Innocoll Receives FDA Approval To Commence A Phase 2 Clinical Trial For The Topical Treatment Of Infected Diabetic Foot Ulcers

Innocoll, Inc., a privately-held
specialty pharmaceutical company, announced that the U.S. Food and Drug
Administration (FDA) has approved its Investigational New Drug (IND)
application to conduct a Phase 2 study for CollaRx(R) GENTAMICIN as a
topical antibiotic treatment for mildly infected diabetic foot ulcers.
CollaRx GENTAMICIN is a biodegradable and fully resorbable
Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's
proprietary CollaRx technology. Upon application to a wound, the product
releases gentamicin, a broad- spectrum, concentration-dependent
aminoglycoside antibiotic, 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, as a surgical implant, is already approved and
marketed in Europe and other non-US territories as an adjunct to systemic
therapy for the treatment and prevention of post-surgical site acquired
infection. Published clinical case studies and anecdotal reports from
clinicians using the marketed product suggest its effectiveness in the
treatment and cure of infected chronic wounds, including diabetic foot
ulcers.



Practically all ulcers are colonized with pathogenic bacteria, and a
high proportion become clinically infected requiring treatment with
antibiotics. Orally administered and injected antibiotics are often
associated with systemic side effects and widespread use leads 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 vascularised than soft tissue.



There are no topically applied antibiotics currently marketed in 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, as defined according to the clinical classification
in the IDSA Guidelines, in a series of phase 2 trials. The lead indication
is for the treatment of mild infection where CollaRx GENTAMICIN will be
compared to an orally administered antibiotic, the current standard of
care. In future trials, Innocoll plans to investigate the product as an
adjunct to systemic therapy for treating infections of higher severity and
also as a method to prevent ulcers from becoming clinically infected.



Commenting on the approval, Dr. Michael Myers, President and CEO of
Innocoll Inc., said, "We strongly believe that CollaRx GENTAMICIN has the
potential to become the standard of care for the treatment and prevention
of infected diabetic foot ulcers and are committed to undertaking the
necessary clinical trials to prove its safety, efficacy, and clinical
advantages. This product opportunity will be a major investment for the
Company and we expect it to become the platform for expanding our direct
sales and marketing from Europe into the US and an important growth driver
for the business as a whole. We are currently in the process of securing
the necessary finance to fund this and other near term clinical programs to
progress our development 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
nation's 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 CollaRx(R)



CollaRx is Innocoll Technologies' lead technology platform for the site
specific targeted delivery of a wide variety of medicines with particular
emphasis on antibiotics and anesthetics. The CollaRx technology also forms
the basis of Innocoll Pharmaceuticals' lead product, Gentamicin Surgical
Implant, a biodegradable leave-behind implant indicated for the treatment
and prevention of post-surgical acquired infection in both hard and soft
tissues. This product has been approved in more than 40 countries and is
marketed under the following different 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 Europe, Middle East, Africa and Asia.



About Innocoll, Inc.



Innocoll is a privately held, fully integrated, global, hospital
specialty pharmaceutical company specializing in surgical and
dermatological products. It develops and markets internationally a range of
medical products using its proprietary collagen-based technologies,
CollaRx(R) and Liquicoll(R). Innocoll, Inc. acquired the product rights for
Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of
Schering-Plough Corporation (NYSE: SGP) and has since assumed all sales,
marketing and distribution activities for the product. For more
information, please visit innocoll.


Innocoll, Inc.

innocoll