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News Release

FOR IMMEDIATE RELEASE
March 13, 2008
For Print (PDF 73KB)

Eisai and Sanko Junyaku introduce New KL-6 Test Kits for LUMIPULS® Systems for Detecting Marker of Interstitial Pneumonia

Eisai Co., Ltd.
Sanko Junyaku Co., Ltd.
FUJIREBIO INC.
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and its diagnostic subsidiary company Sanko Junyaku Co., Ltd. (Headquarters: Tokyo, President: Masao Jinbo) announced today the launch of LUMIPULSE® KL-6 EISAI and LUMIPULSE® PRESTO KL-6 EISAI, new KL-6 test kits that detects KL-6, a marker of interstitial pneumonia, using LUMIPULSE® systems. LUMIPULSE® systems are diagnostic equipments using an automated chemiluminescence enzyme immunoassay system marketed by FUJIREBIO INC. (Headquarters: Tokyo, President: Hiromasa Suzuki). The new kits will be made available on March 17, 2008 in Japan.

KL-6 is a serum marker that has high specificity for interstitial pneumonia. Currently, Sanko Junyaku markets two KL-6 test kits, EITEST® KL-6 (sandwich enzyme immunoassay method) and PICOLUMI® KL-6 (electrochemiluminescence immunoassay method). FUJIREBIO markets three LUMIPULS® systems, LUMIPULSE®f, LUMIPULSE®S, and LUMIPULSE ® PrestoII. Today, more than 1,000 LUMIPULSE® systems are used in medical institutions throughout Japan. The new KL-6 test kits for the LUMIPULSE® systems will further increase the convenience in diagnosis for interstitial pneumonia.

In accordance with the joint research agreement signed on October 19, 2006 among Eisai, Sanko Junyaku and FUJIREBIO, the three companies co-developed the new KL-6 test kits, and obtained manufacturing and marketing approval for the products. The kits will be manufactured by FUJIREBIO, and be marketed by Sanko Junyaku under marketing support by Eisai Co. Ltd.

Cryptogenic interstitial pneumonia and drug-induced pneumonia are common types of interstitial pneumonia. Recently, the number of drug-induced pneumonia cases reported has been increasing, which raised the significance and public concerns about the disease. Through this new test kits, Eisai, Sanko Junyaku and FUJIREBIO will continue to make contributions to increasing the benefits of the patients and their families.


[Please refer to the following note for the product information and glossary]

[Contacts:]
Eisai Co., Ltd.
Corporate Communications Department
Tel: +81-(0)3-3817-5120
Sanko Junyaku Co., Ltd.
Public Relations
Attn: Nishina
Tel: +81-(0)3-3865-4311
FUJIREBIO INC.
Corporate Planning Department
Tel: +81-(0)3-5695-9207


< Product Information >

Product NameLUMIPULSE® KL-6 EISAILUMIPULSE® PRESTO KL-6 EISAI
Assay SystemLUMIPULSE®fLUMIPULSE®SLUMIPULSE ® PrestoII
Package(42 tests) x2(14 tests) x3200 tests
List Price71,400 yen35,700 yen170,000 yen
Intended UseMeasurement of sialylated carbohydrate antigen (KL-6) level in serum or plasma
Manufactured byFUJIREBIO INC.
Marketed bySanko Junyaku Co., Ltd
Marketing supported byEisai Co., Ltd.


Solution and Calibrator (sold separately)
Product NameLUMIPULSE® KL-6 EISAILUMIPULSE® PRESTO KL-6 EISAI
Standard KL-6 SolutionKL-6 CalibratorKL-6 Calibrator
Assay SystemLUMIPULSE®fLUMIPULSE®SLUMIPULSE ® PrestoII
Package5 concentrations x13 concentrations x13 concentrations x1
List Price30,800 yen30,800 yen30,800 yen
Manufactured byFUJIREBIO INC.
Marketed bySanko Junyaku Co., Ltd
Marketing supported byEisai Co., Ltd.


< Glossary >
Automated Chemiluminescence Enzyme Immunoassay System
An automated diagnostic equipment using chemiluminescence enzyme immunoassay (CLEIA)system for detecting and measuring minute substances in vivo.

Interstitial Pneumonia
Human lungs are made up of multiple, small grape-like structures called alveoli, where the exchange of oxygen and carbon dioxide takes place. Inflammation of alveoli causes pneumonia, which can be classified into two groups based on the region where the inflammation occurs: interstitial pneumonia, in which inflammation occurs in the walls of the alveoli (interstitium), and alveolar pneumonia (commonly-termed pneumonia), in which inflammation occurs in the airway between bronchi and alveoli. Differential diagnosis is required since treatment methods for these two types of pneumonia are different.

KL-6 (Sialylated Carbohydrate Antigen)
KL-6 is expressed on the surface of type II alveolar epithelial cells which consist of the walls of the alveolus (interstitium). In interstitial pneumonia, such type II alveolar epithelial cells are excessively formed and the KL-6 level increases. Measurement of serum KL-6 level is effective for the diagnosis of interstitial pneumonia since KL-6 extravasate into blood.