• 28 Jun 2025
• Admin
• News Article

Recordati to market Amarin’s Vazkepa in EU with $25M upfront, $150M in milestones

Overview

Recordati, an international pharmaceutical group listed on the Italian Stock Exchange with a family-run pharmacy in Northern Italy, announced a licensing and supply agreement with Amarin to commercialize the marketed cardiovascular medicine, Vazkepa (icosapent ethyl) across 59 countries, focused in Europe. 

Vazkepa is indicated to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk with elevated triglycerides and either established cardiovascular disease or diabetes with at least one other cardiovascular risk factor. Vazkepa is supported by strong clinical data package and expected to contribute to specialty and primary care growth in coming years.

Vazkepa Gains Broad Regulatory and Guideline Support for Cardiovascular Risk Reduction

• Vazkepa received approval in:
  1. EU and UK in 2021
  2. Switzerland in 2022
• Approval was based on the landmark REDUCE-IT trial, a Phase 3 cardiovascular outcomes study involving over 8,000 patients, which demonstrated:
  1. Statistically significant and
  2. Clinically meaningful reductions in major adverse cardiovascular events (MACE)
• Vazkepa is the only approved therapy to reduce cardiovascular risk in statin-treated patients with elevated or high triglycerides, validated in a cardiovascular outcomes trial.
• Due to its robust clinical evidence, it has been incorporated into multiple treatment guidelines and scientific statements.
• Patent protection in Europe extends through 2039, supporting long-term market presence.

Vazkepa: Net sale

Vazkepa is currently commercialized in eleven European countries, generating net sales of €12 million in 2024 and is expected to achieve over €40 million in revenues in 2027 and to be EBITDA positive from 2026.

The terms of the agreement

• Under the terms of the agreement, Recordati will pay Amarin an upfront cash payment of US$ 25 million. 
• Amarin will supply finished product to Recordati and is eligible to receive royalties for the supply of the product under the terms of the agreement and commercial milestones up to a total of US$ 150 million if annual revenues for Vazkepa in the territories in scope exceed certain sales thresholds starting from €100 million.
• More details will be provided during the first half 2025 conference call on July 30th.

EXPERT COMMENT ON THE AGREEMENT

• From Rob Koremans: CEO, Recordati
  Rob Koremans, CEO, Recordati, commented, “We are extremely pleased with the agreement with Amarin for Vazkepa which underscores our deep expertise in the Cardiovascular space and our ongoing commitment to continue strengthening our specialty & primary care business with innovative medicines in our core therapeutic areas. Vazkepa is a best-in-class treatment option that complements our existing portfolio, is supported by a robust clinical data package, has the ability to make a meaningful impact for cardiovascular patients and contribute to the growth of specialty & primary care for years to come.""
• From Alberto Martinez: EVP, specialty & primary care
  Alberto Martinez, EVP, specialty & primary care: “Vazkepa complements our portfolio well. Supported by strong science, growing medical advocacy, and recently granted patent protection extending the exclusivity in Europe up to 2039, Vazkepa has a long runway to make a meaningful impact for millions of cardiovascular patients. We are confident that together we can deliver accelerated growth in Europe and significant value for both Amarin and all stakeholders of Recordati.”
• From Aaron Berg: CEO, Amarin
  Aaron Berg, president & CEO of Amarin, added, “Recordati is a successful, well-established partner uniquely positioned to maximize the commercial opportunity for Vazkepa. We are confident in Recordati’s ability to lead the next phase of growth and impact patient care with Vazkepa throughout Europe.”