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CHIRON INTRAOPTICS TO ENTER LASER FIELD VIA LICENSING PACT WITH TECHNOLAS

This article was originally published in The Gray Sheet

Executive Summary

CHIRON INTRAOPTICS TO ENTER LASER FIELD VIA LICENSING PACT WITH TECHNOLAS that grants Chiron the U.S. marketing rights to ophthalmic applications of the Munich, Germany-based firm's Keracor excimer laser. The Keracor laser is not approved for use in the U.S.; Chiron expects to file an investigational device exemption application for refractive surgery applications during 1993. Technolas introduced the multi-purpose laser in markets outside the U.S. in September. To date, the firm has sold 175 systems, of which 85 are being used in the ophthalmic field. Chiron currently is negotiating with Technolas for worldwide marketing rights for ophthalmic uses of the laser and hopes to reach an agreement in the early part of this year. Technolas would retain rights to non-ophthalmic applications of the laser. Upon gaining FDA approval of the Keracor ophthalmic products, Chiron will market the devices through its 60-member U.S. sales force. In Europe, it would distribute the lasers through its German subsidiary Adatomed and the European operation of IntraOptics, which the company acquired in January 1992 ("The Gray Sheet" Jan. 13, 1992, In Brief). Commenting on the move into the laser field in a Jan. 11 press release, Chiron says that "excimer lasers complement our strong R&D pipeline in refractive surgical instruments and further strengthen our position in the evolving refractive surgery segment, Chiron IntraOptics' fastest-growing market." On Jan. 11, Chiron IntraOptics also announced a development/marketing pact with Hamden, Connecticut-based Control Delivery Systems, Inc. related to "a drug implant system for intraocular delivery of therapeutic products." Under the agreement, Chiron gained exclusive worldwide marketing rights for ophthalmic applications of the drug delivery technology. Chiron is making an approximately $2 mil. equity investment in CDS for a 30% stake in the firm. CDS is retaining rights to non-ophthalmic applications of the technology, which it licenses from the University of Kentucky. Chiron will take over clinical trials of the technology, which currently is being studied as a treatment for cytomegalovirus (CMV-retinitis) in AIDS patients under an investigational new drug application granted to CDS. The drug delivery system under study consists of a quarter-inch long plastic tab that is 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, according to Chiron. Syntex' ganciclovir is approved for treatment of CMV via intravenous injections. Chiron says 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 estimates that total costs for the delivery system, drug and surgery would be about $10,000; treatments with intravenous injections of ganciclovir cost between $20,000 and $40,000 annually, according to Chiron. Currently in Phase II, the 80-patient, seven-site CMV study is evaluating the efficacy of four-month and eight-month versions of the drug delivery system. In Phase I trials, "the four-month method of delivery halted progression of CMV-retinitis in 28 of 30 patients, without the disadvantages associated with daily intravenous administration," according to Chiron. The firm says it expects to enter Phase III in the first quarter of 1993.
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