Innocoll receives fast track designation for Gentamicin surgical implant

Nov 17 2008

Innocoll, Inc., a privately-held biopharmaceutical company, announced that the FDA has designated Gentamicin surgical implant as a Fast Track development program.

Gentamicin surgical implant is currently being evaluated in two phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections.

The FDA's fast track programs are designed to facilitate the development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This summer, Innocoll entered into an exclusive License and Distribution Agreement with Baxter Healthcare Corporation for its Gentamicin surgical implant for the U.S. market. Baxter has not yet determined a brand name for this product.

Michael Myers, Ph.D., Innocoll chief executive officer said, "We are very pleased that the FDA has granted the product Fast Track status which recognizes that the product is intended to prevent a serious or life-threatening condition and represents an unmet medical need. We look forward to working closely with Baxter to register and commercialize the product in the U.S., which will provide surgeons across a broad range of surgical specialties with more options for their patients."

Gentamicin surgical implant is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and (outside of the U.S.) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. Gentamicin surgical implant is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and there are more than 60 prospective clinical trials and published case reports totaling over 7,500 patients documenting its safety and efficacy over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures.