Keynote speaker CEO John Thero telling this remarkable story on our BioCapital conference last week
When we first encountered Amarin Corporation it was a microcap company incorporate in Dublin. Despite the size of the company, we invested in the great science. It is now almost 10 years since we participated in a financing to fund the first Phase 3 studies. To say a lot has happened since – would be a massive understatement.
John Thero, CEO of Amarin and the outright star of this story, was kind enough to accept an invitation to present at the BioCapital Europe conference in Amsterdam which was held last Thursday March 14th. While we wanted him give the corporate presentation – we really wanted everyone to hear The Story. We all know that the world of drug development can be fraught and high risk but the Amarin Story is full of twists and turns, ups and downs – a better white knuckle ride than any rollercoaster.
Needless to say John did not disappoint and told how Vascepa demonstrated statistically significant results in Phase 3 studies which were conducted under an SPA with the FDA. Drug approval was within their grasp, when the FDA pulled the rug out from under their feet by demanding a cardiovascular outcomes study (CVOT). This meant thousands of patients needed to be treated for several years and would cost hundreds of millions of dollars. Investors walked and the share price plummeted.
Because of their strong belief in the potential of Vascepa and with a true desire to bring this important treatment to patients in need - John and the Amarin team stuck with the story. John has said that cardiovascular disease has impacted his family, so for him, this is personal.
Vascepa was launched with a limited label and sales were ramping up gradually as John managed to raise sufficient funding to conduct the large outcomes studies mandated by FDA. Fast forward to September of 2018 – over 8,000 patients had been treated for over 5 years and the experts and investors remained skeptical. This skepticism was supported by the fact that most CVOT studies had failed – certainly all those with a fish oil based product. Why would Amarin succeed – they argued!
A dramatic story deserves a dramatic outcome and the results of the Reduce-it study, Amarin’s CVOT, were better than anyone could have hoped or expected. Vascepa demonstrated a 25% improvement in major adverse cardiovascular events or MACE. This improvement is all the more impressive in that it is on top of standard of care. In other words, even in patients who are receiving the best possible care – patients who also received Vascepa had a 25% lower rate of CV events (such as heart attack, stroke, CV death).
So what happens next? We can expect to see many more presentations of additional data from this large study. The data will be filed with FDA shortly such that an approval can be expected early next year – perhaps a little earlier. The only question that remains is how big this can be – a very safe, effective treatment which dramatically lowers cardiovascular risk! We think it will be huge.
Bravo John and the Amarin team. Your belief in Vascapa means that millions of patients look set to benefit from this important new treatment for cardiovascular disease.« back to overview