-- Planned Marketing Authorization Application for Locilex® in Europe for treatment of patients with diabetic foot infection appropriate for topical therapy not expected to require any new clinical trials
NEW YORK, June 2, 2015 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), today announced that it has received advice from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) with regard to the clinical and regulatory aspects of Dipexium's planned submission of a Marketing Authorization Application (MAA) for Locilex® for topical treatment of patients with diabetic foot infection (DFI) in European Union.
Based upon the clinical and regulatory advice received, Dipexium plans to file an MAA under EMA's centralized process without the need to conduct European clinical trials. This submission will consist of efficacy results from the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials currently enrolling in the U.S., as well as the safety, microbiological, and systemic exposure/pharmacokinetic data from these studies and other studies that Dipexium intends to submit in its planned New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). Subject to obtaining favorable efficacy, safety and pharmacokinetic (PK) data in the OneStep-1 and OneStep-2 clinical studies, the Company intends to submit the MAA promptly following the NDA submission anticipated for 2016.
"We are delighted to have the opportunity to access the European market, the second largest pharmaceuticals market in the world, while avoiding the significant time, resource and customary risk associated with conducting additional clinical trials, assuming favorable data from the OneStep clinical trials," stated David P. Luci, President & CEO of Dipexium. "We believe approval of Locilex® in Europe would constitute a significant therapeutic advance as it would constitute one of the few new classes of antibiotics approved in decades," Mr. Luci added.
"We are very appreciative and gratified by the advice from the EMA and expect that the U.S. non-clinical and clinical data package to be submitted in our NDA will be acceptable to EMA without the need to conduct any additional clinical or microbiology studies," stated Robert J. DeLuccia, Executive Chairman of Dipexium. "As we continue enrollment in our OneStep pivotal Phase 3 clinical trials, we look forward to successful completion of these groundbreaking studies that have the potential to change the paradigm of treatment for this common and frequently limb-threatening infection in diabetic patients with foot ulcers," Mr. DeLuccia added.
About Dipexium Pharmaceuticals, Inc.
Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide. Initially, Locilex® is targeted for the treatment of Mild DFI. Based on a compilation of available clinical and microbiology data, Locilex® is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of Dipexium Pharmaceuticals, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submission for Locilex®) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
David P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
© 2015 Dipexium Pharmaceuticals, Inc. All rights reserved.
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