JERUSALEM, September 3, 2013 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
(http://www.oramed.com), a developer of oral drug delivery systems,
announced today that it has submitted a pre-Investigational New
Drug (pre-IND) package to the U.S. Food and Drug Administration
(FDA) for ORMD-0901, an orally administered exenatide capsule.
Oramed's pre-IND package submission follows its recently
announced meeting request letter submitted to the FDA.
The submitted pre-IND package provides the FDA with information
on Oramed's ORMD-0901 research conducted to-date, as well as a
clinical trial outline for a proposed U.S. clinical trial. The
FDA's response to the pre-IND package will serve as a guide to the
Company for product development and preparation of a full IND
application.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of
oral delivery solutions for drugs and vaccines currently delivered
via injection. Established in 2006, Oramed's technology is based on
over 30 years of research by top research 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)
currently initiating Phase 2 clinical trials on patients with type
2 diabetes (T2DM) under an Investigational New Drug application
with the U.S. Food and Drug Administration, and with its oral
exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on
healthy volunteers (Phase 1b) and T2DM patients (Phase 2a)
underway. Oramed is also moving forward with clinical trials of
ORMD-0801 for the treatment of type 1 diabetes. The company's
corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of
this press release, please
visit http://www.oramed.com
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss our clinical trials,
revolutionizing the treatment of diabetes with our products, and
ORMD-0901 being a more patient-friendly form of treatment or it
addressing a significant market. 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 final 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
Aviva Sherman
Cell: +972-54-792-4438
Office: +972-2-566-0001
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.