As FDA Decision Nears, Amarin CEO Retires And Investors Petition

Just days before the FDA is expected to decide whether to approve the controversial Vascepa fish oil pill that is sold by Amarin, the little drugmaker has announced that its chairman and chief executive, Joseph Zakrzewski, is retiring at the end of the month. John Thero, who has been Amarin president since 2009, was promoted to replace him (here is the statement). The move caps a disappointing year for Amarin, which has been one of the more interesting biotech stock stories of the past year. Two months ago, an FDA advisory committee voted against recommending broader use of Vascepa until an outcomes study is completed in 2016 and then, the FDA rescinded a special protocol agreement the drugmaker was counting on to widen the appeal of its pill. As noted previously, Vascepa is already approved for treating people with very high triglyceride levels, or more than 500 mg/dL, which is approximately 4 million people in the US. Amarin, however, has sought FDA approval to market Vascepa to people with high cholesterol and high triglycerides, which is between 200 and 500 mg/dL, a market that is estimated to be as many as 36 million people. Investors were captivated by the possibility that Amarin might market a potential blockbuster amid a swirling debate over the virtue of using lower triglycerides as a predictive metric for lowering cardiovascular risks. Amarin was betting the clinical effect of combining Vascepa and a statin would prove beneficial to cardiovascular outcomes. On that ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs