- Medicox to Distribute Oramed's Oral Insulin in South Korea, if approved
- Oramed to Receive Up to $18
Million in Developmental Milestones
- Oramed to Receive up to 15% Royalties on Gross
Sales
- Large Market Potential: 1 in 7 Koreans Over Age 30 Has
Diabetes
NEW YORK ,
Nov. 14,
2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc.
(Nasdaq/TASE: ORMP) (www.oramed.com), a clinical-stage
pharmaceutical company focused on the development of oral drug
delivery platforms, today announced it has signed an exclusive
commercial distribution agreement for the Republic of Korea
(formerly South Korea) with
Medicox Co., Ltd., an emerging biotech company with an excellent
consortium of proven partnerships in the Republic
of Korea.
The agreement grants Medicox an exclusive license to apply for
regulatory approval for and distribute Oramed's oral insulin
candidate (ORMD-0801) for ten years in the Republic of Korea.
Medicox will purchase ORMD-0801 at an agreed upon transfer
price and will additionally pay Oramed up to $18 million, $2
million of which have already been received by Oramed to
date, in developmental milestones and up to 15% royalties on gross
sales. Medicox will additionally be responsible for gaining
regulatory approval in Republic of Korea.
Oramed is seeking to transform the treatment of diabetes through
its proprietary lead candidate, ORMD-0801, which is currently in
two pivotal Phase 3 studies, with top-line results of the first
Phase 3 study expected in January
2023. ORMD-0801 has the potential to be the first commercial
oral insulin capsule for the treatment of diabetes. The unmet
need for diabetes treatment is significant in the Republic of
Korea, with one in every seven Koreans over the age of 30 having
diabetes.
"This collaboration offers Oramed a great opportunity to
participate in the large and growing Korean market and leverages
the commercialization strength of our partner, while allowing
Oramed to focus on other key markets, including the United States," stated Oramed Chief
Executive Officer Nadav Kidron.
"We are very excited to grow and expand our pharma business by
partnering with Oramed to bring a potentially breakthrough
treatment to the Republic of Korea," commented Medicox Chief
Executive Officer Dae Hwan Oh.
About Oramed
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. Established in 2006, with
offices in the United States and
Israel, Oramed has developed a
novel Protein Oral Delivery (POD™) technology. Oramed is seeking to
transform the treatment of diabetes through its proprietary lead
candidate, ORMD-0801, which is being evaluated in two pivotal Phase
3 studies and has the potential to be the first commercial oral
insulin capsule for the treatment of diabetes. 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.
About Medicox
Medicox Co., Ltd. (Kosdaq: 054180) is a pharmaceutical
R&D company with a shipbuilding and generator manufacturing
business. The company was established in 1995, and has 3 offices in
Korea (Seoul, Jinhae, Kimhae).
Medicox has a subsidiary called Mecox CureMed Co., Ltd., which
focuses on clinical trials of drugs under development. Mecox holds
a pipeline of Tubulysin (Solid Cancer/Phase 1), Bozanics
(Orthopedic Arthritis/Phase 3), Mecbentu (Blood Cancer/Phase 2).
For more information, please visit www.medicox.co.kr.
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss the potential for
regulatory approval or development of ORMD-0801 in Korea or
elsewhere, potential future payments to Oramed from Medicox,
including pursuant to milestone or royalty payments the potential
size of the diabetes market in Korea and the potential of ORMD-0801
to be the first commercial oral insulin capsule for the treatment
of diabetes. 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.
Company Contact:
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.