Oramed Announces Successful FDA Phase 2a Clinical Trial Results

       Oramed Announces Successful FDA Phase 2a Clinical Trial Results

Company to Move Forward with FDA Phase 2b Multi-Center Trial

PR Newswire

JERUSALEM, Jan. 30, 2014

JERUSALEM, Jan.30, 2014 /PRNewswire/ --Oramed Pharmaceuticals Inc.
(NASDAQCM: ORMP), a developer of oral drug delivery systems, announced today
results from its Phase 2a clinical trial for its ORMD-0801 oral insulin
capsule for the treatment of type 2 diabetes. The trial was conducted under a
United States Food and Drug Administration (FDA) IND (Investigational New
Drug) protocol. The Phase 2a study met all primary and secondary endpoints.

30 patients with type 2 diabetes took part in the trial in an in-patient
setting for one week. Endpoints of safety as well as pharmacodynamic and
pharmacokinetic effects were evaluated against a placebo control. For full
information on the Phase 2a trial design and endpoints please see Clinical
Trials*. Further information on the safety results of the Phase 2a clinical
trial can be found on Oramed's website. Full results are expected to be
presented at a scientific conference in the future.

"We are extremely pleased with the results which give a solid validation for
Oramed's platform technology in general and our oral insulin program in
particular," stated Oramed CEO Nadav Kidron. "Following on the results from
this type 2 diabetes study we are gearing up to start a multi-center Phase 2b
study later this year. We are also excited about the potential of this drug
for type 1 diabetes and plan to initiate a Phase 2a FDA study for this
indication in the near term."

About ORMD-0801 Oral Insulin

Oramed's ORMD-0801 is an orally ingestible insulin capsule 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, 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). 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 please visit www.oramed.com*

* The content of which is not part of this press release

Forward-looking statements:This press release contains forward-looking
statements. For example, we are using forward-looking statements when we
discuss the results of our phase 2a clinical trial validating our technology
platform and insulin oral program, the future announcement of the full results
of this trial, our planned clinical trials, the potential of ORMD-0801 oral
insulin capsule for type 1 diabetes, 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
Cell: +972-54-792-4438
Office:+972-2-566-0001
Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.

Website: http://www.oramed.com
 
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