Amarin Files Patent Infringement Lawsuit Against Hikma
November 30, 2020 at 19:54 PM EST
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), announced today the filing of a patent infringement lawsuit by Amarin affiliates and a licensor against Hikma Pharmaceuticals PLC and Hikma’s U.S. affiliate. The lawsuit was filed in the United States District Court in Delaware. A copy of the complaint is available in the FAQ section of Amarin’s investor relations website.
The Amarin complaint alleges that Hikma has induced the infringement of U.S. Patent Nos. 9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States. Amarin is seeking remedies including a permanent injunction against Hikma’s unlawful inducement of infringing uses of its generic product to reduce cardiovascular risk and monetary damages in an amount sufficient to compensate Amarin for such infringement. Amarin is considering its legal options against similarly situated parties acting in concert with Hikma by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.
“Amarin has the benefit of multiple issued patents in the United States and worldwide designed to protect its substantial investment in drug development based on the use of icosapent ethyl in the treatment of serious diseases including cardiovascular disease and based on Amarin’s expertise in lipid science and the therapeutic benefits of polyunsaturated fatty acids,” stated Joseph T. Kennedy, Amarin executive vice president and general counsel. “We intend to pursue this litigation vigorously and to protect our intellectual property rights and our VASCEPA® (icosapent ethyl) franchise in the United States and globally.”
In December 2019, following over a decade of development and clinical study, VASCEPA was approved by the U.S. Food and Drug Administration as the first and only drug for reduction in cardiovascular risk in the patient population detailed below. This approval was heralded as one of the most significant advances in preventative cardiovascular care in decades. Amarin has the benefit of multiple patents that cover the use of VASCEPA for this important indication. Separately, Hikma has the benefit of court decisions that have led to its introduction of a generic version of VASCEPA for the drug’s original indication, use as an adjunct to diet to lower triglyceride levels in adult patients with very high (>500 mg/dL) triglyceride levels. In November 2020, Hikma began to market and sell a generic version of VASCEPA. The Amarin complaint details its position that Hikma has knowingly and willfully introduced its generic product in a manner that infringes Amarin’s patent rights and has exceeded the scope of permitted Hikma activity.
About Cardiovascular Risk
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%.2 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.3,4,5
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.6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.8 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use
○ established cardiovascular disease or
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Availability of Other Information About Amarin
Amarin Contact Information
1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139–e596.