Download rrd international and dipexium pharmaceuticals, llc

For Immediate Release
RRD INTERNATIONAL AND DIPEXIUM PHARMACEUTICALS, LLC PARTNER TO
ADVANCE LOCILEX™ THROUGH CLINICAL TRIALS
ROCKVILLE, Md. and WHITE PLAINS, N.Y. – February 3, 2014 – RRD International, LLC (RRD), a product
development company that provides expert-level support to biopharmaceutical companies and
investors, announced today a partnership with Dipexium Pharmaceuticals, LLC (Dipexium) to develop
Locilex™ (pexiganan acetate cream 1%), a broad spectrum, small peptide topical antibiotic for the
treatment of mild to moderate skin infections in superficial wounds. Working closely with Dipexium’s
senior management under a product development team (PDT) structure, RRD will provide strategic,
regulatory and operational support to advance Locilex through clinical trials and New Drug Application
(NDA) submission.
“We’ve been working with Dipexium since 2010, planning for pivotal trials and resolving formulation
issues of Locilex based on feedback from the United States Food and Drug Administration (FDA),” said
Scott Tarrant, president, RRD. “With the establishment of this partnership, we will be able to leverage
our expertise to advance Locilex through clinical trials and the NDA review process.”
In addition to strategic oversight of the development program, RRD will be operationally responsible for
executing the clinical program, including interfacing with the FDA, trial management and vendor
contracting and coordination. The clinical program includes completion of two Phase 1 studies (DPX-110
and DPX-120) for skin irritation and skin sensitization and two Phase 3 registration trials (DPX-305 and
DPX-306) in patients with mild infections of diabetic foot ulcers.
“As an emerging biotechnology company, we quickly realized the value of RRD’s approach,” said David
P. Luci, co-founder and managing partner of Dipexium. “Engaging RRD has enabled us to more
effectively deploy capital, ensuring Locilex’s program spend is directed at maximizing commercialization
potential, while preventing premature investment in costly infrastructure. It is a resource-efficient
model that allows Dipexium to remain a lean, asset-focused company with what we believe is the
swiftest path to product approval.”
To meet its specific requirements, Dipexium was seeking a partnership with RRD that provided ongoing
senior-level, strategic guidance through the formation of a dedicated product development team and a
financial structure consisting of a fixed-fee development budget and equity participation by RRD.
“For us, it was critical that the partnership work for our stage of business, and we worked closely with
RRD to design a win-win agreement,” said Luci. “We look forward to a productive partnership, ultimately
resulting in the successful NDA submission and approval of Locilex.”
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About RRD International:
RRD International is a product development company that provides integrated, expert-level strategic,
regulatory and operational support to biopharmaceutical companies and investors. The Company’s
unique Product Development Team model (PDT) provides an effective, asset-centric alternative to
traditional industry practices. While comprehensive in value, structure and function – encompassing all
aspects of a development program including strategic planning, management and execution – the PDT
model is also highly resource efficient with an intense focus on minimizing cost, time and risk to achieve
human proof-of-concept (POC). Since 2002, RRD has worked with more than 100 organizations across all
major classes and therapeutic areas. For more information, visit rrdintl.com.
About Dipexium Pharmaceuticals, LLC:
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 microbiology data, Locilex™ is also considered a
promising product candidate, to treat acute bacterial skin and skin structure infections (ABSSSI) in
superficial wounds, including infected decubitus ulcers, infected burns, infected surgical wounds and
nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).
Contact Information:
Lisa Fels, Brightline Strategies on behalf of RRD International
703.739.2424 x110
[email protected]