After Amarin suffered a surprise patent loss for its key drug Vascepa, the company is appealing and generics makers are hoping their arguments hold. Now, one of them has an FDA go-ahead to launch.
Hikma on Friday scored an FDA green light for its generic of Vascepa, a fish-oil derivative approved to cut cardiovascular risks in certain high-risk patients. The generics company was one of the drugmakers that challenged Amarin’s patents in Nevada federal court and prevailed.
In late March, that federal court struck down Amarin’s patents for obviousness, sending the company's shares into freefall. As the company appeals, it’s also weighing options for its path forward.
If the appeal fails, the company said it’ll reduce its marketing and commercial spend in the U.S. and consider launching its own generic, according to a quarterly SEC filing.
Theoretically, Hikma could roll out its copy "at risk" now, but if Amarin prevailed on appeal, the generics maker would face the prospect of paying hefty damages. Its approval announcement didn't specify any launch plans, only noting that the appeal is pending.
After Vascepa’s cardiovascular label expansion late last year, Amarin had big plans for the drug. In fact, the company predicted 2020 sales would hit $650 million to $700 million this year. But with the COVID-19 pandemic and patent loss, those forecasts are up in the air.
Meanwhile, Amarin is also supporting efforts to test Vascepa in COVID-19, the company said on Thursday. Researchers with the Canadian Medical and Surgical Knowledge Translation Research Group are sponsoring a study to examine whether the drug can beat usual care in certain high-risk COVID-19 patients.