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

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

PR Newswire

JERUSALEM, 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 viewedhere.

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 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.
 
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