Recordati announced a comprehensive licensing and supply agreement with Amarin to commercialize Vazkepa® (icosapent ethyl), a cardiovascular medicine, across 59 countries focused in Europe. The deal represents a significant expansion of Recordati's cardiovascular portfolio and positions the company to capitalize on a proven therapy with substantial market potential.
Clinical Foundation and Market Position
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. The drug received approval in 2021 in the EU and UK, followed by Swiss approval in 2022, based on the robust REDUCE-IT study.
The REDUCE-IT study, a Phase 3 Cardiovascular Outcomes Trial, enrolled over 8,000 patients and demonstrated statistically significant and clinically meaningful results in Major Adverse Cardiovascular Events (MACE). This clinical evidence has established Vazkepa as the only treatment option that has effectively reduced cardiovascular risk in statin-treated patients with elevated or high triglycerides in a cardiovascular outcomes trial.
The drug's clinical profile has led to its incorporation as a therapeutic option within multiple treatment guidelines and scientific statements, supported by its robust clinical data package. Patent protection extends through 2039 in Europe, providing long-term commercial exclusivity.
Financial Terms and Revenue Projections
Under the agreement terms, Recordati will make an upfront cash payment of $25 million to Amarin. The deal structure includes additional commercial milestones up to $150 million if annual revenues for Vazkepa in the covered territories exceed certain sales thresholds starting from €100 million.
Amarin will supply finished product to Recordati and receive royalties for product supply under the agreement terms. Current market performance shows Vazkepa is commercialized in 11 European countries, generating net sales of €12 million in 2024. Revenue projections indicate the drug is expected to achieve over €40 million in revenues by 2027 and become EBITDA positive from 2026.
Strategic Rationale and Leadership Perspectives
Rob Koremans, Chief Executive Officer of Recordati, emphasized the strategic fit: "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."
Alberto Martinez, EVP of Specialty & Primary Care at Recordati, highlighted the drug's long-term potential: "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."
Aaron Berg, President & CEO of Amarin, expressed confidence in the partnership: "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."
Market Opportunity and Future Outlook
The agreement positions Recordati to address a significant unmet medical need in cardiovascular care, particularly for patients with elevated triglycerides who remain at high cardiovascular risk despite statin therapy. The drug's unique clinical profile and established efficacy data provide a strong foundation for market expansion across the 59-country territory.
Recordati plans to provide additional details about the agreement and its strategic implications during the first half 2025 conference call scheduled for July 30th. The company's established presence in approximately 150 countries across EMEA, the Americas, and APAC, with over 4,450 employees, provides the infrastructure necessary to maximize Vazkepa's commercial potential in the European market.
