Iberian support for new flu vaccine
Madrid –The Spanish Ministry of Health is investing in future biotech treatments. In July, it signed a EUR60m contract over a recombinantly manufactured flu vaccine developed by Rockville-based Novavax.
In Phase II trials, the company is currently testing a vaccine based on virus-like particles without viral RNA. Novavax hopes to develop pandemic and seasonal flu vaccines, and plans to seek regulatory approval by 2012 in Europe.
The company will develop the vaccines with Spanish drugmaker ROVI Pharmaceuticals. Under separate agreements that are being negotiated by both companies, ROVI will receive exclusive licenses to Novavax’s portable VLP vaccine technology to commercialise flu vaccines in Spain and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. Furthermore, under a stock purchase agreement, ROVI has committed to make a US$3m equity investment in Novavax at $2.74 per share,
To acccomplish the deal, ROVI and the Spanish authorities will establish a joint non-profit foundation to be initially funded with a a25m line of credit from the Spanish government. The funds will support Phase III clinical development and other studies necessary to achieve marketing authorisation of the VLP influenza vaccines.
Additional clinical development funds will be contributed by ROVI if required. In addition, the State of Andalucía will support the drugmaker in building a new VLP vaccine plant in Granada, and bring it on-line in 2012 at a cost of EUR20m. The plant is expected to have enough manufacturing capacity to service Spain and other parts of Europe, Latin America, and Africa.