Wednesday, October 21, 2009

Amarin Appoints Medpace as CRO for Two Phase 3 Cardiovascular Trials

Reuters reports that Marin Corporation announced that it has executed an
agreement with Medpace, Inc. to engage their services in the execution
of its Phase 3 clinical trials with AMR101 in patients with very high
triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

Amarin has secured agreements from the U.S. Food and
Drug Administration (FDA) through the Special Protocol Assessment (SPA) process
for both of the Phase 3 trials. The trials are expected to commence shortly,
report top line data in 2011 with the New Drug Application (NDA) expected to be
filed with the FDA not later than 2012.

The Phase 3 AMR101 MARINE Study will be a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with fasting triglyceride levels of ≥500
mg/dL.


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