Bayer, Algeta shares spike as FDA fast-tracks blockbuster hopeful

Bayer and its biotech partner Algeta took a big step today toward a relatively quick FDA decision on their closely-watched prostate cancer drug Alpharadin (radium-223 chloride). Regulators are providing an accelerated review of the drug, one of Bayer's top prospects, in a sign that the agency is stepping up its work in some areas as the number of new drug approvals this year promises to surge well ahead of last year's mark.

The FDA's announcement that it will provide fast-track status to the treatment--which analysts widely believe is headed for a likely approval and peak sales of up to $1.7 billion, for all conditions--shaves 6 months off the review process. Shares of Norway's Algeta--which have been on a roll, doubling in value over the past year--jumped 11% this morning while Bayer shares spiked 3% before easing back down somewhat.

Investigators said recently that the median overall survival for patients with symptomatic bone metastases was 14 months in the Alpharadin arm compared to the 11.2 months registered among the standard therapeutic group. Researchers stopped the trial so they could extend treatment to the placebo arm.

Prostate cancer treatments have been a hot field, with Dendreon leading the pack with Provenge. J&J followed up with an approval for Zytiga (abiraterone) and Medivation has a closely watched program underway for MDV3100. But after sales of Provenge fell woefully behind Street expectations for the second quarter, a considerable amount of bloom has left that particular rose. The "Dendreon effect" has tarnished a number of biotechs, including Seattle Genetics, which just won an approval on Friday for its lead program. Analysts are likely to have plenty of questions for Bayer as the drug gets closer to a regulatory decision and a potential rollout.

- check out the Algeta release
- see the WSJ story