More Bad News for GSK: Cervarix Launch in US is Unlikely until 2009
Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December.
Many analysts believe Cervarix is now unlikely to be launched until 2009 at the earliest. GSK won European regulatory approval last July for the vaccine and had originally anticipated a US launch by the start of this year. However, FDA requested clarification after GSK's submission last April based on interim clinical data that the submitted from its most comprehensive five-year clinical trial for the vaccine. Financial analysts believe that FDA concerns may center on GSK's proprietary AS04 adjuvant that is used in Cervarix to improve the effectiveness of the vaccine.
The delay has been a serious blow to GSK’s efforts to generate fresh product sales and catch up with Gardasil, the rival HPV vaccine developed by Merck & Co, which is available in the US and Europe.
I wonder whether the delay at FDA is really based on legitimate regulatory and scientific concerns. As you may recall, Merck launched a flat-out, take-no-prisoners lobbying campaign to get State and Federal legislators to mandate that all girls 10-21 years old be vaccinated with Gardasil. While Merck abruptly abandoned its lobbying efforts last fall after it came under fire from various legislative and regulatory sources, I can’t help but wonder whether Merck achieved its intended objectives anyway—to keep Cervarix out of the US market as long as possible so that Merck can capture a majority share of the lucrative American cervical cancer market.
Until next time….
Good Luck and Good Job Hunting (try Rahway)!!!!!!!!!
