promotes Lipitor, for the treatment of elevated blood cholesterol levels, with the Parke-Davis division of Warner-Lambert Company [NYSE:WLA - news], which discovered and developed the drug. The company also has an agreement with Eisai covering the co-promotion of Aricept, discovered by Eisai, for the treatment of Alzheimer's disease.
''And in February of this year,'' he added, ''we signed an agreement with G.D. Searle -- the pharmaceutical division of Monsanto Company [NYSE:MTC - news] -- to co-develop and co-promote Celebra, a compound with the potential to significantly improve the treatment of arthritis and pain.''
Henry A. McKinnell, Ph.D., and John F. Niblack, Ph.D., also addressed the meeting. Dr. McKinnell, executive vice president of the company and a member of the Pfizer board of directors, heads the company's global pharmaceuticals business. Reviewing the company's performance for 1997, he noted that Pfizer has moved from 11th in the world in pharmaceuticals sales in 1990 to 4th in 1997. ''And compared to those still above us, we enjoy one of the youngest, most patent-protected line-up of current products plus a portfolio of exciting new products in the pipeline,'' he said.
''Lipitor has been the most successful launch of any U.S. product in any therapeutic category ever,'' Dr. McKinnell said. ''This is a powerful testament to the combined impact of a great product, a potent strategy and an extremely productive collaboration.
''By March 1998,'' he continued, ''after only 13 months on the market, Lipitor had achieved a share of over 31 percent of new prescriptions for lipid-lowering agents in the U.S., and has been launched in 20 countries around the world.''
Aricept, a co-promoted product launched in February 1997, was receiving 97 percent of new prescriptions for AD treatments by the end of the year, Dr. McKinnell noted.
''Much more important than capturing the number one spot in a two-product category, is to expand the diagnosed and treated patient population. That is what Aricept has done,'' Dr. McKinnell said. ''Between December 1996 and December 1997, new prescriptions for AD treatments grew from 13,000 to 56,000; the company is optimistic it will be able to continue to grow the product category.''
Dr. McKinnell said that Trovan, the company's new broad-spectrum quinolone antibiotic, was launched in the U.S. in February and has been well accepted, with new prescriptions quickly topping 18,000 per week. Viagra, for erectile dysfunction, was launched in the U.S. in early April.
Dr. Niblack, executive vice president of the company and a member of the Pfizer board of directors, heads the company's global research and development and licensing efforts. He discussed some of the ways Pfizer is reducing the time required to move a medicine from the laboratory to the patient and provided an update on the next wave of new pharmaceuticals emerging from the R&D pipeline. He also noted that to take the best advantage of the explosion of new science and technology, Pfizer continues to enlarge and upgrade its facilities and to increase the research staff. Worldwide, the company is adding more than one million square feet of laboratory space -- an increase of 50 percent.
Using Viagra and Trovan as examples, Dr. Niblack explained that Pfizer is submitting more data than ever before in electronic form, thus helping regulators review data more expeditiously. The company is also performing many development activities in parallel with one another, rather than sequentially as in the past.
''The time-saving techniques we developed and perfected during the Viagra and the Trovan programs will now be used to facilitate the development of our pipeline drugs for the future,'' he said.
Zeldox, a treatment for psychotic disorders, is under review at the U.S. Food and Drug Administration, Dr. Niblack said. Zeldox effectively treats all symptoms of psychosis and has been shown in clinical trials to control them over long-term treatment. Unlike other new anti-psychotic medications, Zeldox has a low propensity to cause weight gain. Dr. Niblack said he expects regulatory action in the next few months.
Tikosyn is the new name for dofetilide, a medicine discovered and developed by Pfizer for the treatment of abnormal heart rhythms, Dr. Niblack said.
''Tikosyn is the first drug with proven safety that specifically targets the serious heart irregularity called atrial fibrillation (AF),'' he said. ''Tikosyn is efficacious and well-tolerated even in patients with a history of heart attacks or chronic heart failure.''
AF leads to inefficient pumping action in the heart, he explained. People with it experience light-headedness, fatigue, palpitations and shortness of breath.
Patients with AF often have normal heart rhythm restored in the hospital by a medical procedure called electrocardioversion. Tikosyn can help maintain that normal rhythm. In clinical studies, 66 percent of patients treated with Tikosyn were found to have normal heart rhythms after one year, compared to only 21 percent of patients on placebo. Dr. Niblack said the complete Tikosyn database and NDA were filed worldwide in March.
The company plans to file an NDA for eletriptan in the U.S. and Europe in September, Dr. Niblack said. Eletriptan is an oral treatment for migraine headache, which afflicts more than 25 million people in the U.S.
Although there are several treatments for migraine headache currently available, Dr. Niblack said, eletriptan will be an improvement on several fronts: ''Eletriptan is orally effective. It offers fast, powerful relief and can be taken when needed. Within one hour, 40 percent of patients experience significant or complete headache relief, and many see results within 30 minutes. It has the potential to be a leading new therapy for migraine.''
In diabetes research, Dr. Niblack said that a Pfizer collaboration with Inhale Therapeutics is developing a system for inhaled insulin as an alternative to daytime injections. One survey found that 88 percent of patients preferred inhaled insulin, which should improve patient compliance. Full Phase III clinical development is expected to begin in November.
Also under development is Alond, for the treatment and prevention of the long-term complications of diabetes, including damage to the nerves, kidneys, heart and eyes. Because these complications occur gradually over years, efficacy studies for Alond are long and complex, Dr. Niblack said, adding, however, that interim results are encouraging.
Some R&D programs also extend to products already marketed, such as Zithromax, the powerful oral antibiotic discovered and developed by Pfizer, Dr. Niblack noted. New evidence implicates the micro-organism Chlamydia in the accumulation of fatty deposits known as plaques in arterial walls. The infection may also increase the chances that a plaque will rupture and lead to a heart attack. Recognizing the powerful effect Zithromax has on the treatment of Chlamydia infections, the company has started a clinical trial to investigate the use of Zithromax in preventing this serious cardiac disease. Dr. Niblack said it will be two to three years before the company is likely to reach any conclusions from the trial.
''In 1997, we advanced a record 19 new drug candidates into exploratory development, giving us a total of 55 drug candidates in early development,'' Dr. Niblack concluded. ''Not all will succeed, of course, but as a whole, this innovative portfolio has significant potential to produce many exciting new Pfizer drugs of the future.''
Forward-looking statements in this document should be evaluated together with the many uncertainties that affect our business, particularly those mentioned in the cautionary statements in Part 1 of our 1997 Form 10-K, which we incorporate by reference. |
