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

Pharma Industry

A drug’s EU launch seldom becomes more important than its U.S. rollout from a market opportunity perspective, but that’s exactly what’s happening to Amarin’s fish oil-derived heart drug Vascepa.

Amarin has started prepping sales reps in Germany for the planned launch of Vascepa—to be sold under the brand Vazkepa in Europe—before the end of September, the company said Tuesday. By mid-second quarter, it expects to have about 150 marketing staffers in place for product and disease awareness programs.

As Vascepa’s already facing a generic made by Hikma in the U.S. after losing a patent defense in an appeals court, industry watchers have pinned a large part of the drug’s commercial potential on the EU market. In an investor note on Tuesday, Cantor Fitzgerald analyst Louise Chen pegged the European opportunity at $1.1 billion in 2029, out of a total of $1.6 billion for Amarin that year.

Vazkepa won its official EU go-ahead a week ago. By SVB Leerink analyst Ami Fadia’s estimates, the drug’s EU label is broader than expected; the EU total addressable market could be 105% that of the U.S., she wrote in a note in February, when drug reviewers at the European Medicines Agency backed the drug’s approval.

In Europe, the drug can be used to reduce the risk of cardiovascular events in high-risk, statin-treated patients who have elevated blood fat and either established heart disease or diabetes plus at least one additional cardiovascular risk factor. In the U.S., the latter part of the indication requires patients to have diabetes and at least two additional risk factors.

RELATED: It’s confirmed: Amarin loses Vascepa patent appeal, putting generics defense on life support

During a recent SVB Leerink event, Amarin management also noted a higher prevalence of statin use as well as heart disease death rate in the EU, highlighting the EU opportunity for Vascepa to be “as large, or larger than in the U.S.,” Fadia wrote in a February note.

As the European market grows more important for Amarin with a broader-than-expected label, the company’s increasing its staffing plan there to about 300 people by the end of 2021, up from the 200 it had previously outlined.

Amarin plans to launch in the EU on a country-by-country basis and will tailor the price to each country based on the addressable patient population, Fadia noted. Now, the company’s targeting 10 countries, with Germany being the first, and will be filing reimbursement documents for those markets in the coming months.

A lot of work awaits Amarin, as no other product on the market has Vazkepa’s indication, and awareness in the region among healthcare professionals is relatively low, the company noted. “Amarin believes that increasing awareness of Vazkepa in Germany and illuminating the patient population that can benefit from this new drug are important to Vazkepa’s early launch success,” it said in a statement Tuesday.

RELATED: AHA: Amarin’s Vascepa cuts cardiovascular events in patients with coronary artery grafts

The 150-strong sales team will utilize digital outreach and “omnichannel engagement” with doctors. Its educational programs will target cardiologists, diabetologists and general practitioners.

“We are taking a thoughtful and proactive approach to leveraging the vast global experience of our team, while incorporating the learnings from other product launches made during the COVID-19 era,” Karim Mikhail, Amarin’s European commercial head, said in a statement.

The EU became more important for Amarin after it lost a patent fight against U.S. generic challengers last fall, and Hikma launched its copycat in November.

Not all is lost for Vascepa in the U.S., though. The Hikma drug only has the originator’s old label, which is meant to reduce blood fat in patients with very high triglyceride levels of at least 500 mg/dL. Vascepa added the key CV reduction indication in December 2019. According to Amarin, that first indication only accounts for about 7% of the brand drug’s use.

Hikma said at the launch that it would be “releasing limited quantities to ensure a consistent supply for customers,” suggesting a constrained supply at least during the early days.

According to data compiled by Cantor’s Chen, the Hikma generic had only been able to take up to around 12% of new-to-brand share as of March. The net pricing of the generic also tends to be higher than the brand for many patients and providers even though its wholesale acquisition price is 12% below Vascepa’s, suggesting Amarin’s offering high rebates to payers, SVB Leerink’s Porges noted.

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