Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has completed construction and officially opened its new parenteral oncology drug production facility at its U.S. plant in North Carolina.
The new 65,000 square-foot (approximately 6,000 m²) facility will serve as Eisai's global production site for the formulation research and development and commercial manufacturing of intravenous drug treatments, including the Company's anticancer agent. Eisai has invested approximately 100 million US dollars in the new facility, which encompasses aseptic processing suites, manufacturing lines for investigational compounds, formulation research laboratories and other support functions. The new operation was designed to handle and process highly potent compounds utilizing state-of-the-art isolator containment technology.
The opening of the new facility has allowed Eisai to further reinforce its seamless value chain, which integrates the Company's global research and development, production, distribution and sales operations.
As part of its commitment to its human health care (hhc) philosophy, Eisai defines integrative oncology as a therapeutic area of focus, and is committed to the development, production and commercialization of highly efficacious anticancer agents and treatments for supportive care in order to satisfy unmet medical needs in this area. The opening of new facility and subsequent commencement of operations will further strengthen the Company's oncology franchise.
Eisai is currently pursuing the global development of several investigational anticancer agents for breast cancer, lung cancer, ovarian cancer, and melanoma. In March this year, the Company submitted regulatory applications for approval of eribulin mesylate (“eribulin”) for the treatment of locally advanced or metastatic breast cancer to the health authorities in Japan (Ministry of Health, Labour and Welfare), the United States (U.S. Food and Drug Administration) and Europe (European Medicines Agency). Eribulin is a potential anticancer agent discovered and developed by Eisai. If and when approved, it will be the first anticancer agent to be produced at the new facility.
With the opening of and commencement of operations at its new parenteral oncology drug production facility, Eisai will continue to further promote the stable supply of high quality drug products tailored to the various needs of each region, thereby making contributions to increasing the benefits provided to patients and their families worldwide.
[Please refer to the following notes for further information and images of the new facility North Carolina Plant facility]
Public Relations Department,
Eisai Co., Ltd.
< Notes to editors >
- Outline of the New North Carolina (United States) Plant Facility
|1) Location:||Research Triangle Park, North Carolina, United States|
|2) Facility Area:||65,000 square feet (approximately 6,000 m²)|
|3) Functions:||Formulation research and development and commercial production of parenteral anticancer agents and other drug treatments|
|4) Products to be Manufactured: ||Anticancer agents, etc. (parenteral formulations)|
|5) Production Capacity:||5,000,000 vials/year (single shift)
- Images of the New North Carolina (United States) Plant Facility
1) Aerial view
*New production facility is located in the front of the photograph
2) Exterior view