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CRUCELL (CRXL)

Marketing of Innovative Vaccine

      The World Health Organization (WHO) has granted Quinvaxem™ vaccine ‘prequalification’. As its name implies, this vaccine, which belongs to Crucell (CRXL) and Novartis 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. The vaccine offers an advantage in terms of convenience of use. Current demand for the vaccine exceeds 50 million doses, with the annual demand expected to increase to more than 150 million doses per year over the next five years.

      In March 2006, the vaccine was awarded licensure by the Korea Food and Drug Administration (KFDA). Ctucell did not hesitate in starting the production of Quinvaxem™ at the facility of its Korean subsidiary immediately following the approval. The first batches of the product have been released by the KFDA and are available for sale, putting Crucell in the position to offer the product to the supranational organizations UNICEF and PAHO.

   The WHO prequalification is a final prerequisite for the combination vaccine to be made available to supranational purchasing organizations. Supranational organizations are major customers for combination vaccines, which are used in mass vaccination programs in developing countries.

"WHO prequalification for Quinvaxem™ marks an important milestone for Crucell as we pursue our strategy of becoming a leading vaccine player," said Crucell's CEO, Dr Ronald H.P. Brus. "The public-private partnership between the United Nations Organizations, Crucell and Novartis over the many years of its development have made this innovative vaccine a reality. We believe this vaccine will make an important contribution to pediatric vaccination programs for the developing world, and will confirm Crucell's place as a leading supplier of such important vaccines."

      Crucell said it expects Quinvaxem™ to become an important contributor to the Company's 2006 revenue forecast and its objective to achieve cash break-even in 2007.

READ MORE: Crucell Announces WHO Prequalification for Quinvaxem(TM) Vaccine

MORE NEWS FOR CRUCELL

        Sanofi pasteur, the vaccines business of the sanofi-aventis Group ( (SNY), initiated its first clinical study today with a new generation of seasonal influenza vaccine produced using the  PER.C6® cell culture technology of Dutch biotechnology company Crucell N.V.

READ MORE: Sanofi pasteur Cell Culture-Based Seasonal Influenza Vaccine Enters First Clinical Trial

        In other news, Crucell announced that the Ebola vaccine it is developing in partnership with the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced its Phase I clinical study. The randomized, double-blind, placebo- controlled study in 48 healthy volunteers will test the single-shot vaccination in a dose-escalation trial.

READ MORE: Crucell and NIH VRC Announce Start of Ebola Vaccine Clinical Trial

      More News from Crucell that Sanofi pasteur, the vaccines business of the sanofi-aventis Group initiated its first clinical study today with a new generation of seasonal influenza vaccine produced using PER.C6(R) cell culture technology developed by Crucell. This trial represents one of the company's initiatives to diversify flu vaccine manufacturing technologies.

READ MORE:   Sanofi pasteur Cell Culture-Based Seasonal Influenza Vaccine Enters First Clinical Trial

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