Oramed Pharmaceuticals Files Investigational New Drug Application with the FDA
for Oral Insulin
Addressing part of $174 billion diabetes treatment market in the U.S.
JERUSALEM, January 7, 2013
JERUSALEM, January 7, 2013 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a
developer of oral drug delivery systems, announced today that it has filed an
Investigational New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested
insulin candidate, ORMD-0801. The IND application was filed with the FDA on
December 31, 2012. The trial is to include 147 type 2 diabetic patients in
multiple centers across the United States. If Oramed does not receive comments
from the FDA on the IND application within 30 days from filing, Oramed intends
to immediately commence the trial to evaluate the safety, tolerability and
efficacy of its oral insulin capsule on type 2 diabetic volunteers.
According to the2011 National Diabetes Fact Sheet as reported by the Centers
for Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes
in 2010 - approximately 25.8 million people. The same report noted that the
2007 expense for diabetes treatment in the Unites states was $174 billion,
with direct costs for treatment representing $116 billion - a number that is
2.3 times higher than the medical costs of someone who does not have diabetes.
"This filing marks a majormilestone for Oramedas it sets the ground for the
largest trial on Oramed's oral insulin to date.We look forward to receiving
FDA approval and initiating the Phase 2 trial on Oramed's oral insulin
candidate. Its success will ultimately present apathway to a better treatment
option for diabetic patients," commented Nadav Kidron, CEOof Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a pharmaceutical company currently engaged in the
research and development of innovative pharmaceutical solutions for the use of
orally ingestible capsules or pills for delivery of polypeptides, such as
insulin and vaccines.Established in 2006, Oramed's technology is based on
over 25 years of research by top research scientists at Hadassah Medical
Center in Jerusalem. Oramed is seeking to revolutionize the treatment of
diabetes through its proprietary flagship product, an orally ingestible
insulin capsule (ORMD-0801) currently approaching an FDA-approved Phase 2
clinical trial, and with its oral exenatide capsule (ORMD-0901), currently
approaching Phase 1b/2a trials. Oramed's corporate and R&D headquarters are
based in Jerusalem.
The company's fact sheet can be viewedhere.
For more information, the content of which is not part of this press release,
Forward-looking statements: This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and other Federal Securities laws.
Statements preceded by, followed by, or that otherwise include the words
"expects," "anticipates," "intends," "plans," "planned expenditures,"
"believes," "seeks," "estimates" and similar expressions or variations of such
words are intended to identify forward-looking statements, but are not deemed
to represent an all-inclusive means of identifying forward-looking statements.
Additionally, statements concerning future matters are forward-looking
statements. For example, we are using forward-looking statements when we
discuss the projected commencement of our upcoming clinical trials, the amount
of patients to be included in the trials, or the impact the study may have on
the treatment options of diabetics. 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
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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