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The collagen-based implant is saturated with a high concentration of anantibiotic, gentamicin, designed to deliver the antibiotic directly to thetarget tissue while maintaining low levels of the drug in order to potentiallyreduce infection during and after surgery. The gentamicin surgical implant isfully biodegradable and can be left in the body after surgery. According tothe Centers for Disease Control and Prevention, SSIs remain an ongoing problemfor surgeons and are a burden on patients and the healthcare system, affectingmore that 500,000 patients a year in the United States.
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The product was developed using Innocoll's proprietary, collagen-baseddrug delivery technology, CollaRx, and is indicated outside of the UnitedStates as an adjunct to systemic antibiotic therapy for the treatment oflocalized, deep tissue infections and the prevention of SSIs in both hard andsoft tissues.
The implant is approved in 49 countries spanning Europe, Latin America,the Middle East, Africa and Asia. It is currently in two Phase III clinicaltrials in the United States to support a planned 2009 New Drug Application forU.S. regulatory approval.
"We look forward to making this product available for surgeons to helpalleviate the burden of infections occurring from surgery. A gentamicinsurgical implant complements Baxter's surgical portfolio of products forhemostasis and tissue sealing," said Ron Lloyd, vice president and generalmanager of Baxter's BioSurgery business.
Baxter is a global, diversified healthcare company with many specialtybiologic products used in surgical settings for hemostasis, tissue sealing,tissue fixation and adhesion reduction. Innocoll, a privately heldbiopharmaceutical company, focuses on targeted biodegradable surgical implantsand topical products to reduce infection.
"We are very pleased to announce this agreement with Baxter, a recognizedmarket leader in specialty biologics," said Dr. Michael Myers, Innocoll chiefexecutive officer. "We look forward to establishing a strong partnership withBaxter as we prepare for NDA filing and subsequent launch in the U.S. market."
Under the terms of the agreement, Baxter will pay a license fee and willmake contingent clinical, regulatory and commercial milestone payments. Baxterwill also contribute to the Phase III clinical costs and a portion of theregistration fees. Innocoll will be responsible for the continued managementof the clinical programs and the regulatory filing. Innocoll will manufactureand supply product to Baxter. In accordance with generally accepted accountingprinciples, Baxter expects to record a pre-tax charge of approximately $12million for in-process research and development associated with thistransaction in the third quarter of 2008.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused onbiodegradable surgical implants and topically applied healthcare products. Itdevelops and manufactures a range of pharmaceutical products and medicaldevices using its proprietary collagen-based technologies, CollaRx(R) andLiquicoll(R). Innocoll's lead product, Gentamicin Surgical Implant for thetreatment and prevention
