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Executive Summary

Wyeth-Ayerst's sales of Premarin grew 21% in 1989 to $285 mil., representing the fourth straight year the conjugated estrogens product has grown by 20% or more. Since 1985 sales of$118 mil., Premarin sales have grown by 142%. "Although Premarin has been available for almost 50 years and accounts for over 60% of all menopausal estrogen prescriptions, its growth potential has never been brighter," Wyeth-Ayerst's parent, American Home Products, stated in its recently released 1989 annual report. The growth of Premarin is tracked in AHP's recently released 1990 Fact Book, which attributes the ongoing expansion of the long-off patent product in large part to use of the product to prevent osteoporosis. Premarin received an expanded indication for osteoporosis prevention in 1989. In addition, AHP noted that an estimated 15% of the 40 mil. postmenopausal women in the U.S. currently are taking estrogen treatment. However, AHP pointed out that demographics are in the product's favor as the size of the elderly population grows 50% faster than the overall population. Wyeth-Ayerst's Premarin is also benefiting from FDA's reassessment of the bioequivalence standards for generic conjugated estrogens. FDA convened an ad hoc subcommittee of FDA's Fertility and Maternal Health Drugs Advisory Committee on May 3-4 in an attempt to resolve the issue of what FDA's requirements should be for conjugated estrogens products (see story, p. 7). Premarin is now Wyeth-Ayerst's best-selling Rx product outside of the company's oral contraceptive line, edging ahead of the beta blocker Inderal (propranolol) in 1988 and the anxiolytic Ativan (Iorazepam) in 1989. The combined AHP and Robins' prescription drug business generated sales of $3.5 bil. in 1989. Wyeth-Ayerst sales climbed 4% to $2.8 bil. in 1989, while Robins' prescription drug sales grew 3% to $545 mil. Inderal, Wyeth-Ayerst's second-biggest prescription drug, with sales of $232 mil. in 1989, has now declined 82% from 1985 -- the year the first generic propranolol products arrived on the U.S. market. Ativan sales were up slightly in 1989 to $244 mil., from 1988 sales of $240 mil., despite heavy generic competition. At Robins, the anti-emetic Reglan (metoclopramide) continues to be described by AHP as a "category leader" despite a 40% decline in sales since 1985, its last full year of patent protection. Reglan, still Robins' biggest selling prescription drug, generated sales of $60 mil. in 1989. The Elkins-Sinn hospital injectable business, meanwhile, has grown into one of the largest contributors at Robins: with 1989 sales of 125 mil., the subsidiary made up 23% of Robins $545 mil. total sales. AHP is hoping for three NDA approvals to come through in 1990: Lodine (etodolac), an NSAID held up at FDA since 1982; Triminulet (gestodene + EE), a new low-dose triphasic oral birth control at FDA since late 1988; and Norplant, a subdermal progestin contraceptive implant for which an NDA was resubmitted last month. Timely marketing approval for Triminulet and Norplant are particularly important to Wyeth-Ayerst given upcoming OC patent expirations. Patents on the company's norgestrel-containing birth control pills expire in November 1991, and Triphasil/Trinordiol (levonorgestrel) goes off patent in May 1993.

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