Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced that the U.S. Food and Drug Administration (FDA) has determined that Vascepa® (icosapent ethyl) capsules are eligible for five-year, new chemical entity (NCE), marketing exclusivity pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. This determination provides Vascepa with the benefits of NCE exclusivity afforded by statute. NCE exclusivity for Vascepa runs from its date of FDA approval on July 26, 2012 and extends until July 26, 2017. The statutory 30-month stay triggered by patent litigation following generic application submissions permitted on July 26, 2016 would expire onJanuary 26, 2020, seven-and-a-half years from FDA approval.
“Amarin’s goal is to protect the commercial potential of Vascepa to 2030,” stated John F. Thero, president and chief executive officer of Amarin. “NCE regulatory exclusivity complements multiple patents covering Vascepa with expiration dates in 2030.” (Original Source)
Shares of Amarin are currently trading at $2.02, up $0.16 or 8.60%. AMRN has a 1-year high of $2.65 and a 1-year low of $1.24. The stock’s 50-day moving average is $1.75 and its 200-day moving average is $1.67.
On the ratings front, Amarin has been the subject of a number of recent research reports. In a report issued on May 12, Jefferies analyst Hugo Ong initiated coverage with a Buy rating on AMRN and a price target of $3.50, which represents a potential upside of 86% from where the stock is currently trading. Separately, on May 6, H.C. Wainwright’s Andrew Fein reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Hugo Ong and Andrew Fein have a total average return of -5.4% and 8% respectively. Ong has a success rate of 30% and is ranked #3050 out of 3891 analysts, while Fein has a success rate of 47% and is ranked #435.
Amarin Corp. Plc is a biopharmaceutical company, which engages in the commercialization and development of therapeutics to improve cardiovascular health. Its product, Vascepa capsules, is use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The company was founded by Geoffrey W. Guy on March 1, 1989 and is headquartered in Dublin, Ireland.