■　"The Second-class Drugs Marketing Authorization Holder" and "The Second-class Medical Devices Marketing Authorization Holder" licenses from Tokyo Metropolitan Government

February 25, 2010

RIKEN GENESIS

As a result, RIKEN GENESIS is now authorized to manufacture and market pharmaceutical products including: in-vitro diagnostic reagents (diagnostic reagents for infectious diseases, hematology reagents, biochemical reagents, immunological reagents, and chips for human genetic testing, etc.), nonprescribed ethical drugs (reagents used in preparations under special circumstances or on a limited basis, etc.), and proprietary drugs (also called over-the-counter drugs, and drugs for self-medication, which include cold medications, gastrointestinal drugs, and vitamins, etc., sold at pharmacies and drug stores); and medical devices including: controlled medical devices (X-ray equipment, MR devices, contrast media injection equipment, electrocardiographs, and dental metal, etc.) and general medical devices (steel instruments, X-ray film, motorized pedestals for patients, stethoscopes, sphygmomanometers, and equipment used for clinical chemical analysis including equipment for genetic analysis, etc.).

 

The guiding philosophy of RIKEN GENESIS is to actively promote the clinical application of genetic analysis to make "Personalized Medicine"（※1） a reality. Specifically, in a joint venture with RIKEN and Toppan Printing, we are working to develop a fully automated genetic analysis system that can be used in clinical settings to conduct rapid, small-scale, genetic analysis (SNP typing).

 

By being granted these two "Marketing Authorization Holder" licenses, for both drugs and medical devices, it is now possible to apply for the marketing and manufacturing authorization required to supply this fully automated genetic analysis system for use in clinical settings (in medical facilities such as hospital laboratories and clinical testing facilities, etc.) both as an "in-vitro diagnostic agent" and as a "medical device."

 

In the future, RIKEN GENESIS will promote the broad clinical application of genetic analysis, beginning with this fully automated genetic analysis system, continue to develop pharmaceutical products and medical devices in related fields, and actively strive to make "Personalized Medicine" a reality.

 

Details of the Marketing Authorization Holder licenses granted to RIKEN GENESIS are set forth below.

 

The Second Class Drugs Marketing Authorization Holder License
License No.: 13A2X10049
Period of validity: December 9, 2009 to December 8, 2014
Name of Authorization Holder: RIKEN GENESIS CO., LTD.

Address of Authorization Holder: 1-5-1, Taito, Taito-ku, Tokyo 110-8560 Japan

 

The Second Class Medical Devices Marketing Authorization Holder License
License No.: 13B2X10123
Period of validity: December 1, 2009 to November 30, 2014
Name of Authorization Holder: RIKEN GENESIS CO., LTD.

Address of Authorization Holder: 1-5-1, Taito, Taito-ku, Tokyo 110-8560 Japan

 

―　Supplementary explanation　―

（※1） Personalized Medicine: To provide effective, scientifically-based, individualized treatment and medication based on the genetic background of each patient. This treatment is not only expected to improve the quality of life (QOL) of each individual patient, but also reduce costs associated with adverse drug reactions and suppress annually increasing healthcare costs in Japan.

 

【Inquiries about this press release】
RIKEN GENESIS CO., LTD.
Corporate Management Department
TEL: +81-45-521-8781 / FAX: +81-45-521-8786 / e-mail: info2@rikengenesis.jp