Amarin's wild 2020 ride continues. Tuesday, the company said COVID-19 took a bite out of second quarter earnings, and it unveiled plans to launch its fish-oil derivative drug Vascepa in Europe without help from a bigger marketing partner.
And that's on top of prepping for federal court this fall, where it will try to salvage Vascepa's key patents.
Amarin positioned its European plans as a positive: It did receive multiple proposals from potential partners. But the significant sales opportunity for Vascepa in the E.U. means retaining product rights is the company's best move, executives said during an earnings call with analysts.
While Vascepa is still awaiting approval in Europe, expected in early 2021, Amarin has already hired a commercial head, Karim Mikhail, who joined from his own commercial consultancy founded in 2018. Before that, though, he spent 22 years in a variety of roles at Merck, including as global leader for its lipid franchise and chief marketing officer for the EMEA region.
Amarin plans to hire a core commercial team of around 12 this year and then add country-by-country sales teams as it builds out approvals and reimbursement. Its initial focus will be on larger E.U. countries, President and CEO John Thero said.
Amarin has plenty of resources available in-house, and it sees no problem recruiting the right people in Europe, Thero said, adding that these are two of the reasons he's confident Amarin can handle the launch on its own.
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Thero called the offers from prospective European commercial partners “thoughtful,” but Amarin ultimately decided to build out its own sales staff to explain the drug’s science and persuade physicians.
Amarin plans to launch Vascepa in Europe using a strategy similar to its U.S. approach, with a tight focus on large markets and local partners in smaller markets. The company figures Europe could ultimately be a multibillion-dollar market for Vascepa.
Meanwhile, Amarin continues to promote Vascepa aggressively in the U.S., most recently launching a DTC branded campaign around its cardiovascular indication approved in December.
A 60-second TV commercial introduced in mid-July highlights Vascepa’s unique FDA approval for cardiovascular risk reduction when used with a statin. Social media and telemedicine components of the U.S. campaign will roll out through the third quarter.
Amarin’s second quarter results took a heavy hit from the COVID-19 pandemic. The company reported revenues of $135.3 million, an increase over 2019, but far short of the pace needed to hit its January prediction of $700 million in 2020 sales.
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Amarin’s double whammy for the year came in March with the surprise district court decision in Nevada that invalidated key patents protecting Vascepa and opened the door for other drugmakers to roll out generic versions in the U.S.
The case heads to appeals court on Sept. 2 where Thero said Amarin will focus on a few key points in trying to overturn the initial ruling. While its best-case scenario is an overturn of the lower court decision, Amarin is preparing for every outcome, he said.
The case could be decided in the generic drugmakers' favor or remanded back to the lower court for review. If that happens, Amarin will reevaluate its U.S. commercial operations, although Thero stressed that any immediate generic launch is expected to be low-volume and not competitively priced. Even in that case, Vascepa manufacturing and cost efficiencies would allow it to remain a branded drug, he said.