The Company is engaged in the research, development and commercialization of novel drugs for the treatment of central nervous system disorders.
Their lead drug Vascepa, a purified fish oil derivative, was approved by the FDA all the way back in 2012 to treat patients with severe hypertriglyceridemia (SHTG). But it’s not Vascepa’s potential in treating SHTG patients that’s got Wall Street excited. Rather, it’s a supplemental new drug application stemming from a five-year Harvard study in 8,179 people with milder (but still high) triglyceride levels. The results showed that the aggregate risk of heart attack, stroke, and death in these patients by 25%. In other words, if Vascepa were to be approved for an expanded label indication to reduce the risk of major adverse cardiovascular events, its potential pool of patients could grow tenfold, as would its sales potential.
Hoping for another pop today having got further FDA approval. Trading was halted most of yesterday I believe.
If approved by the FDA by the 28 December action date – as now seems likely – the new label could hike the number of patients eligible for treatment with Vascepa from around 600,000 to as many as 10 million, and catapult the drug into multibillion-dollar territory.
Yeah, I re-requested Amarin on Trading212 community, this request was only few hours back and it got answered . Hope invest by Freetrade platform hits out soon and stock request gets easier and quicker.
In the wake of the US approval, Amarin raised its forecast for 2020 sales to somewhere between $650 million and $700 million. That compares to sales of $229 million in 2018
The Irish-headquartered business has already settled similar claims with Teva, one of the largest generics producers, in a move that is likely to block the introduction of generic competition by Teva for Vascepa till 2029. That would give the business a clear nine-year run to establish its product and maximise sales.