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MARION's B.I.D. SUSTAINED-RELEASE CARDIZEM APPROVAL EXPECTED

Executive Summary

MARION's B.I.D. SUSTAINED-RELEASE CARDIZEM APPROVAL EXPECTED by mid-January, the developer and manufacturer of the sustained release formulation, Elan Pharmaceutical, predicts. In an Oct. 20 R&D update to shareholders, Elan said the two companies "are expecting approval of our twice-daily dosage form of diltiazem (Cardizem) in 30 to 90 days." Elan said it has already started shipping product from Ireland to Marion "for inventory buildup prior to launch in anticipation of this approval." Elan announced in September that it had begun start-up manufacturing of the b.i.d. Cardizem. An NDA for the product was filed in 1986. Elan is also working on a once-a-day formulation of Cardizem for both Marion and the drug's discoverer, Tanabe. Elan is "continuing the scale up and testing of the once-daily formulation. Clinical studies" are ongoing in Japan and are anticipated to start in the U.S. early next year," Elan said. Cardizem will likely be the third calcium channel blocker to be available in a one-a-day dosage form. Once-daily verapamil was launched by Searle and Knoll late last year and an NDA for Procardia GITS, which uses Alza technology, was submitted by Pfizer in January. In addition, Bayer's nitrendipine, which will be co-marketed with Roche, could be approved with a one-a-day dosage. "We predict that our dosage form will replace a substantial amount of the sales of the conventional Cardizem tablet," Elan told shareholders. "We also believe that our dosage form along with a new hypertension claim would provide a defense against possible ANDAs of the conventional tablet form for this product." Although Marion's patent for Cardizem expires in 1988, the drug carries Waxman/Hatch Act protection from ANDA approvals until 1992. Commenting on the progress of its transdermal nicotine patch, Elan said that "custom designed equipment for the commercial production of our nicotine patch has been delivered to our facilities in Ireland." The company added that it expects marketing of the product in Europe and Southeast Asia "during the next year." Elan announced a worldwide licensing deal with a "major U.S. multinational pharmaceutical corporation" in May ("The Pink Sheet" May 11, T&G-4). The licensee is expected to conduct clinicals in the U.S. Elan retained marketing rights for Southeast Asia and Ireland.

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