Filed by Dipexium Pharmaceuticals, Inc.
Pursuant to Rule 425 under the Securities
Act of 1933
and deemed filed pursuant to Rule 14a-12
under the Securities Exchange Act of 1934
Subject Company: Dipexium Pharmaceuticals,
Inc.
(Commission File No. 001-36351)
PLx Pharma Announces Publication of Positive
Antiplatelet Data for Aspertec in
Peer-Reviewed Medical Journal JACC
HOUSTON, TX February 14, 2017
– PLx Pharma Inc.
(PLx), a late-stage specialty pharmaceutical company developing next-generation nonsteroidal anti-inflammatory drugs and other
pharmaceutical agents today announced that the results of a 40-subject pharmacokinetic/pharmacodynamic (PK/PD) trial of Aspertec™,
a novel, patent-protected, lipid-based aspirin product, have been published by the prestigious, peer-reviewed
Journal of the
American College of Cardiology (JACC)
.
The publication, entitled “Enteric Coating and Aspirin
Nonresponsiveness in Patients with Type 2 Diabetes Mellitus,” describes results of the study, which evaluated Aspertec 325
mg versus two commercially-available 325 mg aspirin products: plain (uncoated) and delayed-release, safety-coated (enteric-coated
or EC) aspirin, over 72 hours.
“This study contributes to the growing body of data on
the antiplatelet activity of different aspirin formulations within 72 hours of starting an aspirin regimen. The information gathered
from this PK/PD trial suggests that, for these patients, there was, initially, substantial variability in antiplatelet activity
depending on the dose form of aspirin administered,” stated Deepak L. Bhatt, MD, MPH, lead author of the study and Executive
Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at the Harvard
Medical School.
“We are very encouraged by the published results of this
study and the potential of our novel lipid-based, liquid-filled Aspertec capsule to provide reliable and predictable antiplatelet
activity. We believe Aspertec, with multiple potential benefits as a fast, predictable and reliable antiplatelet agent, will provide
an important treatment option for prescribers in determining the optimal aspirin formulation for use as the foundational medicine
by their secondary prevention and high-risk primary prevention patients,” stated Natasha Giordano, President and Chief Executive
Officer of PLx.
The article is available online at http://www.onlinejacc.org/content/early/2017/01/05/j.jacc.2016.11.050.
JACC
publishes the highest quality articles highlighting
all aspects of cardiovascular health and disease. With a current impact factor of 17.759, it is one of the most influential journals
in the field of cardiology.
About Aspertec
Aspertec is an approved aspirin product developed to provide
reliable and predictable antiplatelet activity. PLx is focused on completing manufacturing scale-up and label finalization for
Aspertec 325 mg aspirin dosage form and preparing a supplemental new drug application (sNDA) for Aspertec 81 mg maintenance dose
form.
About PLx
PLx Pharma Inc. is a late-stage specialty pharmaceutical company
initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide safe and
effective aspirin products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API)
to various portions of the GI tract. PLx believes this has the potential to improve the absorption of many drugs currently on the
market or in development, and to reduce acute gastrointestinal (GI) side effects—including erosions, ulcers and bleeding—associated
with aspirin and ibuprofen, and potentially other drugs.
On December 22, 2016, PLx announced that it had entered into
a merger agreement with Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX). Following the closing of the merger—which is subject
to a number of conditions precedent, including approval of both PLx and Dipexium stockholders—it is expected that Dipexium
will be renamed “PLx Pharma Inc.” and will operate under the leadership of the PLx management team.
To learn more about PLx and its pipeline, please visit www.plxpharma.com.
Important Additional Information Will
Be Filed with the SEC
This communication does not constitute
an offer to sell or the solicitation of an offer to buy any securities of Dipexium Pharmaceuticals, Inc. (Dipexium), or PLx or
the solicitation of any vote or approval. In connection with the proposed transaction, Dipexium filed a Registration Statement
on Form S-4 with the Securities and Exchange Commission (SEC) on January 25, 2017, containing a joint proxy statement/prospectus.
The joint proxy statement/prospectus contains important information about Dipexium, PLx, the transaction and related matters. Dipexium
will mail or otherwise deliver the joint proxy statement/prospectus to its stockholders and the stockholders of PLx when it becomes
effective. Investors and security holders of Dipexium and PLx are urged to read carefully the joint proxy statement/prospectus
relating to the merger (including any amendments or supplements thereto) in its entirety, because it contains important information
about the proposed transaction.
Investors and security holders of Dipexium
will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger (when it is available) and other
documents filed with the SEC by Dipexium through the website maintained by the SEC at www.sec.gov.
Dipexium and PLx, and their respective
directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of
the transactions contemplated by the Merger Agreement between Dipexium and PLx. Information regarding Dipexium’s directors and
executive officers is contained in Dipexium’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which
was filed with the SEC on January 20, 2017. Information regarding PLx’s directors and officers and a more complete description
of the interests of PLx’s directors and officers in the proposed transaction is available in the joint proxy statement/prospectus
filed by Dipexium with the SEC in connection with the proposed transaction.
Forward Looking Statements
Any statements made in this
press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other
financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug
candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition,
when or if used in this press release, the words “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict”
and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these
forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors
that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience
include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating
to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing,
regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on
intellectual property; risks that PLx may lack the financial resources and access to capital to fund proposed operations; and risks
that the proposed merger with Dipexium may not be consummated. The forward-looking statements represent PLx’s estimate as
of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.
Contact Information
Natasha Giordano
PLx Pharma Inc.
ngiordano@plxpharma.com
713-842-1249
# # #
Citation for this article: Bhatt DL
et al.
Pharmacodynamic
Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients. Journal of the American College
of Cardiology Jan 2017, 23269; DOI: 10.1016/j.jacc.2016.11.050
Source: PLx Pharma Inc.
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