2014

Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections

    ASHBURN, Va., Feb. 19 /PRNewswire/ -- Innocoll, Inc., a privately-held
 specialty pharmaceutical company, announced that the second of two phase 3
 clinical trials sponsored by its wholly owned subsidiary, Innocoll
 Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for
 the prevention of surgical site infections, has commenced dosing.
 
     GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind
 surgical implant impregnated with the broad spectrum aminoglycoside
 antibiotic, gentamicin. It is designed to provide a high concentration of
 gentamicin (which has a concentration-dependent mechanism of action)
 directly to the target tissue for localized action, while maintaining low
 systemic levels well below the toxicity threshold. The product was
 developed using Innocoll's proprietary collagen-based drug delivery
 technology, CollaRx, and (outside of the US) is indicated as an adjunct to
 systemic antibiotic therapy for the treatment of localized, deep tissue
 infections and the prevention of surgical site infections in both hard and
 soft tissues. GENTAMICIN SURGICAL IMPLANT is already approved in 49
 countries spanning Europe, Latin America, Middle East, Africa and Asia and
 there are more than 60 prospective clinical trials and published case
 reports totaling over 7,500 patients documenting its safety and efficacy
 over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and
 neurosurgical procedures.
 
     According to advice from FDA received at both pre-IND and post-IND
 meetings held in 2007, Innocoll will conduct two multi-centered phase 3
 clinical trials in the US to support the planned New Drug Application
 (NDA). The first trial in cardiac surgery patients at higher risk of
 surgical site infection commenced in December 2007. The second trial, which
 has now enrolled its first patient, is in general surgery patients
 undergoing open colorectal surgery. Innocoll has appointed Duke
 University's Duke Clinical Research Institute (DCRI) as the Study
 Coordinating Center for both trials. Approximately 50 sites will be
 recruited for the trial in patients undergoing cardiac surgery and 35 sites
 for the colorectal surgery trial.
 
     Open colorectal surgery is widely considered to be the most prone to
 surgical site infection and the design of the trial is based upon an
 approved and well established use of GENTAMICIN SURGICAL IMPLANT for this
 indication in Europe. The results of several such studies have been
 published, including one prospective, randomized, controlled clinical trial
 in 221 patients which demonstrated a 70% decrease in surgical site
 infections from 18.4% in the control group to 5.6% in the patients treated
 with the implant.
 
     According to the latest statistics published by the Pennsylvania Health
 Care Cost Containment Council (PHC4), one of the few U.S. States mandated
 to collect such data, patients that contracted a surgical site infection
 spent an average of 14.5 days in hospital at an average hospital charge of
 $132,110 compared to 4.7 days and $33,267 for patients that had no
 hospital-acquired infection. Independent market research recently performed
 by L.E.K. Consulting has conservatively projected peak US sales of
 GENTAMICIN SURGICAL IMPLANT to be greater than US$200 million per annum.
 
     Dr. Michael Myers, Innocoll's President and CEO commented, "As an
 already approved product in Europe and elsewhere with proven safety,
 efficacy and pharmacoeconomics, we believe that the development of our
 Gentamicin Implant for the US market represents an excellent commercial
 opportunity and value proposition for our shareholders. With the
 commencement of this second phase 3 trial, our sights are now well and
 truly set on NDA filing once these trials are complete."
 
     About Innocoll, Inc.
 
     Innocoll is a privately held, specialty pharmaceutical 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 http://www.innocollinc.com.
 
 
 

SOURCE Innocoll, Inc.
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