Baxter licensing of Innocoll gentamicin
This article was originally published in The Gray Sheet
Executive Summary
Baxter will have exclusive rights in the U.S. to market and distribute Innocoll's gentamicinsurgical implant - a biodegradable, leave-behind antibiotic surgical sponge used as an add-on therapy for prevention and treatment of surgical site infections - when the device completes Phase III clinical trials and hopefully is approved by FDA sometime in 2009, a spokeswoman said Aug. 25. The device will be regulated as a drug and be reviewed by FDA's Center for Drug Evaluation & Research, according to the firm. Under the terms of the Innocoll deal, Baxter will pay a license fee and make contingent clinical, regulatory and commercial milestone payments, while Innocoll will supply the product and shepherd the FDA process. The product is available overseas