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): July 21, 2009
_____________________
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 July
21, 2009, Oramed Pharmaceuticals Inc. (the “Company”) issued a press release
reporting positive results from a study of its oral insulin capsule on Type 1
diabetic patients.
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.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
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99.1
|
Press
Release dated July 21, 2009
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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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|||
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Dated:
July 21, 2009
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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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|||
Oramed
Pharmaceuticals Reports Positive Results from a Study of Oral Insulin Capsule on
Type 1 Diabetic Patients
JERUSALEM,
Israel – July 21, 2009– Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB)
(http://www.oramed.com), a developer of alternative drug delivery
systems, today reported positive results from a Phase 2A study of its
oral insulin capsule, ORMD-0801, on type 1 diabetic patients. The completion of
this study marks Oramed's first clinical trial on patients with Type 1 Diabetes
Mellitus, whereas, all Oramed’s trials up to date have been conducted
on type 2 diabetic patients. This study evaluated safety, tolerability, and food
effects in type 1 diabetic patients.
Oramed’s
oral insulin capsule, (ORMD-0801), was well tolerated by patients and no serious
adverse events were observed. The insulin absorption was not affected when
given before meal ingestion.
Oramed
Chief Scientific Officer, Miriam Kidron, PhD., remarked, “These results
demonstrate that Oramed’s oral insulin capsule had a good safety profile and was
effective on patients with type 1 diabetes when taken prior to a
meal.”
Currently,
Oramed is conducting its Phase 2B clinical trial in South Africa, in which the
company is evaluating the effects of ORMD-0801 on type 2 diabetic
patients.
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
Tara
Horn
USA: +1
646-240-4193
Int’l: +
972-54-334-318
Office: +
972-2-566-0001
Email: tara@oramed.com