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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections

ASHBURN, Va., April 30 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers, has commenced dosing. CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.

The product is already approved and marketed in Europe and other non-US territories as a surgical implant for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues; and is also in Phase 3 clinical development in the US for the prevention of surgical site infections. The development of the topical indication is based upon a series of published clinical case studies and anecdotal reports from clinicians where the marketed implant product has been used topically for treatment of infected chronic wounds of various etiologies. These data support its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.

CollaRx GENTAMICIN TOPICAL is currently under investigation for the treatment and prevention of diabetic foot infections of varying severity in a series of multi-centred phase 2 clinical trials. The first and second trials are investigating the product as a mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers and as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines. This third and final phase 2 trial will investigate the product for the prevention of diabetic foot infections.

Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. Many such wounds become clinically infected and require treatment with antibiotics. However, early diagnosis of diabetic foot infections is a clinical challenge as typical signs and symptoms of infection, such as pain, redness, or elevated circulating inflammatory markers, can be absent in individuals with neuropathic or neuroischaemic ulcers. Failure to diagnose and treat such infections can lead rapidly to the infection spreading, with the possibility of tissue necrosis, gangrene, osteomyelitis, and ultimately the prospect of a lower leg amputation.

Currently there are no antibiotics on the market specifically indicated for the prevention of diabetic foot infections. There is also reluctance by practitioners to use existing, systemically-acting antibiotics prophylactically because of concerns with systemic side effects and fear of propagating bacterial resistance with widespread use. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow, which may render systemically acting antibiotics less effective. By achieving very high localized concentrations of antibiotic, CollaRx GENTAMICIN TOPICAL is designed to overcome these concerns and this trial has received support from leading podiatrists and infectious disease specialists in the US as the first of its kind. Market research independently performed by L.E.K. Consulting has forecast peak annual US sales revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.

Dr. Michael Myers, Innocoll's President and CEO commented, "This is the third and final phase 2 trial planned for the development of our Gentamicin- Collagen sponge as a topically-acting antibiotic for the treatment and prevention of diabetic foot infections. It represents the seventh phase 2 or phase 3 clinical trial that we have initiated within the past six months on three different products, all of which are fully funded by Innocoll. Furthermore, we have an additional phase 2 and another phase 3 trial that we anticipate dosing within the next 3 months, illustrating our strong commitment to continue investing heavily in our exciting and innovative 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 US 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 Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll 's lead product, Gentamicin Surgical Implant for the treatment and prevention of surgical site infections, is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP(R) G, COLLATAMP(R) EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R), GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R). In 2005, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. 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 .

SOURCE Innocoll, Inc.
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