Amarin Corp. (AMRN) Launches VAZKEPA in Germany

Amarin Corporation plc (NASDAQ: AMRN) today announced the first European launch of VAZKEPA (icosapent ethyl) in Germany. VAZKEPA received marketing authorization from the European Commission in March 2021 and the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain in April 2021. VAZKEPA is indicated as a treatment to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.¹

The European launch of VAZKEPA, beginning in Germany, is supported by more than a decade of evidence-based cardiovascular clinical outcomes research including the landmark REDUCE-IT® study, a groundbreaking study² which established that VASCEPA®/VAZKEPA lowers the risk of a life-threatening heart attack or stroke by 25% when added to a statin in the targeted population. Importantly, VASCEPA/VAZKEPA has been included in the treatment guidelines for cardiovascular disease (CVD) prevention by the European Society of Cardiology, the European Association of Preventive Cardiology and the European Atherosclerosis Society, in addition to 17 other medical guidelines around the world.

The launch of VAZKEPA in Germany featured a scientific conference in Berlin titled, “New therapeutic strategies for residual CV risk management,” which highlighted the scientific underpinnings and clinical benefits of VASCEPA/VAZKEPA in reducing cardiovascular risk. The symposium was led by eleven internationally renowned cardiovascular specialists, was attended by more than 200 healthcare professionals from Germany and was live streamed to many more physicians across the continent. The event has been archived and is available to thousands of physicians across Europe.

Amarin’s president and chief executive officer, Karim Mikhail, stated, “The German launch is a historic moment for Amarin, as it is the first European country where VAZKEPA’s proven cardioprotective benefits are available to healthcare providers and patients. This is particularly important as CVD is the number one cause of death in Europe.” Mr. Mikhail added, “Our European launch marks a key milestone in our corporate growth strategy to bring the cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to at-risk patients around the world. As Germany is the fourth largest global economy and there are more than 300,000 deaths due to CVD in Germany every year³, it represents both a significant market need and opportunity.”

Laurent Abuaf, recently appointed as senior vice president and president of Europe, further noted, “Throughout last year Amarin made great progress building the commercial infrastructure in Europe and has recruited and trained a talented team of nearly 200 professionals to execute VAZKEPA’s launch. We are especially pleased with our successful German launch event and look forward to executing our plans to launch VAZKEPA across multiple European countries before the end of 2022.” Mr. Abuaf continued, “Cardiovascular disease (CVD) is one of Europe’s biggest health crises, costing the European Union €210 billion a year,⁴ and resulting in 3.9 million deaths.⁵ Amarin has ambitious plans to tackle this growing healthcare burden by working in partnership with healthcare professionals across the continent to challenge the conventions surrounding CVD care.”

Amarin has already filed market access dossiers in five out of the ten planned “first wave” European country submissions. The dossiers were filed in Germany, the United Kingdom, France, Italy and Denmark and, over the next quarter, Amarin plans to submit the remaining five dossiers. The company is committed to bringing the benefits of VAZKEPA to as many patients in Europe as quickly as possible.

With its global headquarters in Ireland and a new commercial hub in Zug, Switzerland, Amarin has strong European roots and the infrastructure necessary to support the company’s plans to build a local commercial presence in all major European markets for a series of successful launches across the continent.

About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland and Zug in Switzerland, as well as commercial partners and suppliers around the world. We are committed to advancing the scientific understanding of cardiovascular risk and its impact on society, in particular, the significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.

About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world and one of Europe’s biggest health crises, costing the European Union €210 billion a year,⁶ and resulting in 3.9 million deaths.⁷ In the United States, cardiovascular disease results in 859,000 deaths per year.⁸ And the number of deaths in the United States attributed to cardiovascular disease continues to rise.

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.⁹ Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.^10,11,12

About REDUCE-IT^®

REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.¹³ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.¹⁴ The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.¹⁵ These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

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