NEW YORK, March 26, 2019 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP)
(www.oramed.com), a clinical-stage pharmaceutical company focused
on the development of oral drug delivery systems, announced today
that its Chinese partner, Hefei Tianhui Incubator
of Technologies Co., Ltd. ("HTIT"), has reached the
significant regulatory milestone of approval of an investigational
new drug application ("IND") for two doses of its oral insulin
(ORMD-0801). The approval of the IND by the Center For Drug
Evaluation of the China National Medical Products
Administration ("NMPA", formerly the CFDA) of the oral
insulin paves the way for the start of clinical trials in
China.
"We are pleased that the Chinese regulatory authorities have
approved the IND, as it sets a clear path forward for approval of
oral insulin in China, bringing
oral insulin closer to becoming a reality in the Chinese
market," stated Oramed CEO Nadav
Kidron.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the
field of oral delivery solutions for drugs currently delivered via
injection. Established in 2006, Oramed's Protein Oral Delivery
(PODTM) technology is based on over 30 years of research
by 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). The Company
completed multiple Phase II clinical trials under an
Investigational New Drug application with the U.S. Food and Drug
Administration. In addition, Oramed is developing an oral GLP-1
analog capsule (ORMD-0901).
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 the timing of expected
clinical development programs and clinical trials or
revolutionizing the treatment of diabetes with our products. 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 finally that prod ucts 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
Estee Yaari
Office: +972-2-566-0001
US: +1-877-9-ORAMED
Email: estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.