Amarin Plans to Increase VASCEPA® (icosapent ethyl) Promotion and Education
GlobeNewswire•June 1, 2020
Significant Opportunity Seen as Patient Visits Resume to Emphasize VASCEPA as the First and Only Drug Approved for Its Current Cardiovascular Risk Reduction Indication
DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), today announced that it intends to increase the level and breadth of its promotion and education initiatives regarding VASCEPA® (icosapent ethyl). As early signs emerge of patients returning to physicians’ offices, Amarin plans to emphasize its key marketing messages including positioning VASCEPA as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients.
While VASCEPA has been developed and clinically tested for over a decade, it was less than six months ago (December 2019) that the FDA approved VASCEPA for its unique cardiovascular risk reduction indication. Most healthcare professionals and at-risk patients are unaware that VASCEPA is the first and only drug with this important new indication. For this reason, and the emerging return of patients, Amarin believes the opportunity exists for increasing awareness of VASCEPA and its potential to provide an important healthcare solution to reduce cardiovascular risk in high-risk patients.
In the United States alone, someone suffers a heart attack, stroke, or other major adverse event from cardiovascular disease on average every 13 seconds. Cardiovascular disease impacts adults of all ages and is the number one cause of death in the United States. Urgent attention and a proven treatment, such as VASCEPA, is needed for the vast and growing need to reduce the risk of major adverse cardiovascular events in high-risk cardiovascular patients.
Amarin’s president and chief executive officer, John Thero, commented, “Particularly in these difficult times, Amarin believes that patients would benefit from receiving preventative healthcare solutions with demonstrated outcomes-based results. VASCEPA is one of those solutions. It is proven to reduce risk, it has been found to be affordable and cost-effective and it is covered by most insurance policies. However, while millions of people are included within the new VASCEPA indication, most are unaware of VASCEPA.” He added, “As American society begins to open up again, Amarin currently plans to restore approximately $80 million in educational and promotional spending in 2020 to increase awareness of VASCEPA as an important new treatment recently approved to lower the risk of heart attacks, strokes, and other major adverse cardiovascular events in high risk patients beyond standard of care statin therapy.”
Planned promotion and educational efforts include the sponsorship of continuing medical education, social media-based communications, and advertisements on television and other forms of media. Amarin also plans increased sponsorship of investigator-initiated research, such as the recently announced clinical investigation of VASCEPA in the treatment of COVID-19. These initiatives should become increasingly visible in July 2020 and beyond. At the start of 2020, Amarin had intended to commence such expanded promotion in mid-2020 but cancelled such plans following the onset of COVID-19 and the prospects for a potential launch of generic versions of VASCEPA. Amarin’s current plans restore most of that intended promotion.
In addition, as the United States reopens from the COVID-19 epidemic, Amarin intends to resume field-based face-to-face interactions with healthcare providers by its sales force, commencing on a pilot scale basis before the end of June 2020, based on current expectations. Assuming that these interactions prove to be helpful and other parts of the country reopen, the company plans to expand such interactions on a phased basis across select geographies. Prescription growth on a year-over-year basis in Q2’20 has, as expected due to COVID-19, been considerably slower than in Q1’20. However, Amarin believes that there are early signs that patient care for chronic conditions, such as treating the risks of cardiovascular disease, is increasing with more patients returning to their healthcare providers for routine medical visits.
Amarin plans to adjust its level of promotion and educational activities upward or downward based on various factors, including whether any generic company takes the risk of launching a generic version of VASCEPA during the patent litigation appeal process and the amount of any product launched. Amarin does not believe generic companies have made the investment of resources, know-how and time to develop sufficient quantities of quality supply to meet current and growing demand. Accordingly, Amarin believes that if any generic determines to launch its product after an FDA approval that any such launch would be limited in scope.
If Amarin wins on its patent litigation appeal the benefits of Amarin’s planned increased promotion and education efforts should accrue to both improved patient care and to increased sales of VASCEPA by Amarin. If Amarin loses on the patent litigation appeal, increased VASCEPA usage as a result of increased promotion and education efforts should still benefit patient care. The larger market would potentially be split among branded VASCEPA, a potential authorized generic version of VASCEPA, if then launched by Amarin (which Amarin could launch rapidly if warranted), and generic versions of VASCEPA from third-parties. As noted, Amarin believes any launch of generic versions of VASCEPA by such third parties would be subject to supply limitations. Amarin reiterated that it believes that it has strong arguments in its patent litigation appeal but that it cannot predict the outcome.
Amarin is progressing its plans for international expansion. Those plans are not directly impacted by increased promotion in the United States but could benefit from the company’s anticipated expanded educational initiative