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

    ASHBURN, Va., July 28 /PRNewswire/ -- Innocoll, Inc., a privately-held
 biopharmaceutical company, announced that the third of a series of planned
 phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll
 Technologies Ltd, to investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT
 for the management of post-operative pain, has commenced dosing.
 
     Innocoll's BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fully
 bioresorbable matrix of purified fibrillar collagen impregnated with the
 local anesthetic, bupivacaine, which has been specifically developed and
 formulated using Innocoll's proprietary CollaRx sponge technology. It is
 under development in the US and Europe for the management of post-operative
 pain following moderate/major abdominal, gynecological, abdominal,
 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 peritoneal incision
 and directly below the skin incision, which enables localized treatment of
 both the incisional and deep, visceral pain components normally associated
 with moderate and major surgery. The bioresorbable nature of the collagen
 matrix also offers significant clinical benefits and convenience advantages
 over ambulatory infusion pumps which can be used to provide continuous,
 long-term analgesia at the site of a surgical wound.
 
     Innocoll has already completed a phase 2 clinical trial in patients
 undergoing hysterectomy surgery in the absence of gynecological cancers at
 Wexham Park Hospital, Slough, UK. The results of this trial were
 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 systemic morphine administered by
 PCA (patient- controlled analgesia). This extended analgesic action was
 achieved despite a low total bupivacaine dose (150mg as the hydrochloride
 salt), which is well below the allowable daily dose and equivalent to that
 used by some practitioners for a once-off wound infiltration with
 bupivacaine solution prior to wound closure.
 
     Innocoll has appointed Premier Research Group, a recognized industry
 leader in clinical research for acute and chronic pain, to co-ordinate up
 to five US phase 2 multi-centered, controlled clinical trials in a variety
 of soft and hard tissue procedures; including hysterectomy, herniorrhaphy,
 open gastrointestinal surgery and orthopedic surgery. The first of these
 trials in women undergoing abdominal hysterectomy commenced dosing in
 December 2007 and the second in men undergoing inguinal hernia repair
 commenced dosing in March 2008. This third multi-centered trial will
 compare the analgesic effect of BUPIVACAINE SURGICAL IMPLANT versus placebo
 in patients undergoing open gastrointestinal surgery.
 
     In addition to those surgeries currently being studied, other
 procedures where the product could potentially be used routinely include
 caesarean section, mastectomy, cholecystectomy, open heart surgery,
 vascular surgery, and various orthopedic 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 "The dosing
 of this third phase 2 trial is an important milestone in the development of
 our Bupivacaine Implant for the management of post-operative pain. Patient
 enrollment for the first two phase 2 trials is progressing well and we are
 eagerly anticipating the results of the US multi-centered hysterectomy and
 hernia trials later this year, which we believe will underpin the
 commercial opportunity this product presents."
 
     About Innocoll, Inc.
 
     Innocoll is a privately held, biopharmaceutical company focused on
 biodegradable surgical implants and topically applied healthcare products.
 It develops and manufactures a range of pharmaceutical products and medical
 devices using its proprietary collagen-based technologies, CollaRx(R) and
 Liquicoll(R). 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(R) G, COLLATAMP(R)
 EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R),
 GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R). 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. Gentamicin Surgical Implant is
 currently in phase 3 development in the US for the prevention of surgical
 site infections. 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.innocollinc.com.
 
 
 

SOURCE Innocoll, Inc.