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Amarin Corporation : ウィキペディア英語版
Amarin Corporation

Amarin Corporation is a biopharmaceutical company headquartered in Bedminster, New Jersey. The company develops and markets medicines for the treatment of cardiovascular disease. Amarin develops the drug Vascepa (AMR-101) which is a prescription grade omega-3 fatty acid. In December 2007, the company acquired Ester Neurosciences Limited for 8.1 million USD. Amarin CEO Joe Zakrzewski has said that the company would like to first work on building its infrastructure out to commercialize the drug in the United States.
Recently on July 26, 2012, their lead-candidate drug named Vascepa (AMR-101) received FDA-approval. Vascepa will also be a key competitor against GlaxoSmithKline's Lovaza.
==Products and development==

Amarin's only product is Vascepa, an approved prescription grade Omega-3 fatty acid drug (Ethyl eicosapentaenoic acid) that helps with the management of hypertriglyceridemia. Vascepa's clinical-data trials were the MARINE and ANCHOR studies.
In November 2010, Amarin's MARINE study, which was to treat patients with very high triglycerides (>500 mg/dL), Vascepa showed a decrease in triglycerides. Unlike Vascepa's competitor Lovaza, which can raise median LDL-C from 40% to 50%, Vascepa did not result in a significant increase in median LDL-C.
In April 2011, Amarin's ANCHOR study which was to treat patients with high triglycerides (200 mg/dL to less than 500 mg/dL), Vascepa also displayed a decrease LDL-C. Another unique detail about the ANCHOR study is that Vascepa was able to get approved for the patient population of 200 mg/dL to less than 500 mg/dL, unlike Lovaza which was not approved for this patient population.
These studies displayed that Vascepa reduced triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP.
On 10/16/2013, after FDA's ADCOM panel voted 9-2 against recommending an expanded drug label for Vascepa, for treatment of cardiovascular disease, shares dropped over 60%. As of 02/01/2015 their stock price had not recovered.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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