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Zoloft Approved for Obsessive Compulsive Disorder
NEW YORK, Oct. 28, 1996 --
Pfizer Inc. (NYSE: PFE) has a record number of growing in-line products, and new therapies in all stages of development, William C. Steere, Jr., chairman and chief executive officer, told a meeting of financial analysts and guests today.
At the core of the company's success, Mr. Steere said, is a clear strategic focus to discover, develop, and bring to market innovative products that address major unmet health care needs. "New products are, and will continue to be, the keys to the future," he said.
John F. Niblack, Ph.D., executive vice president for research and development, announced that Zoloft, the company's selective serotonin re-uptake inhibitor for the treatment of depression, has just received regulatory approval from the U.S. Food and Drug Administration for the treatment of obsessive compulsive disorder.
Dr. Niblack also described the company's strategy for sustained output of innovative therapies. The keys to this strategy, he said, are an emphasis on the early stages of the R&D pipeline, while continually adding extra value to Pfizer products already on the market, for example, the new indication for Zoloft. Elaborating on the status of the pipeline, he noted that Pfizer discovery scientists, in this calendar year, will deliver 17 new drug candidates to the early development stage of the pipeline -- a new discovery record for the company and possibly the industry.
Dr. Niblack also reported on a new once-a-week form of Zithromax for prevention of Mycobacterium infections in AIDS patients; U.S. Food and Drug Administration (FDA) approval of Norvasc for use in treating hypertension and angina in patients with severe congestive heart failure; FDA approval for a pediatric dosage form for Zyrtec; and approvable letters from FDA for Zoloft for the treatment of obsessive compulsive disorders and for Aricept, a treatment for Alzheimer's disease discovered by the Eisai Company, Ltd., of Japan, which Pfizer will co-promote in the U.S. and elsewhere with Eisai.
"All in all," Dr. Niblack said, "1997 is shaping up to be one of the busiest, but also one of the most exciting years that our R&D operations have ever experienced."
George M. Milne, Jr., Ph.D., president of Pfizer Central Research announced that Pfizer expects to file three major new product registrations per year for the next three years for a total of 9 new drugs. Additionally, he said, the company has a record number of "First-in-Man" studies underway.
In his overview of drug candidates that the company plans to submit to the FDA for approval by the end of 1997, Dr. Milne stated:
- Trovafloxicin, the advanced quinolone antibiotic, has demonstrated a broad spectrum of activity, including difficult to treat infections. It is safe and well-tolerated and will be available in both oral and intravenous forms.
- Ziprasidone, a novel anti-psychotic therapy, has a rapid onset of action coupled with a favorable side-effects profile, that will enable patients to receive a full therapeutic regimen with no dose titration necessary.
- Preliminary, unpublished data show Viagra to be extremely effective in patients suffering from organic, inorganic and mixed-source impotence.
- Results reported last month showed eletriptan to have a rapid onset of action and to be significantly more effective in treating migraine than sumatriptan and with fewer reported side effects.
- In metastatic breast cancer, droloxifene has demonstrated efficacy similar to tamoxifen without the toxicity that has been associated with tamoxifen in pre-clinical studies.
Five more drug candidates follow, in earlier stages of development, Dr. Milne said, for treatment of congestive heart failure, diabetic complications, irritable bowel syndrome, anxiety and depression, and fungal diseases. Finally, complementing the company's internal discovery programs, Dr. Milne outlined various external research collaborations with scientists in both industry and academia. Pfizer has entered into seven new collaborations since September 1995.
Commenting on third quarter financial performance, David Shedlarz, chief financial officer, said the company's focus on four core health care businesses, strong acceptance of a broad array of new products and numerous productivity improvement initiatives have resulted in strong earnings growth and a steady improvement in profit margins since the beginning of the 1990's. "What makes our strong earnings growth and improved profit margins all the more impressive, is the high level of investment in new product support and R&D we've made, not just in 1996 but over this sustained period," he said.
Mr. Steere noted that as Pfizer looks to the future, the company will continue to rely on the vision elements which have been so successful to date -- an unwavering focus on health care and a continuing commitment to research and innovation. These elements -- coupled with a balance between growth and investment -- are fundamental to sustaining the company's momentum long-term, he said.
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