Oramed Pharmaceuticals Moves Forward with Investigational New Drug Application
for Oral Insulin
FDA requires company to conduct a sub study before it begins the clinical
JERUSALEM, February 14, 2013
JERUSALEM, February 14, 2013 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a
developer of oral drug delivery systems, announced today that it has been in
communication with the U.S. Food and Drug Administration (FDA) regarding its
Investigational New Drug (IND) application for oral insulin. The FDA has asked
Oramed to perform a sub study in a controlled in-patient setting for up to a
one-weekperiod. In order to accommodate the FDA's request, Oramed will submit
a new IND with a clinical protocol for the aforementioned sub study.
"We are very pleased to be in close and positive communications with the FDA,
as well as having a clear path which meets the FDA's input. This positions us
for imminent clearance from the FDA to proceed with our planned clinical
studies," commented Nadav Kidron, CEO of Oramed.
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.
For more information, the content of which is not part of this press release,
The company's fact sheet can be viewedhere.
Forward-looking statements: This press release contains forward-looking
statements. For example, we are using forward-looking statements when we
discuss receiving imminent clearance from the FDA as well as the projected
commencement dates for our upcoming clinical 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.
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