Healthcare Industry News:  diabetic foot ulcers 

Biopharmaceuticals Wound Care

 News Release - October 17, 2007

Innocoll Files Investigational New Drug Application for its CollaRx(R) BUPIVACAINE TOPICAL for the Treatment of Painful Chronic Skin Ulcers and Burns

ASHBURN, Va., Oct. 17 (HSMN NewsFeed) -- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has filed an Investigational New Drug (IND) application for its CollaRx® BUPIVACAINE TOPICAL, which is under development for the treatment of painful chronic skin ulcers and burns. The product is a biodegradable and fully resorbable BupivacaineCollagen Sponge formulated using Innocoll's proprietary CollaRx technology, which is already under phase 2 clinical development for the management of post-operative surgical wound pain.

Painful skin ulcers can affect a variety of patient populations, from bedridden persons suffering from decubitus or pressure ulcers to patients with venous stasis ulcers and other chronic wound conditions. It has been estimated that more than 20% of people who reside in long-term care facilities for 2 or more years will develop at least one pressure ulcer. Approximately 25% of sickle cell anemia patients experience chronic or recurrent leg ulcers. These ulcers can be intensely painful and can persist for months or years. Aside from escalating health care costs, persistently painful chronic wounds can affect patients emotionally, mentally, physically and socially. The development of more effective methods for relieving pain associated with burn injury is also identified as a major unmet medical need.

Chronic wound pain is typically controlled with oral analgesics, including narcotic opioids, but long-term systemic administration of these drugs can result in unfavorable side effects. The CollaRx BUPIVACAINE IMPLANT is intended to provide pain control at the wound site and thus reduce or eliminate the requirement for systemic analgesics. The product is comprised of a fully biodegradable and bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine. The collagen matrix naturally biodegrades and the bupivacaine is released to provide sustained local analgesia. It is anticipated that CollaRx BUPIVACAINE TOPICAL will provide long-acting analgesia between dressing changes and significantly reduce pain at the time of dressing change. In addition to the analgesia provided by the bupivacaine, the fibrillar collagen matrix is expected to provide supplementary wound healing benefits, ultimately leading to accelerated wound closure.

Under the IND, Innocoll initially plans to conduct a two-way, placebo- controlled, multi-centered phase 2 clinical trial in patients with a painful chronic skin ulcer. Commenting on the filing, Dr. Michael Myers, Innocoll's President and CEO said 'We already have very encouraging clinical data for our CollaRx Bupivacaine product in the management of surgical wound pain and we view this new indication as an exciting opportunity to extend its application from acute to chronic use. Patients suffering from painful chronic wounds and burns can be extremely debilitated and we hope this product will offer a novel method of treatment."

About CollaRx®

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 and is in phase 3 development in the US. 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 topical products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen- based technologies, CollaRx® and Liquicoll®. 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® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL®. 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. 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 www.innocoll.com.


Source: Innocoll

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