Innocoll AG Announces Qualified Infectious Disease Product (QIDP) Designation for Cogenzia for the Adjunctive Treatment of Moderate and Severe Diabetic Foot Infection
The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the
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
“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
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