UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
_____________________
FORM
8-K
_____________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the
Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported): November 14, 2008
_____________________
ORAMED
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
|
Nevada
(State
or other jurisdiction
of
incorporation)
|
000-50298
(Commission
File Number)
|
98-0376008
(IRS
Employer
Identification
No.)
|
Hi-Tech
Park 2/5 Givat Ram
PO
Box 39098
Jerusalem,
Israel 91390
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: 972-2-566-0001
_____________________
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
| o |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
| o |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
|
ITEM
7.01
REGULATION
FD DISCLOSURE
|
On
November 14, 2008, Oramed Pharmaceuticals Inc. (the "Company") issued a press
release announcing the presentation of the results of its exploratory study
entitled “Enteral Administration of Exenatide-4; Proof of Concept
Pharmacodynamic Study in Dogs” which was presented at the Diabetes Technology
Society’s Conference in Bethesda, Maryland.
A
copy of
the press release and an abstract of the presentation materials are attached
to
this Current Report on Form 8-K as Exhibit 99.1 and 99.2 respectively and are incorporated
herein by
reference.
|
ITEM
9.01
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
|
Exhibits
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
|
|
ORAMED
PHARMACEUTICALS INC.
|
|
|
Dated:
November 14, 2008
|
|
|
|
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|
By:
|
/s/
Nadav Kidron
|
|
|
|
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Nadav
Kidron
|
|
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|
|
President,
CEO and Director
|
Oramed
Pharmaceuticals Presents Results of Oral Administration of
Exenatide-4;
Proof
of Concept Pharmacodynamic Study in Dogs
The
study
suggests that the GLP-1analog exenatide -4 when combined with
Oramed’s
absorption
promoters is absorbed through the gastrointestinal tract and retains its
biological activity
JERUSALEM,
Israel - November 14, 2008- Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
www.oramed.com),
a
developer of proprietary drug delivery systems, presented the results today
of
its exploratory study entitled “Enteral Administration of Exenatide-4; Proof of
Concept Pharmacodynamic Study in Dogs” at the Diabetes Technology Society’s
Conference in Bethesda, Maryland.
Oramed’s
drug delivery technology is being utilized for the oral delivery of polypeptides
and proteins. The Company previously demonstrated that using its proprietary
technology enables the delivery of insulin when administered orally.
Exenatide
-4 is a GLP-1 analog belonging to a new family of drugs referred to as the
incretin mimetics. In addition to exenatide-4, incretin mimetics include
liraglutide and a number of other GLP-1 analogs under development.
Incretins are produced in the intestines and are released in response to
meals. Incretins stimulate insulin secretions from the pancreas as well as
delay
gastric emptying. This has the effect of reducing blood glucose, which is
central in the management of diabetes. Incretins have also been associated
with
reduction in appetite and may bring about gradual weight loss. Further,
incretins appear to promote beta-cell regeneration and survival.
The
study
was conducted in dogs and the absorption of exenatide was assessed by measuring
the effect of exenatide-4 on glucose absorption after oral glucose
administration. Control experiments consisted of oral administration of the
same
amount of glucose but without exenatide-4. Two doses of exenatide -4 were tested
and the drug was administered 30 minutes prior to the oral glucose load. The
study suggested that exenatide-4 when combined with Oramed’s absorption
promoters significantly reduces glucose absorption and does so in a dose
proportional manner.
Currently,
exenatide-4 and all other GLP1 analogs are only available as injections. An
oral
dosage form such as a tablet or capsule that would replace the injection is
likely to broaden the use of these important drugs and foster compliance and
adherence among patients. Furthermore, it is plausible that the oral route
of
administration may convey physiological advantages for exenatide-4 and other
analogs as it replicates the physiological route of incretin absorption, from
the gut and conveyed to the portal vein and liver.
About
Oramed Pharmaceuticals
Oramed
Pharmaceuticals is a technology pioneer in the field of oral delivery solutions
for drugs and vaccines presently delivered via injection. Oramed is
seeking to revolutionize the treatment of diabetes through its patented flagship
product, an orally ingestible insulin capsule currently in phase 2 clinical
trials. Established in 2006, Oramed’s technology is based on over 25 years of
research by top research scientists at Jerusalem’s Hadassah Medical Center. The
Company’s corporate and R&D headquarters are based in Jerusalem.
For
more information, please visit www.oramed.com
Forward-looking
statements
Some
of
the statements contained in this press release are forward-looking statements
which involve known and unknown risks, uncertainties and other factors which
may
cause the actual results, performance or achievements of the company, or
industry results, to be materially different from any future results,
performance or achievements expressed or implied by such 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 for our product
candidates; competition from other pharmaceutical or biotechnology companies;
and the company’s ability to obtain additional funding required to conduct its
research, development and commercialization activities. Please refer to the
company’s filings with the Securities and Exchange Commission for a
comprehensive list of risk factors that could cause actual results, performance
or achievements of the company to differ materially from those expressed or
implied in such forward looking statements. The company undertakes no obligation
to update or revise any forward-looking statements.
Company
and Investor Relation Contacts:
Oramed
Pharmaceuticals
Eric
Rosenberg
Cell:
+
972-54-566-7713
Office:
+
972-2-566-0001
Email:
eric@oramed.com
Media
Contacts:
Ruder
Finn Israel for Oramed
Matthew
Krieger
Cell:
+
972-54-467-6950
Office:
+
972-2-589-2003
Email:
matthew@oramed.com
