Future prospects for Irish biopharma group Amarin are uncertain after it raised doubts last night about its ability to fund a key trial to extend the commercial prospects of its sole drug on the market.
Reporting third quarter figures that showed the company made a loss of close to $50 million on sales of $8.4 million in the three months to the end of September, said funding the Reduce-IT trial would be difficult in the absence of increased earnings from its drug Vascepa, which lowers levels of triglycerides – blood fats that can cause cardiovascular disease – in patients.
Vascepa is currently licensed for patients with extremely high levels of triglycerides but Amarin had been hoping to secure approval to treat patients with lower, but still high, levels of the blood fats and who were also taking statins – a move that would have increased its potential market tenfold to include approximately one in five of all Americans, 40 million patients.
Chief executive Joe Zakrzewski said the company had reduced staff levels by half as announced in the aftermath of its failure to secure support from a Food and Drug Administration (FDA) advisory panel for its proposal to expand its target market. The company said it is in the process of appealing that decision.
The panel last month voted by 9-2 that Amarin should await the results of another clinical trial before a decision was made on the efficacy of Vascepa in significantly reducing the risk of “cardiovascular events” among patients with high levels of triglycerides who are taking statins.
However, in a conference call last night, Mr Zakrzewski said it was uncertain whether Amarin could now continue to fund that trial, which would not be producing the data it needs to prove its case until 2016.
Shares edged up just a cent to $1.41 ahead of the results last night but are trading at just 15 per cent of their $12.90 12-month high and well below the $7.25 level just ahead of the FDA advisory panel meeting.
The company reported revenues from Vascepa of $8.4 million for the three months to September 30th – the second full quarter in which it was marketed in the US – and $16.2 million in the year to date. The quarterly sales figures is up on the $5.5 million recorded in the second quarter.
Prescription figures for the purified omega-3 fish oil drug were up 58 per cent in the third quarter, the company said.
However, given the increased cots in supporting a direct sales operation during the market launch of the drug, Amarin reported a loss after tax of $48.9 million in the quarter, or 29 US cents a share, compared to a loss of $26.4 million, or 18 cents a share, in the year-ago period.
So far this year, losses of $150.8 million remain below the $168.6 million recorded in the same period in 2012.
Amarin said it had cash and cash equivalents on-hand of $225.9 million at the end of September, including the $121.2 million net raised in a public offering by the company in July.
