JERUSALEM, Nov. 30, 2015 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage
pharmaceutical company focused on the development of oral drug
delivery systems, announced today it has signed definitive
licensing and investment agreements valued at up
to $50,000,000 with Hefei Tianhui Incubator of
Technologies Co., Ltd. ("HTIT") for exclusive rights to market
Oramed's oral insulin capsule, ORMD-0801, in China, Hong
Kong and Macau. The
agreements were signed at the Israel Knesset (Parliament).
The license agreement payments include a $3 million payment due upon execution of the
agreement, $8 million in
near-term payments subject to Oramed entering into certain
agreements and the balance payable upon achievement of
certain milestones. In addition, if all conditions are met, HTIT
will pay a 10% royalty on net sales of the related commercialized
products.
In addition to the contemplated payments under the license
agreement, pursuant to the investment agreement, Oramed will issue
to HTIT 1,155,469 restricted shares of Oramed's common stock at a
price per share of approximately $10.39 and $12
million in total, subject to customary closing
conditions.
"China recently became the
country with the largest number of diabetics in the world. Having
signed these definitive license and investment agreements, our oral
insulin capsule could help serve the growing population of people
in China living with diabetes,"
stated Oramed's CEO Nadav
Kidron. "In addition to the $50
million in milestone payments and investments, we believe
the royalties on net sales throughout China will have a very significant impact on
Oramed's future revenues and earnings, upon market approval of
ORMD-0801 in China."
About Hefei
HTIT, which is partially owned by Sinopharm Group Company
Limited, has state of the art insulin production facilities in
Hefei, China. HTIT has a business
focus which includes industrial investment and incubation services;
high-tech product R&D; technology transfer and related
consulting services.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of
oral delivery solutions for drugs currently delivered via
injection. Established in 2006, Oramed's Protein Oral Delivery
(PODTM) technology is based on over 30 years of research
by top scientists at Jerusalem's
Hadassah Medical Center. Oramed is seeking to revolutionize the
treatment of diabetes through its proprietary flagship product, an
orally ingestible insulin capsule (ORMD-0801). Having
completed separate Phase IIa clinical trials, the company
anticipates the initiation of separate Phase IIb clinical trials,
in patients with both type 1 and type 2 diabetes under an
Investigational New Drug application with the U.S. Food and Drug
Administration. In addition the company is developing an oral
GLP-1 analog capsule (ORMD-0901).
For more information, please visit www.oramed.com, the
content of which is not part of this press release.
Forward-looking statements: This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Words such as "expects," "anticipates," "intends,"
"plans," "believes," "seeks," "estimates" and similar expressions
or variations of such words are intended to identify
forward-looking statements. For example, we are using
forward-looking statements when we discuss the closing of the
issuance of the shares to HTIT, expected future milestone and
royalty payments under the license agreement, our product's
potential to help serve the growing population of people in
China living with diabetes, the
significant impact that the expected royalties on net sales
throughout China will have on our
future revenues and earnings, upon market approval of ORMD-0801 in
China, and our expected initiation
of separate Phase IIb clinical trials in patients with both type 1
and type 2 diabetes under an Investigational New Drug application
with the U.S. Food and Drug Administration, and revolutionizing the
treatment of diabetes with our products. These forward-looking
statements are based on the current expectations of the management
of Oramed only, and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements, including
the satisfaction of closing conditions in the investment agreement
prior to the issuance of shares to HTIT; meeting certain conditions
and future milestones pursuant to the license agreement; 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 or patent protection for
our product candidates; competition from other pharmaceutical or
biotechnology companies; and our ability to obtain additional
funding required to conduct our research, development and
commercialization activities. In addition, the following factors,
among others, could cause actual results to differ materially from
those described in the forward-looking statements: changes in
technology and market requirements; delays or obstacles in
launching our clinical trials; changes in legislation; inability to
timely develop and introduce new technologies, products and
applications; lack of validation of our technology as we progress
further and lack of acceptance of our methods by the scientific
community; inability to retain or attract key employees whose
knowledge is essential to the development of our products;
unforeseen scientific difficulties that may develop with our
process; greater cost of final product than anticipated; loss of
market share and pressure on pricing resulting from competition;
laboratory results that do not translate to equally good results in
real settings; our patents may not be sufficient; and finally that
products may harm recipients, all of which could cause the actual
results or performance of Oramed to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Oramed undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Oramed,
reference is made to Oramed's reports filed from time to time with
the Securities and Exchange Commission.
Company Contact
Oramed Pharmaceuticals
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: 1-718-831-2512 ext. 2
Email: ariella@oramed.com
Photo - http://photos.prnewswire.com/prnh/20151130/291560
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oramed-signs-up-to-50-million-licensing-and-investment-agreements-for-oral-insulin-capsule-in-china-300185175.html
SOURCE Oramed Pharmaceuticals Inc.