|Courtesy of Amarin|
Amarin's ($AMRN) lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AstraZeneca, who is awaiting FDA approval for its own product for treating super-high cholesterol.
According to The Wall Street Journal, Amarin has sued Omthera Pharmaceuticals, which AstraZeneca ($AZN) bought last May, alleging Omthera's cholesterol-lowering drug candidate Epanova has trampled on one of Amarin's patents. The newspaper was unable to get a comment from either company.
Before the FDA approved Vascepa in July 2012, there was talk that the highly refined fish-oil drug might reach blockbuster status if Amarin could find the right partner to help market it--and if it could grab approvals for the right indications. But the drugmaker's efforts have been thwarted time and again. The FDA approved it for a very limited use, then rescinded an assessment that might have led to a broader treatment indication. Last month, it granted it only three years of exclusivity because its active ingredient didn't seem unique.
Amarin, which never attracted a partner, struck out on its own, hiring a bunch of sales folk to push its prescription omega-3 product. But in October the drugmaker cut its staff in half after FDA experts recommended against a broader use of the product. The drug generated only $26 million in its first full year in the market, although $10 million of that came in the fourth quarter after sales reps were let go. That compares to GlaxoSmithKlines's ($GSK) Lovaza, which last year had sales of £584 million ($975.8 million), although GSK reported that sales of Lovaza were off 5% as the market for non-statin treatments has shrunk.
The FDA is expected to rule by May 5 on Omethea's new drug application for use of Epanova for treating severe hypertriglyceridaemia, triglyceride levels of 500mg/dL or above, the same indication for which Vascepa and Lovaza are approved. The market has not been very excited about that drug's potential either and AstraZeneca grabbed the Princeton, NJ-based Omthera in May for $323 million. The biotech had gone to the market in March with an IPO, just months ahead of filing its NDA for Epanova. After setting a range of $12 to $14 a share for the company, the IPO went out at $8 and shares subsequently declined. But AstraZeneca, which has been looking to fill a weak pipeline, sees potential in the product and is planning an ambitious sales drive.
- here's the WSJ story (sub. req.)