WYETH-AYERST ESI-PHARMA TAKING ORDERS FOR FIRST ORAL GENERIC PRODUCT,

Executive Summary

WYETH-AYERST ESI-PHARMA TAKING ORDERS FOR FIRST ORAL GENERIC PRODUCT, the progestin Cycrin, the company announced May 10. "The changing pharmaceutical environment in these cost conscious times demands that Wyeth-Ayerst broaden its product line and its appeal to large purchasers," the American Home Products subsidiary said, explaining its decision to re-enter the oral generic drug field. Cycrin (medroxyprogesterone acetate) is available in 2.5 mg, 5 mg, and 10 mg strengths. Cycrin is bioequivalent to Upjohn's Provera, which is indicated for amenorrhea (menopause) and abnormal uterine bleeding. Wyeth-Ayerst sells generic versions of injectable drugs through its Elkins Sinn subsidiary. The company briefly entered the oral generic drug business when it bought Quantum Pharmics in 1986. However, the generics firm was dissolved following FDA's discovery of fraudulent information in submissions. Wyeth's move follows similar actions by a number of major pharmaceutical companies. Merck announced in April that its West Point Pharma subsidiary plans to introduce 10 generic versions of off-patent Merck brands ("The Pink Sheet" April 19, T&G-12). Warner-Lambert, Zeneca (formerly ICI) and Marion Merrell Dow are manufacturing generic versions of their top-selling brandname drugs. Other firms, including Syntex and Upjohn, have disclosed plans to do the same. The rapid introduction of the progestin Cycrin may allow Wyeth-Ayerst managers to familiarize the trade with the combined use of Premarin conjugated estrogens and a cyclic progestin for post menopausal women. The company said it will file an NDA for its estrogen/progestin combination product Premarin MPA in the next few months. A study published in The New England Journal of Medicine, shows that Premarin and progestin in combination have an equal or superior effect on cardiovascular risk compared to conjugated estrogens alone in postmenopausal women ("The Pink Sheet" April 19, T&G-7). Progestin is added to hormone therapy to reduce the risk of uterine and breast cancer associated with estrogens in women who have not undergone hysterectomies. Wyeth-Ayerst said that generics manufactured by ESI-Pharma will be represented to the trade and managed care groups by Wyeth- Ayerst trade and government relations managers and managed care corporate account managers.