Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate...

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

ASHBURN, Va., April 17 /PRNewswire/ -- Innocoll, Inc., a privately-held
biopharmaceutical company, announced that the second 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.
CollaRx GENTAMICIN TOPICAL is the clinical development of Innocoll's
Gentamicin-Collagen Sponge as a therapy for the treatment and prevention of
infected chronic wounds. 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. 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 was
applied topically to chronic wounds of various etiologies. These data support
its effectiveness for such clinical applications, particularly in the
treatment of infected diabetic foot ulcers.
Chronic ulcerations are often colonized or contaminated with bacterial
pathogens that can prevent ulcers from healing. A high proportion of such
wounds becomes clinically infected and requires treatment with antibiotics.
Orally and parenterally administered antibiotics are often associated with
systemic side effects and widespread use can lead 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 vascularized than soft tissue.
Currently, there are no topically applied antibiotics marketed in the US that
are specifically indicated for the treatment of infected diabetic foot ulcers
and recent market research independently performed by L.E.K. Consulting
forecast peak annual US sales revenues for CollaRx GENTAMICIN TOPICAL
approaching US$270 million, when limiting the sales projections to diabetic
foot indications only.
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 of these trials,
which commenced in late 2007, is investigating the product as a
mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers
where the safety and efficacy of CollaRx GENTAMICIN TOPICAL will be compared
to an orally administered antibiotic (the current standard of care). This
second phase 2 trial will investigate the product as an adjunct to systemic
antibiotic therapy for treating moderately infected ulcers, as defined
according to Infectious Disease Society of America (IDSA) guidelines. The
third phase 2 trial, planned to commence later this month, will investigate
the product for the prevention of infection in diabetic foot ulcers.
Dr. Michael Myers, Innocoll's President and CEO commented, "Our
Gentamicin-Collagen sponge is already used successfully in Europe and
elsewhere as an adjunct for the treatment diabetic foot infections, where
physicians have reported it can help to salvage limbs that may otherwise be
amputated. Since there are currently no topical antibiotics on the market for
infected diabetic foot ulcers, we view this phase 2 program as a significant
step towards treating and potentially preventing this highly serious and
widely prevalent complication of diabetes."
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 www.innocollinc.com .
SOURCE Innocoll Inc

Martha Clancy, Corporate Communications Officer of Innocoll Inc, +353 (0) 9064
86834, mclancy@innocollinc.com