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Last updated on April 17, 2014 at 21:23 EDT

Oramed Pharmaceuticals Files Investigational New Drug Application with the FDA for Oral Insulin

January 7, 2013

JERUSALEM, January 7, 2013 /PRNewswire/ –

Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a developer
of oral drug delivery systems, announced today that it has filed an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2
clinical trial of its orally ingested insulin candidate, ORMD-0801. The IND application
was filed with the FDA on December 31, 2012. The trial is to include 147 type 2 diabetic
patients in multiple centers across the United States. If Oramed does not receive comments
from the FDA on the IND application within 30 days from filing, Oramed intends to
immediately commence the trial to evaluate the safety, tolerability and efficacy of its
oral insulin capsule on type 2 diabetic volunteers.

According to the 2011 National Diabetes Fact Sheet as reported by the Centers for
Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes in 2010 -
approximately 25.8 million people. The same report noted that the 2007 expense for
diabetes treatment in the Unites states was $174 billion, with direct costs for treatment
representing $116 billion – a number that is 2.3 times higher than the medical costs of
someone who does not have diabetes.

“This filing marks a major milestone for Oramed as it sets the ground for the largest
trial on Oramed’s oral insulin to date. We look forward to receiving FDA approval and
initiating the Phase 2 trial on Oramed’s oral insulin candidate. Its success will
ultimately present a pathway to a better treatment option for diabetic patients,”
commented Nadav Kidron, CEO of Oramed.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a pharmaceutical company currently engaged in the research
and development of innovative pharmaceutical solutions for the use of orally ingestible
capsules or pills for delivery of polypeptides, such as insulin and vaccines. Established
in 2006, Oramed’s technology is based on over 25 years of research by top research
scientists at Hadassah Medical Center in Jerusalem. Oramed is seeking to revolutionize the
treatment of diabetes through its proprietary flagship product, an orally ingestible
insulin capsule (ORMD-0801) currently approaching an FDA-approved Phase 2 clinical trial,
and with its oral exenatide capsule (ORMD-0901), currently approaching Phase 1b/2a trials.
Oramed’s corporate and R&D headquarters are based in Jerusalem.

The company’s fact sheet can be viewed here
[http://oramed.com/ufiles/Oramed-fact-sheet-Oct-2012.pdf ].

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
within the meaning of the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995 and other Federal Securities laws. Statements preceded by, followed by,
or that otherwise include the words “expects,” “anticipates,” “intends,” “plans,” “planned
expenditures,” “believes,” “seeks,” “estimates” and similar expressions or variations of
such words are intended to identify forward-looking statements, but are not deemed to
represent an all-inclusive means of identifying forward-looking statements. Additionally,
statements concerning future matters are forward-looking statements. For example, we are
using forward-looking statements when we discuss the projected commencement of our
upcoming clinical trials, the amount of patients to be included in the trials, or the
impact the study may have on the treatment options of diabetics. 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 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.


Source: PR Newswire