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Crucell Announces Product Approval in Korea for Quinvaxem Vaccine LEIDEN, NETHERLANDS -- March 27, 2006 -- Dutch biotechnology company Crucell N.V. announced today that the Korea Food and Drug Administration (KFDA) has awarded licensure to Quinvaxem(TM), a fully liquid pentavalent vaccine to be produced by Crucell in Korea. Quinvaxem was co-developed with Chiron Corporation, which provides four of the five components as bulk. The vaccine combines antigens for protection against five important childhood diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b, one of the leading causes of bacterial meningitis in children. It is the first internationally available fully liquid vaccine containing all five of the above antigens to reach the market, offering a major advantage in terms of convenience of use. Supranational organizations are major customers for combination vaccines, which are used in mass vaccination programs in developing countries. The Quinvaxem product dossier was filed in 2005 with both the KFDA and the World Health Organization (WHO). The paediatric vaccine addresses an important unmet medical need in many parts of the developing world. As a next step, the WHO is expected to finalize its own review in order to grant WHO ‘pre-qualification’, a pre-requisite for the combination vaccine to be made available to supranational purchasing organizations. Crucell will start production of the Quinvaxem(TM) vaccine immediately at its Korean subsidiary. First sales are expected in the second half of 2006. The current demand exceeds 50 million doses, with the annual demand expected to increase to more than 150 million doses per year over the next five years. Ronald H. Brus, Crucell’s CEO commented: “This approval by the Korean FDA is an important first step towards becoming a major supplier in paediatric vaccination programs for the developing world. The approval of Quinvaxem(TM) is an important milestone for us, which fits perfectly in our strategy to become a leading vaccine player.” SOURCE: Crucell N.V. E-mail this page to a friend or colleague! To print, use this version