JERUSALEM, Jan. 19, 2018 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP)
(www.oramed.com)
Dear Shareholders,
All the hard work and dedication in 2017 has successfully
positioned Oramed to initiate a U.S. based multicenter 90-day
treatment study under a FDA IND focused on the lowering of HbA1c in
type 2 diabetic patients later this quarter. This is just one
of many milestones achieved in 2017 and one of the forward-looking
milestones we anticipate in the coming year.
2017 Major Milestones Achieved
- Building U.S. based management team which
includes:
- Chief Strategy Officer, Dr. Ron
Law joins Oramed
- VP Medical Affairs, Dr. Simon
Bruce joins Oramed
- CEO, Nadav Kidron's
relocation to Oramed's NYC office
- Oramed begins dual listing on the Tel Aviv Stock
Exchange (TASE)
- Approval from the Israel Ministry of Health to begin two
exploratory human trials for NASH and Leptin
- Successful call with the FDA for oral insulin
(ORMD-0801)
- BLA indication (12 years marketing exclusivity, if
approved)
- Identified pathway to Phase 3 trials
- ~$40 million in cash and
investments at year end; no debt
2018 Major Anticipated Milestones
- ORMD-0801 (oral insulin)
- HbA1c study initiation
- NASH study initiation
- ORMD-0901 (oral GLP-1)
- IND submission
- Phase 1 PK study initiation and completion
- Phase 2 study initiation
- Leptin study initiation
- HTIT – Chinese partner
- HTIT continuing work on building manufacturing
capabilities in China
- Continuing big pharma collaboration
- Strong balance sheet
Oral insulin (ORMD-0801) Completes Successful Meeting
with FDA
On August 31, 2017, Oramed had a
call with the FDA. At this meeting, the FDA advised that the
regulatory pathway for the submission of ORMD-0801 would be a
Biologics License Application (BLA). Such a pathway would grant 12
years of marketing exclusivity for ORMD-0801, if approved, and an
additional six months of exclusivity may be granted if the product
also receives approval for use in pediatric patients. Oramed
plans to initiate a 90-day treatment HbA1c trial under an FDA IND
this quarter.
GLP-1 Headed into Phase II
Our oral GLP-1 analog (ORMD-0901) development is rapidly
proceeding. We anticipate submitting an IND with the FDA and
the initiation of a Phase II study in the
United States in 2018.
Chinese Partnership Strengthens
We have successfully completed multiple milestones outlined in
our license agreement with China-based HTIT. This has triggered some
$30 million in payments received from
HTIT to date. HTIT is investing substantial funds to build the
manufacturing infrastructure to make oral insulin a reality in
China. If approved, HTIT plans to
manufacture and sell ORMD-0801 in China, with 10% royalties on any future net
sales paid to Oramed.
Strong Balance Sheet
2018 kicks off with roughly $40
million in cash and investments. This capital enables
us to successfully execute on our planned late-stage clinical
studies for oral insulin and GLP-1 as we move towards
commercialization. Our balance sheet puts Oramed in a positive
position as we enter into and continue discussions with potential
strategic partners.
We believe that 2018 will be an exciting and event driven
year. We anticipate that the advancement of our late-stage clinical
pipeline in 2018 will contribute to real value creation. We
look forward to keeping you posted on our achievements throughout
the year.
Sincerely,
Nadav Kidron
Chief Executive Officer
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
(PODTM) 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 2018 anticipated
milestones, the BLA pathway, that our cash positions us to execute
our studies and puts us in a positive position and the timing of
expected clinical development programs and clinical trials and FDA
submissions. 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
U.S.: +1-844-9-ORAMED ext. 2
Email: josh@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.