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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers
Date:12/18/2007

is a huge problem for sufferers and an overwhelming burden on healthcare systems worldwide. We understand from talking to physicians that our product can and has saved limbs when applied topically to infected ulcers. Since there are no other topical antibiotics on the market for infected diabetic foot ulcers, we view this trial as a significant step forward in treating and potentially preventing the condition. Being the first of two phase 2 and two phase 3 studies on three different products that we anticipate starting this month, the dosing of this patient represents the start of Innocoll's first clinical trial to be performed in the US and so marks an important milestone for the Company."

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, specialty pharmaceutical company focused on biodegradable surgical implants and topicall
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SOURCE Innocoll, Inc.
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