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SANDOZ TO DEVELOP AND CO-MARKET SCHERING's ACE INHIBITOR SPIRAPRIL

Executive Summary

SANDOZ TO DEVELOP AND CO-MARKET SCHERING's ACE INHIBITOR SPIRAPRIL under an agreement announced by Schering-Plough on April 23. Under the terms of the agreement, Schering said, "Sandoz will complete product development and worldwide health registration of spirapril and has the right to manufacture the product." Schering will retain rights to comarket the angiotensin converting enzyme (ACE) inhibitor worldwide. Schering expects to complete Phase II studies of spirapril (formerly designated SCH 33844) in the U.S. this summer. Sandoz will then conduct Phase III studies of the drug both in the U.S. and overseas. The agreement "calls for Sandoz to pay an undisclosed sum of money at the outset," Schering said, "and provides for specific royalty obligations and profit sharing arrangements." Schering added that "both companies expect significant market benefits to be derived from spirapril." The ACE inhibitor is being studied in both hypertension and congestive heart failure. Explaining Schering's reasons for entering into the Sandoz agreement, Schering-Plough Group VP-Pharmaceutical Operations Donald Conklin noted: "Schering is intent upon expanding its presence in the worldwide cardiovascular market through various business strategies. This agreement enhances Schering's ability to market a variety of unique antihypertensive agents for different segments of the cardiovascular market, by marshalling the resources of two large multinational companies to launch this product." There are currently two ACE inhibitor agents on the U.S. market: Squibb's Capoten and Merck's recent entry, Vasotec. In addition, Merck announced at its annual meeting April 22 that an NDA for its second generation ACE inhibitor Prinivil (lisinopril) has been filed with FDA. Squibb has a second generation ACE inhibitor, zofenopril, in Phase III clinicals. Other ACE inhibitors in development include Parke-Davis' indolapril (in Phase III), quinapril (in Phase II), and CI 925 (Phase II); Hoechst-Roussel's ramipril; and Rorer's pivopril. Ciba-Geigy and Wyeth have ACE inhibitor agents further back in development.
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