NEW YORK, July 15, 2020 /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, today announced that the FDA
provided positive feedback during the company's End of Phase
2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801). Based
on the FDA's feedback, Oramed intends to initiate two Phase 3
clinical trials following FDA review of those Phase 3 protocols,
and nonclinical documents. The FDA outlined its expectations for
design of the ORMD-0801 Phase 3 trials as well as submission of the
Biologics License Application (BLA) that would follow successful
trials. Oramed plans to conduct the two Phase 3 trials
concurrently.
Oramed's Chief Executive Nadav
Kidron said, "We are very pleased with the results of our
meeting with the FDA and look forward to submitting our finalized
protocols for the Phase 3 trials to the FDA. Following successful
Phase 3 trials, we would submit the BLA, which when approved would
grant a full 12 years of marketing exclusivity for
ORMD-0801. Based on our science and clinical trial results to
date, we strongly believe our oral insulin product will address
unmet needs among people with diabetes. Oramed is proud to be the
global leader in bringing an oral insulin capsule towards
commercial availability."
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, with offices in New
York and Israel, Oramed has developed a novel Protein
Oral Delivery (POD™) technology. Oramed is seeking to revolutionize
the treatment of diabetes through its proprietary lead
candidate, ORMD-0801, which has the potential to be the first
commercial oral insulin capsule for the treatment of
diabetes. The Company has 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 (Glucagon-like peptide-1) analog
capsule, ORMD-0901.
For more information, 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 initiation of Phase
3 trials, the potential submission and approval of a BLA, the
validation of preliminary findings in future trials, the potential
of ORMD-0801 to be the first commercial oral insulin capsule for
the treatment of diabetes or revolutionizing the treatment of
diabetes with our products. In addition, historic results of
scientific research and clinical trials do not guarantee that the
conclusions of future research or trials will suggest identical or
even similar conclusions. 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
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.
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Company Contact
Estee Yaari
+1-844-9-ORAMED
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.