A federal court in Nevada struck down the patent protection on a drug used to lower the risk of heart attacks, sending the manufacturer’s shares diving.
Las Vegas District Judge Miranda Du ruled Monday in favor of two generic companies that had filed for Food and Drug Administration approval for their generic versions of Dublin- and Bridgewater, New Jersey-based Amarin’s Vascepa (icosapent ethyl), used to treat high triglycerides in patients at high risk of events like heart attack and stroke. The generic companies, Dr. Reddy’s Laboratories and Hikma, had filed abbreviated new drug applications, or ANDAs, for their generics.
Shares of Amarin fell 67% following the ruling on the Nasdaq and were down more than 68% when markets opened Tuesday. Shares of Dr. Reddy’s and Hikma were up more than 4% on the National Stock Exchange of India and 2.7% on the London Stock Exchange, respectively.
Amarin has said it will appeal the ruling, and as yet no ANDA has received FDA approval. In a statement about the ruling Tuesday, Hikma cited research from IQVIA showing that Vascepa’s U.S. sales for the 12-month period ending in February were $919 million.
“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,” Amarin CEO John Thero said in a statement. “At Amarin, we have a strong balance sheet with capacity and flexibility, and we plan to fight to protect our Vascepa franchise for the benefit of our patients, physicians the broader healthcare community and our investors.”
Still, the outlook for Amarin doesn’t look good, an analyst wrote.
In a note to investors, Oppenheimer analyst Leland Gershell wrote that despite the company’s plans to appeal the ruling, “this decision significantly reduces expectations around the product’s market exclusivity period, and we see a reversal unlikely.” A best-case scenario for Amarin, he added, would be a generic launch in 2022-2023, though generic launches could occur even sooner despite the presumption of an injunction being granted. Moreover, he wrote, although there had been speculation about Amarin becoming an attractive acquisition target, invalidation of its patent for Vascepa means any such interest will “all but vanish.”
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