Oramed Pharmaceuticals Signs Agreement With Encorium Group To Commence Investigational New Drug Application
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Oramed Pharmaceuticals, Inc.(OTC BB:ORMP), an Israeli company
focused on the development of oral delivery solutions based on
proprietary technology and Encorium Group, Inc. (Nasdaq: ENCO),
an international full service contract research organization (CRO) that
provides comprehensive clinical and drug development solutions for
pharmaceutical, biotechnology and medical device companies today
announced an agreement that is intended to expedite the development of
Oramed’s lead product for treatment of
diabetes mellitus. Encorium Group has extensive worldwide experience in
the drug/biologics development process for a multitude of agents and
disease conditions and specifically in diabetes, including preclinical
to post-marketing support studies. This agreement engages Encorium Group
to assist Oramed in the design, implementation, advancement, and
oversight of a sound scientific and regulatory strategic plan for the
filing and ultimate approval of Oramed’s oral
insulin product on a worldwide basis. The initial focus of this combined
effort between Oramed and Encorium Group is to assemble the information
required for the opening of an investigational new drug application
(IND) and its subsequent filing with the FDA.
Nadav Kidron, Chief Executive Officer for Oramed Pharmaceutical, Inc.,
stated, "We are delighted to be working with
Encorium Group, a company with a strong track record of successfully
integrating early stage development, consulting services, and clinical
trial execution for small as well as large biopharmaceutical companies
on a global basis. We believe that by working closely with Encorium
Group, we can proactively reach our immediate goal of filing an IND in
the United States. Subsequently, we intend to move forward quickly to
systematically evaluate the oral bioavailability of our insulin product
from the gastrointestinal tract in humans as well as evaluate the impact
of our oral formulation on blood glucose levels.”
Kenneth M. Borow, M.D., President and Chief Executive Officer for
Encorium Group, Inc. commented, "We are
enthusiastic about the opportunity to work with Oramed Pharmaceuticals.
Its oral delivery technology for insulin is both timely and innovative.
This is especially important when considered within the framework of a
worldwide epidemic of diabetes and the trend towards earlier use of
insulin in type 2 diabetic patients. Based on numerous in vivo
preclinical studies, Oramed Pharmaceutical’s
oral insulin technology is unique and holds the promise for being of
significant therapeutic benefit in the management of diabetes. We at
Encorium Group look forward to working with Oramed on this exciting and
potentially medically important product.” About Diabetes Mellitus:
The incidence of diabetes has increased significantly in recent years at
least in part due to changes in obesity rates and lifestyle. Obesity and
weight gain are leading risk factors for diabetes. In turn, diabetes and
obesity are significant risk factors for cardiovascular disease and
stroke. In the United States, Canada, and Europe, type 2 diabetes
accounts for approximately 90 percent of all cases of diabetes. More
than 6 percent of all people between the ages of 20 and 74 years and
more than 12 percent of persons over age 40 have type 2 diabetes; these
numbers continue to increase. Insulin is used in the treatment of
patients with diabetes of all types. The need for insulin depends upon
the balance between insulin secretion and insulin resistance. All
patients with type 1 diabetes need insulin treatment permanently, unless
they receive an islet or whole organ pancreas transplant; many patients
with type 2 diabetes will require insulin as their pancreatic beta cell
function declines over time. Recently, there has been growing interest
in the concept of earlier treatment with insulin in patients with type 2
diabetes.
About Oramed Pharmaceuticals:
Oramed Pharmaceuticals' is an Israeli based company focused on the
development of oral delivery solutions based on proprietary technology.
Diabetes is one of the most rapidly growing diseases in the world and is
one that requires constant and often unpleasant monitoring and drug
therapy regimen. Oramed is currently developing an orally ingestible
soft gel insulin capsule for the treatment of diabetes. The Company is
also pursuing the development of oral delivery solutions for other drugs
and vaccines. For more information please visit our website at www.oramedpharma.com About Encorium Group, Inc.
