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Devices Surgery

 News Release - April 4, 2007

Innocoll Receives FDA Approval to Commence Phase 2 Clinical Development with its CollaRx(R) BUPIVACAINE IMPLANT for the Management of Post-operative Pain

ASHBURN, Va., April 4 (HSMN NewsFeed) -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase 2 clinical trial with its long-acting CollaRx® BUPIVACAINE IMPLANT for the management of post-operative pain in patients undergoing abdominal hysterectomy. The implant is a biodegradable and fully resorbable Bupivacaine-Collagen Sponge formulated using Innocoll's proprietary CollaRx technology. It is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic or orthopedic surgeries.

Post-operative 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 infusion pumps often used to provide continuous, long-term analgesia. Furthermore, infusion catheters 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 bupivacaine dose (150mg) far lower than administered by continuous or intermittent ambulatory infusion pumps of bupivacaine and 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."

In the US, Innocoll is planning to investigate the safety and efficacy of the product aimed at a variety of moderate and major surgical procedures in a series of phase 2 clinical trials. The lead study approved by FDA is a multi- centered trial in patients undergoing abdominal hysterectomy surgery in the absence of gynecological cancers. 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 after Caesarean section. About one third of women in the United States have had a hysterectomy by age 60h year and each year, more than 600,000 hysterectomies are performed across the country. Other procedures where the product could potentially be used routinely include caesarean section, inguinal hernia repair, open heart surgery, mastectomy, open gastrointestinal surgery, cholecystectomy, vascular surgery, and various orthopaedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone graft procedures.

Dr. Michael Myers, Innocoll's President and CEO commented, "This is the second of Innocoll's INDs that FDA has approved in the first quarter of this year. Furthermore, following a productive pre-IND meeting with FDA held on February 28, we expect to file a third IND in the second quarter for our Gentamicin Surgical Implant. The Gentamicin Implant is already on the market in Europe and we plan to open the IND at phase 3 for the US development of the product as an adjunctive therapy for the prevention of surgical-site infections. This marks an exciting time for Innocoll as we embark upon three clinical development programs in three different therapeutic categories."

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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