Oramed Announces Last Patient Out in Phase 2a FDA Trial of its ORMD-0801 Oral Insulin Capsule

Oramed Announces Last Patient Out in Phase 2a FDA Trial of its ORMD-0801 Oral
                               Insulin Capsule

PR Newswire

JERUSALEM, November 12, 2013

JERUSALEM, November 12, 2013 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a
clinical-stage pharmaceutical company focused on the development of oral drug
delivery systems, announced today that the last patient has left the clinic
from its U.S. FDA Phase 2a safety study for ORMD-0801, an oral insulin capsule
based on the Company's platform Protein Oral Delivery (POD™) technology.

The Phase 2a trial, which enlisted 30 type 2 diabetes patients in an in-clinic
setting for a seven-day period, was implemented in response to FDA feedback
requesting a safety study on ORMD-0801 prior to initiating a larger
multi-center trial in the US.

"We are thrilled to announce the last patient out of our Phase 2a clinical
trial under the FDA. We look forward to announcing the results," said Oramed
CEO Nadav Kidron.

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 Protein Oral Delivery (POD^TM) technology is
based on over 30 years of research by top research scientists
atJerusalem'sHadassah Medical Center. Oramed is seeking to revolutionize the
treatment of diabetes through its proprietary flagship product, an orally
ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on
patients with type 2 diabetes (T2DM) 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), with trials on healthy
volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also
moving forward with clinical trials of ORMD-0801 for the treatment of type 1
diabetes. The company's corporate and R&D headquarters are based inJerusalem.

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 our clinical trials or revolutionizing the treatment of diabetes with
our products. These forward-looking statements and their implications 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
Office:+972-2-566-0001
Int'l: 1-718-831-2512
Mobile: +972-54-792-4438
Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.
 
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