Eisai scraps blockbuster app after Ph3 sepsis drug trial derails

Tools

Just two months ahead of its self-imposed deadline to file a marketing app for a sepsis drug with blockbuster potential, Japan's Eisai says that it is now scrapping those plans after the therapy flunked its pivotal trial. Eritoran has been tapped as one of the company's most promising new therapies. But it failed to perform better than a placebo in the study.

For Eisai, the trial failure marks something worse than a setback. The company had been on track to hustle up key approvals in the U.S. and Europe this year, with plans to drive it to more than a billion dollars in annual revenue to make up for the money it is now losing to generic competition for the Alzheimer's drug Aricept. Atsushi Seki at Barclays had estimated potential peak sales at $2 billion.

About 750,000 people develop sepsis in the U.S. every year, and a third of them die from the condition. In a brief statement Eisai said it will continue an analysis of the data and determine next steps.

- read the Eisai release
- here's the Reuters story
- see the Bloomberg report

Related Article:
Eisai plans pivotal trial of experimental sepsis therapy

Filed Under