Eisai Launches REVOVIR® in the Philippines for the Treatment of Chronic Hepatitis B

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that the Company's Philippine subsidiary, HI-Eisai Pharmaceutical Inc. (Headquarters: Makati City, the Philippines, President: Lourdes Magno), launched “REVOVIR® 30mg Capsules” (generic name: clevudine) in the Philippines for the treatment of chronic hepatitis B.

REVOVIR® is a Nucleoside Reverse Transcriptase Inhibitor (NRTI). It exerts anti-hepatitis B virus (HBV) effects by inhibiting DNA polymerase, the enzyme that is necessary for the virus to replicate. Clinical studies have shown that a once-daily oral dose of REVOVIR® not only reduces the amount of HBV DNA, but also normalises alanine aminotransferase (ALT) levels in patients experiencing deterioration in liver function caused by chronic hepatitis B.

REVOVIR® was approved in the Philippines in February 2009 and it is indicated for the inhibition of virus replication in chronic hepatitis B patients (HBeAg-positive or HBeAg-negative) with evidence of active viral replication and elevations in serum aminotransferases.

It is estimated that approximately 1.7 million people suffer from chronic hepatitis B in the Philippines. However, there are many patients who are unable to receive diagnosis and medical attention or who find it difficult to continue treatment due to a lack of awareness of the disease or their own economic circumstances. Eisai will strive to fulfil its commitment as a human health care (hhc) company to bring this new treatment to as many of these patients as possible at affordable prices and to contribute to the treatment of patients with chronic hepatitis B in the Philippines.

Eisai obtained the exclusive rights to develop, market, and manufacture clevudine in eight Asian countries from Bukwang Pharma, a South Korean pharmaceutical company, and the development of the compound is ongoing in these countries with the exception of the Philippines. A Phase III clinical trial of clevudine has been initiated in China and marketing authorisation applications have been submitted in India, Indonesia, Malaysia, and Thailand.

Eisai considers hepatic disease as a therapeutic area of focus in China and other Asian countries and thus markets and develops drugs such as hepatic disease/allergic disease agents Stronger Neo-Minophagen C® and Glycyron® Tablets as well as branched-chain amino acid formula Livact® Granules. Through these efforts, Eisai will continue to make further contributions to increasing the benefits to patients with hepatic disease across Asia.

[Please refer to the following notes for information on HI-Eisai Pharmaceutical Inc. and the product]


Eisai Co., Ltd.
Public Relations Department
Tel. +81-(0)3-3817-5120

< Notes to Editors >

■ About HI-Eisai Pharmaceutical Inc.

Corporate Name: HI-Eisai Pharmaceutical Inc.
Location: Makati City, the Philippines
Date of Establishment: July 1974
Paid-in Capital: 56,250 Thousand Philippine Pesos (as of December 31, 2009)
Scope of Business: Manufacture and Marketing of pharmaceutical products
President: Lourdes Magno

■ About REVOVIR®

Product Name: Revovir®
Generic Name: clevudine
Formulation: Capsule (30mg)
Indication: Inhibition of virus replication in chronic hepatitis B patients (HBeAg-positive or HBeAg-negative) with evidence of active viral replication and elevations in serum aminotransferases (ALT or AST)
Dosage and Administration: The usual adult dose for oral use is 1 capsule (30mg of clevudine) once daily or as prescribed by the physician.

■ Eight Eisai Licensed Territories for Clevudine

China, India, Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam