Medpace lands Ph III AMR101 trial contract
US specialist cardiovascular CRO Medpace will run Phase III trials of Amarin’s candidate triglyceride drug, AMR101.
Under the deal, announced yesterday, Cincinnati, Ohio based Medpace will run two trials of the drug in hypertriglyceridemia and mixed dyslipidemia, in support of Amarin’s efforts to gain Food and Drug Administration (FDA) approval sometime in 2012.
Amarin’s interim CEO, Declan Doogan, said that Medpace’s expertise in cardiovascular and metabolic disease studies as well as its regulatory knowledge was critical in winning the contract research organisation (CRO) the contract.
Dr Doogan added that: “We were also impressed by their international reach, an important requirement given that one of the Phase 3 trials with AMR101 will be conducted across a number of international regions.”
