|
|
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, 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):
¨ 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))
|
ITEM 7.01
|
REGULATION
FD DISCLOSURE
|
On
September 14, 2010, Oramed Pharmaceuticals Inc. issued a press release
announcing successful results in an exploratory clinical trial testing the
effectiveness of its oral insulin capsule (ORMD-0801) in Type I diabetes
patients suffering from uncontrolled diabetes.
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)
|
Exhibits
|
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated September 14,
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.
|
|||
|
Dated:
September 16, 2010
|
|||
|
By:
|
/s/ Nadav
Kidron
|
||
|
Nadav
Kidron
|
|||
|
President,
CEO and Director
|
|||
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated September 14,
2010.
|
Oramed
Pharmaceuticals Announces Successful Results of a Novel
Exploratory
Clinical Study of its Flagship Oral Insulin Capsule
Proof of
Concept Study for a New Indication of Oral Insulin Capsule for Type
1
Diabetics
JERUSALEM,
Israel – September 14, 2010 – Oramed Pharmaceuticals Inc. (OTCBB:
ORMP.OB) announced today successful results in an exploratory clinical trial
testing the effectiveness of its oral insulin capsule (ORMD-0801) in Type I
diabetes patients suffering from uncontrolled diabetes.
In
parallel to Oramed's main focus in developing an oral insulin capsule for
management of Type II diabetes the company is exploring an application of its
oral insulin capsule toward cases of uncontrolled Type I
diabetics. Unstable or labile diabetes is characterized by recurrent,
unpredictable and dramatic blood glucose swings often linked with irregular
hyperglycemia and sometimes serious hypoglycemia affecting Type I diabetes
patients. This newly completed exploratory study was a proof of
concept study for defining a novel indication for ORMD-0801. The encouraging
results justify further clinical development of ORMD-0801 capsule
application toward management of uncontrolled diabetes.
“This
study marks an impressive milestone for Oramed” says Nadav Kidron, CEO of Oramed
Pharmaceuticals. “These results suggest a possible novel and unique indication
for our oral insulin product in the treatment of Type I diabetes in addition to
our main indication for Type II 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
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 http://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 Inc.
Tara
Horn
Office:
646-240-4193
Cell:
+972-54-334-4318
Email:
tara@oramed.com