Takara Bio Inc. (president: Ikunoshin Kato) announced patents on internal tandem duplication (ITD) mutations of FLT3 genes, the main cause of refractory leukemia, was registered by the Japan Patent Office on October 15, 2004 (Japanese Patent No.3607704) and by the United States Patent and Trademark Office (US patent No. 6,846,630) on January 25, 2005.

FLT3/ITD mutations are mutations of the FMS-like tyrosine kinase 3 (FLT3) gene, a receptor tyrosine kinase gene, which plays an important role in early hematopoietic control. Shohei Yokota, M.D. of the 3rd Internal Medicine division, Kyoto Prefectural University of Medicine, first reported the mutations. The mutation is detected in about one third of acute myelogenous leukemia patients and patients with these gene mutations are usually refractory to treatment. Because patients with these mutations have a poor prognosis, drugs targeting mutated FLT3 tyrosine kinase are in demand.

This newly registered US patent covers a method of detection of FLT3/ITD gene mutations, which offers important index for applicability of drugs that target these mutations and for assessment of therapeutic effects by monitoring the mutations. The corresponding Japanese patent covers a wider range including not only the mutation detection method but also the polypeptides and nucleic acids of the FLT3/ITD mutants.

The Takara Bio believes the patent covers an important technique that opens the way to tailor-made treatment of refractory leukemia. Clinical development of molecular-targeting drugs, FLT3 tyrosine kinase inhibitors for patients with FLT3/ITD mutations, is active worldwide. Takara Bio plans to undertake commercialization of this patent in the fields of drug R&D, development of diagnostics and contracted laboratory testing services and licensing agreements with pharmaceutical companies worldwide.

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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