Oramed Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral GLP-1 Analog for the Treatment of Type 2 Diabetes

Oramed Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral
              GLP-1 Analog for the Treatment of Type 2 Diabetes

Company's 2nd product slated for U.S. clinical trials offers a more
patient-friendly form of GLP-1 analog which had more than $2 billion USD in
2012 sales

PR Newswire

JERUSALEM, September 3, 2013

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 atJerusalem'sHadassah 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 inJerusalem.

For more information, the content of which is not part of this press release,
please visithttp://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.