FDAnews
www.fdanews.com/articles/109779-baxter-signs-licensing-agreement-for-innocoll-rsquo-s-surgical-implant

Baxter Signs Licensing Agreement for Innocoll’s Surgical Implant

August 25, 2008

As part of a new licensing agreement, Baxter Healthcare has gained exclusive rights to market and distribute Innocoll Pharmaceuticals’ gentamicin surgical implant in the U.S.

The collagen-based implant is the first biodegradable, leave-behind surgical sponge used as an adjunct therapy for preventing and treating surgical site infections, Baxter said. It delivers the antibiotic gentamicin to the target tissue while maintaining low levels of the drug to reduce infection during and after surgery.

The product is approved in 49 countries in Europe, Latin America, the Middle East, Africa and Asia and is in two Phase III clinical trials in the U.S. to support a planned 2009 NDA for regulatory approval.

Under the agreement, Baxter will pay a license fee and clinical, regulatory and commercial milestone payments, as well as contribute to the Phase III clinical costs. Innocoll will manage the clinical programs and regulatory filing, and will manufacture and supply the product.