Merck receives approval to market Gardasil, Zolinza, and Cubicin in Japan

WHITEHOUSE STATION,  N.J., July 1, 2011 – Merck (NYSE: MRK), known  as MSD outside the United States and Canada,  announced today that the Japanese  Ministry of Health, Labour and Welfare (MHLW) approved three products – GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,  Recombinant], ZOLINZA^® vorinostat) and  CUBICIN^® (daptomycin for injection) – for use in Japan.

“These three new approvals will enable Merck to bring these new medicines and vaccines to the people of Japan,” said  Tony Alvarez, president, MSD Japan. “Doing so will help Merck continue to fulfill its mission and  deliver growth.”

In Japan, GARDASIL, a quadrivalent  human papillomavirus (HPV) vaccine, was approved for the prevention of cervical  cancer (squamous cell cancer and adenocarcinoma) and their precursor lesions  (cervical intraepithelial neoplasm grade 1/2/3 and cervical adenocarcinoma in  situ), vulvar intraepithelial neoplasia grade 1/2/3, vaginal intraepithelial  neoplasia grade 1/2/3 and genital warts caused by HPV types 6, 11, 16 and 18 in  females 9 years of age and older.

ZOLINZA is an oral anticancer drug and was approved in Japan for the treatment of cutaneous T-cell lymphomas. As the result of a distribution agreement signed in 2011, Taiho  Pharmaceutical Co., Ltd. will promote and distribute ZOLINZA in Japan.

CUBICIN is an antibacterial agent with activity against methicillin-resistant Staphylococcus aureus (MRSA)  and was approved in Japan for the treatment of MRSA infections. Under a licensing agreement signed in 2007 between Merck and Cubist, MSD obtained the rights for development and distribution of CUBICIN in Japan. CUBICIN is marketed in the United States by Cubist Pharmaceuticals.

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