JERUSALEM, July 11, 2017 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a
clinical-stage pharmaceutical company focused on the development of
oral drug delivery systems, announced today that the U.S. Food and
Drug Administration (FDA) has agreed to schedule an End-of-Phase II
meeting with Oramed for its successfully completed Phase IIb trial
of its oral insulin capsule ORMD-0801 in the treatment of type 2
diabetes. The Phase IIb trial met primary and secondary endpoints
by indicating a statistically significant lowering of glucose
relative to placebo.
The purpose of the End-of-Phase II meeting, which is expected to
take place on August 31, 2017, is to
review the Phase IIb results with the FDA and seek guidance from
the regulatory agency on the clinical design and protocol of
Oramed's upcoming pivotal Phase III trial, in preparation for
filing a New Drug Application (NDA).
"Effective and safe oral insulin delivery can change and improve
the way diabetes is treated today. We are very encouraged by the
Phase IIb results and have been diligently developing our Phase III
protocol. We look forward to a very productive meeting with the
FDA," stated Oramed CEO Nadav
Kidron.
About ORMD-0801 Capsule for Type 2 Diabetes
Intestinally-absorbed oral insulin mimics insulin's natural
location and gradients in the body by first passing through the
liver before entering the bloodstream. ORMD-0801 has the potential
to create a new paradigm in the treatment of diabetes by oral
delivery of insulin at an earlier stage of treatment, potentially
slowing disease progression and delaying or eliminating late-stage
complications. Orally administered insulin is also expected to
enhance patient compliance.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the
field of oral delivery solutions for drugs currently delivered via
injection. Established in 2006, Oramed's PODTM
technology is based on over 30 years of research by scientists at
Jerusalem's Hadassah Medical
Center. Oramed is seeking to revolutionize the treatment of
diabetes through its proprietary flagship product, an orally
ingestible insulin capsule (ORMD-0801). The Company completed
multiple Phase II clinical trials of ORMD-0801 under an
Investigational New Drug application with the U.S. Food and Drug
Administration. In addition, Oramed is developing an oral GLP-1
analog capsule (ORMD-0901).
For more information, the content of which is not part of this
press release, please visit www.oramed.com
Forward-looking statements: This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Words such as "expects," "anticipates," "intends,"
"plans," "believes," "seeks," "estimates" and similar expressions
or variations of such words are intended to identify
forward-looking statements. For example, we are using
forward-looking statements when we discuss the expected timing for
our meeting with the FDA and our expected Phase III trial and NDA,
as well as when we discuss revolutionizing the treatment of
diabetes with our products. These forward-looking statements are
based on the current expectations of the management of Oramed only,
and are subject to a number of factors and uncertainties that could
cause actual results to differ materially from those described in
the forward-looking statements, including the risks and
uncertainties related to the progress, timing, cost, and results of
clinical trials and product development programs; difficulties or
delays in obtaining regulatory approval or patent protection for
our product candidates; competition from other pharmaceutical or
biotechnology companies; and our ability to obtain additional
funding required to conduct our research, development and
commercialization activities. In addition, the following factors,
among others, could cause actual results to differ materially from
those described in the forward-looking statements: changes in
technology and market requirements; delays or obstacles in
launching our clinical trials; changes in legislation; inability to
timely develop and introduce new technologies, products and
applications; lack of validation of our technology as we progress
further and lack of acceptance of our methods by the scientific
community; inability to retain or attract key employees whose
knowledge is essential to the development of our products;
unforeseen scientific difficulties that may develop with our
process; greater cost of final product than anticipated; loss of
market share and pressure on pricing resulting from competition;
laboratory results that do not translate to equally good results in
real settings; our patents may not be sufficient; and finally that
products may harm recipients, all of which could cause the actual
results or performance of Oramed to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Oramed undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Oramed,
reference is made to Oramed's reports filed from time to time with
the Securities and Exchange Commission.
Company Contact
Oramed Pharmaceuticals
Josh Hexter
Office: +972-2-566-0001 ext. 2
US: 1-718-831-2512 ext. 2
Email: josh@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.