ATHLONE, Ireland -- 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 forInnocoll. "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.