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.
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.
SOURCE Oramed Pharmaceuticals Inc.