Morphotek, Inc., a U.S. subsidiary of Eisai Co., Ltd., announced today that the company has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
EXTON, PA, USA | May 21, 2007 | Morphotek, Inc., a U.S. subsidiary of Eisai Co., Ltd., announced today that the company has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
“We are extremely pleased to have selected CMC as our contract manufacturer for this IgM monoclonal antibody,” said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. “CMC has production and scale up experience with IgM monoclonal antibodies and a team of dedicated scientists that have tackled difficult purification and analytical development programs. We are confident that CMC, with its state-of-the-art manufacturing facilities, will meet both our production and quality goals as well as timelines for product supply to support our planned clinical trials.”
“We are thoroughly excited to partner with Morphotek and are eager to embrace an active role in the development and manufacturing aspects of MORAb-028,” said Mads Lausten, CEO of CMC Biopharmaceuticals. “Our facilities, staff and technology will help Morphotek achieve tremendous success with MORAb-28 – and we are looking forward to that with great anticipation.”
Through the use of the company’s antibody development technologies and expertise, Morphotek has successfully developed this unique IgM antibody and established a process for large-scale production. Historically, IgM monoclonal antibodies have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints. This molecule represents another therapeutic antibody candidate in Morphotek’s growing monoclonal antibody pipeline through use of its proprietary Human MORPHODOMA® technology and antibody development expertise.
MORAb-028 is being prepared to enter clinical evaluation in 2008 and represents a growing list of therapeutic monoclonal antibodies being developed by Morphotek for the treatment of cancer.
About Morphotek
Morphotek®, Inc., a U.S. subsidiary of Eisai Co., Ltd., 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 Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: Integrative neuroscience including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 9,000 people worldwide. For more information, please visit www.eisai.co.jp.
SOURCE: Morphotek
Post Views: 132
Morphotek, Inc., a U.S. subsidiary of Eisai Co., Ltd., announced today that the company has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
EXTON, PA, USA | May 21, 2007 | Morphotek, Inc., a U.S. subsidiary of Eisai Co., Ltd., announced today that the company has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
“We are extremely pleased to have selected CMC as our contract manufacturer for this IgM monoclonal antibody,” said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. “CMC has production and scale up experience with IgM monoclonal antibodies and a team of dedicated scientists that have tackled difficult purification and analytical development programs. We are confident that CMC, with its state-of-the-art manufacturing facilities, will meet both our production and quality goals as well as timelines for product supply to support our planned clinical trials.”
“We are thoroughly excited to partner with Morphotek and are eager to embrace an active role in the development and manufacturing aspects of MORAb-028,” said Mads Lausten, CEO of CMC Biopharmaceuticals. “Our facilities, staff and technology will help Morphotek achieve tremendous success with MORAb-28 – and we are looking forward to that with great anticipation.”
Through the use of the company’s antibody development technologies and expertise, Morphotek has successfully developed this unique IgM antibody and established a process for large-scale production. Historically, IgM monoclonal antibodies have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints. This molecule represents another therapeutic antibody candidate in Morphotek’s growing monoclonal antibody pipeline through use of its proprietary Human MORPHODOMA® technology and antibody development expertise.
MORAb-028 is being prepared to enter clinical evaluation in 2008 and represents a growing list of therapeutic monoclonal antibodies being developed by Morphotek for the treatment of cancer.
About Morphotek
Morphotek®, Inc., a U.S. subsidiary of Eisai Co., Ltd., 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 Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: Integrative neuroscience including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 9,000 people worldwide. For more information, please visit www.eisai.co.jp.
SOURCE: Morphotek
Post Views: 132
