Amarin Announces FDA Award Of Three-Year Exclusivity For Vascepa, Sues For Five Years
By Cyndi Root
Amarin Corporation announced in a press release that the Food and Drug Administration (FDA) awarded marketing exclusivity to Vascepa (icosapent ethyl) capsules. The three year exclusivity stems from 2012 approval of Vascepa. Therefore, Amarin has the rights until July 25, 2015. The company may be able to receive a 30 month extension due to new or ongoing patent infringement litigation with generic competitors. Amarin has other protections including trade secrets.
John Thero, President and Chief Executive Officer of Amarin, said, "Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision.” He added that Vascepa is well positioned with its patent, which may make the FDA’s approval not as important. The drug has 40 patents and all but two do not expire until 2030.
After further review, Amarin decided to ask a federal judge to force the FDA to award five years of exclusivity. The company’s position was that the FDA agreed that Vascepa and a competitor, Lovaza, work to lower triglycerides even though the two drugs have different ingredients. The company says that FDA precedents allow five year exclusivity under these conditions without securing a new chemical entity (NME) designation.
The FDA reviews many new drugs including those that have never been used in clinical practice. Some drugs are the same as or similar to existing drugs and the agency must classify these agents. Some drugs earn status as NMEs. Some are single ingredients, some are used in new combinations, and some are entirely new entities.
Vascepa is a prescription strength medicine for adults. Used in conjunction with a low-fat and low-cholesterol diet, it helps lower triglycerides (fats). It is indicated for patients with severe hypertriglyceridemia (≥ 500 mg/dL). The agent is an ethyl ester of eicosapentaenoic acid (EPA), also known as fish oil. Derived from marine sources, fish oil is emerging as an effective treatment for other conditions. It has anti-inflammatory and insulin-sensitizing effects. It shows promise for cardiovascular diseases, cancer, depression, and arthritis, among others.
Amarin Corporation develops therapeutics for heart health. The company relies on lipid science and polyunsaturated fatty acids. While pofits for Ascepa grew, the company reported losses overall. The company plans to continue expanding label options for its leading drug.