Eisai opens $100m parenterals plant in North Carolina
pharmafile | May 24, 2010 | News story | Manufacturing and Production, Research and Development |Â Â Aricept, Eisai, eribulin, parenteralsÂ
Japanese drugmaker Eisai has opened a 65,000-sq.ft. facility at Research Triangle Park in North Carolina, USA, which will serve as the firm’s global commercial manufacturing and drug development site for intravenous drug products.
The $100 million plant features aseptic processing suites, laboratories and other support functions and will use isolator technology to allow it to handle and process highly potent compounds, including cancer drugs.
There has been a wholesale shift towards the use of isolators in the pharmaceutical sector because they save on space and offer more reliable containment and contamination protection. Use of an isolator means that process machinery no longer stands in a sterile room, but in a sterile chamber within a regular cleanroom.
One of the first new compounds to be made in the plant could be Eisai’s candidate breast cancer drug eribulin mesylate (E7389), which was submitted simultaneously for approval in the US, EU and Japan towards the end of March.
Eribulin is a non-taxane inhibitor of microtubule function and has been developed in the first instance for the treatment of locally recurrent or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane.
Eisai’s president and chief executive Haruo Naito described the opening of the new facility as “a major milestone” for the company which “will support the advancement of important new therapies for patients, especially those who are battling life-threatening illnesses”.
Eisai has said it expects revenues of more than $1 billion a year from eribulin, and that it hopes to start rolling it out commercially in its first markets during the current fiscal year that started 1 April.
Eisai is hoping that eribulin will help it offset the impact of losing patent protection in the US for Alzheimer’s drug Aricept (donepezil), the firm’s biggest-selling product, in November.
Aricept is made in another facility that Eisai operates in Research Triangle Park. That 190,000 sq.ft. solid oral dosage facility carries out commercial manufacturing as well as formulation and development work for products in trials, and in 2008 was joined by a $22 million support facility at the site to supply power, steam, chilled water and compressed air.
Phil Taylor
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