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CHIRON INTRAOPTICS IN OPHTHALMIC PACT WITH CONTROL DELIVERY SYSTEMS

Executive Summary

CHIRON INTRAOPTICS IN OPHTHALMIC PACT WITH CONTROL DELIVERY SYSTEMS that grants the Chiron ophthalmic unit exclusive world- wide marketing rights for ophthalmic applications of Hamden, Conn.-based CDS' drug delivery technology. Announced Jan. 11, the development/marketing agreement relates to CDS' "drug implant system for intraocular delivery of therapeutic products." Chiron is making an approximately $2 mil. equity investment in CDS for a 30% stake in the privately held firm. CDS is retaining rights to non-ophthalmic applications of the technology, which it licenses from the University of Kentucky. Chiron IntraOptics will take over clinical trials in the treatment of cytomegalovirus (CMV-retinitis) in AIDS patients being conducted under an IND granted to CDS. The drug delivery system under study consists of a quarter-inch long plastic tab inserted through a small incision in the posterior chamber of the eye. One end of the tab is sutured in place, while the opposite, bulge-shaped end is loaded with ganciclovir (Syntex' Acyclovir). The drug permeates the eye over a period of several months by seeping through a small opening in the inner container of ethyl vinyl acetate and migrating through an outer membrane of polyvinyl alcohol. FDA has not indicated whether the product will be regulated as a device, drug or a combination product. It is possible that the drugs in the system may require separate approvals. The system is currently in Phase II, with Phase III trials slated to begin in the first quarter of 1993. Syntex' ganciclovir is approved for treatment of CMV via I.V. injections. Chiron said it is in discussions with Syntex regarding the regulatory status and commercial rights to the drug when used in the delivery system. Chiron believes the CDS system could decrease costs of treatment for CMV-retinitis. The company estimated that total costs for the delivery system, drug and surgery would be about $10,000; annual treatments with I.V. ganciclovir cost between $20,000 and $40,000, Chiron calculated.

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