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Executive Summary

LEDERLE WILL MARKET ELAN's VERELAN-SODAS ONCE-DAILY VERAPAMIL following its approval on May 29 for essential hypertension. Under a May 10 agreement announced when Verelan was "approvable," Lederle has exclusive marketing rights to the sustained-release version of the calcium channel blocker in the U.S. Terms were not disclosed. To be launched in midsummer and detailed by Lederle's 700-plus salesforce, Verelan gives the Cyanamid subsidiary another opportunity with a branded multisource drug a la Maxzide. Elan will manufacture the drug at its Gainesville, Georgia plant. Verelan is currently marketed in the U.K. and the Far East and recently received approval by the European Community. Labeling provides for once-daily morning dosing starting at 120 mg to up to 480 mg per day. The usual dosing in clinical trials was 240 mg, but must be individualized through titration, Elan said. Verelan will be available in both 120 and 240 mg capsules. Pricing and promotions for the product have not yet been set. The drug employs Elan's SODAS (spheroidal oral drug absorption system), which is also used by Marion Merrell Dow's Cardizem SR and in a sustained-release theophylline sold overseas. The SODAS technology, a pellet-filled capsule system, provides a "more uniform blood pressure response...over existing verapamil products," Elan said. Advantages over other SR verapamils include truly once-a-day dosing; administration with or without food; and slow release over a 24-hour period to minimize peak effects, according to an Elan spokesperson. The Athlone, Ireland-based drug delivery systems company filed the original NDA for Verelan-SODAS in April 1986, with data from European clinical trials. FDA put the NDA on hold pending additional clinical data, which Elan submitted on Oct. 28, 1988. Because clinicals were necessary for approval of the new dosage form, Verelan will receive three years of market exclusivity. Searle and Knoll also obtained exclusivity for their sustained-release verapamil products (Calan SR and Isoptin SR, respectively); exclusivity for their products expired in December. To date, no generic versions have been approved. Calcium antagonists control the largest share (an estimated$1.5 bil.) of the U.S. hypertension market and Elan estimates that verapamil accounts for about $400 mil. of the channel blocker sales. The lion's share of the verapamil market is controlled by Searle, which reported Calan and Calan SR sales last year of $364 mil. Searle has been fighting additional FDA approvals of verapamil products. The company filed a petition in late November asking FDA to issue a bioequivalence and therapeutic equivalence guideline for sustained-release verapamils ("The Pink Sheet" Jan. 1, T&G-2). The petition followed Searle requests in August 1989 that FDA stay approval of ANDA suitability petitions filed by Lederle and Pioneer for sustained release verapamil products.

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