Shares in the small biopharma company Amarin has quadrupled in value after it released remarkable data showing its purified fish oil product Vascepa could cut the risk of heart attacks and stroke by 25% in high risk patients.
While omega-3 fish oils products have been around for many years and help cut triglyceride levels, none have been able to demonstrate significant cardiovascular outcomes benefits for patients until now.
Achieving a reduction of 25% in major adverse CV events (MACE) is an uncommon achievement (though Amgen’s Repatha achieved a similar effect) but the product’s relatively low cost and absence of side-effects will make it particularly attractive to healthcare systems.
The company’s cardiovascular (CV) outcomes trial, REDUCE-IT, is a global study of 8,179 statin-treated adults with elevated CV risk which has been ongoing since 2011, and examined Vascepa’s effects in patients already treated with statins to lower their LDL cholesterol, who had various cardiovascular risk factors, including persistent elevated trigylcerides.
Few outside the company had high hopes for the trial, but REDUCE-IT met its primary endpoint demonstrating in major adverse CV events (MACE) risk reduction in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo.
Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 150-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort).
Amarin has long maintained that Vascepa (icosapent ethyl) is different from other products – it is a highly purified version of the omega-3 acid commonly known as EPA in ethyl-ester form. The company says this stringent manufacturing process eliminates impurities and isolates the single molecule active ingredient.
Amarin CEO John Thero
“We are delighted with these topline study results,” said John Thero, president and CEO of Amarin. “Given Vascepa is affordably priced, orally administered and has a favourable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
“Considered against the backdrop of multiple unsuccessful cardiovascular outcomes studies of earlier generation drug therapies, including multiple recent failed cardiovascular studies of omega-3 mixture products that contain the omega-3 acid DHA, REDUCE-IT topline results stand alone as positive and confirm our hypothesis that pure EPA Vascepa at 4 grams/day can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard of care statin therapy in studied patients,” added Craig Granowitz, MD, PhD, senior vice president and chief medical officer of Amarin.
The company now aims to capitalise on the new data by increasing the number of sales reps promoting Vascepa to over 400 across the US, and says it will also start conversations with US insurers about the trial results and the product’s potential for broader use.
In addition to this US sales force expansion, it also plans to work with international partners to support regulatory efforts in other countries based on the REDUCE-IT results.
Analysts believe that millions of patients already taking cholesterol-lowering drugs could benefit from taking the medication.
Roger Song, an analyst at Jefferies, estimates sales could reach as high as $2bn a year – a huge leap from its modest $93m revenues earned in the first half of this year.
If this transformation in fortunes takes place as predicted, Amarin could also become a target for deal-hungry big pharma – although its market capitalisation has now shot up to $3.64bn.