FDA Designates Gentamicin Surgical Implant (Collatamp G) as a Fast Track Development Program

Published Monday, November 17 2008

Gentamicin Surgical Implant, presently sold in Canada under the brand name Collatamp G, is currently being evaluated in the US 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.

In 2008, 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. Mississauga-based Theramed Corporation has exclusive rights to Collatamp G in Canada.

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.

About Innocoll

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx® and Liquicoll®.

Other late stage pharmaceutical products in Innocoll’s development pipeline include CollaRx GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers and CollaRx BUPIVACAINE IMPLANT for the management of post-operative pain, both of which are currently in Phase 2 development.

For more information, please visit www.innocollinc.com

Veronica Kelly
Business Development
Innocoll Pharmaceuticals
Midlands Innovation & Research Centre
Dublin Road
Athlone
Co Westmeath
Phone: +353 (0) 90 6486834