AMRN stock surged 10% in after-hours trading on December 13, 2019.
Amarin Corporation plc (NASDAQ: AMRN) received approval from the FDA for the use of Vascepa as an secondary therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood). Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease. The early decision comes ahead of the assigned PDUFA date of December 28, 2019.
“We at Amarin are excited and gratified to now have the opportunity to introduce VASCEPA as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies,” said John F. Thero, president and chief executive officer of Amarin. “We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin. We look forward to helping educate physicians and patients on the value of VASCEPA. The expanded indication and related clinical study labeling is broadly worded, informative on the many effects of VASCEPA and will empower physicians with critical information to help them apply their clinical judgment in addressing cardiovascular disease risk for patients in need.”
Amarin reaffirmed its intention to promptly launch VASCEPA in the United States for this important new preventative care indication. As previously disclosed, Amarin doubled the size of its sales force near the beginning of 2019 and is on track to double the size of its sales force again to a total of 800 sales representatives near the beginning of 2020.
“The FDA approval of icosapent ethyl as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and lead investigator of the REDUCE-IT study which served as the basis for the supplemental New Drug Application to the FDA for VASCEPA. “Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly three decades ago. Many patients stand to benefit from this historic advance in care.”
The company raised its FY19 revenue view to $410M-$425M from $380M-$420M, against a consensus of $410.25M, and gave FY20 revenue guidance of $650M-$700M, against a consensus of $654.55M. The company said, “Amarin is providing this projected revenue guidance for 2020 and has based its projection on a number of factors, including, but not limited to, expectations on market acceptance of the newly expanded label for Vascepa and current plans for expanded promotion. Vascepa revenues are anticipated to continue to increase in 2020, accompanied by quarterly industry variability, including recurring seasonal factors, particularly in the first quarter… Beyond 2020, Amarin believes that Vascepa total net revenue will grow to reach multiple billions of dollars.”