UK drug giant GlaxoSmithKline, which has finally received US Food and Drug Administration for its cervical cancer vaccine (The Pharma Letter October 19) plans to challenge the US market dominance of rival Merck & Co's Gardasil with a price war, according to Financial Times pharmaceutical correspondent Andrew Jack.
GSK said it would charge less than Gardasil, which generates more than $1 billion in annual sales after wide adoption in the USS, in a fight that will stress Cervarix' exclusive concentration on those most at risk. The UK fir revealed a wholesale acquisition cost ' ahead of discounts ' in the USA of $386 a three-course dose, compared with $399 for Gardasil, the FT article notes.
'We will be focused on cervical cancer in women,' said Len Friedland, GSK's US vice-president of medical and clinical affairs. He drew a distinction with Gardasil, which is also marketing its vaccine to young men and is stressing protection
While already approved in 99 other markets, including across the European Union, GSK's sales of Cervarix had been hampered by US reluctance to approve AS03, the adjuvant used in its vaccine. US regulators also helped Merck by extending the market for Gardasil ' which has no adjuvant ' by approving its use to protect against genital warts in boys and young men, who represent about 6% of those who contract cancer caused by HPV strains.
The US Centers for Disease Control and Protection's advisory committee on immunization and practice must on October 21 decide whether to recommend use of Cervarix, after which GSK will be required to negotiate with US individual states and insurance companies, the FT pointed out.
Analysts at investment bank Leerink Swann estimate that, based on the different authorizations for the two vaccines, GSK could take 15%-20% of the US market for HPV vaccinations. But it said that Merck's additional approval for non-cancerous genital warts would help it remain dominant and highlighted a regulatory reference for Cervarix that included potential side-effects, including auto-immune diseases, not mentioned for Gardasil.
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