OPKO Health, Inc. (NYSE:OPK) today announced that it has signed an agreement with Laboratory Corporation of America Holdings (LabCorp) under which LabCorp licensed exclusive rights in North America and the United Arab Emirates to OPKO’s intellectual property to develop and commercialize laboratory testing services for Alzheimer’s disease. Financial terms of the transaction were not disclosed. OPKO’s diagnostic is designed to detect elevated levels of antibodies that appear to be unique to Alzheimer’s disease. The Alzheimer’s disease-specific antibodies were discovered using OPKO’s novel proprietary platform that OPKO has demonstrated in initial studies to be capable of identifying biomarkers for a wide range of diseases to which the immune system reacts, including Alzheimer’s disease, as well as cancers, autoimmune diseases, neurodegenerative diseases and infectious diseases. In addition to Alzheimer’s disease, OPKO is pursuing the development of diagnostics for non-small cell lung cancer, pancreatic and other cancers, and diseases for which early detection could lead to earlier therapy and dramatically improved outcomes. “Licensing of our Alzheimer’s diagnostic technology to a major clinical laboratory, such as LabCorp, marks a significant milestone for OPKO’s diagnostics program and the advancement of our molecular diagnostics tests,” commented Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “LabCorp, one of the world’s leading suppliers of diagnostic services, has a track record of introducing new testing services that improve patient disease management.” “We believe that OPKO's innovative technology will lead to more accurate diagnoses, more effective treatment, and better patient outcomes,” said David P. King, Chairman and Chief Executive Officer of LabCorp. “We are pleased to offer this important diagnostic tool to our customers in North America and the UAE.” About Alzheimer’s Disease Currently it is estimated that over five million people in the United States, and over 35 million people worldwide, have Alzheimer’s disease and the national cost of caring for people with Alzheimer’s and other dementias was estimated to be $172 billion in 2010 in the United States alone. By 2050, it is estimated that between 11 and 16 million people in the United States over the age of 65 will have Alzheimer’s, and the global prevalence of people living with Alzheimer’s and other dementias is expected to be greater than 115 million. Currently there are no specific tests to detect Alzheimer’s disease and follow its progression. Current diagnosis tools such as behavioral and cognitive measurements, brain scans and spinal fluid analysis have limited diagnostic accuracy, may not detect early stage disease, and in the case of spinal fluid analysis are highly invasive. Definitive diagnosis can currently be made only from examination of postmortem brain tissue samples. An effective early diagnostic blood test would provide a significant breakthrough in supporting definitive early diagnosis.
About OPKO Health, Inc.OPKO is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "could," "intends," "estimates," and other words of similar meaning, including statements regarding our product development efforts and product expectations, including our ability to develop and commercialize a diagnostic test for Alzheimer's and other diseases, our ability to develop tests to identify biomarkers for a wide range of diseases to which the immune system reacts, and the potential of the technology to lead to more accurate diagnoses, more effective treatment, and better patient outcomes, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors, including those described in our filings with the Securities and Exchange Commission, could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include, that initial testing may not be indicative of future success and we will be unable to successfully develop or commercialize a diagnostic test for Alzheimer's disease or other diseases such as other neurodegenerative disorders, autoimmune diseases, and various cancers, that the diagnostic test may fail and not be successful in identifying biomarkers or antibodies unique to Alzheimer's Disease or other diseases or achieve the expected results or effectiveness, and may not generate data that would support the approval or marketing of this or other diagnostic products, that others may develop products, including other early stage diagnostic products which are superior to the test we are developing, and that the diagnostic test if developed may not have advantages over other marketed products. In addition, forward-looking statements may also be adversely affected by risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.