NEW YORK, April 4, 2011 /PRNewswire/ -- Dipexium Pharmaceuticals today provided an update of its development activities and announced its milestones to be achieved during 2011. Management announced that it has completed successfully initial six-months' stability testing on the original formulation of Locilex™ (pexiganan acetate 1% cream) and has moved on with its manufacturers to expand the batch size for clinical and commercial production. In addition, the Company has received formal and clear clinical guidance from the FDA to support its Phase 3 clinical and regulatory pathway to resubmission of its new drug application (NDA) for Locilex™ in the U.S.
The Company also announced that its critical milestones for 2011 include the following:
- Manufacturing: The Company anticipates completing the work required to support its chemistry, manufacturing and controls (CMC) meeting with FDA in May 2011;
- CMC Meeting: The Company anticipates convening a CMC meeting with FDA in August 2011 to finalize the Company's manufacturing plans and use of product supply in the upcoming Phase 3 program;
- Special Protocol Assessment (SPA) Filing: The Company intends to file for a SPA designation in September 2011 shortly after the tentatively planned scheduled CMC meeting.
"Successfully achieving these value-inflection points should significantly reduce the risk associated with completing the drug development of Locilex™ and position the Company for further financing or other strategic alternatives," stated David P. Luci, Co-Founder & Managing Partner.
Dipexium Pharmaceuticals, LLC is an emerging biopharmaceutical company initially formed to complete the development and initiate the commercialization of Locilex™ (pexiganan acetate 1% cream), a novel, small peptide anti-infective agent. Locilex™ is formulated as a topical cream and, with its compilation of clinical data in over 1,100 evaluable patients to date, we believe Locilex™ will be indicated to treat patients with mild diabetic foot infection, an area of substantially unmet medical need. With limited resource required to complete clinical development, management believes Locilex™ has peak year sales potential of hundreds of millions of dollars in the U.S. and separately in the EU.
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.
Dipexium implements a "de-risking strategy" designed to enhance value by achieving a series of near-term value inflection points for its products with significant commercial potential. 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, (3) successfully completing non-dilutive capital formation transactions, and (4) maintaining operational efficiencies through a virtual corporate business model which draws on the expertise of its managing partners and their broad network of drug development professionals; all to achieve the common goal of long-term drug development success.
By executing the most direct regulatory/clinical pathway and by selecting lower-risk, late-stage product candidates with significant commercial potential, Dipexium believes it can leverage a modest amount of capital into a multifold financial return in a relatively short timeframe. With Locilex™, several value-creating milestones have already been achieved internally and by our predecessors and several near-term value-inflection points exist on what we believe is a relatively short pathway to approval for an early-stage company.
For additional information about Dipexium Pharmaceuticals or Locilex™, please visit: www.dipexiumpharmaceuticals.com or contact the Company as follows:
David P. Luci
Co-Founder & Managing Partner
Tel: (917) 533-1469
SOURCE Dipexium Pharmaceuticals