Amarin Corporation plc (ADR) (NASDAQ:AMRN) will give a presentation on their new findings about Vascepa and eicosapentaenoic acid (EPA) at the National Lipid Association 2016 Scientific Sessions. The conference will be held in New Orleans on May 19 to 22, 2016.
A presentation from two posters on Vascepa will be given as well as an oral presentation about EPA. Their data about the MARINE trial from a subgroup of women with very high triglyceride levels will also be presented. In the MARINE trial, Vascepa was used on adult patients, including those who are undergoing statin therapy, with severe hypertriglyceridemia (≥500 mg/dL).
Vascepa, a drug whose main component is fish oil, was introduced by Amarin to be used to lower fat levels. It has been under the microscope lately after Amarin was allowed by the FDA to promote the drug for off-label uses not approved by the agency up to 2020. Amarin’s contention was based on free speech. Based on the terms of their settlement with the agency, Amarin has to make sure that they are responsible enough to disclose only information that is truthful and not misleading. The company has also been allowed to use the results of their clinical trials in their marketing efforts
Though drugmakers are not allowed to market drugs for uses they were not approved for, companies Amarin claims that discussing off-label uses with doctors is an issue of free speech. The settlement for this case will greatly impact pharmaceutical companies’ off-label efforts.
Amarin’s reported net product revenue from Vascepa for the first quarter of 2016 as $25.3 million. This is around $10 million higher or an increase of 63% from $15.6 million recorded in the year-ago period.
Lower cost of inventory purchases due to expanded supplier network and higher purchasing volumes have made an impact on gross margin on product sales. It increased to 73% for the first quarter of this year from 64% of the same period last year. Number of prescriptions for the drug has also increased. Data from Symphony Health Solutions and IMS Health show that prescriptions have increased by around 55% – 56% compared to the first quarter of last year. Amarin has also moved towards completing their application for approval from China’s Food and Drug Administration.