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News Release

February 3, 2003

E7155, MRI contrast agent application withdrawn in Japan

Eisai Co., Ltd.
Bracco-Eisai Co., Ltd.

Eisai Co., Ltd. (Tokyo, Japan, President: Haruo Naito) and Bracco-Eisai Co., Ltd. (Tokyo, Japan, President: Toshio Matsumoto) decided to withdraw the new drug application (NDA) of E7155 (gadobenate meglumine), since new indications are emerging for the product and additional clinical data was necessary to complete the targeting product competitive risk/benefit profile. The product is currently marketed in other countries, and both companies are discussing a future development plan in Japan.

E7155 is a novel gadolinium-based contrast agent for Magnetic Resonance Imaging (MRI), which was licensed from Bracco Imaging s.p.a. (Italy), with the unique pharmacokinetic behavior, as it behaves both as an extracellular contrast agent as well as a liver-specific agent.

E7155 has been successfully marketed since 1998 with indications for liver and central nervous system imaging in Europe, and a NDA has been submitted in the USA. Bracco Imaging s.p.a. is currently performing additional studies in Magnetic Resonance angiography and in other MR indications to fully exploit the product potentialities.

In Japan, Bracco s.p.a. and Eisai Co., Ltd. established the joint venture company (Bracco-Eisai Co., Ltd.), and have co-operated in the development and promotion of the non-ionic X-ray contrast agent, "Iomeron" and the non-ionic MRI contrast agent, "ProHance".

[ Reference ]

< MRI >
Magnetic Resonance Imaging
MRI is a computed tomography for human body, which is visualized by magnet and radio frequency wave, but not by X-ray as X-ray CT. Proton in human cell molecules are resonated with specific frequency, and different developed radio wave between tissues was visualized with computer.

< MRA >
Magnetic Resonance Angiograpy
MRA is a method to visualize vessels with 3-dimension immediately after intravenous injection of contrast agent. MRA has lower invasion than conventional aniograhy with catheter and X-ray contrast agent.

< Extra-cellular contrast agent >
Extra-cellular contrast agents are distributed into only extra-cellular space and almost all of the agents are eliminate into urine. For example, gedopentetate meglumine, ProHance (marketed by Eisai) and so on.

< Liver-specific contrast agent >
Ferumoxides and Ferucarbotran are currently marketed liver-specific contrast agents. These are iron-oxide particle and up-taken by Kupffer cell. On the other hand, E7155 is a gadolinium chelate as extra-cellular agents but is up-taken by hepatocyte.