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Executive Summary

Wyeth-Ayerst's injectable cephalosporin antibiotic cefpiramide was approved by FDA on Jan. 31. The drug was rated 1-C (new chemical entity with no advantage over current treatments). Anti-infective research has not been a high priority area for the American Home Products subsidiary. The company has yet to announce launch plans for cefpiramide, which would be marketed along with Wyeth-Ayerst's line of antibiotics, including Bicillin and Wycillin injectable penicillins and the Wyeth line of ampicillin, penicillin, and cyclacillin products. Cefpiramide is licensed from the Japanese firm Sumitomo. Wyeth-Ayerst announced in late January a restructuring of its recently unified sales force of 1,800 reps into four specialized entities -- Wyeth, focusing on female healthcare products; Ayerst, targeting cardiology and primary care markets; Wyeth Pediatric and Consumer; and a hospital sales group that details the firm's entire ethical line (see chart below). (FOOTNOTE) * Will be emphasized by separate hospital sales force in promotion of entire ethical products line.(END FOOT) The restructuring "anticipates any further acquisitions . . . without disrupting our new organization or the Robins organization," the company said. Since Jan. 26, AHP has had the option to terminate the A. H. Robins acquisition announced in January 1988 because the Dalkon Shield court case has not been finalized and plaintiff appeals are still possible. Wyeth-Ayerst had 15 INDs in development in 10 therapeutic categories at year-end, as well as "extensive programs underway" to expand markets for existing drugs, AHP notes in its recently-released annual report. The firm began filing an NDA for an oral contraceptive containing the low progestational agent gestodene in 1988, the annual report notes, and expects to complete the filing in 1989. Also in the hormonal product area, a 1989 NDA filing is anticipated for an undisclosed "nonsteroidal chemical" for osteoporosis, the annual report notes. Among other anticipated filings, AHP expects to apply for U.S. registration in 1991 for recainam, a cardiac depressant/anti-arrhythmic, and for a low molecular weight heparin as an anticoagulant therapy for preventing thrombus formation. Further down the cardiovascular pipeline, AHP has a antihypertensive potassium channel activator "with possible broader efficacy" than existing treatments, the firm says. An IND is slated for submission late in 1989. The company is expending a major effort on developing new chemical entities for the treatment of psychoses. Phase III clinicals began in 1988 on the fast-acting antidepressant venlafaxine, with an NDA filing expectancy in 1991. The company also plans to investigate the drug's possible use for obsessive/compulsive and panic disorders and obesity. Chart omitted.

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