JERUSALEM, July 30, 2013 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQCM: ORMP) (www.oramed.com), a developer
of oral drug delivery systems, announced today that it submitted a
pre-Investigational New Drug (pre-IND) meeting request to the U.S.
Food and Drug Administration (FDA) for a US-based trial on its
orally ingestible exenatide capsule, ORMD-0901.
Nadav Kidron, CEO of Oramed,
commented, "We are very pleased to have submitted this pre-IND
meeting request letter as part of our efforts to advance ORMD-0901
into US clinical trials. We look forward to the FDA's response and
preparing ourselves accordingly in our efforts leading up to full
IND submission on our second product."
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 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. 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 visit 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, any
future meetings with the FDA, our anticipated IND submission
regarding ORMD-0901, 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
Mobile: +972-54-792-4438
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.