Amarin Restructures, Charting Course That Braces for Generic Competition

The restructuring of cardiovascular drugmaker Amarin means the layoff of about 30% of staff. Sales of Vascepa, the company’s only commercialized product, have suffered as generic versions gain traction in the market.

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With sales of its flagship cardiovascular drug flagging, Amarin is implementing acompanywide restructuringthat considers the reality of the generic competition eating away at its revenue.

The corporate shakeup will shave headcount by 30%, resulting in about $40 million in annual savings. At the end of 2022, Amarin reported a headcount of 365 full-time workers in 15 countries. The company is pursuing its new course under new leadership. Soon after the restructuring announcement late Tuesday, Amarin announced theappointment of Patrick Holt作为总统和首席执行官立即生效。他肌萎缩性侧索硬化症o joins the company’s board of directors. Holt was most recently president of Cordis, a cardiovascular medical device subsidiary of Cardinal Health.

Amarin, which is based in Dublin but maintains most of its operations in Bridgewater, New Jersey, has one commercialized product: Vascepa. The twice-daily capsule was first approved by the FDA in 2012 for patients with hypertriglyceridemia, a condition characterized by elevated triglycerides, a type of fat in the blood that in high amounts increases the risk of heart disease and stroke. In 2019, the drug was approved for reducing the risk of cardiovascular complications more broadly in patients who have elevated triglyceride levels. The Amarin product received regulatory approvals in Europe in 2021, where it is marketed under the name Vazkepa.

Vascepa’s main ingredient is an omega-3 fatty acid that comes from fish oil. In 2020, afederal court struck down Amarin’s patent on its product. The company appealed, but the U.S. Supreme Court in 2021 declined to take the case.

The loss of patent protection opened the door to generic versions of Vascepa from companies such as Dr. Reddy’s Laboratories, Hikma, Teva Pharmaceuticals, and Apotex. Consequently, Vascepa’s sales have plunged. In 2022, Amarin reported $366.5 million in revenue, down nearly 37% from the prior year. In preliminary second quarter 2023 results reported Tuesday, sales of the drug were $65 million, down from $85 million in the first quarter.

Amarin said the restructuring will cut jobs mainly in the company’s U.S. sales force, which has already been cut. Last year, Amarin implemented cost cutting that slashed its U.S. sales staff from 300 to 75. The firm is also exploring ways to grow revenue and compete against generics. One of those ways is offering an authorized generic—Vascepa that’s marketed by Amarin but without the brand name on its label or the brand name price. While launching its own generic Vascepa will better enable Amarin to compete against field of generic versions now available, it will also erode the sales of the brand name product. Amarin said it is weighing the timing of an authorized generic launch to ensure the company keeps a leadership position in the market of cardiovascular drugs derived from fish oil.

Europe will continue to be a focus for commercialization efforts, but the sales infrastructure will streamlined, Amarin said. The company added that it would continue its commercialization push for Vascepa in other markets.

With the appointment of Holt as CEO, interim CEO Aaron Berg will return to his role as executive vice president, president U.S. In aregulatory filing, Amarin said it estimates the restructuring will incur about $10 million in one-time costs, comprised mostly of termination benefits.

“We are grateful for the efforts and commitments of our impacted colleagues who have worked tirelessly to advance our mission in the U.S. and globally,” Berg said in a prepared statement. “These are difficult, but necessary decisions to best position Amarin for the future and ensure we can give millions of patients globally the opportunity to access Vascepa/Vazkepa.”

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