Takara Bio to establish a new facility for the research and manufacturing of pharmaceutical products for cell and gene therapies[New!]

2012

2012.08.09
TAKARA BIO INC.

Takara Bio to establish a new facility for the research and manufacturing of pharmaceutical products for cell and gene therapies

August 9, 2012 ---- Takara Bio announced that it has entered into an agreement with a third party to purchase its land and buildings, and the Company will build a new facility for the research and manufacturing of pharmaceutical products for cell and gene therapies. The role of the new facility will be to manufacture gene modified cells or viruses in compliance with GMP (Good Manufacturing Practice) as well as vectors for gene transduction, which include retroviral, plasmid, lentiviral, adenoviral and adeno-associated viral vectors etc. In this new facility, the Company will also conduct research and development of fundamental biotechnologies in the field of cell and gene therapy.

Takara Bio is conducting clinical trials of HSV-TK gene therapy for leukemia in Japan, MazF gene therapy for HIV and HF10 anti-cancer therapy in the U.S., and plans to commercialize these gene therapy drugs in 2017 and beyond. The Company is also developing core technologies on cell and gene therapy, and manufacturing GMP vectors for its own clinical trials or as contract services at facilities located in the Otsu and Kusatsu cities of Shiga Prefecture.

Our clinical development projects are progressing as scheduled. However, the manufacturing capacity of the vectors for the later phase of clinical trials is expected to be insufficient, and will ultimately place increased demand on contract services to manufacture vectors as well as gene modified cells in compliance with GMP.

As Takara Bio is the only Company which is conducting clinical trials of ex vivo gene therapy in Japan, the establishment of the new facility will allow the Company to gain more advantage over other competitors. The Company expects the establishment of the new facility will accelerate the research and development of its projects, and will expand the business of vector manufacturing contract services in compliance with GMP.

The investment in construction of the new facility is estimated to be around 4 billion Japanese yen. The total amount of the investment, which includes expenses of purchasing the land, is planned to amount to 7 billion Japanese yen, and all of which is payable by cash on hand. The new facility construction is planned to be completed in March 2014.

Takara Bio is now operating multiple facilities in Shiga and Mie Prefectures. Having taken this opportunity to acquire new land, the Company will also begin to consider possibilities for further business integration in order to improve its productivities, increase efficiency and lower operating costs going forward.

[ About Takara Bio Inc. ]

Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin^® reagent, which is a world-standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy, and agricultural biotechnology; and is committed preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, the Company aims to extend its reach around the world. More information is available at http://www.takara-bio.com.

For more information:Corporate Communications, Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp

This article is translated from press release in Japanese for your convenience.

Forward-Looking Statements

Statements in this news release, other than those based on historical fact, concerning the current plans, prospects, strategies and expectations of the Company and its Group represent forecasts of future results. While such statements are based on the conclusions of management according to information available at the time of writing, they reflect many assumptions and opinions derived from information that includes major risks and uncertainties. Actual results may vary significantly from these forecasts due to various factors. Factors that could influence actual results include, but are not limited to, economic conditions, especially trends in consumer spending, as well as exchange rate fluctuations, changes in laws and government systems, pressure from competitors' prices and product strategies, decline in selling power of the Company's existing and new products, disruptions to production, violations of our intellectual property rights, rapid advances in technology and unfavorable verdicts in major litigation.

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