Healthcare Industry News: Organon
News Release - February 11, 2008
Schering-Plough and OraSure Technologies Sign International Collaboration for Rapid Point-of-Care Oral Hepatitis C TestNew Agreement Provides for Development and Promotion of OraQuick(R) HCV Test Outside the United States
KENILWORTH, N.J. & BETHLEHEM, Pa.--(HSMN NewsFeed)--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.
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.
Source: OraSure Technologies
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