Oramed Pharmaceuticals Signs Agreement with Encorium Group to Commence Investigational New Drug Application
19 June 2007 - 11:47PM
PR Newswire (US)
JERUSALEM and WAYNE, Pa., June 19 /PRNewswire-FirstCall/ -- Oramed
Pharmaceuticals, Inc.(OTC:ORMP) (BULLETIN BOARD: 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
http://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 http://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.
DATASOURCE: Oramed Pharmaceuticals CONTACT: FOR ORAMED
PHARMACEUTICALS, INC.: Investor Relations: Vinisha Agnihotri,
+1-646-467-2252 Office, ; FOR ENCORIUM GROUP, INC., Investor
Relations: The Equity Group Inc., Adam Prior, +1-212-836-9606, , or
Business Development: Helen Springford, V.P., Global Business
Development, +44-1344-769011 Office, +44-7785-366604, Cell phone,
Web site: http://www.oramedpharma.com/ http://www.encorium.com/
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