Innocoll Receives FDA Approval to Commence a Phase 2 Clinical Trial for the Topical Treatment of Infected Diabetic Foot Ulcers With its CollaRx(R) GENTAMICIN

Announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase 2 study for CollaRx® GENTAMICIN as a topical antibiotic treatment for mildly infected diabetic foot ulcers.

ASHBURN, VA, USA | Jan 22, 2007 |
Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase 2 study for CollaRx® GENTAMICIN as a topical antibiotic treatment for mildly infected diabetic foot ulcers. CollaRx GENTAMICIN is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll’s proprietary CollaRx technology. Upon application to a wound, the product releases gentamicin, a broad-spectrum, concentration-dependent aminoglycoside antibiotic, for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.

CollaRx GENTAMICIN, as a surgical implant, is already approved and marketed in Europe and other non-US territories as an adjunct to systemic therapy for the treatment and prevention of post-surgical site acquired infection. Published clinical case studies and anecdotal reports from clinicians using the marketed product suggest its effectiveness in the treatment and cure of infected chronic wounds, including diabetic foot ulcers.

Practically all ulcers are colonized with pathogenic bacteria, and a high proportion become clinically infected requiring treatment with antibiotics. Orally administered and injected antibiotics are often associated with systemic side effects and widespread use leads to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective. Infection can also spread to the bone (osteomyelitis), which is less well vascularised than soft tissue.

There are no topically applied antibiotics currently marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers. Innocoll plans to study the treatment of diabetic foot infections of varying severities, as defined according to the clinical classification in the IDSA Guidelines, in a series of phase 2 trials. The lead indication is for the treatment of mild infection where CollaRx GENTAMICIN will be compared to an orally administered antibiotic, the current standard of care. In future trials, Innocoll plans to investigate the product as an adjunct to systemic therapy for treating infections of higher severity and also as a method to prevent ulcers from becoming clinically infected.

Commenting on the approval, Dr. Michael Myers, President and CEO of Innocoll Inc., said, "We strongly believe that CollaRx GENTAMICIN has the potential to become the standard of care for the treatment and prevention of infected diabetic foot ulcers and are committed to undertaking the necessary clinical trials to prove its safety, efficacy, and clinical advantages. This product opportunity will be a major investment for the Company and we expect it to become the platform for expanding our direct sales and marketing from Europe into the US and an important growth driver for the business as a whole. We are currently in the process of securing the necessary finance to fund this and other near term clinical programs to progress our development pipeline.“

About Infected Diabetic Foot Ulcers
According to the Centers for Disease Control and Prevention (CDC), the estimated incidence of diabetes in the US exceeds 1.5 million new cases annually, with an overall prevalence of 20.8 million people, or 7% of the nation’s population. By 2030, the International Diabetes Federation predicts that the Global prevalence of diabetes will almost double from 193 million people (estimated in 2003) to 366 million.
An estimated 15% of patients with diabetes will develop a lower extremity ulcer during the course of their disease. According to a large prospective study, approximately 7% of diabetic patients with foot ulcers will require an amputation. Diabetic foot is the most common cause of nontraumatic lower extremity amputations in the US and Europe, with an average of 82,000 amputations per year in the US costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years post diagnosis. The total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.

About CollaRx
CollaRx is Innocoll Technologies’ lead technology platform for the site specific targeted delivery of a wide variety of medicines with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll Pharmaceuticals’ lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues. This product has been approved in more than 40 countries and is marketed under the following different trade names (COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL®) in Europe, Middle East, Africa and Asia.

About Innocoll, Inc.
Innocoll is a privately held, fully integrated, global, hospital specialty pharmaceutical company specializing in surgical and dermatological products. It develops and markets internationally a range of medical products using its proprietary collagen-based technologies, CollaRx and Liquicoll®. Innocoll, Inc. acquired the product rights for Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit www.innocoll.com.

SOURCE: Innocoll, Inc

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