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Devices Surgery

 News Release - March 29, 2007

Innocoll Files US and Irish Patent Applications for its CollaRx(R) BUPIVACAINE IMPLANT for the Management of Post-operative Pain

ASHBURN, Va., March 29 (HSMN NewsFeed) -- Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd has filed US and Irish patent applications for its CollaRx® BUPIVACAINE IMPLANT, which is under development for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic or orthopedic surgeries. The implant is a biodegradable and fully resorbable Bupivacaine-Collagen Sponge formulated using Innocoll's proprietary CollaRx technology.

Pain has been designated as the '5th vital sign' by the WHO and post- operative pain is often poorly controlled and widely considered as a poorly met medical need. Every year over 150 million people undergo surgery and billions of dollars are spent on post-operative pain management. Post-surgical pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including difficulty breathing, sedation, nausea and vomiting and can affect patients' recovery. The CollaRx BUPIVACAINE IMPLANT is intended to provide pain control at the surgical site and thus reduce the level of additional analgesia required after surgery. The product is comprised of a fully biodegradable and bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine. The bioresorbable nature of the collagen matrix avoids the need for removal of a catheter by a healthcare professional, as is necessary for ambulatory pain pumps. Furthermore, ambulatory pain pumps can fall out, shift, lead to infection and can be cumbersome during physical therapy.

A key feature of Innocoll's Bupivacaine implant is the ability to place it directly into the surgical vault and at different layers within the wound such as across the incision in the peritoneum and between the sheath and skin around the incision. This enables the effective, localized treatment of both the incisional and deep, visceral pain components associated with moderate and major surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post-operatively. In addition to pain relief, the collagen matrix also provides hemostasis and promotes wound healing after surgery.

Innocoll is currently conducting a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers at Wexham Park Hospital, Slough, UK. The preliminary results of the ongoing trial are particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on morphine by PCA (patient-controlled analgesia). This has been achieved despite a low dose (150mg), which is comparable to that sometimes used by practitioners for a once-off wound infiltration prior to wound closure. Commenting on the UK trial, the Principal Investigator, Mr. P.W. Reginald, said "To date all patients have responded very well to treatment and were mobilised by the first day after surgery. VAS pain scores were consistently low and post-operative PCA morphine was very low or even zero. These observations indicate that the bupivacaine sponge is providing the desired analgesic effect and patient outcomes have been most convincing."

Innocoll has recently filed an Investigational New Drug (IND) application with the FDA and plans to conduct a, US multi-centered phase 2 clinical trial in hysterectomy patients. The three-armed trial will compare the analgesic effect of the Bupivacaine Implant versus a placebo implant and current standard of care. Hysterectomy is the second most common major surgery among women in the United States and each year, more than 600,000 hysterectomies are performed. About one third of women in the United States have had a hysterectomy by age 60. Hysterectomy is just one of many surgeries where Innocoll's Bupivacaine Implant could potentially be used routinely; others may include open inguinal hernia repair, open gastric procedures, cholecystectomy, vascular surgery, and various orthopedic surgeries such as hip and knee replacement, bunionectomy and certain bone graft procedures.

Dr. Michael Myers, Innocoll's President and CEO stated 'We are very pleased to have filed these patent applications for the Bupivacaine Implant, which is an important new application of our proprietary CollaRx technology following the successful commercialization of our Gentamicin Collagen Implant for the treatment and prevention of surgical site infections. We are particularly excited about the promising early results from the ongoing UK clinical trial, which have shown sustained analgesia throughout the vital three to four day post-operative period despite only a low total dose of anesthetic being used. We believe this gives the product significant commercial advantage over the pain pumps, which are not only inconvenient to use, but require much higher doses of drug to be effective over the same time period."

About CollaRx®

CollaRx is Innocoll's lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll's lead product, Gentamicin Surgical Implant, a biodegradable leave- behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues. This product has been approved in over 40 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®.

About Innocoll, Inc.

Innocoll is a privately held, fully integrated, global, hospital specialty pharmaceutical company specializing in surgical and dermatological products. It develops and markets internationally a range of medical products using its proprietary collagen-based technologies, CollaRx® and LiquiColl®. Innocoll acquired the product rights for Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP ) and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit www.innocoll.com.


Source: Innocoll

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