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): October 23, 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 October
23, 2008, the registrant issued a press release announcing that it has received
approval from the South Africa Medicines Control Council (MCC) to begin
conducting Phase 1A trials on eight healthy human volunteers for ORMD 0802,
the
company’s newly developed insulin suppository. 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 October 23, 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:
October 23, 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 Phase 1A Trials of its Insulin Suppository
An
insulin suppository represents an important development in the treatment
of
diabetes as it provides a painless alternative for effective insulin delivery
JERUSALEM,
Israel - October 23, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
www.oramed.com),
a
developer of alternative drug delivery systems, announced today that it has
received approval from the South Africa Medicines Control Council (MCC) to
begin
conducting Phase 1A trials on eight healthy human volunteers for ORMD 0802,
the
company’s newly developed insulin suppository.
Oramed's
Phase 1A trials on its insulin suppository mark an important step in the history
of insulin delivery as it will provide a painless option for diabetics who
seek
an alternative to current delivery methods. An insulin suppository is especially
important for small children and seniors, who often struggle with
injections.
“The
Phase 1A trial of our insulin suppository is a natural expansion of Oramed’s
pursuit and development of alternative insulin delivery systems,” said Oramed’s
CEO, Nadav Kidron. “By creating an insulin suppository, Oramed hopes to ensure
that diabetics will be able to receive insulin in the form which is most
suitable to their lifestyle and/or age.”
This
Phase 1A trial follows Oramed’s announcement of its successful Phase 2A clinical
trials on its oral insulin capsule, ORMD 0801, which demonstrated that the
product has a strong safety profile and was well tolerated, as well as being
effective in lowering blood glucose levels, in patients with type 2
diabetes.
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