Shares in Amarin dropped as much as 70% on Monday after a Nevada district court judge ruled that six patents on Vascepa (icosapent ethyl), which all expire in 2030, are invalid. The FDA expanded approval of the fish-oil-derived drug in December to include lowering the risk of cardiovascular (CV) events in adults with triglyceride levels of 150 mg/dL or more, who also have either established CV disease or diabetes, as well as at least two additional risk factors for CV disease.
Dr. Reddy's Laboratories and Hikma Pharmaceuticals are seeking to market generic versions of Vascepa, which was initially approved in the US in 2012 for patients with severe hypertriglyceridaemia, with Amarin arguing that this would infringe its patents on the drug. However, according to the ruling from District Court Judge Miranda Du, "all [Amarin's] asserted claims are invalid as obvious."
Commenting on the news, Amarin noted that based on its review of the FDA's website, a generic version of Vascepa has not yet been approved and it does not believe there is an impending launch by the litigants. CEO John Thero remarked "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."
Meanwhile, Hikma said it is working with the FDA to gain approval for its generic version of Vascepa and is evaluating launch options, including an at-risk launch in the event Amarin appeals the district court's decision.
Amarin reported revenues totalling $429.8 million last year, up 87% over 2018, growth the company attributed mainly to higher Vascepa revenues in the US. In late February, when the company released financial results for 2019, it projected sales this year to reach $650 million to $700 million, mostly stemming from US Vascepa sales. Amarin also said the expansion of its US sales force to about 800 representatives, double that from last year, would likely be completed in early 2020.
For additional analysis, see Pharma Leaders: Amarin CEO John Thero, and ViewPoints: Amarin clinches preliminary FDA victory.
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