The pharma company with a build-as-you go approach

Amarin Corporation is the pharmaceutical company behind Vazkepa, the first approved prescription drug for cardiovascular disease that contains just one active ingredient: icosapent ethyl (IPE). IPE is made from the omega 3 fatty acids normally found in oily fish.

Vazkepa has a different mode of action to the typical treatments that tackle low-density lipoprotein (LDL) cholesterol, a main factor that raises the risk of heart disease. Laurent Abuaf, SVP and President for Europe at Amarin explains: “We are bringing a new paradigm of treatment beyond LDL to the table, which is around inflammation and how lipids accumulate in the vascular wall.”

Cardiovascular diseases are currently the leading cause of death worldwide, claiming the lives of 17.9 million people each year. Abuaf says that Amarin is pursuing the bold mission of changing this statistic so that heart disease is no longer the world’s main cause of death: “Our mission is anchored in health economics. If all eligible patients were treated with Vazkepa, numerically that would become true, so it is not completely plucked out of thin air,” he explains.

An agile business model

During clinical trials, patients with elevated triglyceride levels who received IPE daily had a reduced risk of ischemic events such as stroke and cardiovascular death, compared to patients who received a placebo.

“We are backed by incredible scientific data,” Abuaf says. “We are a one-product company, which means it is high risk for us, but we have a strategy to mitigate that risk because in Europe we submitted to 13 markets at the same time.”

The company was founded in England in 1989, before going public four years later and expanding to the US in 2011. The way Amarin operates is rather different to typical biopharma companies – by adopting a very agile business model, it has been able to adapt to changing circumstances, using a build-as-you-go approach that has enabled it to establish a commercial presence in multiple European countries in record time.

Market access country-by-country

“We got approval from the European Medicines Agency in March and we launched fully in Germany in September,” Abuaf notes. “That means zero market preparation. We are unlike big companies who have a pre-launch 18 months earlier and then have an easier evolution because they have more time.”

“Our strategy is to operate in parallel. We don't have a portfolio or pipeline of products, so we are creating a portfolio of markets. We are here for the long term, and when it pays off we can start to enrich our pipeline with new assets,” he continues.

Future plans include offering a fixed dose combination of IPE and statins, a class of lipid-lowering medications that are usually administered together with IPE to treat cardiovascular illness.

A strategy backed by patient data

Amarin’s other differentiator is that rather than launch Vazkepa while Phase III trials are still underway, which is permitted by the Food and Drug Administration (FDA), the company decided to complete its studies first and launch the drug with all its patient outcome data.

“In the context of cardiovascular disease it is extremely rare to market a drug with outcome data at launch,” Abuaf says. “Even the big companies provide all the outcome data of Phase III trials after they launch.”

He adds: “We took the risk 11 years ago to launch a Phase III trial that cost more than US$500 mn. We ran that trial for seven years with more than 8,000 patients. Despite an extremely tough environment, from a market access perspective the strength of the data is so striking that we were able to give a positive scientific assessment and gain a positive reimbursement decision in market after market.”

Tackling unmet need

Amarin plans to launch in up to six key European markets by the end of 2022, although Abuaf admits it is not the ideal time to launch a new product given the deficit in national health systems. “At the same time, it is also the year when unmet need is at its highest,” he says. “During the Covid-19 pandemic new patients were not properly diagnosed and existing patients have not been escalated in terms of treatment. There is an urgency to do something about this.”

Abuaf states that there are three reasons why he joined Amarin in 2021, “great science, a growth story, and a very constructive company culture”.

“We are not big pharma, so we cannot pursue huge unmet need programs. But we can collaborate smartly with scientific societies like the World Heart Federation and patient associations like Heart UK. We try to give them a platform to increase awareness of the burden of heart disease, from both the patient and the societal perspective,” he shares.

Quick links

• Steps for a successful merger and acquisition in pharma
• Why change management is necessary in the pharmaceutical industry
• Putting patient benefits at the center of digital transformation and marketing strategies

Get exclusive access to member-only articles, reports, videos, interviews, webinars and other premium content from industry experts and thought leaders by signing up to Pharma IQ here.