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Executive Summary

ADRIA LABS TO MARKET ADRIAMYCIN IN PRE-FILLED VIALS UNDER LICENSING ACCORD with Duoject Medical Systems. Duoject granted Adria exclusive rights to its Vari-Vial drug packaging and delivery technology for its chemotherapy agents in North America. Adria Labs U.S. has filed for FDA approval of the new delivery system for Adriamycin (doxorubicin). Adria Labs of Canada received permission to sell the product in that country in May; sales will begin in August or September. Duoject says its patented technology allows manufacturers to make pre-filled Type 1 glass vials that can be converted into pre- filled syringes. The vials are designed to be open at both ends. One end has the traditional rubber stopper and aluminum seal, while the other accepts a rubber piston before the vial has been filled. The piston is the vial's bottom, becoming the plunger when the vial's content is injected. Vials are supplied with a cap containing a needle which fits on the top of the vial. Adria Labs estimates that it will be able to deliver commonly administered doses of Adriamycin to between 80% and 85% of users via the Vari-Vial system. Adria describes Vari-Vial delivery as "safer" and "more convenient." The system will cost Adria more per unit to manufacture but could give Adriamycin a convenience advantage over generic versions. Albuquerque N.M.-based Adria SP, which manufactures Adriamycin for Adria Labs U.S. and Canada, will manufacture the Vari-Vial dosage and supply it to both firms for marketing. Adria's parent company Erbamont has worldwide marketing rights for Vari-Vial with chemotherapy agents outside of North America. Duoject has licensed exclusive worldwide rights for use with hypnotic sedatives to ICI Pharma of Britain. Quebec-based Duoject maintains the technology is compatible with all parenteral injection and infusion systems.

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