FDA rejects Amarin appeal on Vascepa trial design, shares slump

[riky]

FDA rejects Amarin appeal on Vascepa trial design, shares slump

<p><a href="http://news.yahoo.com/fda-rejects-amarin-appeal-vascepa-trial-design-shares-134940172--finance.html"><img src="http://l1.yimg.com/bt/api/res/1.2/A0v8UJXUPQIU8A2hrYA8Ng--/YXBwaWQ9eW5ld3M7Zmk9ZmlsbDtoPTg2O3E9NzU7dz0xMzA-/http://media.zenfs.com/en_us/News/Reuters/2014-01-21T190359Z_1_CBREA0K12EW00_RTROPTP_2_CHINA-PHARMACEUTICALS.JPG" width="130" height="86" alt="A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver Spring" align="left" title="A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver Spring" border="0" /></a>(Reuters) - Amarin Corp Plc's shares fell more than 26 percent after U.S. health regulators rejected a preset testing process that was critical to the company seeking broader use of its blood fat-lowering drug. Analysts are skeptical of Amarin's ability to run a profitable business without the new indication of its only approved drug, Vascepa. Amarin recorded third-quarter Vascepa sales of $8.4 million in the quarter ended Sep. 30, 2013. Vascepa was approved in 2012 to reduce high levels of a type of blood fat, called triglycerides, in patients not taking cholesterol-lowering statins such as Pfizer Inc's Lipitor.</p><br clear="all"/>

Source: You are not allowed to view links. Register or Login