- JV will have global marketing rights to oral drug
delivery technology
- HTIT to invest $60 million,
Oramed to invest $10 million into
JV
- HTIT to provide a supply agreement for oral insulin
capsule
- JV to advance registration of oral insulin in
the United States and other
countries
NEW
YORK, Aug. 2, 2023 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com)
announced today that it has signed a non-binding term sheet with
Hefei Tianhui Biotech Co., Ltd. ("HTIT") to establish a joint
venture ("JV") based on Oramed's oral drug delivery technology. The
proposed JV would focus on the development and worldwide
commercialization of innovative products based on Oramed's oral
insulin and POD™ (Protein Oral Delivery) pipeline and HTIT's
manufacturing capabilities and technologies. The JV is subject to
the execution of a binding definitive agreement.
"We are thrilled to further our relationship with HTIT,
expanding the reach of our oral drug delivery technology to a
global market," said Oramed Chief Executive Officer, Nadav Kidron. "HTIT has successfully completed a
Phase 3 oral insulin trial and submitted a New Drug Application
("NDA") to the National Medical Products Administration ("NMPA"),
with marketing approval currently pending in China. HTIT has state-of-the-art facilities,
manufacturing capabilities and the know-how needed to produce oral
insulin on an international scale. This JV is a true opportunity to
leverage our strengths as well as those of our partners to
fast-track our pipeline towards commercialization."
Scope of the Joint Venture
The JV would be responsible for developing, marketing and
commercializing drug products globally, focusing on Oramed's oral
insulin and POD™ technology, as well as other assets in the Oramed
pipeline. The parties intend for the JV to initiate a Phase 3
oral insulin trial in the United
States.
Structure of Joint Venture
Oramed and HTIT would initially hold equal shares in the JV,
with each owning 50% of the equity. The Board of Directors
would initially consist of equal representation from HTIT and
Oramed, ensuring that both parties have an equal say in
decision-making. As part of the Joint Venture, HTIT will make
an initial investment of $60 million,
while Oramed will invest $10 million.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. The company's novel
Protein Oral Delivery (POD™) technology is designed to protect drug
integrity and increase absorption. Oramed has offices in
the United States and Israel. For more information, please
visit www.oramed.com.
About HTIT
Hefei Tianhui Biotechnology Co., Ltd. (HTIT) has a
state-of-the-art oral insulin manufacturing facility in
Hefei, China. HTIT is a
high-tech company focused on biopharmaceutical product
manufacturing and R&D with an emphasis on the oral delivery of
therapeutic macromolecules.
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss potential marketing
approval by HTIT and commercialization in China, the potential to enter into definitive
documentation with respect to the JV, which is currently still
under negotiation according to the understanding set forth in the
non-binding term sheet, the potential safety and efficacy of oral
insulin and the potential of Oramed and/or the JV to move forward
with its oral insulin product and fast-track its pipeline towards
commercialization. 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 ability of the
parties to reach agreement on a definitive JV agreement and the
transactions contemplated by the term sheet, which may not
occur; Oramed's process to evaluate strategic options; the
terms, timing, structure, benefits and costs of any strategic
transaction and whether any transaction will be consummated at all;
the impact of any strategic transaction on Oramed; the outcomes of
any litigation, regulatory proceedings, inquiries or investigations
to which Oramed may be subject; the ability to obtain financing or
third-party approvals as needed; our ability to achieve the
intended benefits of our strategic initiatives; 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; that products may
harm recipients; and other factors discussed in the "Risk Factors"
section of Oramed's most recent Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q, which are on file with the
Securities and Exchange Commission and in other filings that Oramed
makes with the Securities and Exchange Commission in the future.
All of these factors 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.
Company Contact:
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com
Logo:
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SOURCE Oramed Pharmaceuticals Inc.