Eisai Inc. and Morphotek announced that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis
WOODCLIFF LAKE, NJ, USA & EXTON, PA, USA | June 28, 2010 | Eisai Inc. and Morphotek®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.
MORAb-022 is a fully-human antibody developed using Morphotek’s proprietary Human MORPHODOMA® technology. In-vitro studies have shown that the antibody targets a protein associated with inflammatory diseases, such as rheumatoid arthritis (RA).
“We are extremely pleased to be carrying out the study for MORAb-022 in the European Union,” said Yasunobu Kai, President of Eisai’s Frontier Product Creation Unit. “Our clinical development team is eager to begin this study with the goal of expanding clinical studies worldwide in the future.”
“Our collaboration with the Frontier Unit for the development of MORAb-022 represents how Eisai’s new Product Creation System is working to leverage internal resources and expertise for the development of new agents that may help further our human health care (hhc) mission,” said Nicholas Nicolaides, President and Chief Executive Officer, Morphotek, Inc. “In this collaboration, Morphotek is providing its preclinical and human antibody development expertise while the Frontier Unit is applying its drug development expertise in inflammatory disease to design and carry out clinical studies.”
In July 2009, Eisai announced the reorganization of its global R&D organization into the Eisai Product Creation System (EPCS). Under this new structure, Eisai’s R&D organization was organized into multiple individual operating units focused on product creation in strategic therapeutic areas referred to as Product Creation Units (PCUs) as well as Core Functional Units (CFUs) that provide technology, regulatory and clinical support to enable the discovery and development goals of each PCU. The Frontier clinical development team is located at Eisai’s Knowledge Centre located in Hatfield, England; Woodcliff Lake, NJ; and Tokyo, Japan.
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 novel and proprietary technologies. The technologies have been successfully applied to a variety of molecules 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 with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. 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 Maryland, 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.
SOURCE: Morphotek, Inc.
Post Views: 47
Eisai Inc. and Morphotek announced that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis
WOODCLIFF LAKE, NJ, USA & EXTON, PA, USA | June 28, 2010 | Eisai Inc. and Morphotek®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.
MORAb-022 is a fully-human antibody developed using Morphotek’s proprietary Human MORPHODOMA® technology. In-vitro studies have shown that the antibody targets a protein associated with inflammatory diseases, such as rheumatoid arthritis (RA).
“We are extremely pleased to be carrying out the study for MORAb-022 in the European Union,” said Yasunobu Kai, President of Eisai’s Frontier Product Creation Unit. “Our clinical development team is eager to begin this study with the goal of expanding clinical studies worldwide in the future.”
“Our collaboration with the Frontier Unit for the development of MORAb-022 represents how Eisai’s new Product Creation System is working to leverage internal resources and expertise for the development of new agents that may help further our human health care (hhc) mission,” said Nicholas Nicolaides, President and Chief Executive Officer, Morphotek, Inc. “In this collaboration, Morphotek is providing its preclinical and human antibody development expertise while the Frontier Unit is applying its drug development expertise in inflammatory disease to design and carry out clinical studies.”
In July 2009, Eisai announced the reorganization of its global R&D organization into the Eisai Product Creation System (EPCS). Under this new structure, Eisai’s R&D organization was organized into multiple individual operating units focused on product creation in strategic therapeutic areas referred to as Product Creation Units (PCUs) as well as Core Functional Units (CFUs) that provide technology, regulatory and clinical support to enable the discovery and development goals of each PCU. The Frontier clinical development team is located at Eisai’s Knowledge Centre located in Hatfield, England; Woodcliff Lake, NJ; and Tokyo, Japan.
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 novel and proprietary technologies. The technologies have been successfully applied to a variety of molecules 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 with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. 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 Maryland, 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.
SOURCE: Morphotek, Inc.
Post Views: 47
