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Eisai sepsis drug fails phase III trial

Eisai has said it will delay the submission of regional marketing applications for investigational sepsis drug eritoran due to disappointing trial results

Eisai has announced that it will delay the submission of US, European and Japanese marketing applications for its investigational sepsis drug eritoran due to disappointing preliminary results from a global phase III trial. The company had been aiming to submit the applications by March 31, the end of its fiscal year.

A preliminary analysis suggested that the trial, known as ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) did not meet its primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis. The trial enrolled 2,000 patients with moderate-to-high risk of death from sepsis.

Eisai said it would continue to analyse the data and has not yet determined next steps for the drug. Eritoran, which was discovered and developed by the company in-house, is believed to block the activation of toll-like receptor 4 (TLR4).

Phase II results for the drug had shown a reduction in mortality in eritoran-treated patients compared to placebo, with the greatest benefit in the population at the highest risk of mortality.

If it is eventually approved, eritoran would be the first new drug for sepsis in a decade. Financial analysts have emphasised the importance of the drug for Eisai as part of a strategy to replace profits lost when the blockbuster Alzheimer's disease drug Aricept (donepezil) lost its patent protection late last year.

Eisai estimates that there are 18m cases of sepsis worldwide each year. In the US, there are about 750,000 cases of sepsis annually, with around 215,000 of them resulting in death.

Separately, Eisai has announced that it will submit simultaneous US and EU marketing applications during the first quarter of its 2011 fiscal year for the epilepsy drug perampanel based on three phase III studies showing the drug to be safe and well tolerated. Perampanel is being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy.

25th January 2011

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