GlaxoSmithKline submits Cervarix application

Share this article:
The pursuit to become the top-selling cervical cancer vaccine intensified last week as GlaxoSmithKline submitted its Biologics License Application (BLA) for Cervarix with the FDA. Cervarix is being developed to prevent strains of the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer. The vaccine could reach the market by the end of 2007, if the FDA grants it “fast-track” status and then approves it, GlaxoSmithKline CEO Jean-Pierre Garnier said in a recent interview with CNNMoney.com. Cervarix faces tough competition from Merck’s Gardasil. Launched in 2006, Gardasil has gained an early advantage as the only cervical cancer vaccine on the market. Analysts are giving Gardasil the edge. Gbola Amusa, analyst for Sanford C. Bernstein, projects $2.5 billion in peak annual sales for Gardasil and $1.5 billion for Cervarix. But GlaxoSmithKline counters that Cervarix is more powerful. The drugmaker is funding an unusual head-to-head study to try to prove that Cervarix is more potent than Gardasil. Results of the study are anticipated by January 2008.
Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...