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

Apr 30, 2008, 01:00 ET from Innocoll, Inc.

    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
     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)
 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.