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GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behindsurgical implant impregnated with the broad spectrum aminoglycosideantibiotic, gentamicin. It is designed to provide a high concentration ofgentamicin (which has a concentration-dependent mechanism of action) directlyto the target tissue for localized action, while maintaining low systemiclevels well below the toxicity threshold. The product was developed usingInnocoll's proprietary collagen-based drug delivery technology, CollaRx, and(outside of the US) is indicated as an adjunct to systemic antibiotic therapyfor the treatment of localized, deep tissue infections and the prevention ofsurgical site infections in both hard and soft tissues. GENTAMICIN SURGICALIMPLANT is already approved in 49 countries spanning Europe, Latin America,Middle East, Africa and Asia and there are more than 60 prospective clinicaltrials and published case reports totaling over 7,500 patients documenting itssafety and efficacy over a broad range of orthopedic, colorectal,cardiothoracic, vascular, and neurosurgical procedures.
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According to advice from FDA received at both pre-IND and post-INDmeetings held in 2007, Innocoll will conduct two multi-centered phase 3clinical trials in the US to support the planned New Drug Application (NDA).The first trial in cardiac surgery patients at higher risk of surgical siteinfection commenced in December 2007. The second trial, which has now enrolledits first patient, is in general surgery patients undergoing open colorectalsurgery. Innocoll has appointed Duke University's Duke Clinical ResearchInstitute (DCRI) as the Study Coordinating Center for both trials.Approximately 50 sites will be recruited for the trial in patients undergoingcardiac surgery and 35 sites for the colorectal surgery trial.
Open colorectal surgery is widely considered to be the most prone tosurgical site infection and the design of the trial is based upon an approvedand well established use of GENTAMICIN SURGICAL IMPLANT for this indication inEurope. The results of several such studies have been published, including oneprospective, randomized, controlled clinical trial in 221 patients whichdemonstrated a 70% decrease in surgical site infections from 18.4% in thecontrol group to 5.6% in the patients treated with the implant.
According to the latest statistics published by the Pennsylvania HealthCare Cost Containment Council (PHC4), one of the few U.S. States mandated tocollect such data, patients that contracted a surgical site infection spent anaverage of 14.5 days in hospital at an average hospital charge of $132,110compared to 4.7 days and $33,267 for patients that had no hospital-acquiredinfection. Independent market research recently performed by L.E.K. Consultinghas conservatively projected peak US sales of GENTAMICIN SURGICAL IMPLANT tobe greater than US$200 million per annum.
Dr. Michael Myers, Innocoll's President and CEO commented, "As an alreadyapproved product in Europe and elsewhere with proven safety, efficacy andpharmacoeconomics, we believe that the development of our Gentamicin Implantfor the US market represents an excellent commercial opportunity and valueproposition for our shareholders. With the commencement of this second phase 3trial, our sights are now well and truly set on NDA filing once these trialsare complete."
About Innocoll, Inc.
Innocoll is a privately held, specialty pharmaceutical company focused onbiodegradable surgical implants and topically applied healthcare products. Itdevelops and manufactures a
