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07-Sep-2020

Hikma receives favourable court ruling for its generic Vascepa®

London, September 3, 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical

company, announces that the US Court of Appeals for the Federal Circuit today upheld a ruling by the

US District Court for the District of Nevada finding that Hikma’s generic version of Vascepa®1 (icosapent

ethyl) 1gm does not infringe any valid claim of six key Amarin-owned patents. Hikma received FDA

approval for the product in May 2020 and is working towards a launch.

Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride

levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. According to IQVIA, US sales of

Vascepa® were approximately $1.1 billion in the 12 months ending July 2020.

“We are very pleased with the Federal Circuit’s swift decision and to be one step closer to launching a

generic version of this important medicine for US patients and healthcare providers, helping us to

continue putting better health, within reach, every day,” said Brian Hoffmann, President of Hikma

Generics. “Today’s decision demonstrates Hikma’s ability to successfully challenge patents on important

medicines and to provide value to our customers and millions of patients across the United States.”

About Hikma

(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and Ba1/stable Moody’s)

Hikma helps put better health within reach every day for millions of people in more than 50 countries

around the world. For more than 40 years, we've been creating high-quality medicines and making them

accessible to the people who need them. Headquartered in the UK, we are a global company with a

local presence across the United States (US), the Middle East and North Africa (MENA) and Europe,

and we use our unique insight and expertise to transform cutting-edge science into innovative solutions

that transform people's lives. We're committed to our customers, and the people they care for, and by

thinking creatively and acting practically, we provide them with a broad range of branded and nonbranded

generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that

enriches all our communities. We are a leading licensing partner, and through our venture capital arm,

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Last Updated: 07-Sep-2020