ASHBURN, Va., Sept. 26 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced the following status and progress updates regarding its clinical development programs and specialty pharmaceutical operations:
- Three Investigational New Drug (IND) Applications already approved
- GENTAMICIN SURGICAL IMPLANT to commence two US phase 3 multi-centered
clinical trials for the prevention of surgical site infection.
- CollaRx(R) GENTAMICIN TOPICAL to commence a series of phase 2 clinical
trials for the treatment and prevention of infected diabetic foot
- BUPIVACAINE SURGICAL IMPLANT to commence a series of phase 2 clinical
trials for the management of post-operative pain in a variety of soft
tissue and orthopedic surgery models.
- First patient dosing in at least five different clinical trials (three
in phase 2 and two in phase 3) expected before the end of 2007.
- IND submission planned for CollaRx(R) BUPIVACAINE TOPICAL, a new product
opportunity for the management of painful chronic and acute wounds.
- US Launch of CollaGUARD(TM), an advanced wound care product developed by
Innocoll and its first to be launched in the US, is planned for the
fourth quarter 2007.
- European sales and marketing infrastructure sold to EUSA Pharma in
Commenting on the update, Dr. Michael Myers, President and CEO of Innocoll Inc., said, "Our successes over the past few months have established a solid platform on which to build the future growth of the business. We are looking forward to the launch of our first product in the US with CollaGUARD and are poised to commence the clinical development of an exciting portfolio of late- stage pharmaceutical products. According to recent market research performed by L.E.K. Consulting, these three products between them have projected annual sales of approximately $800 million in the US alone."
About Gentamicin Surgical Implant
GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It was developed using Innocoll's proprietary collagen-based technology, CollaRx(R), and is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) at the target tissue while maintaining low systemic levels well below the toxicity threshold. The product is indicated as an adjunct to systemic antibiotic therapy for the prevention of surgical site infections and for the treatment of deep, localized infections in both hard and soft tissues. There are more than 60 prospective clinical trials and published case reports totalling over 7,500 patients documenting safety and efficacy over a broad range of orthopaedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and is marketed by EUSA Pharma 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).
GENTAMICIN SURGICAL IMPLANT is under development in the US for the prevention of surgical site infections. An IND has been approved by the FDA and Innocoll plans to conduct two US multi-centered phase 3 clinical trials; one in cardiac surgery patients at higher risk of surgical site infection and the other in patients undergoing open colorectal surgery. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Co-ordinating Center for both trials. Independent market research recently performed by L.E.K. Consulting projected peak US sales of greater than US$200 million per annum.
About CollaRx(R) Gentamicin Topical
CollaRx GENTAMICIN TOPICAL is a biodegradable collagen-based dressing that delivers the broad-spectrum antibiotic, gentamicin, directly to the infected wound environment for localized action. The product is already approved and marketed in countries outside the US as GENTAMICIN SURGICAL IMPLANT where a number of published clinical case studies and anecdotal reports from clinicians have pointed to its effectiveness in the treatment of infected chronic wounds of various etiologies. Innocoll plans to develop the topical indication for the global market. Initially the product will be investigated for the treatment of diabetic foot infections across the full range of severities in a series of phase 2 trials and has appointed the full-service Clinical Research Organization, Premier Research Group, to co-ordinate these studies. The lead indication is the treatment of diabetic ulcers having a mild infection where the safety and efficacy of CollaRx GENTAMICIN TOPICAL will be compared to an orally administered antibiotic. In subsequent phase 2 trials, Innocoll will investigate the product as an adjunct to systemic antibiotic therapy for treating diabetic foot infections of higher severity and also as a method to prevent diabetic ulcers from becoming clinically infected.
Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers and recent market research independently performed by L.E.K. Consulting forecast peak annual revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.
About Bupivacaine Surgical Implant
BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine. It has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge 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.
About CollaRx(R) Bupivacaine Topical
CollaRx BUPIVACAINE TOPICAL is the clinical development of BUPIVACAINE SURGICAL IMPLANT when applied topically for the management of painful chronic and acute wounds, including ulcers of various etiologies and burns. Patients with such wounds can suffer severe pain, especially when the dressing is changed. It is anticipated that CollaRx BUPIVACAINE TOPICAL will provide long- acting analgesia between dressing changes and significantly reduce pain at the time of dressing change. In addition to the analgesia provided by the bupivacaine, the fibrillar collagen matrix is also expected to provide supplementary wound healing benefits, ultimately leading to accelerated wound closure.
CollaGUARD is comprised almost entirely of purified type-I collagen protein and is clinically indicated in the US for the management of pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, partial and full thickness wounds, and superficial injuries. Unlike alginates, hydrogels and hydrocolloids used in other categories of advanced wound care products, collagen is a fully biodegradable and bioactive material with a pharmacological action that stimulates the natural wound healing process. In addition, CollaGUARD provides the barrier protection and transparency of film dressings, which allows the clinician to visually inspect and monitor the wound without removal.
About Innocoll, Inc.
Innocoll is a privately held, specialty pharmaceutical company focused on surgical and topical 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 and is entering phase 3 development in the US. 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. 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 Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit http://www.innocoll.com.
|SOURCE Innocoll, Inc.|
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