Tokyo, Japan, August 21, 2009 - Astellas Pharma Inc. (headquarters: Tokyo; President and CEO: Masafumi Nogimori; “Astellas”) today announced that the groundbreaking ceremony for Fermentation Technology Research Building in the Toyama Plant of its subsidiary Astellas Toyama Co., Ltd. (President and CEO: Kinji Nakajima; “Astellas Toyama”) will be held on August 24, 2009. 

The Fermentation Technology Research Building will have three stories above the ground and a total floor area of approximately 9,000 m2. It will meet the standards for manufacturing and quality control for clinical trial material (CTM) – active pharmaceutical ingredient (API) (GMP for investigational products) applicable in Japan, the US and Europe. It will be able to simultaneously manufacture multiple API for CTM. It is also equipped with facilities for scale-up research and will be able to conduct a seamless series of studies from the establishment of scale-up technology to the optimization of the manufacturing process required for commercial production. 
Once completed, the Fermentation Technology Research Building will greatly enhance Astellas’s capacity to manufacture API for CTM and establish a global system to supply API for CTM that can flexibly deal with changes in the environment in the future. The total construction cost will be approximately ¥5.5 billion. Construction will be initiated in September 2009 and completed in October 2010. 

Astellas makes uninterrupted efforts for drug discovery research based on fermentation of natural substances and chemical synthesis. It has discovered numerous new drugs including an immunosuppressant and anti-infectious drugs. At present, it has several candidate compounds obtained through fermentation-based drug discovery research at a preclinical stage. Astellas has decided to construct the Fermentation Technology Research Building in order to ensure stable global supply of active pharmaceutical ingredient API for CTM as the development of these candidate compounds progresses. 

Astellas Toyama is a domestic core drug manufacturing facility of the Astellas Group. At present, it manufactures drug substances and commercial products for the immunosuppressant Prograf ® and the treatment for atopic dermatitis Protopic®. Products manufactured by it are supplied to not only the domestic but also global markets. Astellas Toyama is responsible for the production of these mainstay products and works hard to speedily deliver new drugs to patients and further upgrade Astellas’s production technology by establishing a more efficient technology development system in close cooperation with Astellas’s other laboratories.

(References)

[Profile of the Fermentation Technology Research Building]
(1) Location: Toyama Plant of Astellas Toyama Co., Ltd.
(2-178 Kojinmachi, Toyama City, Toyama)
(2) Number of stories/ total floor area: 3 stories above the ground with the total floor area of approximately 9,000 m2
(3) Total construction cost: Approximately ¥5.5 billion
(4) Construction starts: September 2009
Date of completion: October 2010

[Profile of Astellas Toyama Co., Ltd.]
Foundation: October 2003
Headquarters: 2-178 Kojinmachi, Toyama City, Toyama
Representative: Kinji Nakajima (President and CEO)
Number of employees: Approximately 420 (as of March 31, 2009)
Business sites: Toyama Plant, Takaoka Plant and Fermentation Technology Research Center (Kiyosu)
Businesses description: Contract manufacturing of drug substances and products for ethical pharmaceuticals for supply in Japan and abroad and contract manufacturing of investigational drugs