- Amarin's Vascepa demonstrated significant cardiovascular benefits in a multi-year Phase 3 trial that could position the fish oil-derived drug as a potential blockbuster treatment.
- The main study result found a 25% relative reduction of major adverse cardiovascular events, such as nonfatal heart attacks and strokes, in addition to statin therapy. The REDUCE-IT trial enrolled 8,179 statin-treated adults with bad cholesterol, defined as an LDL-C between 41-100 mg/dL.
- Company shares skyrocketed. After closing last week with a share price of $2.99 apiece, Amarin opened trading at $10.44 apiece on Monday morning, up 249%. The news in effect transformed Amarin from a company worth $885 million into a $3 billion company.
Amarin CEO John Thero succinctly summed it up: "That's huge, folks," he said on a Monday morning call with investors.
Heart disease is the leading cause of death in the U.S. and a high source of healthcare spending.
While statin therapy will generally lower cardiovascular risk by 25% to 35%, that leaves 65% to 75% of residual risk. According to REDUCE-IT's results, Vascepa (icosapent ethyl) gives an additional 25% relative risk reduction to statin treatment.
Thero told investors this result "positions Vascepa as the single most significant advance in preventative cardiovascular drug therapy since the advent of statin therapy."
Amarin's chief executive said Vascepa "has the potential to overcome the limitations of multiple blockbuster prior generation therapies" and can become "a significant blockbuster and help millions of patients reduce cardiovascular risk on top of standard of care statin therapy."
Thero brought up Lipitor by name, noting it also has a relative risk reduction of 25%. Before facing generic competition, Pfizer raked in more than $12 billion in annual sales for multiple years in the mid-2000s from Lipitor.
PCSK9 inhibitors have previously shown a significant reduction in heart risks on top of their potent LDL-lowering effect. The risk reduction in adverse heart events, however, was less impressive than some had hoped, potentially opening an opportunity for Vascepa.
Thero noted the results appeared to beat analyst expectations for Amarin of "even the highest degree of success," and the market proved that statement to be true Monday morning, with shares more than tripling.
REDUCE-IT started in 2011 and has cost Amarin roughly $300 million, Thero noted. The median follow-up time for the study was 4.9 years.
Vascepa also showed a well-tolerated safety profile in line with omega-3 fatty acids.
Amarin is now in the process of growing its U.S. sales representative count to 400 and doubling its U.S. physician target from roughly 20,000 to 40,000.
The company will also pursue international expansion, noting it has commercial partners seeking regulatory OKs in Canada, China and the Middle East.
Study results will be presented Nov. 10 at the American Heart Association's annual conference in Chicago. The company also expects to publish the trial findings in a journal by the end of 2018.