If Amarin’s seven-year study of omega-3 drug Vascepa comes back positive, the company could be in for major financial gains, according to analysts from Jeffries.
The study, called Reduce-It, is evaluating whether Vascepa plus a statin can reduce the change of a cardiovascular event like a heart attack or stroke better than a statin alone. The study data is expected by the end of September.
Vascepa has been approved to lower triglycerides, or fat in the blood, that can cause cardiovascular problems. Positive results from the Reduce-It study could expand that indication to include prevention of cardiovascular events, the primary endpoint in the study. That indication would put Vascepa against blockbuster statins such as Lipitor, Crestor, and Livalo.
Jefferies analysts gave Reduce-It a 55% chance of success. If it achieves a positive result, Vascepa could reach up to $2 billion in sales, analysts said.
Vascepa is running a TV ad campaign to differentiate itself from fish oil supplements, which also contain omega-3. The ad encourages viewers to avoid “unapproved” fish oil supplements.
In the second quarter of 2018, Vascepa brought in $52.5 million in revenue for Amarin, a 17% increase over last year. Prescription rates were also up more than 20% for the drug.
In 2016, Amarin settled a lawsuit over off-label promotion of Vascepa with the FDA. The pharma company wanted to promote Vascepa to treat people with triglyceride levels between 200 and 499 mg/dL, when the drug was only approved for levels above 500. Amarin claimed the FDA was curbing its First Amendment rights expressed through its promotion.