Shares of Amarin Corporation are down more than 3% in premarket trading after the company reported Thursday that a panel of three judges from the U.S. Court of Appeals upheld a lower court’s ruling that paved the way for generic competition for the company’s heart disease drug, Vascepa.
Amarin reported the court upheld a March ruling from the U.S. District Court for the District of Nevada against patents blocking the way for generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to file Abbreviated New Drug Applications (ANDA) for Vascepa generics.
Hikma received regulatory approval from the U.S. Food and Drug Administration for its Vascepa generic in May 2020 and said Thursday it is working towards the launch of the product in the United States.
Vascepa, a fish oil derivative, was first approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Then, in December, Vascepa became the first medication greenlit by the FDA as an adjunct to maximally tolerated statin therapy to reduce cardiovascular risk, including myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients. Vascepa (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid.
Although the Court of Appeals upheld the lower court ruling, Amarin said it is reviewing its legal options. Within 30 days, the company expects to file a petition for an en banc review of the decision. An en banc review will allow for the full 12-judge Court of Appeals to hear the case, which could result in a different legal outcome.
John Thero, president and chief executive officer of Amarin, said he was extremely disappointed in the legal ruling and will pursue all available remedies.
“Importantly, we and our partners are continuing to pursue additional regulatory approvals for Vascepa in China, Europe and the additional countries in the Middle East, and remain confident in the global market potential of Vascepa. We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021. At the same time, we will continue to meet the strong demand for Vascepa here in the United States through our proven manufacturing capabilities,” Thero said in a statement.
There is no generic litigation pending in areas outside the United States where Vascepa is currently sold, including Canada, Lebanon and the United Arab Emirates.
At the same time, Amarin looks to foreign markets for Vascepa, the company said it will continue with its current marketing programs in the United States due to the limited supply capacity of the new generic competitors. After assessing the scope, timing and pricing of potential generic competition, Amarin will decide whether to further expand, contract or maintain such levels of Vascepa promotion.