Dendreon Preview: Drama Could Culminate in the First Cancer Vaccine Approval
Next week brings the highly anticipated FDA decision on the approval of Dendreon's (DNDN) prostate cancer vaccine Provenge (sipuleucel-T).
Most analysts expect the drug to be approved -- and to achieve blockbuster status within the next few years. But Dendreon's ride to the top has been anything but smooth, delivering more drama than daytime television. Themes from the company's contentious history include:
- The Cancer Vaccine Stigma: The cancer vaccine field suffered so many failures that investors would run for the hills at its mere mention, forcing the remaining biotechs in the space to collectively re-brand themselves as "specific active immunotherapy" companies. The late-stage trial graveyard includes Antigenics, BioVest, CancerVax, Cell Genesys, Favrille, Genitope, Progenics, Therion... and Dendreon itself (see next bullet).
- The Pivotal Trials: Dendreon's first two Phase III Provenge trials missed their primary endpoint of time to progression but showed a survival benefit in post-hoc analyses. The company filed for approval anyway, arguing that survival was the most important measure, and an FDA advisory committee agreed. But the agency rejected the drug (see next bullet) until a third Phase III trial designed to show survival turned out positive two years later.
- The Conspiracy Theory: Some Dendreon fans have argued that politics and conflicts of interest at the FDA blocked Provenge's approval the first time around. And the SEC is currently investigating an alleged short-selling scandal that caused Dendreon's stock to tank 65 percent in 75 seconds just before the release of the final Phase III data.
- The Credibility Issue: Dendreon execs have raised some eyebrows by selling off chunks of stock, once right before the first FDA rejection and again last year.
- The Commercial Questions: The champagne corks had barely popped on the successful Phase III trial when analysts started raising questions about the magnitude of benefit, the challenges of manufacturing a personalized vaccine, and potential pricing/reimbursement issues.
Soap Opera photo by Flickr user Mike Licht, NotionsCapital.com, CC.