Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has entered into a collaboration and license agreement with Biocare Medical, LLC. Under the agreement, the parties will collaborate to develop and commercialize an immunohistochemical (IHC) diagnostic kit utilizing Morphotek’s proprietary monoclonal antibody to specifically detect human folate receptor alpha (FRA) with Biocare’s intelliPATH™ Automated Stainer. The agreement provides Biocare with a worldwide non-exclusive license to develop, manufacture and commercialize an IHC kit for detection of FRA on formalin-fixed paraffin-embedded (FFPE) tumor tissues.
FRA is a cell surface protein that is over-expressed in a variety of cancers including non-small cell lung adenocarcinoma and ovarian carcinoma. Studies have found its expression variable among different cancer types. In light of this variability, a diagnostic assay that can identify patients with FRA-positive cancers may enable better diagnosis and treatment of patients affected with FRA-expressing cancers. FRA is the target of Morphotek’s lead therapeutic candidate, farletuzumab, which is currently being tested in several clinical trials against different types of cancers.
“We are excited to continue development of our first diagnostic product using a novel Morphotek antibody in cooperation with Biocare and their innovative IHC platform technology,” stated Daniel J. O’Shannessy, Ph.D., Director of Diagnostic Development at Morphotek. “We believe that the development of a validated IHC assay (and subsequent submission to the FDA) will be a significant step forward for our drug development programs. Furthermore, it supports our human health care (hhc) mission by better defining a patient’s disease subtype to help design more appropriate therapeutic regimens.”
“Biocare is enthusiastic about joining with a leader in the application of personalized medicine to develop oncology therapies,” stated David Tacha, Ph.D., CSO and VP of R&D at Biocare Medical. “Our diagnostic detection kits developed at Biocare are a perfect match for Morphotek and their endeavor for diagnostic kits that will help determine which patients will best respond to therapy.”
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About Biocare Medical
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC lab testing. Biocare is the market leader in simultaneous Multiplex IHC and antibody development which solves difficult clinical problems and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in Concord, California, and has a global distribution network. For more information, please visit www.biocare.net.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.