Dipexium Pharmaceuticals Updates Locilex(TM) Development Activities and Announces 2011 Milestones
By Dipexium Pharmaceuticals, PRNESunday, April 3, 2011
NEW YORK, April 4, 2011 - 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(TM) (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(TM) 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(TM) and position the Company for further financing or other
strategic alternatives," stated David P. Luci, Co-Founder & Managing Partner.
About Dipexium:
Dipexium Pharmaceuticals, LLC is an emerging biopharmaceutical company
initially formed to complete the development and initiate the
commercialization of Locilex(TM) (pexiganan acetate 1% cream), a novel, small
peptide anti-infective agent. Locilex(TM) is formulated as a topical cream
and, with its compilation of clinical data in over 1,100 evaluable patients
to date, we believe Locilex(TM) 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(TM) 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(TM), 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(TM),
please visit: www.dipexiumpharmaceuticals.com or contact the Company
as follows:
David P. Luci Co-Founder & Managing Partner Tel: +1-917-533-1469
.
Tags: April 4, Dipexium Pharmaceuticals, New York