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- The year of the vaccine
The year of the vaccine
GSK is a world-leading supplier of vaccines. “Our vaccines business had one of its best years, with sales growing by 15% to £1.4 billion,” says Jean Stéphenne, President and General Manager of GSK Biologicals, the company’s vaccines business. “This growth was led by Infanrix and helped by the launches of Boostrix and Fluarix in the USA. This, together with a strong product pipeline, gives us confidence in the future prospects for our business.”
Vaccines pipeline
With 60 years’ experience, the company continues to build a very productive R&D pipeline and, in the next five years, expects five major new vaccines to be launched. One of these is Cervarix, for the prevention of human papilloma virus (HPV), which causes cervical cancer – a disease second only to breast cancer in the list of most common cancers affecting women. Global clinical trials have shown that Cervarix provides excellent efficacy against HPV16 and HPV18, which are responsible for over 70% of cervical cancers.
"Our pipeline of vaccines promises real opportunities to improve the quality of health worldwide."
“Cervarix is a genuine breakthrough in women’s healthcare. It meets a clear medical need and the sheer volume of women who will benefit gives it great potential,” says Jean. Cervarix is expected to be submitted for European Union approval in March 2006 and in the USA before the end of the year.
The other major new products expected in the next five years will be Rotarix, for rotavirus gastroenteritis (already launched in a number of countries in Latin America, Africa and Asia, with launch in Europe expected in the first half of 2006); Streptorix, for pneumococcal disease; an improved influenza vaccine for older people; and vaccine combinations against meningitis.
“We know more about the body’s immune system and how it works than ever before, which enables us to produce safer, stronger and more targeted vaccines,” says Jean. “Our pipeline of vaccines promises real opportunities to improve the quality of health worldwide.”
Vaccines investment
In 2005, GSK made a number of moves to be a major force in vaccines against influenza, the subject of heightened global concern during the year. The company invested over £1 billion to expand its flu vaccine manufacturing capabilities. This included more than doubling flu vaccine production capacity at its Dresden site to 80 million doses a year by 2008. GSK also acquired the Canadian vaccine manufacturer ID Biomedical and a vaccines production facility in Marietta, Pennsylvania, which will focus on the development and production of tissue culture technology that will be used for seasonal and pandemic flu vaccines. The company also purchased Corixa in the USA, a developer of adjuvants, which are agents that boost human immune response to vaccine antigens.
With approval in 2005 by the US Food and Drug Administration (FDA), Fluarix became the first biological product to be reviewed under accelerated approval regulations. “The shortage of flu vaccine in the USA in 2004 was a reminder of the importance of vaccines in healthcare,” says Jean. “We worked quickly with US government officials to make Fluarix available and increase supply at a critical time.”
Preparing for a flu pandemic
GSK is committed to doing everything it can to support governments and health authorities around the world in planning responses to a possible global influenza pandemic. The company is developing a prototype H5N1 pandemic vaccine, and clinical trials testing this vaccine against the H5N1 flu strain are taking place in 2006. This prototype uses an innovative adjuvant which may allow lower amounts of antigen to be used, which is essential for manufacturing a large number of doses in the event of a pandemic. GSK has also invested to significantly increase production capacity of GSK’s antiviral Relenza to help meet increased global demand. “Work is going on across GSK to anticipate and address all aspects of a potential flu pandemic,” says Jean.
GSK had 25 vaccines in clinical development at the end of 2005, with five major vaccine launches anticipated in the next five years.
Annual epidemic
A seasonal epidemic, influenza is a significant economic burden through hospital and other healthcare costs as well as lost productivity. The World Health Organization says an estimated 5-15% of the global population is affected with upper respiratory tract infections each year. Although difficult to assess, annual flu epidemics are thought to result in 250,000-500,000 deaths every year around the world.
