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Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
Date:9/26/2007

technology and is under international development for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic, and 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 suppression of breathing, sedation, nausea and vomiting; and can also affect patient recovery. Innocoll's BUPIVACAINE SURGICAL IMPLANT is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following 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. A key feature of Innocoll's product is the ability to implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneum incision and directly below the skin incision, which enables localized treatment of both the incisional and deep, visceral pain components in tandem.

The results of an initial clinical study performed at Wexham Park Hospital, Slough, UK, in patients undergoing hysterectomy surgery were particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours. Innocoll filed an IND in March 2007 and intends to conduct a series of phase 2, multi-centered, controlled clinical trials in a variety of soft tissue and orthopedic surgical models; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and anterior cruciate ligament (ACL) repair. BUPIVACAINE SURGICAL IMPLANT is believed to offer broad utility across a variety of surgical disciplines, as reflected in independent market research recently performed by L.E.K. Consulting which expects the product to achieve peak US sales nearing US$310 million.

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