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RECORDATI SEEKING U.S. PARTNERS FOR CONTROLLED-RELEASE SUSPENSION SYSTEM

Executive Summary

RECORDATI SEEKING U.S. PARTNERS FOR CONTROLLED-RELEASE SUSPENSION SYSTEM and is negotiating with a U.S. firm to bring a non-steroidal anti-inflammatory drug using the system into U.S. clinical trials this year, the Italian pharmaceutical/chemical firm said. Recordati R&D Director Abraham Sartani, MD, unveiled his company's new controlled-release suspension system (CRSS) at the Mabon Securities drug delivery conference in New York City Feb. 19. A controlled-release NSAID drug suspension began "pilot kinetic studies" in humans in Europe this year, Sartani said. The original product is a market leader, the company said. Recordati expects that the U.S. partner will begin clinical trials before the end of 1992. The controlled-release suspension system is designed to provide controlled delivery of therapeutics to patients, especially the elderly, who may have difficulty swallowing pills. The controlled-release microgranules are stable in solution but release their contents at a controlled rate inside the body. Sartani presented human pharmacokinetic data showing that CRSS can deliver drugs in a profile similar to that of solid controlled- release formulas and without a significant food effect. European clinical trials of a theophylline CRSS began in 1991, Recordati said. In development is an analgesic CRSS which could be in U.S. trials via a partner in 1992, the firm said. The Italian company is also in negotiations with a U.S. firm to develop CRSS forms of other drugs. That deal, if concluded, could lead to U.S. clinical trials during 1993, Recordati said. Pennwalt attempted to use an extended release solution formulation (Pennkinetic) in the early 1980's to create a special niche in the cough/cold product market. Other European products that could come to the U.S. via marketing partners include: the topical antifungal fenticonazole, which is approved in Europe and is the subject of negotiations with a U.S. firm; the calcium channel blocker REC 15-2375 (Phase II/III); terflavoxate for urinary incontinence urge syndrome (Phase II); and a line of selective alpha blockers for benign prostatic hyperplasia (preclinicals). While currently relying on partners for any near-term pharmaceutical products in the U.S. market, Recordati hopes to develop a U.S. drug presence. The company operates a fine chemicals subsidiary in Pompton Plains, N.J. and has a drug delivery R&D presence through its subsidiary Pharmetrix. Recordati has a nicotine patch patent, which it licensed to Pharmetrix, which in turn licensed it to Elan. The patent is the basis of Elan's suits against other nicotine patch manufacturers and Pharmetrix will share any recoveries from the litigation ("The Pink Sheet" Feb. 24, p. 13). Lederle markets the patch developed by Elan in the U.S. as ProStep. Recordati expects to launch a patch in Italy this year as Nico-trans. Milan-based Recordati had sales of $260 bil. lira in 1991, or about $200 mil., Santamato told the Mabon Securities meeting. Pharmaceuticals accounted for about two-thirds of sales with fine chemicals and diagnostics providing the remainder. The successful launch of Syntex' Toradol injectable analgesic in Italy during 1991 was a primary factor driving sales growth, Santamato said. The company is forecasting 1992 sales of about $244 mil. Recordati has had a long relationship with Syntex. The firm has marketed Syntex pharmaceutical products in Italy since 1961 under an agreement that runs past the end of the decade.
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