Shares of Amarin plunged as much as 63 percent Thursday, the day after an FDA advisory panel voted 9-2 against recommending expanded approval for the company's prescription-grade omega-3 fatty acid Vascepa (icosapent ethyl) prior to completion of the ongoing REDUCE-IT cardiovascular outcomes study. Amarin president John Thero indicated that the study is likely to be finished in 2017, although R&D chief Steven Ketchum suggested an interim analysis of the trial could take place near the end of 2015.
Thero noted the company will incur $30 million to $40 million in expenses related to the trial in 2013, adding that "costs continue to be fairly significant for a good portion of next year." Vascepa was approved in the US last year to reduce triglyceride levels in patients with severe hypertriglyceridaemia, and Amarin is seeking clearance to also market the drug in combination with statin therapy as a treatment for adults with high triglycerides who have mixed dyslipidaemia and coronary heart disease (CHD), or a CHD risk equivalent. Prior to the panel vote, FDA staff also questioned whether the therapy should be approved for the expanded indication without data from REDUCE-IT, as recent trials "have failed to demonstrate a reduction in residual cardiovascular risk with non-statin lipid-altering treatment."
Jefferies analyst Thomas Wei expressed surprise in the panel's recommendation, indicating that he expected a vote of 7-3 in favour of recommending approval of the expanded indication. Wei mentioned that as a result, Vascepa may not be launched until 2019.
The FDA is expected to make a final decision on the drug by December 20. Expanded approval could grant the drugmaker potential access to approximately nine-fold the number of people with severely elevated triglycerides. Although Amarin reported sales of only $5.5 million in the second quarter for Vascepa, analysts project the therapy could amass $1.2 billion in revenue in 2017.
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