- Upon Marketing Authorization Orphan Status Would Provide for Ten Years of Market Exclusivity in the European Union for Both Investigational Treatments
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EXTON, Pennsylvania, April 16EXTON, Pennsylvania, April 16 /PRNewswire/ -- Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that the European Commission has granted orphan drug status to the monoclonal antibodies - farletuzumab (also known as MORAb-003) for the treatment of ovarian cancer and MORAb-009 for the treatment of pancreatic cancer.
Farletuzumab is currently being evaluated in a Phase II efficacy study in patients with platinum sensitive ovarian cancer. In Phase I studies, farletuzumab was well tolerated in patients with advanced, platinum-resistant or refractory ovarian cancer over the course of the treatment period and clinical observations therein suggested pharmacological activity on the disease. MORAb-009 is currently being evaluated in a Phase II study in first-line therapy with gemcitabine in patients with inoperable pancreatic cancer. MORAb-009 was well tolerated in Phase I studies and clinical observations from those studies suggested anti-tumor activity.
"We are very pleased to have received the European Commission's orphan drug designation for these investigational treatments," said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. "This further strengthens these two important programs by offering several clinical development and commercialization benefits."
"We are making good progress with our clinical development programs for farletuzumab for the treatment of ovarian and MORAb-009 in pancreatic cancer," said Martin D. Phillips, M.D., Senior Vice President of Clinical Development for Morphotek. "The Phase I study results for each molecule were promising, and the ongoing Phase II studies are designed to evaluate their efficacy in combination with currently accepted chemotherapy regimens in patients with ovarian or pancreatic cancer. These studies are being conducted in Europe, the United States, Argentina and Brazil."
Created to encourage research and development of drugs for diseases with small patient populations, orphan drug designation in the European Union provides for 10 years of market exclusivity in the European Union following marketing authorization, fee reductions for certain regulatory activities related to the development of the antibodies, direct access to the Centralized Procedure of the European Medicines Agency (EMEA) for review of marketing applications and possible research and development grants from certain EU member states. An orphan designation is not a marketing authorization, which can only be granted after the quality, safety and efficacy of the product are demonstrated.
In the European Union, ovarian cancer is estimated to affect approximately 2.9 people in 10,000 and pancreatic cancer is estimated to affect 1.2 people in 10,000.
About Morphotek
Morphotek, Inc., a subsidiary of Eisai Corporation of North America, 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 http://www.morphotek.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
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 therapeutic areas: 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 affiliates, Eisai actively participates in all aspects of the worldwide healthcare system.
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