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): December 1, 2010
_____________________
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
December 1, 2010, Oramed Pharmaceuticals Inc. issued a press release announcing
a publication in the Journal of Diabetes Science and Technology's November issue
describing evaluation of the company's glucagon-like peptide- (GLP-1) analog
formulation (ORMD-0901) in regulating glucose excursions in animal
models.
A copy of
the press release is attached to this Current Report on Form 8-K as Exhibit 99.1
and is incorporated by reference herein.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated December 1, 2010.
|
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.
|
|||
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Dated:
December 1, 2010
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|||
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By:
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/s/
Nadav Kidron
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||
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Nadav
Kidron
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|||
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President,
CEO and Director
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Exhibit
Index
|
Exhibit
Number
|
Description
|
|
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99.1
|
Press
Release dated December 1, 2010.
|
Oramed
Pharmaceuticals Announces
Publication
in the Journal of Diabetes
Science
and Technology
Results
describe preclinical trials demonstrating retained GLP-1 analog activity when
delivered with Oramed's oral drug delivery formulations
JERUSALEM,
Israel – December 1, 2010 – Oramed Pharmaceuticals Inc. (OTCBB:
ORMP.OB; www.oramed.com), a
developer of oral drug delivery solutions, announces a publication in the
Journal of Diabetes Science and Technology's November issue describing
evaluation of the company's glucagon-like peptide- (GLP-1) analog formulation
(ORMD-0901) in regulating glucose excursions in animal models.
GLP-1 and
its analogs harbor significant therapeutic potential for management of Type 2
diabetes mellitus through their broad physiological impact on glucose
regulation-related mechanisms. However, the naturally secreted GLP-1 is degraded
within minutes and in cases of impaired release or activity, is typically
substituted by exogenously supplied, long-lived analogues. To date, these drugs
are only available in injectable forms, leading to systemic effects upon
administration as well as unsatisfactory patient compliance and
adherence.
With the
objective of offering a safer, more practical and physiologically relevant
alternative, Oramed has applied its oral drug delivery platform to the GLP-1
analog family. High sugar-content meals were delivered to animals in
the presence or absence of ORMD-0901, followed by close monitoring of blood
glucose levels. Specific formulations were found to effectively blunt
expected glucose surges in both ORMD-0901-treated porcines and canines. The two
animal models used for testing the performance of ORMD-0901, indicated
retained drug activity when delivered using Oramed's oral drug delivery
platform.
Oramed
has already embarked on clinical testing of its ORMD-0901 product to assess the
formulation's safety and efficacy in healthy individuals. Further
testing and development are expected to significantly contribute to current
diabetes control options and success rates.
In
addition to an oral GLP1 analog capsule, the Company’s flagship product is an
oral insulin capsule. The Company is currently working towards submission of an
IND to the FDA for a Phase 2 clinical trial.
To view
the article abstract please click on the link below: http://www.journalofdst.org/November2010/PDF/Abstract/VOL-4-6-ORG20-ELDOR-ABSTRACT.pdf
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 performed 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
Safe Harbor
Statement
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
Tara
Horn
Cell: +
972-54-334-318
Office: +
972-2-566-0001
Email:
tara@oramed.com