OraSure Technologies (NASDAQ:OSUR)
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Schering-Plough Corporation (NYSE:SGP) and OraSure Technologies, Inc.
(NASDAQ:OSUR) today announced an agreement to collaborate on the
development and promotion of a rapid oral hepatitis C virus (HCV) test
utilizing OraSure Technologies’ OraQuick®
technology platform on a worldwide basis outside the United States.
This new agreement expands the existing collaboration announced in
January 2007 when the parties signed an agreement to develop and promote
a rapid oral HCV test in the U.S. physicians’
office markets. OraSure is a leader in oral fluid diagnostics and
developer and manufacturer of the OraQuick ADVANCE®
Rapid HIV-1/2 Antibody Test, the first and only U.S. Food and Drug
Administration (FDA) approved rapid oral fluid HIV-1/2 Test.
Schering-Plough is a worldwide leader in the discovery and development
of novel HCV therapies.
“We are very pleased to announce the expansion
of our collaboration with Schering-Plough internationally,”
said Douglas A. Michels, President and CEO of OraSure Technologies. “Schering-Plough
is a recognized leader in HCV therapy and has the capability to promote
our rapid HCV test throughout the world. We believe the global market
opportunity for a rapid HCV test is significant and this expansion of
our collaboration with Schering-Plough should help drive the adoption of
this important product around the world.”
Under terms of the agreement, Schering-Plough will reimburse OraSure for
certain development costs and will provide payments to OraSure based on
the achievement of certain regulatory and commercial milestones in
international markets. Schering-Plough will also provide promotional
support for the product in international markets. All sales of the HCV
test will be made by OraSure, and OraSure will retain the rights to
market and sell the test in all markets throughout the world. During the
collaboration period, the test may, at Schering-Plough’s
option, be labeled and promoted under both Schering-Plough and OraSure
trademarks.
Schering-Plough is committed to advancing the science and treatment of
hepatitis C, both in terms of its internal research and development
programs, and by collaborating with other companies. In addition,
Schering-Plough is committed to supporting hepatitis C patients through
its leading disease awareness, education and service programs.
Approximately 170 million people are chronically infected with hepatitis
C worldwide and there are approximately 3 to 4 million new HCV
infections each year on a global basis. Chronic hepatitis C can cause
cirrhosis, liver failure and liver cancer. About half of all cases of
primary liver cancer in the developed world are caused by hepatitis C,
and hepatitis C related liver disease is now the leading cause for liver
transplants. Most people who develop chronic hepatitis C infection are
not aware that they have the disease.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid
specimen collection devices using proprietary oral fluid technologies,
diagnostic products including immunoassays and other in vitro
diagnostic tests, and other medical devices. These products are sold in
the United States as well as internationally to various clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, distributors, government agencies,
physicians' offices, and commercial and industrial entities.
In addition, OraSure sells products for the cryosurgical removal of
common and plantar warts in the over-the-counter or retail market in the
Mexico, Canada, certain European countries, Australia and New Zealand,
and a product for the cryosurgical removal of common and plantar warts
and several other benign skin lesions to the professional or physician
office market in the United States and many foreign countries. For more
information on the Company, please go to http://www.orasure.com.
OraSure Technologies Forward-Looking Statement
This press release contains certain forward-looking statements,
including with respect to product development, commercialization and
markets. Actual results could be significantly different. Factors that
could affect results include the ability to market and sell products;
changes in relationships, including disputes or disagreements, with
strategic partners and reliance on strategic partners for the
performance of critical activities under collaborative arrangements;
failure of distributors or other customers to meet purchase forecasts or
minimum purchase requirements for the Company’s
products; impact of competitors, competing products and technology
changes; ability to develop, commercialize and market new products;
market acceptance of oral fluid testing or other products; changes in
market acceptance of products based on product performance; continued
bulk purchases by customers, including governmental agencies, and the
ability to fully deploy those purchases in a timely manner; ability to
fund research and development and other products and operations; ability
to obtain and maintain new or existing product distribution channels;
reliance on sole supply sources for critical product components;
availability of related products produced by third parties or products
required for use of our products; ability to obtain, and timing and cost
of obtaining, necessary regulatory approvals for new products or new
indications or applications for existing products; ability to comply
with applicable regulatory requirements; history of losses and ability
to achieve sustained profitability; volatility of our stock price;
uncertainty relating to patent protection; uncertainty and costs of
litigation relating to patents and other intellectual property;
availability of licenses to patents or other technology; ability to
enter into international manufacturing agreements; obstacles to
international marketing and manufacturing of products; ability to sell
products internationally; loss or impairment of sources of capital;
ability to meet financial covenants in agreements with financial
institutions; ability to retain qualified personnel; exposure to patent
infringement, product liability and other types of litigation; changes
in international, federal or state laws and regulations; customer
consolidations and inventory practices; equipment failures and ability
to obtain needed raw materials and components; the impact of terrorist
attacks and civil unrest; ability to complete consolidation or
restructuring activities; ability to identify, complete and realize the
full benefits of potential acquisitions; and general political, business
and economic conditions. These and other factors are discussed more
fully in the Securities and Exchange Commission (“SEC”)
filings of OraSure Technologies, including its registration statements,
its Annual Report on Form 10-K for the year ended December 31, 2006, its
Quarterly Reports on Form 10-Q, and its other filings with the SEC.
Although forward-looking statements help to provide complete information
about future prospects, readers should keep in mind that forward-looking
statements may not be reliable. OraSure Technologies undertakes no duty
to update any forward-looking statements after they are made.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and
collaborations with partners, Schering-Plough creates therapies that
help save and improve lives around the world. The company applies its
research-and-development platform to human prescription and consumer
products as well as to animal health products. In November 2007,
Schering-Plough acquired Organon BioSciences, with its Organon human
health and Intervet animal health businesses, marking a pivotal step in
the company’s ongoing transformation.
Schering-Plough’s vision is to “Earn
Trust, Every Day” with the doctors, patients,
customers and other stakeholders served by its approximately 50,000
people around the world. The company is based in Kenilworth, N.J., and
its Web site is www.schering-plough.com.http:///
Schering-Plough Forward-Looking Statement
The information in this press release includes certain “forward-looking
statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements relating
to the company’s plans and the potential
chronic hepatitis C market. Forward-looking statements relate to
expectations or forecasts of future events. Schering-Plough does not
assume the obligation to update any forward-looking statement. Many
factors could cause actual results to differ materially from
Schering-Plough’s forward-looking statements,
including market forces, economic factors, product availability, patent
and other intellectual property protection, current and future branded,
generic or over-the-counter competition, the regulatory process, and any
developments following regulatory approval, among other uncertainties.
For further details of these and other risks and uncertainties that may
impact forward-looking statements, see Schering-Plough’s
Securities and Exchange Commission filings, including Part II, Item 1A, “Risk
Factors” in the company’s
third quarter 2007 10-Q.