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

Mar 13, 2008, 01:00 ET from Innocoll, Inc.

    ASHBURN, Va., March 13 /PRNewswire-FirstCall/ -- Innocoll, Inc., a
 privately-held biopharmaceutical company, announced that the second 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 peritoneum 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 often 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 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
     For the planned series of phase 2 multi-centered, controlled clinical
 trials to be performed in the US, Innocoll has appointed Premier Research
 Group, a recognized industry leader in clinical research for acute and
 chronic pain, to co-ordinate up to five 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 patients undergoing abdominal hysterectomy commenced dosing in December
 2007. This second trial will compare the analgesic effect of BUPIVACAINE
 SURGICAL IMPLANT versus a placebo implant in patients undergoing open mesh
 herniorrhaphy at five different US sites.
     In addition to hysterectomy and inguinal hernia repair, other surgeries
 where the product could potentially be used routinely include caesarean
 section, mastectomy, open gastrointestinal surgery, 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. Detailed market research performed independently by
 L.E.K. Consulting has predicted peak US sales of BUPIVACAINE SURGICAL
 IMPLANT nearing $310 million.
     Dr. Michael Myers, Innocoll's President and CEO commented, "The dosing
 of this second phase 2 trial with our Bupivacaine Implant for the
 management of post-operative pain follows closely behind other phase 2 and
 phase 3 trials recently initiated with our topically-applied
 Gentamicin-Collagen sponge for the treatment of infected diabetic foot
 ulcers and our Gentamicin Surgical Implant for the prevention of surgical
 site infection. We also have a number of other phase 2 trials that are
 expected to commence in the near future, confirming our strong commitment
 to the development of our late stage product portfolio."
     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)
 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

SOURCE Innocoll, Inc.