On August 29, at this year’s European Society of Cardiology (ESC) conference, Amarin Corporation presented final results from the 80-patient, investigator-sponsored EVAPORATE trial in which Vascepa (icosapent ethyl) demonstrated a significant effect on the progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy. Specifically, Vascepa reduced patients’ coronary plaque by 17% compared to placebo following 18 months. Despite the small sample size, the dataset is of importance from a scientific and clinical standpoint as the coronary plaque regression shown in the trial could partially account for the significant cardiovascular benefit seen in the Phase III REDUCE-IT trial and, in turn, provide further insight into the drug’s mechanism of action. Yet, in light of Vascepa’s limited patent life in the US, the newly presented data can be expected to have a small impact on boosting its commercial potential. However, with no imminent patent threat in the EU market and market exclusivity expected for up to 11 years, GlobalData believes that Amarin has the opportunity to leverage the newly presented results to reinforce physician education and reach its blockbuster opportunity in this region.
By 2025, the total prevalent cases of patients with high triglyceride levels are estimated to reach 83,572,865 and 42,216,230 in the US and 5EU, respectively, according to a GlobalData forecast.
In December 2019, Amarin scored a highly anticipated FDA label expansion to include cardiovascular risk reduction in patients with elevated triglyceride levels (≥150 mg/dL) based on the REDUCE-IT trial. In March 2020, however, the US District Court ruled in favour of generic companies in patent litigation against Vascepa, casting doubt on the drug’s prospects for reaching its initially expected blockbuster potential. While the recently presented data add to the growing body of evidence pertaining to the drug’s cardiovascular benefits and could support commercial efforts in regards to physician education, the company faces an uphill task to retain its blockbuster potential as patent litigation continues with Hikma and Dr. Reddy’s regarding the possible launch of generics in the near future. As such, even with additional new positive data in hand that could further support physician education, Amarin will see little change in the dampened market prospects of Vascepa in the US.
The oral hearing for Amarin’s appeal is scheduled for 2 September and the Federal Circuit Court decision is expected in late 2020 / early 2021. Meanwhile, Hikma Pharmaceuticals USA received FDA approval for its icosapent ethyl capsules, the generic equivalent to Vascepa in May.
In early August, the company announced plans to launch Vascepa without a commercial partner in Europe where its Marketing Authorization Application (MAA) is currently under review for the reduction of cardiovascular risk in high-risk patients based on the REDUCE-IT study. This assertive strategy of retaining the product rights in the region will enable the company to maximise its revenue potential in a market that still retains blockbuster potential. This can be viewed as a necessary approach considering the current litigation environment threating Vascepa’s key patents. Importantly, following this strategy, Amarin has the opportunity to leverage its messaging and marketing experience gained from its ongoing aggressive product promotion in the US.