Only months ago, hopes for Amarin, the maker of fish-oil derivative Vascepa, were sky-high after the FDA expanded the drug’s label to include heart-helping language with blockbuster potential. But those hopes have come crashing down after a judge invalidated Vascepa’s underlying patents.
Amarin’s share price tumbled more than 70% in after-market trading Monday to a low of $4 after a Nevada district judge ruled the key patents protecting Vascepa from generic challengers were legally invalid.
In a statement Monday evening, Amarin said it intended to appeal the ruling and did not anticipate a pending launch of a U.S. generic in the immediate future.
“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…prevent launch of generic versions of Vascepa in the United States,” CEO John Thero said.
The New Jersey drugmaker said its marketing efforts for Vascepa, which included the recent doubling of its field sales team to 800, will continue pending FDA approvals and successful generics launch. Amarin clarified that ruling only applied to Vascepa’s U.S. patent exclusivity and not its patents abroad.
“After we determine the outcome of our effort to prevent a generic launch… we expect to provide an update on how we would adjust certain promotional activities for Vascepa in the United States.”
If the ruling withstands a likely appeal, generic challengers from Dr. Reddy’s Laboratories and Hikma, among others, would be free to market challengers to Vascepa immediately. Amarin’s stock traded at $13.58 at market close Monday––down 37% from Jan. 1.
This story will be updated.