JERUSALEM, January 28, 2015 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP)
(http://www.oramed.com),
Dear Friends, Shareholders and Associates,
As we recently entered into the New Year, I thought this would
be a good opportunity to reflect on the achievements of this past
year while also looking forward to the coming one. I am very proud
to highlight the following milestones which we accomplished:
Positive Data from Phase IIa Studies of ORMD-0801 in Type 1
and Type 2 Diabetes
In early 2014, we reported positive data from our Phase IIa
study of ORMD-0801 to treat type 2 diabetes. The data showed
ORMD-0801 to be safe and well-tolerated. Importantly, the
decreases in blood glucose observed were not associated with any
hypoglycemic events and no treatment related adverse events were
observed. We are very encouraged by the positive trends
showing a pattern of well-defined and short-term increases in
plasma insulin and decreases in blood glucose.
In addition, in October 2014, we
reported positive top-line data from our Phase IIa clinical study
of ORMD-0801 in type 1 diabetes patients. The data showed
that ORMD-0801 appeared to be safe and well-tolerated for the
dosing regimen in this study and no treatment related adverse
events were observed. There were internally consistent trends
observed showing a decrease in rapid acting insulin, a decrease in
post-prandial glucose and a decrease in daytime glucose.
The successful conclusion of these two trials allow us to move
forward with our planned U.S. Phase IIb trial in individuals with
type 2 diabetes, which will investigate ORMD-0801 over a longer
treatment period and which will have statistical power to give us
greater insight into the drug's efficacy. We have received
Institutional Review Board (IRB) approval and anticipate initiating
this trial within the next 90 days.
Financing
In November 2014, we successfully
closed a $5 million investment from
Guangxi Wuzhou Pharmaceutical Co., Ltd., a subsidiary of Guangxi
Wuzhou Zhongheng Group Company Ltd. Wuzhou is a publically
traded company on the Shanghai Stock Exchange, with a market
capitalization of over $3 billion.
Wuzhou's main businesses consists of the manufacturing of
pharmaceuticals, including cardiovascular drugs, medicine for
bruises, gynecology medication and other general drugs. The
shares were sold in a private placement at the market price,
without discount or warrant coverage, minimizing the dilutive
effect to existing shareholders. This investment enhances
Oramed's cash position, which will allow us to continue to execute
on our clinical development activities.
To date, our interactions with Wuzhou as a shareholder have been
very fruitful and have opened new avenues for us and provided us
with new options to explore possibilities in the Asian market.
Intellectual Property
Throughout the past year we have made inroads in strengthening
our intellectual property portfolio. We were granted patents in
multiple jurisdictions including the European Union, Russia, Australia and Israel amongst other areas. We will
continue to build our patent portfolio with the intention of
fortifying our patent position in oral insulin delivery, while
creating additional barriers to entry for any would-be
competitors.
Looking ahead to 2015, we have a number of exciting and
potentially value-creating developments including:
ORMD-0801 Phase IIb Initiation
We are happy to report that we intend to initiate our U.S. Phase
IIb trial for oral insulin in the next 90 days. The trial's
protocol includes approximately 30 U.S. sites covering
approximately 180 patients and has both efficacy and safety as its
primary end-points.
The Phase IIb trial initiation has been made possible following
the successful conclusion of the two Phase IIa trials mandated by
the U.S. Food and Drug Administration (FDA) in both type 1 and type
2 diabetes patients, which we believe convincingly demonstrated
that the oral administered insulin (ORMD-0801) was absorbed and
successfully decreased blood glucose levels.
ORMD-0901 Development
Our oral GLP-1 project is also on track, and we anticipate an
exciting 2015. We recently initiated IND-enabling studies, as
per the guidance we received from the FDA. We then intend to
file an IND and move immediately and directly into a large Phase II
multi-center trial in the U.S.
We completed the revamping of our website and launched it
this past week. Please visit us at http://www.oramed.com.
We are on the threshold of what we expect to be a very exciting
year ahead - and we look forward to sharing news of our progress
throughout the coming 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,
including the design and expected timing thereof, including the
timing of any data from such clinical trials. 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 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.