Amarin (AMRN) top executives will earn cash bonuses if the company is able to convince FDA or a judge to allow some expansion of the label covering its prescription-grade fish pill Vascepa.
The new Amarin executive bonus plan was disclosed in a regulatory filing Monday night and echoes what the company told investors on the last quarterly conference call: If FDA cannot be convinced to approve Vascepa for the treatment of mixed dyslipidemia patients (the so-called "Anchor" patient population), Amarin intends to push for inclusion of the "Anchor" data in the Vascepa label without an expanded label indication.
If Plan A and B fail, Amarin will sue FDA on first amendment grounds, seeking a judge's ruling which would allow the company to speak with doctors about the "Anchor" trial data.
Amarin President John Thero, R&D chief Steven Ketchum and General Counsel Joe Kennedy are eligible for the one-time cash bonuses of $1500,000 to $250,000 if the company is successful on or before June 30, 2014. Amarin CEO Joe Zakrzewski is not included in the bonus program, according to the company.
The FDA is expected to decide on the Vascepa label expansion by Dec. 20, but Amarin executives have warned investors not to expect good news based on the agency's stated opposition and the negative votes of an advisory panel in October.
The most likely outcome, absent Amarin's successful intervention, will be an FDA decision to reject Vascepa's for mixed dyslipidemia and ask the company to resubmit with additional clinical data demonstrating a positive cardiovascular benefit for patients. Amarin is conducting a large phase III study known as Reduce-It which might provide these data but results are still 3-4 years away.
Amarin shares have lost 77% of their value this year, hurt by disappointing Vascepa sales, the lack of a marketing partner and the setbacks with the FDA over expanded the drug's label to treat a much larger swath of patients.
Ever since the negative FDA advisory panel in October, Amarin executives have issued public comments that walk a fine line between expressing a desire to work cooperatively with the FDA and blasting the agency for changing the rule unfairly.
Amarin's rhetoric against the FDA ratcheted higher after the agency last month revoked the Special Protocol Assessment (SPA) agreement covering Vascepa and the "Anchor" mixed dyslipidemia indication. More than anything, this action signaled the FDA's resolve not to veer from its opposition to an expanded Vascepa label.
Convincing FDA to allow the results from the "Anchor" phase III study to be included in the Vascepa label might be Amarin's best and only shot at partial redemption. The company is likely to argue that a precedent has already been set: FDA granted GlaxoSmithKline's (GSK) request years ago to allow data from a mixed dyslipidemia study to be included in the Lovaza label even though the fish-oil pill is not approved for the treatment of mixed dyslipidemia.
Despite the Lovaza precedent, FDA may still balk at Amarin's demands because of concerns that including Anchor data in the Vascepa label will allow the company to skirt rules prohibiting off-label marketing. The FDA has also clearly become more conservative and skeptical about the efficacy of prescription fish-oil pills in the absence of additional clinical data. This was not an issue for FDA when Glaxo was seeking to include more data in the Lovaza label.
The last step for Amarin will be suing the FDA using the argument that the company has a first amendment right to discuss clinical data with doctors.
<P/> <I>-- Reported by Adam Feuerstein in Boston.</I>
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