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IVES TRANSDERMAL ISOSORBIDE DINITRATE AGREEMENT WITH MOLECULON BIOTECH

Executive Summary

IVES TRANSDERMAL ISOSORBIDE DINITRATE AGREEMENT WITH MOLECULON BIOTECH is aimed at providing Ives with marketing rights to new delivery form for the active ingredient in the Isordil line. A press release announcing the marketing arrangement noted that "the first stage of the agreement contemplates the development of a product as defined in the agreement." Following "necessary FDA approval," Moleculon would become the manufacturing company "on behalf of Ives. Ives has NDAs pending at FDA for several new uses and new dosage forms of Isordil. The company's NDAs are for use of the drug in congestive heart failure and for arterial spasm reduction after coronary bypass. In addition, the firm is trying to get FDA approval for three new dosage forms. With the Moleculon agreement, Ives joins at least one other firm, Marion, in the effort to develop a commercially successful isosorbide dinitrate product incorporating transdermal technology. Last April, Marion entered into a licensing agreement for a transdermal anti-anginal with two Japanese firms, Nitto Electric Industrial Company and Toa Eiyo. Marion's patch is in the early clinical testing stage. Under the terms of the Ives-Moleculon agreement, the marketing territory will be the U.S., its territories and possessions. The release points out that "Moleculon will be compensated by Ives pursuant to the agreement based upon Ives' commercial sales of the product."

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