Anthera Pharmaceuticals Advances Global Development Strategy For Varespladib In Patients With Acute Coronary Syndrome

Anthera Pharmaceuticals
Inc., a privately held biopharmaceutical company developing
anti-inflammatory drugs, announced the initiation of the FRANCIS
(Fewer Recurrent Acute coronary events with Near-term Cardiovascular
Inflammation Suppression) clinical trial designed to examine the impact of
varespladib when administered to patients within 96 hours of an Acute
Coronary Syndrome (ACS) event.



The FRANCIS trial is designed to assess the impact of oral varespladib
on known biological markers of cardiovascular risk. It will enroll up to
500 patients that will be treated for a minimum of six months. The study
will be conducted at sites in North America and Europe. FRANCIS will
provide insight into the prevention of secondary Major Adverse
Cardiovascular Events (MACE) over the duration of the trial. In this study,
MACE is defined as a composite endpoint consisting of cardiovascular death,
non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a
subset of revascularization following the initial event. During the course
of the study, patients will receive therapeutic standard of care in
addition to high dose Lipitor(R) (atorvastatin). In previous clinical
trials, varespladib, a potent and highly selective inhibitor of secretory
phospholipase A2 (sPLA2), has demonstrated marked improvements in
independent markers of cardiovascular risk including, a near complete
suppression of the target enzyme sPLA2, a clinically meaningful and
statistically significant reduction in "bad" LDL cholesterol, and a
reduction in C-reactive protein, a known marker of inflammation.



"We are pleased with the continued progress of our varespladib
cardiovascular program targeting secretory phospholipase A2," said Paul
Truex, President and Chief Executive Officer of Anthera Pharmaceuticals,
Inc. "The FRANCIS trial was designed with input from global regulatory
agencies and industry experts and represents the next key component of our
international cardiovascular development program. The multiple therapeutic
impact of varespladib's mechanism of action provides us with a unique
opportunity to develop a first-in-class product targeting a
life-threatening coronary event for which there are limited therapeutic
options."



"Based upon the success of varespladib in two previous Phase II
clinical trials in patients with cardiovascular disease in which it
demonstrated lipid-lowering and anti-inflammatory benefits, we look forward
to further evaluating the impact of varespladib on the hyper-inflammatory
state presented by ACS patients," said Dr. James Pennington, Executive Vice
President and Chief Medical Officer of Anthera Pharmaceuticals, Inc.



About Acute Coronary Syndrome



Acute coronary syndrome is a heart condition characterized by chest
pain occurring at rest or upon minimal exertion. This condition is also
referred to as unstable angina. If the chest pain is associated with heart
muscle damage and heart tracing abnormalities, it is typically classified
as a heart attack or myocardial infarction.



About Anthera Pharmaceuticals



Anthera Pharmaceuticals is a privately-held company committed to
developing and commercializing clinical pharmaceutical products that
address unmet medical needs of patients with life-threatening, chronic and
acute inflammatory diseases and autoimmune disorders.


Anthera Pharmaceuticals Inc.

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