SAN DIEGO and BEDMINSTER, N.J., Nov. 6, 2013 /PRNewswire/ -- Shareholder rights law firm Robbins Arroyo LLP announces that an investor of Amarin Corporation plc (NASDAQ: AMRN) ("Amarin") has filed a federal securities fraud class action complaint in the U.S. District Court for the District of New Jersey. The complaint alleges that the company and certain of its officers violated the Securities and Exchange Act of 1934 between July 9, 2009 and October 15, 2013 (the "Class Period"). Amarin is a biopharmaceutical company that focuses on the development and commercialization therapeutic products for the treatment of cardiovascular diseases. The company's lead product, Vascepa, is a prescription-only product designed to help reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Amarin Accused of Misleading Investors Regarding the Prospects for FDA Approval of Vascepa for the ANCHOR Indication
On October 11, 2013, shares of Amarin fell $1.38 per share, or 20%, to close at $5.09, after the U.S. Food and Drug Administration ("FDA") published a briefing document of its October 16, 2013 Advisory Committee Meeting. In the document, the FDA summarized the significant doubt the agency expressed to Amarin in July 2008 that reduction of triglycerides alone evidenced an improved risk of cardiac issues. Further, the document stated that published test results available to Amarin in 2010 demonstrated little evidence that a reduction in triglycerides alone would improve the incidence of cardiac events.Then on October 16, 2013, the Advisory Committee rejected Amarin's New Drug Application for Vascepa for the treatment of patients with high triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol. In rejecting this so-called ANCHOR indication, the FDA adopted the position that Amarin's study was not indicative of the efficacy of the drug to reduce severe cardiac events. On this news, shares of Amarin fell an additional $3.16 per share, or 20%, to close at $2.01 per share on October 17, 2013. According to the complaint, defendants made false and/or misleading statements and/or failed to disclose: (i) that Amarin had been informed by the FDA as early as 2008 that there was a lack of prospective, controlled clinical trial data demonstrating that pharmaceutical reduction of triglycerides significantly reduces residual cardiovascular risk; and (ii) the prospects for FDA approval of Amarin's Vascepa drug for ANCHOR indication.
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