2/3/2014 9:43:03 AM
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.”
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).
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