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

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

PR Newswire

JERUSALEM, 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 stillslow the rate of
degeneration of the diseaseby 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 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 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.
 
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