Innocoll Announces Dosing of First Patient in a Second US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain

Friday, March 14, 2008 General News
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ASHBURN, Va., March 13 Innocoll, Inc., aprivately-held biopharmaceutical company, announced that the second of aseries of planned phase 2 clinical trials sponsored by its wholly ownedsubsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) BUPIVACAINESURGICAL IMPLANT for the management of post-operative pain, has commenceddosing.

Innocoll's BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fullybioresorbable matrix of purified fibrillar collagen impregnated with the localanesthetic, bupivacaine, which has been specifically developed and formulatedusing Innocoll's proprietary CollaRx sponge technology. It is underdevelopment in the US and Europe for the management of post-operative painfollowing moderate/major abdominal, gynecological, abdominal, thoracic, andorthopedic surgeries.

Post-operative pain is typically controlled with narcotic analgesics suchas morphine, but systemic administration of these drugs can result inunfavorable side effects including suppression of breathing, sedation, nauseaand vomiting, and can also affect patient recovery. Innocoll's BUPIVACAINESURGICAL IMPLANT is intended to provide pain control directly at the surgicalsite and thus reduce the level of additional analgesia required followingsurgery. The collagen matrix naturally biodegrades over a few days and thebupivacaine 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 itdirectly 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, visceralpain components normally associated with moderate and major surgery. Thebioresorbable nature of the collagen matrix also offers significant clinicalbenefits and convenience advantages over ambulatory infusion pumps often usedto provide continuous, long-term analgesia at the site of a surgical wound.

Innocoll has already completed a phase 2 clinical trial in patientsundergoing hysterectomy surgery in the absence of gynecological cancers atWexham Park Hospital, Slough, UK. The results of this trial were particularlyencouraging, showing evidence of sustained, post-operative analgesia forapproximately 96 hours as measured by VAS (visual analogue scale) scores andreduced dependence on systemic morphine administered by PCA (patient-controlled analgesia). This extended action was achieved despite a low totalbupivacaine dose (150mg as the hydrochloride salt), which is well below theallowable daily dose and equivalent to that used by some practitioners for aonce-off wound infiltration with bupivacaine solution prior to wound closure

For the planned series of phase 2 multi-centered, controlled clinicaltrials to be performed in the US, Innocoll has appointed Premier ResearchGroup, a recognized industry leader in clinical research for acute and chronicpain, to co-ordinate up to five trials in a variety of soft and hard tissueprocedures; including hysterectomy, herniorrhaphy, open gastrointestinalsurgery and orthopedic surgery. The first of these trials in patientsundergoing abdominal hysterectomy commenced dosing in December 2007. Thissecond trial will compare the analgesic effect of BUPIVACAINE SURGICAL IMPLANTversus a placebo implant in patients undergoing open mesh herniorrhaphy atfive different US sites.

In addition to hysterectomy and inguinal hernia repair, other surgerieswhere the product could potentially be used routinely include caesareansection, mastectomy, open gastrointestinal surgery, cholecystectomy, openheart surgery, vascular surgery, and various orthopedic surgeries such as hipand knee replacement, bunionectomy, open fracture repair and certain bonegraft procedures. Detailed market research performed independently by L.E.K.Consulting has predicted peak US sal

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