Schering-Plough and OraSure Technologies Sign International Collaboration for Rapid Point-of-Care Oral Hepatitis C Test
February 11 2008 - 8:50AM
Business Wire
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.
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