Amarin has been hit with a judgement ruling that invalidates key patents protecting its fish-oil med Vascepa from generic competition.
A Nevada district court judge ruled on Monday that six patents on Vascepa (icosapent ethyl) – which were set to expire in 2030 – are invalid. Shares in the company fell by over 70% in response to the news.
The ruling is a huge blow to Amarin, especially since it gained approval for a blockbuster extension for Vascepa to reduce the risk of cardiovascular events in high-risk patients only a few months ago.
It became the first US Food and Drug Administration (FDA)-approved drug to reduce cardiovascular risk in patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.
This expanded indication opened Vascepa up to millions of US patients and set it on course for blockbuster sales – a possibility which is now cast with severe doubt.
Amarin has said that it plans to appeal the decision, and also added that it did not anticipate a launch of a US generic in the near-future based on a review of the FDA’s website.
“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,” said John Thero, CEO of Amarin.
Dr Reddy’s Laboratories and Hikma Pharmaceuticals are already queueing up to launch generic versions of Vascepa, with Hikma reporting that it is working with the FDA to gain approval for its generic Vascepa product and is evaluating launch options.
Last year, Amarin reported total revenues of $429.8m – an increase of 87% on 2018 – which the company attributed mostly to Vascepa’s growth in the US.
The company projected sales to reach $500m to $700m this year, also thanks in large part to an expected growth in Vascepa sales as it is launched in its new expanded cardiovascular indication.
The patent ruling only applies to Vascepa’s US patent exclusivity, with Amarin clarifying that its patents elsewhere in the world still stand.
“As we work to take all legal actions necessary to defend and protect our intellectual property, we will continue to press forward with our educational and promotional efforts for Vascepa in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke,” said Thero
“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 US,” he added.