Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to E... (with FDA and the product is expected to ...)

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Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma

Date:9/6/2007

with FDA and the product is expected to commence phase 3 clinical trials in the US later this year.

About CollaRx(R) Gentamicin Topical

CollaRx GENTAMICIN TOPICAL is a biodegradable collagen-based dressing that is under clinical development for the topical treatment and prevention of infected diabetic foot ulcers. The product is already approved and marketed in Europe as Gentamicin Surgical Implant and various clinical case studies and anecdotal reports from clinicians strongly suggest the product is similarly effective for the topical treatment and cure of infected chronic wounds, including diabetic foot ulcers. Currently, there are no topically applied antibiotics marketed in Europe or 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 in a series of phase 2 clinical trials scheduled to commence later this year under an approved IND. The lead indication is for the treatment of ulcers with a mild infection, where CollaRx GENTAMICIN will be compared to an orally administered antibiotic, the current standard of care. In other planned trials, Innocoll will investigate the product as an adjunct to systemic therapy for treating infections of higher severity and also as a prophylactic treatment to prevent ulcers from becoming clinically infected.

About CollaRx(R) Bupivacaine Implant

CollaRx BUPIVACAINE IMPLANT is biodegradable and fully resorbable surgical implant impregnated with the local anesthetic, bupivacaine. The product is formulated using Innocoll's proprietary CollaRx sponge technology and is currently under development for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic or orthopedic surgeries. The collagen matrix naturally biodegrades over a few days during which time the bupivacaine is released to provide sustained local analgesia. The results of an initial cl
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