Founded in January 2010, Dipexium Pharmaceuticals, LLC is an emerging biotechnology
company formed to develop and commercialize Locilex™ (pexiganan acetate cream 1%), a novel,
broad spectrum, small peptide topical antibiotic for the treatment of certain mild and moderate skin
infections in superficial wounds. Initially, Locilex™is targeted for the treatment of mild infections of
diabetic foot ulcers. Based on a compilation of available clinical and pre-clinical data, Locilex™ is
also considered a promising product candidate, to treat mild or moderate acute bacterial skin and
skin structure infections in superficial wounds, including infected decubitus ulcers, infected burns,
infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus
Locilex™ has been used successfully in Phase 3 clinical studies demonstrating significant clinical
benefit in patients with mild or moderate diabetic foot infections (See “About Locilex™”). Dipexium
has supported the Locilex™ clinical database recently by conducting microbiology studies that
highlight the sensitivity of resistant bacteria, including MRSA, VRE (vancomycin-resistant
Enterococcus), ESBL (extended-spectrum β-lactamase) and multi-drug resistant (MDR) bacteria,
to Locilex™’s active ingredient. Because of the increased prevalence throughout the world of multi-
drug-resistant bacteria and XDR bacteria in all types of skin infections Locilex™ may provide an
important therapeutic advance.
Currently, Dipexium is working actively with the Food and Drug Administration (FDA) to complete
certain regulatory matters required to initiate two new Phase 3 LocilexTM registration trials.
Expected to be run in parallel, these randomized, placebo-controlled, double-blind trials are
designed to demonstrate the superiority of Locilex™ vs. placebo in treating mild infections of
diabetic foot ulcers.
Dipexium was co-founded by Robert J. DeLuccia and David P. Luci, pharmaceutical executives
who together have over 50 years’ experience in the healthcare industry sector with a strong track
record of drug development and creating shareholder value.
Dipexium implements a “de-risking strategy” designed to enhance value by achieving a series of
near-term value inflection points designed to reduce risk and thereby create shareholder value.
Executing the most direct regulatory/clinical pathway to market embraces four primary operating
principles: (1) reducing the execution risk associated with selecting more comprehensive, costly
and time consuming clinical and regulatory pathways, (2) achieving multiple, near-term, targeted
value inflection points critical to corporate and business development for an emerging
biopharmaceutical company, and (3) successfully completing non-dilutive capital formation