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Innocoll, Inc. Enters Into Collaboration With TGR Biosciences for Development of a Novel Wound Healing Product


9/12/2007 9:25:17 AM

ASHBURN, Va., Sept. 12 /PRNewswire/ -- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has entered into a strategic collaboration with TGR BioSciences Pty Ltd to evaluate the combination of Innocoll's collagen-based drug delivery technology, CollaRx(R), with TGR Biosciences' proprietary wound healing compound, TGR-265.

Innocoll's CollaRx technology platform is a biocompatible and fully bioresorbable collagen matrix for localized drug delivery. It is comprised of purified type I fibrillar collagen and can be prepared in the form of a lyophilized sponge or film-cast membrane using a proprietary manufacturing process. Both CollaRx formats can be surgically implanted or applied topically to wounds, enabling drugs to be delivered locally to the intended site of action and thereby minimize any systemic-related side effects.

CollaRx matrices are biodegraded by natural enzymatic activity and fully resorbed within a few days or up to several weeks according to the local physiological environment. The in vivo release of drug from the CollaRx matrix takes place via a combination of diffusion and natural breakdown of the collagen to provide both rapid and prolonged release, which can be controlled through formulation techniques and processing variables. The CollaRx matrix also provides an initial scaffold for cell migration and proliferation, thereby stimulating production of certain cytokines and growth factors and so itself plays an integral role in the repair and replacement of both hard and soft tissue by accelerating tissue granulation and epithelialization.

TGR-265 is a naturally derived bioactive protein that has been shown through extensive in vitro and in vivo pre-clinical testing to stimulate the fibrogenic response, production of host type 1 collagen and deposition of extracellular matrix.

Under the terms of the collaboration, Innocoll will incorporate TGR-265 into the CollaRx sponge and membrane formats for further evaluation. TGR BioSciences will fund development of the formulated products.

Commenting on the agreement, Joan FitzPatrick, Executive VP Research & Development of Innocoll Technologies, said, "We are excited to be working with TGR BioSciences on development of this novel product concept combining both the wound healing properties of native collagen and TGR-265. We believe there is potential for their mechanisms of action to be both complementary and synergistic, which could then create a highly potent, elegant, and cost- effective wound healing product."

Dr. Michael Myers, President and CEO of Innocoll, Inc., stated, "This strategic collaboration is indicative of Innocoll's intention to fully exploit its technology platforms through partnership with innovative biotechnology and pharmaceutical companies looking to deliver their drugs locally. Despite investing heavily in the late stage clinical development of our own internal pipeline of products, we believe that partnerships such as this with TGR BioSciences are important for providing the Company with a wide and diversified portfolio of development projects for long term, sustainable growth."

About CollaRx(R)

CollaRx is Innocoll's lead technology platform for the site specific, local delivery of a wide variety of drugs with particular emphasis on antibiotics, anesthetics, anti-cancer agents and tissue regeneration proteins and peptides. The CollaRx technology forms the basis of Innocoll's lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant indicated for the treatment and prevention of surgical site infection in both hard and soft tissue. This product is already approved 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).

Other CollaRx sponge products under clinical development by Innocoll include a CollaRx Bupivacaine Implant for the management of post-operative pain and a topically-applied CollaRx Gentamicin Sponge for the treatment and prevention of diabetic foot infections. Innocoll's CollaRx membrane technology forms the basis of Innocoll's CollaGUARD(TM) advanced wound care product, which is approved as medical device in the EU and US. Both CollaRx formats can be surgically implanted or applied topically.

About Innocoll, Inc.

Innocoll is a privately held, specialty pharmaceutical company focused on surgical and dermatological 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 and is entering phase 3 development in the US. In 2005, Innocoll, Inc. acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. 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 Bupivacaine Implant for the management of post- operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocoll.com.

About TGR Biosciences

TGR BioSciences Pty Ltd is a private biotechnology company based in Adelaide, South Australia. TGR discovers and develops novel biologically active compounds by using a unique, proprietary high throughput screening technology developed by TGR. In addition to the application of this proprietary technology to its own discovery program, TGR generates revenues through the sale of SureFire(TM) assay kits to biotechnology and pharmaceutical companies through an alliance with Perkin Elmer LS, and by offering bioactive discovery collaborations worldwide.

TGR's primary business focus is on the discovery and development of scientifically proven products that can be marketed as high-value therapies in oral, gastro-intestinal health, dermatology, and skin repair. Its lead product is in Phase 2 clinical trials for the prevention of oral mucositis, the debilitating mouth ulcers that affect over 40% of all chemotherapy patients and 60% of head-neck radiotherapy patients. For more information, please visit www.tgr-biosciences.com.au.

Innocoll, Inc.

CONTACT: Martha Clancy, Corporate Communications Officer of Innocoll Inc.,+353(0)906-634902, mclancy@innocoll-tech.com



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