GSK in 1.5 billion-euro deal with Brazil for pneumococcal vaccine; first Cervarix death reported

Leading UK drugmaker GlaxoSmithKline has secured an innovative 1.5 billion-euro ($2.39 billion) contract with the Brazilian government guaranteeing sales of its pneumococcal vaccine, designed to prevent pneumonia and meningitis, over the entire life of the product, according to local press reports and the UK's Financial Times.

The deal marks a watershed in negotiation of a long-term contract in a way that provides GSK with an agreed price and volume, starting at 11.50 euros a dose and falling to 5 euros in future years. The deal comes as GSK continues to expand in emerging markets and is diversifying away from drugs into vaccines and other products.

The company agreed to supply enough doses of Synflorix to vaccinate the 13 million children requiring coverage each year for at least eight years, underpinned by a technology transfer agreement that will eventually allow Brazil to manufacture the vaccine itself.

Brazil's Health Minister and Andrew Witty, GSK's chief executive, unveiled the deal in London to strengthen Brazil's pharmaceutical R&D capacity, including a 1 7million-euro joint project to develop a Dengue vaccine. Last August, GSK announced that it has launched a unique partnership with Brazil's Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil. The agreement will establish a new R&D collaboration program at Fiocruz to develop a vaccine for dengue fever, a mosquito-borne disease that globally places 2.5 billion people at risk of infection

Depending on the extent of technology transfer and Brazil's ability to manufacture the vaccine, which Mr Witty described as 'probably the most technically complex vaccine in the world,' GSK may still earn some income even after the contract ends, the FT reported. The price represents a significant discount to that of about 35-40-euro a dose at which the vaccine is sold in Europe, but the high volumes and long timescale provide unusual certainty to the company.

GSK's Cervarix implicated in death of UK girl

News broke on September 28 that a 14 year old girl in the UK, who had been given GSK's cervical cancer vaccine Cervarix, had died. This is the first reported death in Britain since the national vaccination program began last September.
There have been 4,657 suspected reactions to Cervarix from more than 1.4m doses, according to experts. The Medicines and Healthcare Regulatory Agency (MHRA) added it had received 2,137 reports between 14 April 2008 and 23 September this year.

When Britain's national immunization project was announced, there was some controversy about the selection of Cervarix over US drug major Merck & Co's Gardasil, which is used by the majority of vaccination programs worldwide. The GSK product is thought to have been selected on cost grounds.

For its part, GSK said it has notified by the UK's Department of Health on September 28 of the death of the schoolgirl who was vaccinated with GSK's cervical cancer vaccine, Cervarix, as part of the national HPV immunization program. Pim Kon, the firm's medical director, said: 'We are working with the Department of Health and MHRA to better understand this case, as at this stage the exact cause of this tragic death is unknown. As a precautionary measure, the batch of vaccine involved has been quarantined until the situation is fully understood.'