The biotech firm Amarin Corp. appears to be a winner as potential competitors to its fish oil-derived cardiovascular drug fall by the wayside.
In announcements made as J.P. Morgan’s annual health care investor extravaganza got under way on Monday morning, the small biotech Acasti Pharma (ticker: ACST) and the British pharmaceutical companies firm AstraZeneca (AZN) each announced disappointing results from Phase 3 trials of their own cardiovascular drugs, derived from fish and krill oil.
Amarin’s (AMRN) fish-oil-derived heart drug, Vascepa, won expanded approval from the Food and Drug Administration late last year after a lengthy battle.
“AMRN has been the only company in its class with an outcomes study (REDUCE-IT) that has shown a statistically significant benefit in reducing [cardiovascular] disease,” Cantor Fitzgerald analyst Louise Chen wrote in a note out Monday morning. “We think the news today underscores our view that AMRN is an interesting asset in a consolidating space.”
Chen rates the stock Overweight, with a $35 price target. The stock closed at $18.95 on Friday.
Shares of Amarin were up 7.6% on Monday morning, while shares of Acasti were cratering, down 73.9%. AstraZeneca’s American depositary receipts, meanwhile, were almost flat, with a loss of just 0.6%.
The back story. Amarin shares shot up late last year as Vascepa neared, and then received, approval from the FDA to be marketed to reduce the risk of cardiovascular events such as heart attack and stroke. The drug previously had a far narrower label, or array of uses for which it could be prescribed.
Shares of Amarin are up 10.7% over the past 12 months, although they have fallen 11.6% since the start of the year.
What’s new. The disappointing data disclosed Monday came from two separate studies, one by Acasti and one by AstraZeneca. Acasti said that its Phase 3 study of its experimental drug CaPre in severe hypertriglyceridemia, a cardiovascular disorder, failed to show a statistically significant benefit. The company attributed the failure to an unusually large placebo effect.
Acasti said that patients receiving CaPre, derived from krill oil, saw a 30.5% median reduction in triglyceride levels, but that the comparable figure among patients receiving a placebo was 27.5%.
The company said it is investigating why the placebo response levels were so high. “While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials,” said Acasti’s president and CEO, Jan D’Alvise.
AstraZeneca, meanwhile, said that it was shutting down a Phase 3 trial of Epanova, its own fish-oil-derived drug, for patients with a cardiovascular condition known as mixed dyslipidemia, on the recommendation of an independent data-monitoring committee. The company determined that the drug had a low likelihood of benefiting patients.
Looking ahead. The announcements come on the first day of a week-long conference that serves as the Super Bowl of the biotech and pharmaceutical industries. Amarin is scheduled to present on Wednesday afternoon, Eastern time.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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