Tokyo, Japan – 20 January 2006: Sosei Co. Ltd. (“Sosei” – 4565, Tokyo Stock Exchange MOTHERS index) today announces the company withdrew the Marketing Authorisation Application in Japan for Eligard® (indication: prostate cancer). Discussions and deliberations with regard to the drug’s development plan are ongoing.
Sosei applied to the Japanese Ministry of Health, Labour and Welfare (MHLW) on the 28th February 2005 for marketing approval of this drug under the generic drug classification. Subsequently Sosei was advised by the Ministry that obtaining approval under that classification would be difficult. This was reported in the press release dated the 16th December 2005, and after further consultations the application has now been withdrawn.
Note: The company regards this withdrawal as a means to proceed with the development reconstruction for the approval of the drug and does not intend to abandon its development at present.