Amarin Corp Plc - AMRN STOCK NEWS

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.

Amarin Corporation plc (NASDAQ: AMRN) announced a conference call on August 4, 2020, at 7:30 a.m. ET to discuss its Q2 2020 financial results and provide an operational update. The call will follow the earlier release of its financial results and will be accessible via the investor relations section of Amarin's website or by telephone. A replay will be available for two weeks. Investors can submit questions until August 3, 2020, at 4:00 p.m. ET. Amarin focuses on developing therapeutics for cardiovascular health, with its lead product, VASCEPA®, available in several countries.

Amarin Corporation plc (NASDAQ: AMRN) has reached a settlement agreement with Apotex Inc., resolving patent litigation regarding a generic version of VASCEPA (icosapent ethyl). The agreement prohibits Apotex from selling the generic version in the U.S. until August 9, 2029, unless specific conditions allow for earlier approval. This settlement avoids further litigation costs for Amarin and resolves potential future litigation linked to VASCEPA's cardiovascular risk indication. The deal is subject to federal review and does not involve any financial payment from Amarin.

Amarin Corporation plc (NASDAQ:AMRN) announced plans to enhance promotion and education for VASCEPA® (icosapent ethyl), targeting high-risk cardiovascular patients. Following its FDA approval in December 2019, awareness is crucial as many healthcare providers and patients are unaware of VASCEPA's unique benefits. Amarin intends to restore $80 million in marketing efforts and resume face-to-face interactions with healthcare providers by late June 2020. Prescription growth has slowed due to COVID-19, but patient visits are increasing. The company also anticipates potential impacts from ongoing patent litigation concerning generic versions of VASCEPA.

Amarin Corporation plc (NASDAQ:AMRN) is supporting a clinical trial to examine the effects of icosapent ethyl (IPE) on inflammatory biomarkers in COVID-19 patients. Sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, the trial is led by Dr. Subodh Verma and Dr. Deepak L. Bhatt. The primary endpoint is the impact of VASCEPA on high-sensitivity C-reactive protein levels after 14 days. Given the potential risks of COVID-19 in cardiovascular patients, VASCEPA may offer beneficial effects. The study aims to assess various outcomes and may lead to larger studies if positive results are observed.