ATHLONE, Ireland, June 30, 2015 (GLOBE NEWSWIRE) -- Innocoll AG (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the Cogenzia gentamicin collagen matrix has received Qualified Infectious Disease Product (QIDP) designation for the adjunctive treatment of moderate and severe diabetic foot infection from the FDA.
The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, to increase the incentives for drug manufacturers to produce new antibiotics for serious and hard-to-treat bacterial and fungal infections. Receiving QIDP designation means that Cogenzia is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
Diabetic foot ulcers are a serious health concern and affect approximately 7% of diabetic patients each year. Up to approximately 58% of these ulcers may become infected. Published data demonstrates that the current standard of care for diabetic foot infections (DFIs) with systemic antibiotics has a 30-50% failure rate. Failure of treatment can lead to significantly increased risk of hospitalization and often to the need for amputation resulting in increased costs to the healthcare system and a much higher risk of mortality for patients. We believe that Cogenzia has the potential to be the first topical antibiotic approved as adjunctive therapy for the treatment of DFIs and that it could significantly improve upon the current cure success rate.
Cogenzia acts in conjunction with systemic antibiotics and standard wound care to provide high concentrations of gentamicin directly to the site of DFIs. These concentrations are not normally possible with systemic gentamicin treatment due to the risk of side effects. In the Cogenzia Phase 2 program, data demonstrated a statistically significant improvement in the clinical cure rate when compared to systemic antibiotics and wound care alone. In the Phase 2 study, 100% of Cogenzia-treated subjects experienced a clinical cure compared to 70% for the control group.
"We are very pleased to receive QIDP designation for Cogenzia for the treatment of moderate and severe diabetic foot infections," stated David Prior, Executive Vice President of Global Regulatory Affairs for Innocoll. "We believe the importance of Cogenzia as a new treatment option is further endorsed by FDA granting this designation."
About Innocoll AG
Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.
Forward-looking Statements
"Any statements in this press release about our future expectations, plans and prospects, including statements about the development of Cogenzia for the adjuvant treatment of diabetic foot infections, such as the timing, conduct and outcome of the Phase 3 studies for Cogenzia, including Cogenzia receiving Fast Track designation and Priority Revie, the likelihood it would receive extended market exclusivity and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of Cogenzia. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in developing and commercializing our products and product candidates, the timing for results, the initiation, conduct and timing of clinical trials, delays in potential approvals by FDA of the commencement of trials, availability of data from clinical trials, positive results from such trials and timing and expectations for regulatory approvals, our scientific approach and general development progress, the composition of our supervisory board, the availability or commercial potential of our product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release."