среда, 4 мая 2011 г.

Innocoll Files CollaRx(R) GENTAMICIN SURGICAL IMPLANT In Australia

Innocoll, Inc. announced its
wholly-owned subsidiary, Innocoll Pharmaceuticals Ltd., has submitted a
class III medical device application for its CollaRx(R) GENTAMICIN SURGICAL
IMPLANT to the Australian Therapeutics Goods Administration (TGA).



GENTAMICIN SURGICAL IMPLANT is a biodegradable leave-behind surgical
implant impregnated with the broad spectrum aminoglycoside antibiotic,
gentamicin. The product was developed using Innocoll's proprietary
collagen- based technology, CollaRx(R), and has been approved in 49
countries as either a medicinal product for the treatment and prevention of
surgical site infections or as a medical device. There are more than 50
prospective clinical trials and published case reports which document the
safety and efficacy of the product over a broad variety of orthopaedic,
abdominal, colorectal, cardiothoracic, vascular and neurosurgical
procedures totaling over 7,500 patients. It is currently marketed in
Europe, Latin America, Middle East, Africa and Asia 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).



According to the National Surveillance of Healthcare Associated
Infection in Australia (2001), it was estimated that surgical site
infections occur in 2% to 13% of patients, depending on the type of
surgery, and representing an annual healthcare burden of AU$268 million
(US$220 million).



Commenting on the announcement, Dr. Michael Myers, President and CEO of
Innocoll, Inc., said "The official estimates of costs associated with the
treatment of surgical site infections are quite staggering, even for a
country like Australia with a population of only 20 million. We further
believe that official estimates of infection rates grossly underestimate
the true extent of the problem when patients are properly followed in
well-controlled trials. Our product is clinically proven to prevent such
infections. This filing in Australia follows hot on the heels of our recent
Canadian submission and shows our commitment to growing the worldwide sales
of our leading Gentamicin Implant through launches in new international
markets and appointment of local distribution partners."



About CollaRx(R)



CollaRx is Innocoll's lead technology platform for the site specific
targeted delivery of a wide variety of drugs with particular emphasis on
antibiotics and anesthetics. The CollaRx technology also forms the basis of
Innocoll's 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.



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 innocollinc.


Innocoll, Inc.

innocollinc

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