JERUSALEM, January 6, 2016 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP)
(http://www.oramed.com), today issued the following shareholder
letter:
Dear Shareholders,
2015 was a very significant year for us at Oramed setting the
bar high for what we anticipate to be a momentous year ahead in
2016.
2015 Major Milestones Include:
- Global Out-licensing and Investment Deal Valued at
$50 Million Plus 10% Royalties in
China
- Initiation of Phase IIb Study in Type 2 Diabetes for
ORMD-0801 (in progress)
- Initiation of Phase Ib Study for ORMD-0901 (in
progress)
- Collaboration with Big Pharma Partner
- Patent Granted in U.S.
2016 Milestones Expected to Include:
- Starting Out with Strong Balance Sheet with Roughly
$40 Million Cash
- ORMD-0801 Phase IIb Study Completion:
- Last Patient In in Q1, 2016
- Topline Data Release in Q2, 2016
- Milestone Achievements/Payments in China License Deal
- ORMD-0901 IND and
Follow on
Study
2015 Major Milestones Included:
- First Global Out-licensing and Investment Deal Valued at
$50 Million Plus 10% Royalties in
China
We recently closed a license and investment agreement with Hefei
Tianhui Incubator of Technologies Co. Ltd. (HTIT) for exclusive
rights to market our oral insulin capsule, ORMD-0801, in
Greater China. The
agreements were signed at a ceremony which took place at the
Israeli Knesset/Parliament and included Bin Zhou, Sinopharm Vice
General President and Xiaoming Gao,
HTIT Chairman.
In addition to the $12 million
investment and the $38 million in
milestone payments, Oramed will receive up to a 10% royalty on any
future net sales. This double digit royalty enhances the already
positive financial aspects of the deal for Oramed. China
currently has more people living with diabetes than any other
country in the world and this points to a tremendous market
opportunity in the area of diabetes care. We were very pleased to
reach this agreement with HTIT and look forward to a long term
working relationship with them.
II. ORMD-0801 Phase IIb Study in Type 2 Diabetes is on
Schedule for Completion in Q1/2 2016
The recruitment in our Phase IIb trial of ORMD-0801 has
proceeded on-schedule. The study is being conducted under an
Investigational New Drug (IND) filing with the U.S. Food and Drug
Administration (FDA). We anticipate sharing topline data from
this study during the second quarter of this year
III. ORMD-0901 Phase Ib Study Currently in
Progress
ORMD-0901, our proprietary oral GLP-1 analog, is a diabetes
medication that mimics the natural GLP-1 hormone the body produces
to regulate blood glucose levels. In preparation for filing our IND
application with the FDA for a Phase II trial, we are currently
conducting an ex-U.S. Phase Ib study and expect to announce data
from this trial in the first calendar quarter of 2016. Concurrent
with this Phase Ib study, we are also conducting 90-day toxicity
studies. We hope to file an IND with the FDA and initiate a
Phase IIb study in the United
States later this year.
IV. Collaboration with Big Pharma Partner
We entered into an agreement with a large international
pharmaceutical company to conduct feasibility studies using one of
their propriety injectable compounds. The studies will use Oramed's
proprietary PODTM Technology to deliver the compound
orally. We are very excited about the potential that this
collaboration can bring Oramed.
V. Patent Granted in U.S.
The U.S. Patent and Trademark Office granted Oramed a key patent
for our invention "Methods and Compositions for Oral
Administrations of Proteins" addressing our platform oral
administration technology. This patent is a very important
milestone that helps pave Oramed's entrance into the U.S. market.
The United States is the single
largest diabetes market in the world with annual insulin sales of
well over $8 billion.
We Look Forward To Numerous Value-Creating Events In 2016
Including:
Strong Balance Sheet
Kicking off 2016 with roughly $40
million in cash should allow us to successfully execute on
an enormous global opportunity which includes bringing our oral
insulin and oral GLP-1 towards commercialization. This puts Oramed
in a very strong position as we enter into and continue discussions
with potential strategic partners.
Achieving Development Milestones in our HTIT Deal in
China
We expect to receive additional milestone payments from HTIT
based on achieving multiple development milestones in 2016.
ORMD-0801 Phase IIb Study Completion and Topline Data
We expect to complete our Phase IIb study of ORMD-0801 this
quarter and announce top line data by mid-2016.
ORMD-0901 IND and Phase II Study
Data from our small Phase Ib study of ORMD-0901 is expected upon
completion of the trial in the first quarter of 2016. We anticipate
finishing off the FDA requested 90-day preclinical toxicology study
later this year and would look to file an IND soon thereafter;
putting us in a position to kick off a U.S. based multicenter Phase
II study.
We believe that 2016 will be an exciting and event driven
year. We anticipate that numerous milestones will likely contribute
to building further value in our Company based on the advancement
of our clinical pipeline. We encourage you to follow our
achievements throughout the year.
Sincerely,
Nadav Kidron, CEO
Forward-looking statements: This letter contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. Words such as "expects," "anticipates," "intends,"
"plans," "believes," "seeks," "estimates" and similar expressions
or variations of such words are intended to identify
forward-looking statements. For example, we are using
forward-looking statements when we discuss our clinical trials and
feasibility studies, including the design and expected timing
thereof, including the timing of the release of any data, as well
as our use of cash and our expected milestone and royalty payments
from, and ongoing relationship with, HTIT. 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;
failure to meet the conditions set forth in the HTIT license
agreement; 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 Securities and Exchange
Commission.
Company Contact
Oramed Pharmaceuticals
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: 1-718-831-2512 ext. 2
Email: ariella@oramed.com
SOURCE Oramed Pharmaceuticals Inc.