- New Jersey drugmaker Amarin on Tuesday announced plans to commercialize its heart drug Vascepa in Europe on its own, rather than with the help of a large pharmaceutical partner.
- Amarin CEO John Thero said the company made the decision after an "extensive evaluation" of its options and after considering some licensing deals. Vascepa is currently under review in Europe, with a decision from regulators there expected in early 2021.
- The decision adds pressure on Amarin to grow Vascepa's sales, which haven't yet taken off following a critical heart benefit approval last year. And if an appeals court doesn't overturn a recent federal court ruling, Vascepa could face a generic competition in the U.S. as early as next year, making the drug's sales trajectory in Europe even more critical.
Amarin entered the year with momentum. Last December, the Food and Drug Administration had granted a long-sought clearance allowing the company to claim Vascepa can reduce the risk of heart attacks and strokes, not just levels of a fat called triglycerides.
The drugmaker announced plans to dramatically boost its sales force, and projected the fish oil-derived pill would generate $650 million to $700 million this year.
Yet 2020 hasn't gone as planned. Despite the new label, Vascepa sales ticked up just $12 million, to $155 million, in the first quarter. Then the coronavirus pandemic hit, forcing Amarin to stop all face-to-face meetings with doctors. Sales slipped to $135 million in the second quarter, as patients dramatically reduced doctor visits, company chief commercial officer Aaron Berg said.
In April, a district court judge invalidated five patents covering Vascepa, potentially clearing the way for generic competition in the U.S. from Hikma Pharmaceutical and Dr. Reddy's Laboratories as early as next year. Some 70% of Amarin's market value was erased.
Amarin appealed the decision, and a ruling could come late this year or early 2021, CEO John Thero said on an earnings call Tuesday. Thero claimed it's "unlikely" both Hikma or Dr. Reddy's would launch generics "at risk" before then, or that the parties would reach a settlement.
Even if generic competitors are successful, he argued, they would likely only capture a small share of the market, given limited manufacturing capacity.
Despite those overhangs, Amarin is doubling down on its efforts to sell Vascepa both in the U.S. and abroad, signaling Tuesday optimism in a market recovery from COVID-19 and confidence in an Amarin-led Europe sales strategy.
The company reviewed "multiple proposals" from potential pharmaceutical partners interested in European rights to the drug, Thero said. Even with what Amarin claims is a "potential multibillion-dollar opportunity" in Europe, Thero said the company was concerned Vascepa would not be the focus of a pharma sales team.
Amarin still intends to consider future, smaller licensing deals in Europe, but in the meantime it has hired ex-Merck & Co. executive Karim Mikhail — who once led the sales push for the heart drug Zetia — to head up its efforts across the continent.
In Europe, Vascepa's market position appears better protected, with patents on the drug that could extend to 2039.
Amarin shares ticked up about 8%, but at $7.30 apiece are still worth just a fraction of their value late last year.