Amarin takes legal action against FDA over patent protection for Vascepa

Amarin has today asked a federal court to order the US Food and Drug Administration to give the company's Vascepa fish oil pill five years of market exclusivity, according to a lawsuit filed in Washington

The report came as the troubled Irish biopharma group reported that net sales revenue grew to $10.1 million in the final quarter from its one drug, Vascepa, bringing the full year figure to $26.4 million.

However, it reported losses of $15.4 million for the final three months of 2013, and $166.2 million for the full year. This equates to nine US cents and $1.03 per share respectively.

"2013 was a year of significant achievement for Amarin as a commercial organization was established and Vascepa helped to improve patient care options in the treatment of severe hypertriglyceridemia," said John Thero, chief executive of Amarin. "As we embark on our second year as a commercial organization we stand by our commitment to work toward label expansion for Vascepa to improve treatment options for patients with mixed dyslipidemia."

Amarin is battling the US regulator, the Food and Drug Administration to expand the marketing options for its prescription grade omega3 fish oil Vascepa.

Vascepa is used to lower blood fats, or triglycerides, in people at risk of cardiovascular disease but the company has struggled to secure full patent protection for the drug, or permission to broaden its use.

The company recently secured three-year marketing exclusivity for Vascepa after a long waiting period. This remains significantly shorter than the five-year period sought by the company for Vascepa and confirms its failure to secure “new chemical entity” status for the drug.

Amarin is likely to gain a further 30-month window of exclusivity under US rules by challenging generic rivals when they seek approval to enter its market.

The company said yesterday that it planned further discussions with the FDA and, on the basis of those, it would assess its options both in regard to the prospects for securing approval to use Vascepa as a treatment for people with lower, but still very elevated levels of triglycerides, and also on the extent to which Amarin should continue its other clinical trials, including the ongoing Reduce-IT outcomes trial.

The company said enrolment on the key Reduce-IT outcomes trial was continuing, with more than 6,500 patients now enrolled at over 400 centres in 11 countries. The company confirmed that the trial is not expected to finish until 2017 and reiterated that, at a cost of more than $100 million, Amarin may not be in a position to fund it to completion on current marketing approvals.

The company’s liabilities as of December 31st last total about $279.4 million, it said tonight. – Bloomberg