Amarin Stock Price, News & Analysis

Amarin Corporation provided an update on its patent litigation concerning the VASCEPA® (icosapent ethyl) capsule. The U.S. Court of Appeals upheld a ruling favoring two generic companies regarding their abbreviated new drug applications. Amarin plans to petition for an en banc review of this decision. Despite the setback, Amarin is pursuing additional regulatory approvals for VASCEPA in various international markets, including Europe and China, aiming for commercialization in early 2021. Amarin will maintain promotion efforts in the U.S. amidst expected limited generic competition.

Amarin Corporation presented significant findings at ESC Congress 2020 regarding VASCEPA, the first agent shown to induce coronary plaque regression in hypertriglyceridemic patients on statin therapy. The EVAPORATE trial revealed a 17% reduction in low attenuation plaque volume after 18 months of VASCEPA treatment. In the REDUCE-IT study, VASCEPA achieved statistical significance in reducing major adverse cardiovascular events across various patient subgroups. These results underscore VASCEPA's potential efficacy in mitigating cardiovascular risks and enhancing patient outcomes.

Amarin Corporation (NASDAQ:AMRN) announced positive results from the EVAPORATE trial, which evaluated the effects of VASCEPA on coronary plaque progression in patients treated with statins. The trial showed a significant 17% regression in low attenuation plaque (LAP) volume after 18 months compared with placebo. 80 patients participated, and although EVAPORATE was not powered for long-term outcomes, its findings reinforce VASCEPA's cardiovascular benefits demonstrated in the REDUCE-IT trial. While the study's sample size is a limitation, it provides valuable insights into VASCEPA's mechanisms.

Amarin Corporation announced new data on VASCEPA® (icosapent ethyl), to be presented at the ESC Congress 2020 from August 29 to September 1. Key presentations include the Late-Breaking Science session focusing on the EVAPORATE Study results, showing VASCEPA's effects on coronary atherosclerosis in patients on statin therapy. Other findings from the REDUCE-IT trials will also be shared, emphasizing data on ischemic events across different LDL cholesterol levels. This research underscores VASCEPA's potential in managing cardiovascular risks.

Amarin Corporation plc (NASDAQ:AMRN) has announced an investigator-initiated trial called MITIGATE COVID-19, which studies the effects of icosapent ethyl (VASCEPA) on viral upper respiratory infections, including COVID-19, in adults with atherosclerotic cardiovascular disease (ASCVD) at elevated risk. Sponsored by Kaiser Permanente Northern California, the trial will enroll 1,500 patients aged 50 and older. Participants will receive 4 grams per day of VASCEPA for at least six months. The study aims to evaluate the drug’s impact on severe viral infections and associated clinical outcomes.

Amarin Corporation plc (NASDAQ:AMRN) plans a dedicated launch of VASCEPA® in Europe, pending Marketing Authorization Application approval. The company anticipates a significant market opportunity for cardiovascular risk reduction, with over 80 million affected individuals in Europe. Amarin is set to retain most economic benefits from this venture. Regulatory exclusivity could protect VASCEPA for up to 11 years, with potential patent extensions to 2039. Karim Mikhail has been appointed as senior vice president, leading commercialization efforts, focusing on market access and physician education for VASCEPA.

Amarin Corporation has announced its plans for a focused commercial launch of VASCEPA in Europe, pending the approval of its Marketing Authorization Application (MAA) by the European Medicines Agency. The potential market opportunity is significant, with over 80 million people in Europe suffering from cardiovascular disease. Amarin anticipates a 10-11 year regulatory exclusivity period and has recently appointed Karim Mikhail as Senior Vice President to lead the launch efforts. The company believes it has sufficient resources to achieve positive cash flows from the product.

Amarin Corporation (NASDAQ: AMRN) reported Q2 2020 net revenue of $135.3 million, a 34% increase from Q2 2019, and H1 2020 revenue of $290.3 million, up 67%. Despite COVID-19 challenges, normalized prescriptions for VASCEPA increased by approximately 44%, with a year-to-date growth of 57%. The company is advancing plans for VASCEPA's approval in Europe, expecting a launch in early 2021. As of June 30, 2020, cash and investments totaled $611.3 million. However, SG&A expenses rose 26% due to sales force expansion. Amarin aims to boost VASCEPA awareness through a direct-to-consumer campaign.

Amarin Corporation (AMRN) announced significant findings from the REDUCE-IT study regarding its product, VASCEPA. The data revealed a 34% reduction in first coronary revascularization events and 36% reduction in total revascularizations, with sustained statistical significance achieved by 11 months. The study highlighted consistent reductions across various types of interventions, including elective and emergency procedures. These results support VASCEPA's potential to transform cardiovascular care for high-risk patients with elevated triglycerides.