GSK excited about new vaccines
pharmafile | July 4, 2005 | News story | Sales and Marketing |
GlaxoSmithKline has updated investors on its vaccine pipeline, with the company expecting to launch five major vaccines within as many years.
The company is particularly sanguine about the prospects of its cervical cancer vaccine Cervarix with chief executive Jean-Pierre Garnier claiming in a recent television interview that it will be the "largest ever vaccine sold".
GSK believes the potential for the vaccine is enormous, estimating that up to 80 million women worldwide could be vaccinated by 2010 against cervical cancer, the second most common cause of cancer deaths amongst women.
Cervarix must still go through late-stage trials but could have an enormous public health impact, providing cost savings for health services as well as being very profitable for the company.
However it will face stiff competition from Merck's Gardasil, a similar vaccine that is expected to be filed with US regulators in the autumn of this year, before Cervarix.
Cervarix is expected to be filed in European and international markets during 2006 and GSK is in discussions with the FDA over its US filing, where it has been granted fast-track status.
Neither Cervarix or Gardasil is likely to show much uptake until 2007, with strict regulatory hurdles to clear, but both appear effective, with GSK reporting up to 100% success in trials.
Cervarix will be filed for the prevention of Human Papilloma Virus (HPV) which causes cervical cancer and is tipped to generate peak year sales of between $1-4 billion.
GSK is also buoyant about Rotarix, its vaccine for rotavirus, the virus that causes gastroenteritis and one of the leading causes of childhood hospitalisation in the US and Europe.
The vaccine has been administered in over 70,000 infants during clinical trials and filing has been submitted in Europe and 50 other markets while the company is in discussion with the FDA over its US status.
GSK will be hoping that Rotarix will fill the void left by Wyeth's Rotashield, a similar vaccine that was pulled from the market in 1999 after causing serious side-effects.
Its three other vaccines: Streptorix for pneumococcal disease, which GSK believe will rival Wyeth's Prevnar; a combination vaccine for meningitis and a new influenza vaccine are all expected to capture significant market share.
"The global vaccines market is poised for accelerated growth due to product innovations and a growing appreciation of the benefits of prevention over treatment," commented David Stout, president of pharmaceuticals for GSK.
"With over 20 vaccines in clinical development and five major launches expected in the next five years, GSK's vaccines business is set for rapid growth, and will be a major contributor both to the company's overall success and to improved health across the globe."
GSK also plans to double manufacturing capacity of its older influenza vaccine, Fluarix, to 80 million doses annually by 2008.
