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Last updated on April 24, 2014 at 10:53 EDT

Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.

May 17, 2013

JERUSALEM, May 17, 2013 /PRNewswire/ –

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer
of oral drug delivery systems, announced today that the United States Food and Drug
Administration (FDA) has cleared the Company’s Investigational New Drug application(IND)
for ORMD-0801, its oral insulin capsule.

“We are very pleased to have the FDA clearance to proceed,” stated Nadav Kidron, CEO
of Oramed. “The upcoming trial is a major milestone for Oramed and we look forward to
continuing to progress ORMD-0801′s clinical development in the US.”

About ORMD-0801 Oral Insulin

Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early
stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease
by providing additional insulin to the body and allowing pancreatic respite. Moreover,
orally administered insulin has the potential benefit of enhanced patient compliance at
this crucial stage as well as the advantage of mimicking insulin’s natural location and
gradients in the body by first passing through the liver before entering the bloodstream.

For more information on ORMD-0801, the content of which is not part of this press
release, please visit http://oramed.com/index.php?page=14

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 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), currently approaching Phase 2a trials. 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 ORMD-0801 slowing the
rate of diabetes, increasing patient compliance, and our products approaching Phase 2
trials. 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
        Mobile: +972-54-792-4438
        Office: +972-2-566-0001
        Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.


Source: PR Newswire