Eisai Plans to Continue Eritoran (E5564) Phase III Severe Sepsis Trial, Based on Interim Analysis That Evaluated Efficacy and Safety Data

By Eisai, PRNE
Thursday, March 25, 2010

LONDON, March 26, 2010 - Eisai Europe Ltd. announced today that the Phase III ACCESS (A Controlled
Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of
the investigational compound eritoran (E5564) will continue enrolling to the
planned 2,000 patients. As part of a planned interim analysis, an independent
Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the
first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS
trial. After evaluating the efficacy and safety data, the DMC recommended
continued enrollment to the planned goal of 2,000 patients, according to the
current protocol. In addition, the DMC did not express safety concerns that
would warrant stopping the trial at this time.

The DMC evaluated data from the Phase III ACCESS trial, which is a
global, randomized, double-blind, placebo-controlled trial evaluating
eritoran as a potential treatment for severe sepsis. The ACCESS trial targets
a population with severe sepsis that has a moderate-to-high risk of mortality
as determined by baseline APACHE II (Acute Physiology and Chronic Health
Evaluation II) scores from 21 to 37.[i] APACHE II is a severity of illness
scoring system commonly used in sepsis research and intensive care units

Discovered and developed by Eisai, eritoran is believed to block
activation of toll-like receptor 4 (TLR4).[2] TLR4 is part of the innate
immune system and, when it is activated, TLR4 may play an important role in
the course of severe sepsis.[3]

Each year, severe sepsis strikes approximately 750,000 people in the US
alone, - more than breast cancer, colon cancer and AIDS combined[4] - with a
mortality rate of 30-35 percent (depending on population studied).[5] The
incidence of severe sepsis in the European Union has been estimated at 90.4
cases per 100,000 population,[6] with a mortality of 36 percent. [7]
Worldwide, sepsis affects 18 million people every year.[8]

Eisai's research and development efforts regarding eritoran and severe
sepsis illustrate the company's human health care mission, which is to
address unmet medical needs and increase benefits to patients and their

About Eisai

Eisai is one of the worlds leading R&D-based pharmaceutical companies,
that has defined its corporate mission as "giving first thought to patients
and their families and to increasing the benefits health care provides,"
which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas

Integrative Neuroscience, including: Alzheimer's disease, multiple
sclerosis, neuropathic pain, epilepsy, depression

Integrative Oncology including: anticancer therapies; tumour regression,
tumour suppression, antibodies, etc and supportive cancer therapies; pain
relief, nausea

Vascular/Immunological reaction including: acute coronary syndrome,
atherothrombotic disease, severe sepsis, rheumatoid arthritis, psoriasis,
Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, we employ more than 11,000 people worldwide.

In Europe, Eisai undertakes sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal,
Iceland, Czech Republic, Hungary, and Slovakia.


[i] ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo
in Patients with Severe Sepsis. Alec Wittek, MD (sponsor). July 11, 2007;
Pages 6, 29. clinicaltrials.gov/ct2/show/NCT00334828.

2 Mullarkey M et al. Inhibition of Endotoxin Response by E5564, a Novel
Toll-Like Receptor 4-Directed Endotoxin Antagonist. J Pharmacol Exp Ther.

[3] Mullarkey M et al. Inhibition of Endotoxin Response by E5564, a Novel
Toll-Like Receptor 4-Directed Endotoxin Antagonist. J Pharmacol Exp Ther.

[4] Osborn T, Nguyen H, Rivers E. Emergency Medicine and the Surviving
Sepsis Campaign: An International Approach to Managing Severe Sepsis and
Septic Shock. Annals of Emergency Medicine 2005:46:228-231.

[5] International Sepsis Forum. Promoting a Better Understanding of
Sepsis. November 2003.

[6] R. Daniels. Incidence, mortality and economic burden of sepsis.
National Health Service Web site.
www.library.nhs.uk/emergency/ViewResource.aspx?resID=269230&tabID=290&catID=1870. November 2009.

(Due to the length of these URLs, it may be necessary to copy and paste
the hyperlinks into your Internet browser's URL address field. Remove the
space if one exists.)

[7] Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, et
al. Sepsis in European intensive care units: results of the SOAP study.
Critical Care Medicine 2006; 34(2):344-53. September 2007.

[8] Slade E, Tamber P, Vincent JL. The Surviving Sepsis Campaign: raising
awareness to reduce mortality. Critical Care. 2003:7:1-2.

For further information please visit our web site www.eisai.co.jp

Contact: Cressida Robson, Eisai Europe Ltd., +44-845-676-5318, +44-7908-314-155. Andrew Day, Eisai Europe Ltd., +44-845-676-1395, +44-7973-411-419

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