Amarin ($AMRN) and its omega-3 pill have struck out with the FDA again. The Irish company said today that the agency has again turned down its appeal to reconsider its clinical data it hoped would help it win a label extension for Vascepa, dealing a new blow to its efforts and its financial well being. This FDA first rejected Amarin's request in January.
"Amarin had previously expressed that while it believes strongly in its legal, scientific and regulatory appeal arguments that it would be an uphill battle to achieve an SPA agreement reinstatement," the company said today. It pointed out that the FDA has yet to rule on its supplemental new drug application.
The drug is approved to treat adults patients with severe triglyceride levels but the company has been fighting the FDA since it flip-flopped last October on a special protocol assessment (SPA). The FDA initially agreed that a significant drop in triglyceride levels in the drug's pivotal study would be enough to indicate an improvement in cardiac outcomes for a much larger group of patients. It changed course upon receiving new data, one in a series of obstacles Amarin has hit.
The company slashed its workforce by 50% in October after an FDA panel of experts voted 9-2 not to recommend the FDA expand the use of the omega-3 product and FDA staff suggested a heart-risk study be completed before an FDA decision. In February Amarin sued the FDA for not giving the drug a 5-year exclusivity.
Despite all of that, the company continues to soldier on with the pill, its only approved product. In April it struck a deal with Kowa Pharmaceuticals' U.S. unit to help market Vascepa. That tripled the boots on the ground in its behalf, and since Kowa's 250 reps sell statin drugs, they work with many of the same physicians that might take a look at Vascepa.
But whether that will be enough to keep Amarin moving forward is yet to be seen. Its stock price has fallen as its issues with the FDA have piled up and was off more than 23% today in mid-morning trading, to under $1.40 a share.
- here's the release
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