High-volume avian influenza vaccine a step closer

Sanofi Pasteur's pandemic influenza vaccine using Crucell's novel PER.C6 cell-culture technology will be the first influenza vaccine developed using human cell production technology to enter clinical trials in Europe.

According to the World Health Organisation (WHO), the next pandemic is likely to result in 1 to 2.3 million hospitalisations and 280,000 to 650,000 deaths in industrialised nations alone. Its impact will most likely be even more devastating in developing countries.

"We have at this stage made significant progress in scaling up our cell culture production processes to develop clinical lots,"​ said Michel de Wilde, Sanofi Pasteur​'s executive vice president, research and development.

Influenza vaccines are currently produced using embryonated chicken eggs. However, a more timely and economical production method for producing new vaccines in large quantities is required to combat a potential future influenza pandemic.

Crucell's novel PER.C6 technology uses cell culture for the production of influenza vaccine, where the virus is grown on specially selected cell lines instead of chicken eggs.

PER.C6 cells are highly susceptible to influenza viruses, thereby making the production of large amounts of influenza vaccine feasible.

This cell culture process has the potential to reduce from four weeks to two or three weeks the start-up time for manufacturing once the virus strain has been identified and could result in a more predictable manufacturing process.

Sanofi Pasteur also expects to initiate clinical trials for an interpandemic (seasonal) influenza vaccine using PER.C6 cell-culture technology in the US in September 2006.

Sanofi Pasteur was awarded a $97 million (€80 million) contract in April 2005 from the US Health and Human Services Department (HHS) to accelerate the production process for new cell culture influenza vaccines.

This is likely in response to the shortages the US suffered as a result of the suspension of Chiron's flu vaccine in 2004.

In December 2003, Sanofi and Crucell entered into a strategic agreement to further develop and commercialise a new influenza vaccine based on Crucell's proprietary PER.C6 cell line technology.

The deal covers both pandemic and seasonal influenza vaccines and is worth an estimated €30 m in license fees and milestone payments for Crucell.

Crucell recently announced a milestone payment of €1 m from Sanofi Pasteur, acknowledging the progress Sanofi has made so far in the development of novel influenza products using Crucell's PER.C6-based technology.

Sanofi Pasteur, the vaccines subsidiary of Sanofi-Aventis, is market leader in the production and marketing of flu vaccines, with an estimated 38 per cent share of the global market in 2002 from sales of €460 million.

Dutch biotechnology company Crucell has collaborations with Sanofi Pasteur for influenza vaccines, the US National Institutes of Health for Ebola and malaria vaccines, and GlaxoSmithKline, Walter Reed Army Institute of Research and New York University for a malaria vaccine, all based on it's PER.C6 technology.