The UK pharmaceutical company, GSK, will have to wait for the US approval of its cancer vaccine until 2010. The company has pinned its hopes of phenomenal business growth on the magic Cervarix treatment. It is expecting sales of more than $1bn a year after the introduction of vaccine in the market.
Cervarix vaccine already on sale in north America is posing a tough competition to Merck’s Gardasil vaccine. The analysts are worried that this may lead to delays in the US approval for GSK’s vaccine. GSK has restrained from divulging FDA’s concerns over approval, but market observers believe that the concern is primarily about a chemical that boosts immune response to the vaccine.
GSK has already bagged approval for sale of its Cervarix in 67 countries including Europe. It is quite confident that its long-term efficacy trial data of those vaccinated over past 4 years will substantiate its claim for US approval. Barbara Howe, GSK’s vice- president and director for North American vaccine development, informed that the company is continuing its positive discussion with FDA and is confident about the vaccine’s safety and efficacy.