Takara Bio Inc. (President & CEO: Ikunoshin Kato, Ph.D.) announced that it entered into an agreement with InVivoScribe Technologies (San Diego, California) as of July 6, 2006, to grant InVivoScribe Technologies an exclusive worldwide (excluding Japan) license to practice the patent covering detection method of a mutation in FLT3 gene, which is one of the major causes of refractory acute myeloid leukemia (AML).

FLT3 is a receptor protein mainly expressing on surface of immature marrow cells, and is said to be playing an important role in regulation of early hematopoiesis. A mutation of internal tandem duplication (ITD) in FLT3 gene is known as a marker of refractory disease; it is detected in approximately one third of AML patients that usually show a poor prognosis.
AML, which is found approximately 6 out of 100,000 people, has identified with the highest incidence among several types of leukemia. In the United States, approximately 10,000 people are newly diagnosed as AML and more than 7,000 patients die each year. Clinical developments of drugs effective for patients having FLT3/ITD mutation are actively conducted over the world. By testing existence of FLT3/ITD mutation, patients who are qualified for administration of FLT3/ITD-targeted drugs can be identified, resulting in more accurate treatments on them.
Takara Bio has already obtained patents for method of FLT3/ITD detection in Japan and the US, and has recently been granted an allowance by European Patent Office as well.

Under this license agreement, InVivoScribe Technologies is allowed to conduct development, manufacture, and sales of testing reagents for FLT3/ITD detection, and to grant sublicense to testing institutions, such as diagnostic testing firm and sub-organization of a hospital, who engage in commercial service of FLT3/ITD testing. Takara Bio expects to receive from IVS a certain upfront payment, as well as subsequent running royalties based on their sales of FLT3/ITD testing reagents and sublicense revenues.

InVivoScribe Technologies is a US based company who has a strong advantage in the field of PCR testing reagents mainly for leukemia and lymphoma. They have been conducting development, manufacture, and sales of PCR testing reagents for hematological malignancies, and moreover licensing activities of gene testing technologies involved. It is hoped that this collaboration with InVivoScribe Technologies enables the Company to effectively spread the patented technology relating to gene testing of AML over the world.

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.

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