RECORDATI ANNOUNCES EXCLUSIVE LICENSING & SUPPLY AGREEMENT WITH AMARIN TO COMMERCIALIZE VAZKEPA® IN EUROPE
Vazkepa® supported by strong clinical data package and expected to contribute
to Specialty & Primary Care growth in coming years
Milan, 24 June 2025 – Recordati today 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® was approved in 2021 in the EU and UK and in 2022 in Switzerland based on the REDUCE-IT study, a Phase 3 Cardiovascular Outcomes Trial (CVOT) performed in over 8,000 patients with statistically significant and clinically meaningful results in Major Adverse Cardiovascular Events (MACE). Vazkepa® is the only treatment option that has effectively reduced cardiovascular risk in statin-treated patients with elevated or high triglycerides in a Cardiovascular Outcomes Trial and has been incorporated as a therapeutic option within multiple treatment guidelines and scientific statements due to its robust clinical data package. Vazkepa® has patent protection in Europe up to 2039.
Vazkepa® is currently commercialized in 11 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.
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.
Rob Koremans, Chief Executive Officer, 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.”
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.”
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.”
Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,450 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest.
| Investor Relations | |
| Eugenia Litz +44 7824 394 750 investorelations@recordati.it | Gianluca Saletta +39 348 979 4876 investorelations@recordati.it |
Media Relations | |
| ICR Healthcare US: Alexis Feinberg +1 203 939 2225 Alexis.feinberg@icrhealthcare.com | UK, Europe & Rest of World: Jessica Hodgson +44 7561 424 788 jessica.hodgson@icrhealthcare.com |
This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast as a result of a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising.
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