Boston, MA 03/18/2014 (wallstreetpr) – The U.S. Food and Drug Administration (FDA) had granted three-year exclusivity for Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s Vascepa and the exclusivity extends through July 25, 2015. The product is intended to treat cardiac patients with high triglycerides level.
Vascepa
Vascepa is one of Omega 3 fatty acids launched in January 2013. The product reduces the high triglycerides level in adult patients without raising bad cholesterol (LDL-C). It showed positive results when used alone as well as joint therapy in patients with Statin therapy. The product is approved by the FDA for multiple indications.
Therapeutics Market
Cardiovascular market is highly competitive with increasing patients’ needs. Large number of products are available in the market to fight against triglycerides; however, the market is largely driven by Statin therapy. Traditionally, Statin molecules lowers the triglycerides level in cardiac patients; however, it has severe side effects such as raising the bad cholesterol in the blood stream. This compelled companies’ to focus on alternatives like Omega 3 fatty acids.
Competition
In Omega 3 fatty acids market, generic products affect Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s market. Therefore, Amarin is seeking for the approval of five-year marketing exclusivity for Vascepa to fight against generic competition. As the cardiac disorder continue to grow globally with increasing lipid abnormalities including high levels of triglycerides and cholesterol in the blood stream. Vascepa is well accepted in the market as there are no side effects.
Prospects
In last 12 months, Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s Vascepa has received 40 issued and allowed U.S. patents to protect the exclusivity of Vascepa till 2030. With increasing advantage over other drugs, the FDA has granted three-year exclusivity for Vascepa. By performance, Vascepa is also reported increase in prescription and reported sales of $26.4 million in FY2013. Company anticipates opportunities in the cardiovascular therapies market and market exclusivity will support Vacepa’s growth going forward.
