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 9, 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 September
9, 2008, Oramed Pharmaceuticals Inc. (“Oramed”) issued a press release announcing that it has entered
into an agreement with ETI Karle Clinical Pvt. Ltd., a clinical research
organization in India to conduct Phase 2B clinical trials on its oral insulin
capsules. A copy of the press release is being furnished with this report as Exhibit 99.1 and is incorporated herein by
reference.
As
previously disclosed, Oramed, in conjunction
with the Diabetes Unit, Hadassah University Hospital, was selected to display
its abstract, entitled "Open Label Study to Assess the Safety, Pharmacokinetics
(PK) and Pharmacodynamics (PD) of Five Oral Insulin Formulations in Healthy
Subjects," at the 44th Annual Meeting of the European Association for the
Study of Diabetes (EASD) held on September 9, 2008 in Rome, Italy A
copy of the abstract is being furnished with this report as Exhibit 99.2 and is incorporated herein by reference.
Pursuant
to the rules of the Securities and Exchange Commission, the information
contained in this report (including the exhibits) shall not be deemed to be
“filed” for the purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and will not be incorporated by reference into any filing by Oramed
under such Act or the Securities Act of 1933, as amended.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
|
|
Press
Release dated September 9, 2008
|
|
|
Oramed
Pharmaceuticals Inc. Abstract Entitled “Open Label Study to Assess the
Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Five Oral
Insulin Formulations in Healthy Subjects.”
|
||
-
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.
|
|
|
ORAMED
PHARMACEUTICALS INC.
|
|
|
Dated:
September 9, 2008
|
|
|
|
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By:
|
/s/
Nadav Kidron
|
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Nadav
Kidron
|
|
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President,
CEO and Director
|
- 3
-
Oramed
Pharmaceuticals Partners with ETI Karle Clinical to
Conduct
Phase
2B Trials on Its Oral Insulin Capsule, ORMD 0801
ORMD
0801
to be tested on Type 2 Diabetic Volunteers
JERUSALEM,
Israel - September 9, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
www.oramed.com),
a
developer of oral delivery systems, announced today the signing of an agreement
with ETI Karle Clinical Pvt. Ltd. (www.etiklinical.com),
a
clinical research organization (CRO) located in India, to conduct Phase 2B
clinical trials on its oral insulin capsules.
The
study
is intended to evaluate the safety, tolerability and efficacy of ORMD 0801,
Oramed’s oral insulin capsule, on diabetic type 2 patients.
It
is
anticipated that the Phase 2B study will be conducted over several months
starting in the first quarter of 2009, with approximately 60
subjects participating
in the trial.
“Oramed
has been able to demonstrate that ORMD 0801 has a good safety profile and
effective on a small group of diabetes patients. This trial is intended to
affirm that ORMD 0801 will perform to our expectation on a large group of type
2
diabetes patients,” said Nadav Kidron, CEO of Oramed.
ETI
Karle
Clinical Pvt. Ltd is a Pan-Asian CRO, headquartered in Bangalore with a network
of 60 clinical trial sites across all therapeutic areas, with access to 2
million patients, and 120 researchers.
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
ETI’s
Contacts:
Dr.
M.V.
Nagendran,
COO,
ETI
Karle Clinical Pvt. Ltd.
No.
72,
Industrial Suburb,
Ward
No.
10,
Near
Ullas Theatre,
!st
Block, Rajaji Nagar,
BANGALORE-
560 022, India
Cell:
+91
9845010682
Office:
+91 80 23371585
Email:
nagendran@karlegroup.com
