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Last updated on April 20, 2014 at 8:28 EDT

Oramed Submits New IND Application for Oral Insulin Trial in the US

April 11, 2013

JERUSALEM, April 11, 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 new Investigational
New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a
sub-study on its oral insulin candidate, ORMD-0801. This filing is in response to FDA
feedback from Oramed’s initial IND filing on December 31, 2012, wherein the FDA requested
Oramed to perform a sub-study in a controlled in-patient setting for up to a one-week
period prior to beginning the larger multi-centered Phase 2 trial.

“This new IND filing comes after ongoing productive communications with the FDA,”
stated Nadav Kidron, CEO of Oramed. “We look forward to receiving clearance on this IND
and beginning our trials in the US.”

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 approaching Phase 2 clinical trials under U.S. IND, 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.

The company’s fact sheet can be viewed here
[http://www.oramed.com/ufiles/Oramed%20%20fact%20sheet%20April10,2013-website.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.
For example, we are using forward-looking statements when we discuss receiving FDA
clearance on this IND 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
        Cell: +972-54-792-4438
        Office: +972-2-566-0001
        Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.


Source: PR Newswire