NEW YORK, Oct. 30 /PRNewswire/ -- With new product launches, anticipated regulatory filings for additional products, and the introduction this year of two major new drugs with three more anticipated for 1998, Pfizer could set an industry record for productivity, William C. Steere, Jr., Pfizer Inc (NYSE: PFE) chairman and chief executive officer, said today. "In only a few years we could be actively promoting 17 products in the United States," Mr. Steere said at a meeting for financial analysts, the press and guests held at the company's headquarters. "Such an effort far surpasses anything that we -- or anyone else in the industry -- have ever attempted." This year Pfizer, with its partners, introduced two new products: Aricept, for the treatment of mild-to-moderate Alzheimer's disease, and Lipitor, for the treatment of elevated blood cholesterol and triglycerides in patients with high cholesterol. Aricept was discovered and developed by Eisai Co., Ltd., and Lipitor was discovered and developed by the Parke-Davis research division of Warner-Lambert Company. Pfizer has co-marketing and co-promotion agreements with those companies for most key markets around the world. In-line products performed strongly. Norvasc, for the treatment of hypertension and angina discovered by Pfizer, became the top-selling cardiovascular medicine in the world. Zithromax, the Pfizer azalide antibiotic, became the most-prescribed and fastest-growing branded oral antibiotic in the U.S. Aricept, launched in February, quickly expanded the market for treatment for Alzheimer's disease. The launch of Lipitor is considered by many to be the most successful pharmaceutical product launch in history. Pfizer reported that it was on or ahead of schedule in filing three New Drug Applications (NDAs) with the U.S. Food and Drug Administration this year. Furthermore, the company said that its R&D pipeline holds some 57 potential new drugs in various stages of development. Mr. Steere attributed the company's success to its focus on health care, innovation, and commitment to productivity and effectiveness in an era marked by changing market forces, regulatory pressures and new technologies. "We concentrate on what we do best -- discovering, developing, and bringing to market, cures and therapies that will help patients around the world lead healthier, more productive lives," he said. Providing an overview of the company's R&D pipeline, John F. Niblack, Ph.D., Pfizer Inc executive vice president and the company's lead scientist, described several series of products in varying stages of development. The new products, he emphasized, represented significant medical advances with possibilities for value-adding supplemental uses and dosage forms. Included in the first wave are three drugs now undergoing regulatory review: Trovan, a broad-spectrum antibiotic; Zeldox, to treat symptoms of schizophrenia; and Viagra, an oral treatment for male erectile dysfunction. Dr. Niblack also said that the company this year had filed nine applications for new uses for currently marketed Pfizer products and had received approval for seven new indications for Zoloft, Zithromax, and Unasyn. Noting that the company's current product line still has patent protection well into the next century, Dr. Niblack said, "The new wave will give Pfizer the potential for continued strong growth in revenues well into the 2000's." George M. Milne, Jr., Ph.D., president, Pfizer Central Research, said the company's development rate of 15 to 18 new drug candidates each year over the past three years was a company record. Pfizer now has 150 discovery projects in more than 17 therapeutic areas, he said. To continue to enhance that drug discovery record, Dr. Milne said, Pfizer is currently adding more than a million square feet of laboratory space with construction of new facilities at each of the company's research sites in Groton, Connecticut; Sandwich, England; and Nagoya, Japan. Additionally, Pfizer continues to expand its internal programs through a network of partnerships with biotech companies and academic institutions, Dr. Milne said. Dr. Milne highlighted the clinical development programs for several new drugs in key therapeutic areas, including cardiac disease; diseases of the central nervous system; infectious disease; cancer; and metabolic diseases such as osteoporosis and diabetes. Among the late stage candidates he profiled are: -- Dofetilide, in phase III, is a major advance in the treatment of the widespread cardiac arrhythmia condition, atrial fibrillation (AF). The first anti-arrythmic drug to specifically target AF, dofetilide has an unprecedented safety profile. Recently released findings from a global study of dofetilide in 3,000 patients (called the "DIAMOND" study), showed this drug to reduce hospitalization for congestive heart failure and to be very well tolerated. Pfizer plans to file for regulatory approval of dofetilide in the U.S. and Europe in the first quarter of 1998. -- Eletriptan, now in phase III, could emerge as a leading oral treatment for migraine. One head-to-head trial with sumatriptan, the leading approved therapy, showed oral eletriptan to be twice as effective as sumatriptan within one hour of administration. Eletriptan has mild reported side effects. U.S. and European regulatory filings are expected for third quarter, 1998. -- Droloxifene, an estrogen agonist/antagonist, is in phase III development for treatment of breast cancer; Pfizer plans to file an NDA in the fourth quarter of 1998. Phase II trials for osteoporosis and lipid lowering are underway. Dr. Milne also outlined the company's approach to diabetes treatment, which builds on the company's in-line products, Glucotrol and Glucotrol XL. Pfizer is developing a unique system for delivery of insulin by inhalation that will enter phase III development next year. To treat diabetic complications, the company's aldose-reductase inhibitor, Alond, is in phase III development now, Dr. Milne said. "This is a time of extraordinary opportunity for Pfizer," said Dr. Milne, "and the most prolific period in drug discovery in our history, brought about by revolutionary technological advances in biotechnology and genetic research that have markedly increased the number of therapeutic targets available for research." Summarizing the key drivers of the company's continued strong performance, David L. Shedlarz, Pfizer senior vice president and chief financial officer, cited the balancing of growth in earnings today and investments for the future, and strong product performances, with increasing demand for Pfizer's new products. Co-promotion partnerships with the Warner-Lambert Company and Eisai Co. Ltd. further enhanced Pfizer's product line. "In 1997, we are accelerating investment in our sales and marketing organization, fully funding R&D at more than $1.9 billion, absorbing significantly adverse foreign exchange, and targeting growth of at least 10 percent in revenue, net income, and earnings per share for the full year," Mr. Shedlarz said. "In Pfizer's third-quarter earnings release," he continued, "we stated that we were comfortable with the range of the majority of analysts' earnings-per-share estimates at that time of $1.65 to $1.70 for the year. We are currently comfortable with the upper end of this earnings-per-share range for 1997. Of course, such forward-looking statements should be evaluated with due consideration given the many uncertainties inherent in our business, particularly those mentioned in the applicable cautionary statements in Part 1 of our 1996 10-K." Pfizer Inc is a research-based healthcare company with global operations. In 1996, the company reported sales of more than $11 billion and anticipates investing more than $1.9 billion on research and development in 1997.
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