Shareholders tuning into Amarin’s annual shareholders’ meeting in Dublin on Monday had plenty to cheer them.
Shares in the company have risen more than fivefold over the past 12 months on the back of the results from the multiyear Reduce-IT trial that provided convincing evidence of its one drug’s effectiveness in tackling adverse cardiovascular events.
And, if things pan out as the company expects, that could be just the start.
As of now, Amarin's Vascepa is approved only for the treatment of patients with extremely high levels of triglycerides – blood fats that are considered an indicator of cardiovascular risk.
But the Irish company has applied to the US regulator, the Food and Drugs Administration, for a significantly wider marketing approval for Vascepa. A decision is expected in January of next year though it could conceivably come earlier.
Critically, this would allow the company to pitch its fish-oil drug direct to the consumer rather than solely through the medical practitioner channel.
Already Amarin has beefed up its sales force to 400 people, from 150 it had this time last year. It will be some time before those extra sales staff are at full productivity but it does mean they should be well bedded in when any wider FDA approval comes.
Meanwhile, Amarin is turning its attention to Europe where it is still mulling the best approach for distribution, presuming it secures European Medicines Agency approval as a drug to help prevent heart attacks and strokes. That application is due before the year-end.
The drug has also secured the imprimatur of the American Diabetes Association.
For John Thero and the executive team at Amarin, success could prove to be a double-edged sword. If the company delivers on the potential of Vascepa on the back of a broader FDA label, it is likely to spark even more pointed attention and overtures from big pharma companies. Several are understood to have had a look at the company as a target in recent months.
