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Approval of Clevudine for the Treatment of Chronic Hepatitis B in the Philippines

HI-˶ Pharmaceutical Inc. (Headquarters: Makati City, the Philippines, President: Lourdes Magno), a subsidiary in the Philippines of ˶ Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), announced today that the Bureau of Food and Drugs (BFAD) approved “Clevudine” (generic name) 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 (ALT or AST). ˶ will market the drug under a brand name of “REVOVIR” in the Philippines.

Clevudine is an antiviral drug with an inhibitory effect on DNA polymerase for the treatment of chronic hepatitis B. In the Philippines, about 8 million people are believed to be infected with hepatitis B. With its potent and sustained anti-viral effect, Clevudine is expected to be a new treatment option for patients with deterioration in liver function caused by hepatitis B.

˶ obtained exclusive right to develop, manufacture and market Clevudine in eight Asian countries including China from Bukwang Pharma, a South Korean pharmaceutical company, and has been developing Clevudine in those countries. The Philippines is the first country among them to approve Clevudine for marketing. ˶ is currently expediting the development or proceeding with the preparations for filing for approval of Clevudine in the remainder of the countries.

˶ develops and markets drugs for liver diseases that include Stronger Neo-Minophagen C®, Glycyron® and Livact® in China and other Asian countries. ˶ will continue to make further contributions to improving QOL and benefits to patients with liver diseases in Asia.

Contacts:

PR Department
˶ Co., Ltd.

81-3-3817-5120

< Notes to Editors >

  • About HI-˶ Pharmaceutical Inc.

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Corporate Name : HI-˶ Pharmaceutical Inc.
Office : Makati City, the Philippines
Date of Foundation : July 1974
Paid-in Capital : 56,250 thousand PHP (as of 30 of September, 2008)
Business : Distributor/Importer and Trader of pharmaceutical products
President : Lourdes Magno
  • About Clevudine

    Clevudine is an antiviral drug developed for the treatment of hepatitis B. It exerts its anti-HBV effect by inhibiting DNA polymerase, which is necessary for the virus to be replicated. It is also believed to decrease ccc DNA (covalently closed circular DNA, which is a template DNA for viral replication) in the liver cells. Potent and sustained anti-HBV effect of Clevudine is attributed to these mechanisms of action.

    Clevudine was also approved in South Korea back in 2006 and is currently being marketed by Bukwang Pharma.

  • ˶ Licensed Territories for Clevudine

    China, Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Vietnam.