Dutch biotechnology company Crucell N.V. announced that Quinvaxem, its fully-liquid pentavalent vaccine co-developed with Novartis Vaccines and Diagnostics, has been granted 'prequalification' by the World Health Organization (WHO).
Following the awarding of licensure by the Korea Food and Drug Administration (KFDA) in March 2006, 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 programmes in developing countries, a Crucell press release stated.
Crucell commenced production of Quinvaxem at the facility of its Korean subsidiary immediately following the vaccine's licensure by the KFDA. First batches of the product have recently been released by the KFDA and are available for sale. This puts Crucell in the position to now offer the product to the supranational organizations UNICEF and PAHO.
"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 paediatric vaccination programmes 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.
Quinvaxem 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. 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.