February 7, 2007
Tomo Hamazaki
Head of General Affairs and Personnel Department
3-13-5 Nihonbashi, Chuo-ku, Tokyo
Daiichi Pure Chemicals Co., Ltd.
For inquiries: General Affairs Group
TEL: +81 (3)-3272-0672
FAX: +81 (3)-3278-8774

Concerning Application for Approval for Manufacture and Sale of UGT1A1 Gene Polymorphism Identification Kit

Daiichi Pure Chemicals Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Shin-ichiro Ashida; hereinafter referred to as "Daiichi Chemicals") of the Sekisui Chemical Group is pleased to announce that on February 1, 2007, it applied for approval for the manufacture and sale of an external diagnostic drug used to identify the UGT1A1 gene polymorphism that is associated with side effects produced by the anticancer agent irinotecan hydrochloride.

The UGT1A1 gene polymorphism identification kit is used to predict the occurrence of serious side effects produced by the anticancer agent irinotecan hydrochloride from the genetic information of the individual patient thereby enabling selection of treatment options most suited to the individual and is expected to contribute to individualized treatment.

Background to Development

In 1999, Daiichi Chemicals concluded an agreement with the American company Third Wave Technologies Inc. (hereinafter referred to as "TWT") for joint development of UGT1A1*28, UGT1A1*6 and UGT1A1*27 gene polymorphism identification kits using the invader method.
Additionally, from the year 2000, Daiichi Chemicals carried out joint research with Doctor Yoshiki Hasegawa et al of the Medical Department of Nagoya University and confirmed the clinical efficacy of the UGT1A1 gene polymorphism identification kit. The results of this evaluation were acknowledged by Dr. Hasegawa and other researchers and were subsequently published in Clinical Chemistry in 2004.
In America, TWT applied for FDA approval of the UGT1A1*28 polymorphism identification kit (Invader© UGT1A1 Molecular Assay) in July 2005 and approval was granted in August of the same year.

Outline of the Kit

Although the kit that has been approved by the FDA in U.S.A. detects UGT1A1*28 polymorphisms, the kit currently under application by Daiichi Chemicals identifies not only UGT1A1*28, but also UGT1A1*6 and UGT1A1*27. Moreover, this kit features the unique invader method that offers ease of operational procedure.

<Reference>

-Reference Document

Pharmocogenomics, research in focus, special report on anticancer agents, nature asia-pacific, 2005: 1-8

- UGT1A1

The UGT1A1 is a glucuronic acid transferase molecular species that conjugate and detoxicate the active metabolite of the anticancer agent irinotecan hydrochloride in the liver. While over 60 variants of UGT1A1 producing polymorphisms are known, UGT1A1*28 is the most important polymorphism related to the metabolism of irinotecan hydrochloride. UGT1A1*6 and UGT1A1*27 have also been reported as significant polymorphisms for Asians including the Japanese.