JERUSALEM, Sept. 5, 2017
/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 it has successfully concluded its meeting with the U.S.
Food and Drug Administration (FDA) regarding ORMD-0801, the
Company's novel oral insulin formulation.
At the meeting, the FDA gave clear guidance that the regulatory
pathway for submission of ORMD-0801, would be a Biologics License
Application (BLA). Such a pathway would grant a full 12 years
of marketing exclusivity for ORMD-0801 if approved. On top of
this, an additional six months of exclusivity can be granted if the
product also receives approval for use in pediatric patients.
The FDA confirmed that the approach to nonclinical toxicology,
CMC and qualification of excipients would be driven by their
published guidance documents, consistent with the Company's
expectations. They also made specific recommendations for
clinical trials designed to provide pivotal data prior to
registration. Since oral insulin may have a positive more
physiologic first-pass effect on the liver with less systemic
insulin exposure compared to traditional injectable insulin, at the
suggestion of the FDA, Oramed also plans to initiate a three-month
trial in patients with type 2 diabetes to evaluate the effect of
ORMD-0801 on HbA1c, the main FDA registrational endpoint, later
this year. In addition, the FDA confirmed the Company's
ability to use insulin from different suppliers like HTBT (Hefei
Tianmai Biotechnology Development Co., Ltd., Hefei, China) in the Phase 3 study.
"We are very pleased with the outcome and constructive advice
received from the FDA during our meeting. We plan on implementing
the FDA's feedback in the coming months which should facilitate the
confirmatory Phase 3 study and registration of ORMD-0801." said
Nadav Kidron, CEO of Oramed.
"Additionally, the FDA's classification of ORMD-0801 as a BLA
pathway and its significant commercial implications certainly is an
additional exciting outcome for us."
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of
oral delivery solutions for drugs currently delivered via
injection. Established in 2006, Oramed's Protein Oral Delivery
(POD™) technology is based on over 30 years of research by top
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 expected pathway for
ORMD-0801 and related timing and potential benefits of that pathway
and related trials and studies, our 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 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 U.S. Securities and Exchange Commission.
Company Contact
Oramed Pharmaceuticals
Josh Hexter
Office: +972-2-566-0001 ext. 2
US: 1 844 9 ORAMED ext. 2
Email: josh@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.