As Amarin Corp. (NASDAQ: AMRN) awaits a patent trial that could make or break the business, it continues forging ahead. On Monday, the Dublin, Ireland-based pharmaceutical company announced an $80 million marketing and education initiative designed to attract new customers.
Amarin stock has been battered this year, but some analysts remain bullish. Trading at around $6.80 Tuesday morning, the stock is down 68% year to date.
Promotion and Education
With America’s doctor’s offices reopening for non-COVID-related issues, Amarin sees an opportunity for its drug Vascepa. “As early signs emerge of patients returning to physicians’ offices, Amarin plans to emphasize its key marketing messages including positioning Vascepa as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients,” the company said.
Since March, many medical offices have been essentially closed. Some states ordered a stop to non-emergency procedures. In other states, many doctors declined to see patients unless they had symptoms of coronavirus or some other urgent matter. And many patients, fearful of contracting COVID-19, cancelled visits to doctor’s offices.
Now, many practices are trying to get back to normal, though with new social distancing procedures. There could be a rush of patients as doctors see a backlog of issues left untreated for months.
Enter Amarin with its new campaign for Vascepa, which was only approved by the Food and Drug Administration (FDA) in December. The company’s plans to promote the drug were severely disrupted by the pandemic and a federal court case.
Vascepa treats cardiovascular events and reduces the risk of heart attack, stroke and other cardiovascular events through its combination of omega-3 fish oils. Designed to be used along with statins, it’s the only drug of its kind on the market. “Most healthcare professionals and at-risk patients are unaware that Vascepa is the first and only drug with this important new indication,” the company said.
Cardiovascular disease is the leading cause of death in the U.S. One American has a heart attack every 40 seconds, according to the American Heart Association.
“As American society begins to open up again, Amarin currently plans to restore approximately $80 million in educational and promotional spending in 2020 to increase awareness” of Vascepa, said CEO John Thero. He said the drug is “proven to reduce risk, it has been found to be affordable and cost-effective and it is covered by most insurance policies. However … most are unaware of Vascepa.”
The campaign will include medical education for health professionals, social media posts, and advertisements on TV and other forms of media. Earlier this year, Amarin suspended its original plans for a marketing campaign because of the pandemic and uncertainty over a patent lawsuit. Now executives have decided the time is right to go big again.
The Generic Threat
The dark cloud hanging over Amarin is a patent lawsuit brought by drugmakers Dr. Reddy’s Laboratories Inc. (NYSE: RDY) and Hikma Pharmaceuticals. Both companies want to make generic versions of Vascepa.
This would obviously be a major blow to a drug that just got FDA approval a few months ago. But Amarin says its drug is protected by several patents.
Amarin lost the first round back in March when a federal district court in Nevada ruled against it. The case has been appealed to a federal appeals court.
All parties have requested the U.S. Court of Appeals for the Federal Circuit to approve an expedited schedule, including a briefing in the second quarter of 2020 and an expedited hearing. This should facilitate a hearing in the third quarter of 2020 (or perhaps early in the fourth quarter) and position the court to rule thereafter, potentially in 2020 or early 2021.
Meanwhile, Amarin recently announced a clinical trial to see if Vascepa might be an effective treatment for COVID-19. Medical researchers are pursuing many potential treatments, including drugs from a variety of classifications. It’s sort of a throw-everything-at-the-wall-and-see-what-sticks approach.
How could Vascepa help? While many consider COVID-19 primarily a respiratory disease, doctors have learned that it affects many organs beyond the lungs. Hospitals have noted victims suffering from blood clots, which can lead to strokes and cause other problems.
Amarin’s Vascepa is designed to be used along with statins to treat patients with high triglycerides. In announcing its COVID-19 trial, Amarin noted that Vascepa’s ability to lower cardiovascular risk in certain patients could prove effective as patients at high risk for cardiovascular disease also have a higher risk of dying from COVID-19.
A new study found that widely used cholesterol-lowering statin drugs, such as Lipitor, may be associated with substantially fewer symptoms in older COVID-19 patients, according to Reuters. The theory is that Vascepa might complement that statin for coronavirus patients.