PFIZER ZAMIFENACIN TRIALS INCLUDE COST-EFFECTIVENESS STUDY OF SICK DAYS, FIRM TELLS SHAREHOLDERS: IRRITABLE BOWEL SYNDROME TREATMENT MOVES INTO PHASE III
Pfizer's clinical development program for the irritable bowel syndrome (IBS) treatment zamifenacin includes studies of the drug's effect on reducing sick days, Exec VP-R&D Barry Bloom told the company's annual shareholder meeting April 22. In developing zamifenacin, "we set out to discover a drug that could fill an important medical need in a demonstrably cost- effective manner," Bloom said. "We plan to do clinical studies that demonstrate significant cost savings through its use in the form of fewer missed work days." Zamifenacin "stands as a very clear example of our approach to meeting [the] challenge" of demonstrating cost effectiveness, Bloom told Pfizer shareholders. "This kind of economic outcomes research is now an important component of each of our new drug development programs." "In early clinical trials, zamifenacin has shown the ability to significantly reduce abdominal pain and dystention in IBS patients without affecting salivary secretion, heart rate, pupil size...or cognitive function," Bloom said. "Older drugs" for IBS, on the other hand, can "cause troublesome side effects such as blurred vision, dry mouth, a faster heart rate and even slight mental confusion," Bloom maintained. "About 400 patients have already received the drug and we are now proceeding to more extensive clinical trials," Bloom said, indicating that the drug remains on track for an NDA filing in the 1996 range. Bloom first discussed development of the compound during a July meeting with securities analysts ("The Pink Sheet" Aug. 3, 1992, p. 10). Bloom highlighted zamifenacin both as an example of Pfizer's approach to answering cost-effectiveness questions and as a product of the company's investment in rational drug design technologies. "Using the techniques of molecular biology, our scientists were able to prepare quantities of the entity present in the human gut that controls contractions," Bloom said. "With this material in hand, they were able to discover zamifenacin and demonstrate that it acts selectively on the gut to dampen the spasms and hyper-irritability that cause IBS." Pfizer's new anti-arthritic agent tenidap will be marketed in the U.S. under the trade name Enable, Bloom said. Overseas filings will begin "next week" using the tradename Enablex. In the U.S., an NDA filing remains on track for later this year, Bloom said ("The Pink Sheet" March 8, p. 7). Pfizer Chairman William Steere focused his remarks on the "challenges" to the industry from the health care reform effort in the U.S. and from underlying market changes. Pfizer cast its new product launches and its research productivity as the means by which it would succeed in the new environment. "Drug research is now entering what we confidently predict will be a period of unprecendented opportunity for therapeutic innovation" fueled by new technologies, Bloom told shareholders. As an example, Pfizer showed a video describing its automated gene sequencing program ongoing at its Groton, Conn. research center. Pfizer continues to seek to influence the policy direction of the country, Steere noted. "In addition to communicating externally with public officials, we've also begun in recent months to enhance our internal communications efforts," he said. Pfizer employees and retirees are being mobilized to communicate their feelings about health care reform to their political representatives, he indicated. Steere was asked if Pfizer had any plans to re-enter the generic business as other brandname companies have been doing. "This is something we look at periodically," Steere said. "At this point we are not entering the generic business."
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