14 Sep 2020
Posted in Pharma
Amarin’s positive ESC data may boost Vascepa’s EU marketing efforts amid US generic entry threat
Amarin Corporation recently presented final results from the EVAPORATE trial in which Vascepa (icosapent ethyl) reduced patients’ coronary plaque by 17% compared to placebo following 18 months. The newly presented results can be leveraged to reinforce physician education and maximize revenue opportunity in the EU where Amarin is not facing imminent market exclusivity loss, according to GlobalData, a leading data and analytics company.
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). In March 2020, however, the US District Court ruled in favor of generic companies in patent litigation against Vascepa, casting doubt on the drug’s prospects for reaching its initially expected blockbuster potential. In early September an appeals court rejected Amarin’s appeal. In the EU the company has a Marketing Authorization Application (MAA) currently under review for the same indication.
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.
Despite the small sample size, the ESC dataset is of importance from scientific and clinical standpoints and adds to the growing body of evidence pertaining to the drug’s cardiovascular benefits.
Kelly Lambrinos, Managing Analyst at GlobalData comments: “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, provides further insight into the drug’s mechanism of action.”
The data could also further support commercial efforts in regards to physician education. Yet, in light of Vascepa’s possibly limited patent life in the US, the newly presented data are not expected to have an impact on boosting its commercial potential in this market.
Lambrinos continues: “With the launch of generics now seemingly fast approaching and Vascepa’s blockbuster opportunity in the US fading away, Amarin will see little change in the drug’s US market prospects despite the latest set of positive data.”
Meanwhile, in early August, the company announced plans to launch Vascepa without a commercial partner in Europe. With no imminent patent threat in the EU market and market exclusivity expected for up to 11 years, Amarin still has the opportunity to leverage the newly presented data to further reinforced physician education and reach its full market prospects in this region.
Lambrinos adds: “This assertive strategy of retaining the product rights in the region will enable the company to maximize its revenue potential in a market that still retains its blockbuster potential. This can be viewed as a necessary approach considering the current litigation environment revolving around 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.”
Meanwhile, Hikma Pharmaceuticals USA received FDA approval for its icosapent ethyl capsules, the generic equivalent to Vascepa in May.