What: Shares of Amarin (NASDAQ:AMRN), a biopharmaceutical company with a focus on cardiovascular diseases, are soaring 15% higher today after the company announced a positive ruling from a U.S. District Court related to the marketing of its drug Vascepa.
So what: A U.S. District Court has ruled that Amarin is now allowed to promote Vascepa, the company's lead product that is used to control triglyceride levels, beyond the currently approved FDA labeling as long as the promotion is truthful and does not mislead providers.
Specifically, the ruling allows Amarin to speak with providers about the outcomes that Vascepa demonstrated in the company's previously completed ANCHOR clinical trials. The trials showed that Vascepa lowered triglyceride readings in patients with levels between 200 mg/dL and 500 mg/dl who were otherwise not well controlled by diet and statin therapy, and patients who used Vascepa did not experience higher low-density lipoprotein cholesterol, or "bad" cholesterol, readings when compared to placebo.
In order to make sure this data is not misleading Amarin still needs to ensure that they let providers know that the FDA has not approved Vascepa as a treatment to reduce the risk of coronary heart disease, and that additional clinical studies for the drug are currently under way.
Amarin stated that they plan to use this newly-approved language right away in its promotional activities.
Now what: Amarin appears to be on a roll in the court house recently, as today's good news comes only a few short months after the company announced that a judge overturned the FDA's decision to deny Vascepa's "New Chemical Entity" status. This announcement could go a long way in helping to turn Vascepa from a niche drug into one with a much larger addressable market, and could be a much needed catalyst that allows the company to grow sales much faster from here.
Cardiovascular disease remains the the leading cause of death in the United States, and if Amarin can use today's ruling to help drive additional sales growth for Vascepa then the future for the company is certainly looking brighter. Investors were certainly right to cheer this announcement, but personally I'm going to wait on the sidelines for a few more quarters to see if today's ruling has a positive impact on the company's sales growth before I'd be willing to call the stock a buy.