Amarin Corp Plc (AMRN)

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We made the list!

Top 10 drug launch disasters

https://www.fiercepharma.com/special-report/top-10-drug-launch-disasters

Drug name: Vascepa
Company: Amarin
First approval: July 2012, U.S. FDA
Indications: High cholesterol; cardiovascular risk reduction
Past sales estimate: $1.5 billion in 2020
2020 sales: $614 million

Seven years after it hit the market as a drug to reduce bad cholesterol, Vascepa notched a second FDA approval that sparked blockbuster expectations for the fish oil derivative. In 2019, Vascepa became the first drug approved to reduce cardiovascular risks in people with elevated triglyceride levels who don’t respond to statins. Amarin was so buoyed about the label expansion that it doubled its sales staff.

But soon after what seemed a transformational approval, Amarin’s fortunes took a turn. A combination of data that cast doubt on the benefits of Vascepa and the invalidation of several of its patents delivered a punch from which the company may never recover.

The timing never was optimal for Vascepa. By the time it earned its first FDA approval, omega-3 was no longer being touted as the key to heart health. Still, as the only advanced fish oil product made of pure eicosapentaenoic acid (EPA), Vascepa did gain some traction. Vascepa sales have grown by at least 25% a year. Last year’s haul of $614 represented a 40% year-over-year increase, despite pandemic slowdowns in physician office visits.

But in March 2020, a Nevada judge invalidated key patents protecting Vascepa—a major blow, given that it's Amarin's only product. The judge declared that there was nothing remarkable about Amarin’s creation of the drug, calling it “obvious to a skilled artisan.”

RELATED: Amarin launches Vascepa in all-important Europe as it slowly bleeds share to U.S. generic

A few months later, the Supreme Court refused to hear Amarin’s appeal, opening the door for generic competition in the United States. Before the end of the year, London-based Hikma launched a generic version of Vascepa.

For Amarin, answering the court challenge of Hikma and another generics maker, Dr. Reddy’s, was an ill-advised gamble. Had Amarin settled, as it did in 2018 with Teva, the company could have staved off generic competition for several more years.

More adversity came for Amarin when results from two American Heart Association studies suggested that omega-3 fatty acids don't protect cardiovascular health. The data forced a reexamination of the Reduce-It trial, which paved the way for Vascepa’s approval.

With the air out of Vascepa’s balloon, Amarin slashed its sales staff in the United States from 750 to 300 last month, stating it will focus on digital marketing instead. Leerink analysts estimate that Vascepa sales could erode between 6% and 22% by 2023, depending on the success of Amarin’s new strategy and the extent of the generic competition Vascepa will face in the U.S.

RELATED: ESC: Amarin touts Vascepa’s ability to reduce repeat heart problems as it fights generic with ‘skinny label’ claim

Amarin isn't throwing in the towel on Vascepa by any stretch. Amarin is set to roll the drug out in Europe, and other big markets await, including China and Japan.

The EU approved the drug in March to reduce the risk of cardiovascular events in high-risk patients. The European market could be even larger than that of the U.S., given the higher prevalence of statin use and the death rate from heart disease, Amarin management has said. Cantor Fitzgerald has estimated the European market for the drug is $1.1 billion. Leerink pegs Europe, Canada and China as a combined $2 billion opportunity.

“Our vision is to bring the cardioprotective benefits of Vascepa to patients worldwide,” Amarin CEO Karim Mikhail said during the company’s second-quarter earnings call. In August, Mikhail replaced CEO John Thero, who had served in the role for seven years. Mikhail added that Amarin has access to 30 of the top 50 markets. "A new key priority is to ensure we unlock the potential of Vascepa in the balance of these markets, including Australia, New Zealand, select Latin American and additional Asian markets.”