Amarin Corporation plc (ADR) (NASDAQ:AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin’s motion for summary judgment in the company’s lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa® (icosapent ethyl) capsules.
Amarin believes based on the court’s ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA’s approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. The ruling also confirms that acceptance by FDA of abbreviated new drug applications (“ANDAs”) for generic versions of Vascepa is not permitted until July 2016. The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020. An appeal of the court’s decision can be filed within 60 days.
Amarin has multiple patents covering Vascepa that expire in 2030. With this motion granted and FDA’s acceptance of ANDAs not permitted, Amarin plans to move to dismiss pending Vascepa patent litigation in connection with ANDA filings previously submitted.
“Congratulations to the extended Amarin team for delivering on this value-enhancing operational goal,” stated John Thero, President and Chief Executive Officer of Amarin. “NCE exclusivity helps solidify Vascepa’s commercial potential and helps demonstrate Vascepa’s status as a significant and novel treatment option in the management of severely high triglycerides. Amarin’s goal is to protect the commercial potential of Vascepa to beyond 2030. NCE regulatory exclusivity contributes toward this goal by complementing one of the most extensive patent portfolios covering a single product in the industry and existing manufacturing barriers to entry.” (Original Source)
Shares of Amarin Corporation opened today at $1.93 and are currently trading up at $2.26. AMRN has a 1-year high of $3.33 and a 1-year low of $0.78. The stock’s 50-day moving average is $2.13 and its 200-day moving average is $1.59.
On the ratings front, Amarin has been the subject of a number of recent research reports. In a report issued on March 12, H.C. Wainwright analyst Andrew Fein upgraded AMRN to Buy, with a price target of $10, which implies an upside of 418% from current levels. Separately, on March 3, Oppenheimer’s Akiva Felt reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Akiva Felt have a total average return of 24.0% and 33.9% respectively. Fein has a success rate of 61.9% and is ranked #167 out of 3610 analysts, while Felt has a success rate of 65.6% and is ranked #32.
Amarin Corp PLC is a biopharmaceutical company with expertise in lipid science. The Company is engaged in commercialization and development of therapeutics to improve cardiovascular health.