Encorium Group, Inc. is a global clinical research organization that is
a leader in the design and management of complex clinical trials and
Patient Registries for the pharmaceutical, biotechnology and medical
device industries. The Company’s mission is to
provide its clients with high quality, full-service support for their
biopharmaceutical and medical device development programs. Encorium
offers therapeutic expertise, experienced team management and advanced
technologies. The Company has drug and biologics development as well as
clinical trial experience across a wide variety of therapeutic areas
such as diabetes, cardiovascular, vaccines, infectious diseases,
oncology, endocrinology/metabolism, gene therapy, immunology, neurology,
gastroenterology, dermatology, hepatology, women’s
health and respiratory medicine. Encorium believes that its leadership
in the design of complex clinical trials, its extensive early stage
development capabilities, its broad therapeutic expertise and commitment
to excellence, and its application of innovative technologies offer its
clients a means to more quickly and cost effectively move products
through the clinical development process. Encorium is headquartered in
Wayne, Pennsylvania with its European base of operations in Espoo,
Finland. The Company has a geographic footprint that includes over one
billion people in North America, Western/Central/Eastern Europe,
Scandinavia, and the Baltics. For more information please visit our
website at www.encorium.com Legal Notice and Forward Looking
Statements For Oramed Pharmaceuticals
This news release contains statements, which may constitute
"forward-looking statements". Those statements include statements
regarding the intent, belief or current expectations of Oramed
Pharmaceutical Inc., and members of our management as well as the
assumptions on which such statements are based. Forward-looking
statements in this release include: that we are currently developing an
orally ingestible soft gel insulin capsule for the treatment of type 1
and 2 diabetes; that we are pursuing the development of oral delivery
solutions for other drugs and vaccines; that by working closely with
Encorium Group, we can proactively reach our immediate goal of filing an
IND in the United States; and that subsequently, we intend to move
forward quickly to systematically evaluate the oral bioavailability of
our insulin product from the gastrointestinal tract in humans as well as
evaluate the impact of our oral formulation on blood glucose levels.
Factors which may significantly change or prevent our forward looking
statements from fruition include that we may be unsuccessful in
developing any products and we may not continue our collaboration with
Encorium; that human trials may suffer unforeseen difficulties or
adverse medical effects on participants; that our technology may not be
validated as we progress further and our methods may not be accepted by
the scientific community; that we are unable to retain or attract key
employees whose knowledge is essential to the development of our
products; that unforeseen scientific difficulties develop with our
process; that our patents are not sufficient to protect essential
aspects of our technology; that competitors may invent better technology
to treat or cure diabetes or that the market for diabetes drugs does not
increase; that studies are cut short by unexpected problems with our
methodology; that our products may not work as well as hoped or worse,
that our products may harm recipients; and that we may not be able raise
funds for development or working capital when we require it. As well,
our products may never develop into useful products and even if they do,
they may not be approved for sale to the public. For further risk
factors see the Company's latest 10-KSB filed with the SEC and the 8-K
announcing our acquisition of the Oramed technology filed March 8, 2006.
Legal Notice and Forward Looking
Statements For Encorium Group, Inc.
This press release contains forward-looking statements identified by
words such as "estimate,” "project,” "expect,” "intend,” "believe,” "anticipate” and
similar expressions. Actual results might differ materially from those
projected in, expressed in or implied by the forward-looking statements.
Potential risks and uncertainties that could affect the Company's future
operating results and financial condition include, without limitation:
(i) our success in attracting new business and retaining existing
clients and projects; (ii) the size, duration, and timing of clinical
trials we are currently managing may change unexpectedly; (iii) the
termination, delay or cancellation of clinical trials we are currently
managing could cause revenues to decline unexpectedly; (iv) the timing
difference between our receipt of contract milestone or scheduled
payments and our incurring costs to manage these trials; (v) outsourcing
trends in the pharmaceutical, biotechnology and medical device
industries; (vi) the ability to maintain profit margins in a competitive
marketplace; (vii) our ability to attract and retain qualified
personnel; (viii) the sensitivity of our business to general economic
conditions; (ix) other economic, competitive, governmental and
technological factors affecting our operations, markets, products,
services and prices; (x) announced awards received from existing and
potential customers are not definitive until fully negotiated contracts
are executed by the parties;(xi) our backlog may not be indicative of
future revenues and may not generate the revenues expected;(xii) our
ability to successfully integrate the businesses of Encorium and
Remedium Oy which we acquired on November 1, 2006; and (xiii) the
ability of the combined businesses to operate successfully, generate
revenue growth and operating profits. You should not place any undue
reliance on these forward looking statements which speak only as of the
date of this press release. Additional information concerning factors
that might affect our business or stock price which could cause actual
results to materially differ from those in forward-looking statements is
contained in Encorium Group's SEC filings, including its Annual Report
on Form 10-K for the year ended December 31, 2006 and other periodic
reports under the Securities Exchange Act of 1934, as amended, copies of
which are available upon request from Encorium Group's investor
relations department or The Equity Group Inc.