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): September 16, 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):
[
] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[
] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[
] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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ITEM
7.01
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REGULATION
FD DISCLOSURE.
|
On September
16, 2008, the registrant issued a press release announcing that it
has launched pre-clinical trials of ORMD 0901, a GLP1-analog. A copy of the
press release is attached to this Current Report on Form 8-K as Exhibit 99.1
and
is incorporated herein by reference.
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ITEM
9.01
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FINANCIAL
STATEMENTS AND EXHIBITS.
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(d)
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Exhibits
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99.1
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Press
Release dated September 16, 2008
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2
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.
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ORAMED
PHARMACEUTICALS INC.
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|
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Dated:
September 16, 2008
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By:
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/s/
Nadav Kidron
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Nadav
Kidron
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President,
CEO and Director
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3
Oramed
Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug
Delivery Platform
ORMD
0901
is being developed as an oral dosage form of a GLP1-analog aimed at improving
glycemic control in adults with type 2 diabetes
JERUSALEM,
Israel - September 16, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB),
a
developer of oral drug delivery systems, announced today that it has launched
pre-clinical trials of ORMD 0901, a GLP1-analog. ORMD
0901
belongs to the Incretin family of drugs which helps to manage diabetes,
including reduction in blood glucose levels and inhibiting glucagon secretion.
Incretins
have been cited in causing regeneration of pancreatic insulin secreting cells,
and in tissue protective properties including protection of the heart. GLP1
and
analogs are associated with gradual weight loss, which is very desirable in
diabetes patients.
“The
launch of pre-clinical trials of ORMD 0901 and expansion of Oramed’s platform
marks the next strategic milestone for our company as we demonstrate the
effectiveness of our oral delivery technology in yet another important family
of
polypeptide drugs for diabetes, that are until now only available in injection
form,” said Oramed CEO Nadav Kidron.
We
plan
to conduct the ORMD 0901 trials at Hadassah University Medical Center and they
are expected to conclude by the end of 2008.
Oramed
plans to launch phase 2b trials of ORMD 0801, its oral insulin capsule, in
India
in the first quarter of 2009.
About
Oramed Pharmaceuticals
Oramed
Pharmaceuticals is a technology pioneer in the field of oral delivery solutions
for drugs 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