Nasdaq-listed Amarin has entered into an exclusive licensing and supply agreement worth up to $175m with Recordati, granting the Italian pharmaceutical company commercial rights to VAZKEPA (icosapent ethyl), a cardiovascular therapy, in 59 countries across Europe.
The agreement includes an upfront payment of $25m and milestone-based payments of up to $150m. It also provides for ongoing product supply revenues and royalties, as Recordati assumes full responsibility for commercialising the cardiovascular treatment in the region.
Recordati will manage all marketing and distribution efforts across the designated territories, enabling Amarin to streamline its global operations and reduce European commercial expenditure.
Amarin president and CEO Aaron Berg said: “This long-term partnership with Recordati for VAZKEPA in Europe, where we have patent protection up to 2039, combined with the company’s financial strengths – nearly $300m in cash, no debt, an estimated $70m in cost savings over the next 12 months and continued cost efficient revenue generation from multiple revenue streams – accelerates the path to positive cash flow and strengthens our strategic position for the future.”
The transaction aligns with Amarin’s strategy to unlock global value for VAZKEPA while shifting towards a leaner operating model.
The Milan-based pharmaceutical company maintains fully integrated operations across research, manufacturing and commercialisation, with a cardiovascular portfolio that accounts for around 25% of its speciality and primary care business.
The agreement strengthens Recordati’s position in cardiovascular therapeutics across its broad European presence, which spans over 150 countries.
Marketing authorisation for VAZKEPA was granted in the European Union in March 2021 for reducing the risk of cardiovascular events in high-risk patients. Approval followed in Great Britain the following month.
The treatment is currently sold in countries including Sweden, Finland, Spain, the Netherlands, Italy, and the UK.
VAZKEPA, branded as VASCEPA in other regions, is a prescription product containing icosapent ethyl, a purified form of eicosapentaenoic acid.
It received its first US Food and Drug Administration (FDA) approval in 2013 as an adjunct therapy for adults with severely elevated triglyceride levels. It received an expanded approval in 2020 for patients with persistent cardiovascular risk despite statin therapy.
Outside Europe and the US, VASCEPA is also approved and marketed in Canada, China, Australia, the Middle East, and parts of Asia. Amarin said that it will continue to support commercial partners in these regions, aiming to expand access to the treatment with limited capital investment.
The company expects to generate an estimated $70m in cost savings over the next 12 months by reducing its European commercial footprint. Its US business remains a profitable operation with stable cash flows, which Amarin will continue to optimise alongside its international strategy.
Amarin board of directors chairman Odysseas Kostas said: “Over the last couple of years, we have done a lot to thoughtfully redesign our operations and strategy in Europe, and we are proud of the efforts and accomplishments of the team in Europe. That said, partnering with Recordati, a market leader in Europe, is now the right decision for the company, financially and for patients.”
Barclays acted as financial adviser on the transaction, while legal support was provided by Wilkie Farr & Gallagher.
