Amarin Corporation is an Irish-American

biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...

company founded in 1993 and headquartered in

Dublin, Ireland Dublin is the capital and largest city of Republic of Ireland, Ireland. Situated on Dublin Bay at the mouth of the River Liffey, it is in the Provinces of Ireland, province of Leinster, and is bordered on the south by the Dublin Mountains, pa ...

and

Bridgewater, New Jersey Bridgewater Township is a Township (New Jersey), township in Somerset County, New Jersey, Somerset County in the U.S. state of New Jersey, located within the heart of the Raritan River, Raritan Valley region. Situated within Central Jersey, Cen ...

. The company develops and markets medicines for the treatment of cardiovascular disease. It has developed the drug Vascepa (AMR-101), a prescription grade

omega-3 fatty acid Omega−3 fatty acids, also called omega−3 oils, ω−3 fatty acids or ''n''−3 fatty acids, are polyunsaturated fatty acids (PUFAs) characterized by the presence of a double bond three atoms away from the terminal methyl group in their ...

. In July 2012, their lead-candidate drug named Vascepa (AMR-101) received

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

-approval, competing against

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

's Lovaza.

History

Amarin Corporation plc (formerly Ethical Holdings plc) was originally incorporated in England as a private limited company on March 1, 1989, and later re-registered as a public company on March 19, 1993. In 2002, the company suffered losses worth $37 million; 2003 losses exceeded $19 million. As of 2005, it was developing neurology drugs. It developed Miraxion to treat serious hereditary

neurodegenerative disease A neurodegenerative disease is caused by the progressive loss of neurons, in the process known as neurodegeneration. Neuronal damage may also ultimately result in their death. Neurodegenerative diseases include amyotrophic lateral sclerosis, mul ...

. In December 2007, Amarin acquired Ester Neurosciences Limited for US$8.1 million. In 2011,

CEO A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in variou ...

Joe Zakrzewski said that the company would like to first work on building its infrastructure out to commercialize the drug in the United States.

Products and development

Vascepa (USA) / Vazkepa (EU)

Amarin´s sole product VASCEPA® came on the market in 2013 for

triglyceride A triglyceride (from '' tri-'' and '' glyceride''; also TG, triacylglycerol, TAG, or triacylglyceride) is an ester derived from glycerol and three fatty acids. Triglycerides are the main constituents of body fat in humans and other vertebrates ...

levels >=500 milligrams per deciliter. In December 2019, the FDA approved "...the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established

cardiovascular disease Cardiovascular disease (CVD) is any disease involving the heart or blood vessels. CVDs constitute a class of diseases that includes: coronary artery diseases (e.g. angina, heart attack), heart failure, hypertensive heart disease, rheumati ...

diabetes Diabetes mellitus, commonly known as diabetes, is a group of common endocrine diseases characterized by sustained high blood sugar levels. Diabetes is due to either the pancreas not producing enough of the hormone insulin, or the cells of th ...

and two or more additional risk factors for cardiovascular disease....Vascepa is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Furthermore, VASCEPA® is in use in clinical trials by 3rd parties to see, if it has an effect on

Alzheimer Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems wit ...

Colon Cancer Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel ...

, Nonalcoholic Steatohepatitis (NASH), and other diseases. HLS Therapeutics, Amarin´s license partner in Canada, presented results of their

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever ...

clinical trial for Vascepa at National Lipid Association Scientific Sessions 2020, December 12. The results demonstrated a 25% reduction of hs-CRP, a biomarker for inflammation. Most people with COVID-19 die, because of a

cytokine storm A cytokine storm, also called hypercytokinemia, is a pathological reaction in humans and other animals in which the innate immune system causes an uncontrolled and excessive release of pro-inflammatory signaling molecules called cytokines. Cytok ...

, which causes an uncontrolled and excessive release of pro-inflammatory signaling molecules called cytokines. Two more COVID-19 studies are actually running with Vascepa to validate and proof further benefits. On January 28, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

gave a positive recommendation for Vazcepa (its name in the EU), which the

European Commission The European Commission (EC) is the primary Executive (government), executive arm of the European Union (EU). It operates as a cabinet government, with a number of European Commissioner, members of the Commission (directorial system, informall ...

finally approved on March 30.

Patent disputes

On March 30, 2020, the designated patent judge in the U.S. District Court for the District of Nevada, Miranda Du, ruled for generic-drug makers

Hikma Pharmaceuticals Hikma Pharmaceuticals plc is a British multinational pharmaceutical company with headquarters in London, UK that manufactures non-branded generic and in-licensed pharmaceutical products. It was founded by Samih Darwazah in Amman, Jordan in ...

and Dr. Reddy's Laboratories in a lawsuit with Amarin over patents on Amarin's drug, Vascepa. Soon after, on April 2, 2020, Amarin filed an appeal of the ruling. The appeal was lost and an en-banc was also not granted, afterwards. On November 30, three weeks after

started the distribution of their generic version of Vascepa, Amarin filed a complaint of patent infringement against Hikma. On February 11, 2021, Amarin filed a

petition for certiorari In law, ''certiorari'' is a Legal process, court process to seek judicial review of a decision of a lower court or government agency. ''Certiorari'' comes from the name of a prerogative writ in England, issued by a superior court to direct that ...

with the

US Supreme Court The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States. It has ultimate appellate jurisdiction over all Federal tribunals in the United States, U.S. federal court cases, and over Stat ...

. On June 21, 2021, the petition was denied.

Finance

References

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External links

Amarin Corporation Official Website
*Business data for Amarin Corporation plc
Yahoo! FinanceNASDAQSEC filings
Biotechnology companies of the United States Companies based in Somerset County, New Jersey Companies listed on the Nasdaq Pharmaceutical companies based in New Jersey