In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
On Sept. 2, the appeal became reality as a 22-minute oral hearing was held before a three-judge U.S. Court of Appeals panel. A decision from that panel is expected sometime within the next seven months.
Dublin-based Amarin said the March ruling increases the possibility of generics crowding its U.S. sales. At the center of the case were Dr. Reddy’s Laboratories Inc., of Hyderabad, India, and Hikma Pharmaceuticals plc. There is a lot of money at stake, as Hikma has quoted Iqvia Holdings Inc. numbers showing Vasecpa sales were about $919 million in the 12 months ending February 2020.
Amarin stock (NASDAQ:AMRN) has taken a battering since the district court made its decision. After the Sept. 2 hearing, shares closed 30.58% lower, at $5.04 each, which is about 60% below their value on March 30, the day before the ruling.
John Thero, Amarin’s president, CEO and director, has framed the court’s March decision by saying it was “flawed” by ruling that discoveries underlaying Vascepa’s patents protecting the initial FDA-approved indication for Vascepa were “obvious.” In effect, he told investors during the company’s Aug. 4 earnings call, the court ruled the patents upon which Amarin has relied “should not have been granted by the U.S. Patent Office. This decision was unexpected by everyone, including, we understand, the generic companies involved in the litigation.”
Thero added that if Amarin loses the appeal and generic Vascepa becomes available, the company will assess the degree it should continue to promote Vascepa in the U.S. If generics launch in the U.S., Thero said he expects it would be with a limited supply.
“While we could, of course, counter their generic launch with our own authorized generic and leverage the manufacturing cost efficiencies which we have developed over multiple years, we believe that it is more likely that a significant portion of the market will remain branded for a considerable period of time,” he said.
He also said that a settlement with the generic companies is unlikely before the federal circuit court decision on the appeal.
“If the district court's decision is not vacated, our settling with the two generic companies that are litigants in this matter won't stop other generic companies from seeking to fill the void. And it would then be more difficult to stop them,” he said.
SVB Leerink analyst Ami Fadia wrote on Sept. 2 that she does not believe the three-judge panel’s composition improves Amarin’s chances of winning the patent litigation appeal.
“Of the three, we believe Jimmie Reyna is most likely to vote in favor of Amarin, given that he voted against prima facie in the 2012 Cyclobenzaprine case and has a split track record of voting against this procedure,” Fadia wrote. “For the remaining two judges, Timothy Dyk and Todd Hughes, our analysis of select past prima facie cases did not turn up instances where they voted against this procedure, and we would not consider either judge to be in the upper half of the 12 possible active judges most likely to side with Amarin.”
On Aug. 4, Amarin reported total second-quarter revenue of $135.3 million, up 34% over the same period in 2019. Total revenue for the first half of 2020 was $290.3 million, up 67% over the first half of 2019. The increase in product revenue was driven primarily by increased sales of Vascepa, including a “modest increase” in Vascepa’s net selling price in the U.S. The company, however, did report that Vascepa revenue and prescription growth were adversely affected in the second quarter by actions taken to slow the spread of COVID-19 infections. Amarin also disclosed that it plans to undertake its own focused commercial launch of Vascepa in Europe, pending approval of its MAA, currently in the late stages of review for reducing cardiovascular risk in high-risk patients based on the Reduce-IT cardiovascular outcomes study.
On June 23, Amarin said it reached an agreement with Apotex Inc., of Toronto, to resolve patent litigation that would have resulted from the abbreviated new drug application filed by Apotex with the FDA seeking approval of a generic form of Vascepa based on Amarin’s Marine study. Apotex was not a party to the Dr. Reddy’s-Hikma litigation. As part of the settlement agreement, Apotex agreed that it may not sell a generic version of Vascepa in the U.S. until Aug. 9, 2029.