Boston, MA 10/31/2013 (wallstreetpr) – It now seems likely that the U.S. Food and Drug Administration will not overturn the decision by its advisory committee over Vascepa, a cholesterol drug that the biotechnology company Amarin Corporation plc (ADR) (NASDAQ:AMRN) had applied to expand its mandate. This follows the withdrawal of a special protocol assessment agreement (SPA) by the administration.
Due to this bad news, shares of Amarin have continued to bleed at the NASDAQ, plunging by 74% since the year began as investor-confidence wanes. Earlier this month, FDA advisory committee voted 9 to 2 against expanding the mandate of Vascepa.
Basically, the regulatory agency says the outcomes of studies on the drug have failed to justify its efficacy in the category that the manufacturer is seeking to expand its mandate. In attempts to salvage the fate of the drug, Amarin has sought a meeting with FDA to discuss its notice over the new drug application.
Vascepa helps patients lower their blood-fat levels. The drug developer Amarin had applied to expand its market in the treatment of mixed dyslipidemia. But things are no longer holding together for the company as chances of the drug getting approval to this effect have effectively gone slim when FDA rescinded SPA. However, regulatory review on the drug by FDA is expected to come to conclusion on December 20.
It has to be understood that rescinding SPA by FDA is not the dead-end of Amarin’s exploits with its new label Vascepa. The company will still wait for a Complete Response Letter (CRL) from the regulatory agency over the fate of the drug as regards treatment for mixed dyslipidemia as had been applied for by the drug developer. What this means is that maybe some surprises can come through in the form of the drug getting approved.
But before then, Amarin has been on restructuring process to reduce costs and lower cash burn to save the wallets of its investors. Analsysts at Aegis Capital have issued a hold rating on the stock in their note to investors published Wednesday.
