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Executive Summary

ETHEX IS KV PHARMACEUTICAL's NEW MARKETING ARM; the first two products to be marketed by KV's wholly-owned subsidiary -- generic versions of Robins' Micro-K 10 Extencaps potassium chloride and Searle's Norpace CR disopyramide phosphate extended release capsules -- were previously distributed by Bolar under the KV/Bolar label and to 14 other generic firms, including H.L. Moore, Goldline and Rugby-Darby. KV terminated its agreement with Bolar in late February in the wake of Bolar's involvement in the generic drug investigation. * Ethex subsequently opened its doors in St. Louis in late March and is headed by President Raymond Chiostri, who had been KV's VP and president of the Pharmaceutical Division. Ethex is looking for a general manager. The company is beginning to promote its existence to pharmacists this month in a series of ads now running in five pharmacy journals and via direct-mail. The firm has also established an Ethex 800 number. The three-page journal ads are headlined: "Who Has An Exceptional FDA Regulatory Compliance Record?" and include Ethex' slogan: "We dispense confidence in specialty generics." The ads highlight KV Pharmaceutical's clean record with FDA over a 48-year period and the fact that the company has the only "AB" -rated potassium chloride and disopyramide phosphate extended-release products. The "AB" equivalence rating was not previously stressed under the Bolar marketing agreement. The potassium chloride is available in 10mEq (750 mg) capsules of 100 and 500 count with AWPs of $10.71 and $48.42, respectively. The disopyramide is available in 10 mg and 150 mg bottles of 100 for $43.75 AWP and $51.70 AWP, respectively. Ethex is still gearing-up its production operations, although it has been shipping product since the first week of March. The firm plans to make the drugs available to wholesalers and drug chains and is exploring targeting the managed health care sector, an Ethex marketing official indicated. The company anticipates adding several other KV products to its line this year. KV has eight ANDAs pending at FDA.

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