After Amarin lost a U.S. patent defense against generics to its sole product Vascepa, a lot of the heart drug’s future hangs on its ability to crack the EU market. Now, the company has reached a milestone toward its $1 billion-plus revenue goal in the region.
In the first national reimbursement deal Amarin has signed in Europe, Sweden agreed to cover the drug for statin-treated patients with established cardiovascular disease and elevated triglycerides, Amarin said Monday. Vascepa is branded as Vazkepa in Europe.
The Swedish reimbursement price, at 1,640 Swedish krona (about $175) per month, meets expectations and is high relative to the drug’s U.S. net price after discounts and rebates, Cantor Fitzgerald analyst Louise Chen wrote in a Monday note.
“This important decision is a critical milestone as we begin to unlock a multibillion-dollar revenue opportunity for Vascepa/Vazkepa outside of the U.S.,” Amarin CEO Karim Mikhail said in a statement. Mikhail was Amarin’s European head before moving to the top job in August 2021.
Amarin had also recently launched Vazkepa in Germany at about 200 euros ($222) per month with interim reimbursement in place, SVB Leerink analyst Roanna Ruiz, Ph.D., noted in a Monday report. The Swedish price could allay investors’ concerns that a final reimbursed price would come at a large discount off the German price, Ruiz said.
The Swedish price tag could “provide another benchmark” for other European reimbursement discussions, Ruiz said. A similar price in other European countries as the Swedish one “would be very good,” Cantor’s Chen said in her note. For 2022, Amarin expects coverage policies from Norway, Finland, Germany, the U.K., France, Italy, Spain and the Netherlands and to launch Vazkepa in six European countries.
Nonetheless, Vazkepa's European launch in Germany had a rough start because of “significant disruption” from COVID-19, Mikhail told investors during a call about Amarin’s fourth-quarter performance. The company only registered $700,000 in German sales last year after launching mid-September.
Still, two experts in Germany that SVB Leerink spoke with noted Vazkepa’s strong cardiovascular outcomes data among patients on maximally tolerated statin, and they liked the drug’s safety profile. Pointing to that positive feedback, Ruiz believes Vazkepa could reach around $1 billion peak sales in Europe. Amarin itself has stated the drug could exceed $1 billion sales in the region.
The European market has become increasingly important for Amarin. Last summer, the U.S. Supreme Court declined to hear Amarin’s appeal of a patent loss around Vascepa, handing generics makers such as Hikma a critical win. Amarin has recently launched another legal challenge, targeting Hikma’s “skinny label” as well as an insurer’s formulary decision for Hikma’s generic.
As the legal battle drags on, Hikma’s generic fish oil drug continues to be sold in the U.S. with the hypertriglyceridemia label, while Vascepa bears an additional cardiovascular risk reduction indication. In January, Apotex became the third to launch a generic to Vascepa in the U.S., putting additional pressure on the originator.
And back in Europe, Amarin sees hiccups in reimbursement talks in Central and Eastern Europe given “local political conditions,” likely indicating Russia’s war in Ukraine. The company’s search for a partnership in Greece is “advancing well,” Amarin said.
Outside of Europe, Amarin’s applications are under review at Australian and New Zealand authorities, and Vascepa’s package has been accepted in Israel. Amarin said it’s “actively evaluating partnerships” in these countries. In addition, Amarin and partner Edding expect an approval in China this year.