Amarin Corporation AMRN announced that the U.S. Court of Appeals for the Federal Circuit has upheld the ruling by the U.S. District Court for the District of Nevada related to a patent litigation against its marketed drug, Vascepa. In March, the district court had ruled in favor of the generic companies trying to bring a generic version of Vascepa in the market. The court stated that all patent claims made by Amarin in the litigations were “obvious” and thus invalid. The appeals court upheld the unfavorable ruling.
Shares of Amarin fell 9.5% following the announcement on Sep 3. The company’s stock declined almost 31% on Sep 2 as investors had anticipated an unfavorable ruling based on court’s proceedings. In fact, the company’s shares have declined 78.7% so far this year against the industry’s increase of 2.1%.
Vascepa is the sole marketed drug of the company, generating majority of its revenues. A earlier-than-expected generic launch will adversely impact the sales of the drug, reducing the company’s revenues and profits. The company’s patents are expected to cover the drug till 2030. Moreover, in May, the FDA approved a generic version of the drug developed by Hikma Pharmaceuticals. Dr. Reddy’s Laboratories’ RDY abbreviated new drug application, seeking approval for the generic version of 0.5mg and 1mg dosage of Vascepa as a treatment of hypertriglyceridemia was also approved by the FDA last month.
We note that Amarin settled a similar patent litigation with Teva Pharmaceuticals TEVA in 2018. Amarin has granted Teva rights to launch a generic version of Vascepa for treating only hypertriglyceridemia on or after Aug 9, 2029. Amarin has also signed a settlement agreement with Apotex granting rights to launch a generic version on or after Aug 9, 2029.
Amarin stated that it is currently reviewing its legal options and plans to file a petition per which the current panel decision will be reviewed by the full panel of 12 active judges at the U.S. Court of Appeals for the Federal Circuit. Moreover, the company stated that geographies outside the United States are not subject to the judgement of the U.S. Court of Appeals. The company will continue to pursue additional regulatory approvals for Vascepa in Europe, China and other countries in the Middle East.
Please note that Vascepa was initially approved by the FDA in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
In December 2019, the FDA approved a label expansion for Vascepa as a treatment to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol). The approval was based on the results of the REDUCE-IT cardiovascular outcomes study. The patent litigations do not include any patent related to Vascepa’s expanded label.
Amarin Corporation PLC Price
Zacks Rank & Stock to Consider
Currently, Amarin is a Zacks Rank #3 (Hold) stock.
Horizon Therapeutics HZNP is a better-ranked biotech stock, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon Therapeutics’ earnings per share estimates have increased from $2.00 to $2.86 for 2020, and from $3.05 to $4.29 for 2021 in the past 30 days. The company beat estimates in each of the trailing four quarters, the average being 38.63%. The stock has surged 99.4% so far this year.
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