2020-03-31| Trials & Approvals

True to Analyst Predictions, Amarin’s Shares Crash Following Vascepa Patent Invalidation

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

After almost three and a half years of prolonged court battles, Amarin Corporation has eventually lost a patent infringement lawsuit filed against Hikma Pharmaceuticals and Dr. Reddy’s laboratories. Amarin is a pharmaceutical company that develops therapeutics to improve cardiovascular health. Its blockbuster drug, Vascepa (icosapent ethyl) is an omega-3 fatty acid product that contains purified EPA (omega-3 fat eicosapentaenoic acid) from fish oil.

Vascepa was originally FDA approved back in 2012 to treat elevated triglyceride levels (hypertriglyceridemia) in patients, rivaling GlaxoSmithKline’s Lovaza. Over the years, the drug rose to become a major revenue yielder for Amarin. Following a successful “Reduce-It” clinical trial, last December, it bagged authorization for a broader label. The FDA granted approval to Vascepa as an add-on to statin therapy in patients who have either established cardiovascular disease (CV) or diabetes and two or more additional risk factors.

When generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s laboratories initiated new drug applications seeking FDA approval for a generic form of Vascepa, Amarin filed a patent infringement lawsuit against them. However, today, Nevada’s District Court Judge, Miranda Du ruled that the “Defendants’ (generic firm) proposed ANDA Products will induce infringement of the Asserted Claims, but all the Asserted Claims are invalid as obvious under 35 U.S.C. § 103.” The generic companies had argued that the use of fish oil to treat high levels of triglycerides was well known for a long time and GSK’s Lovaza was already in the market.

Since Amarin does not have any other significant asset besides Vascepa, it is overreliant on it for earnings. Several analysts had anticipated a tumble in Amarin’s stock value if they lost the case. True to that prediction, the company’s shares crashed to more than 70% in after-market trading.

Amarin has pledged to appeal against this judgment. “Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of VASCEPA in the United States,” said John F. Thero, President, and CEO of Amarin in a statement.

Related Article: Will Vascepa Receive a FDA Approval as a New Year Gift?



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