The NCE status of AMR101 is controversial because the drug is very similar to Lovaza, another prescription fish-oil pill already approved and sold by GlaxoSmithKline (GSK). The active ingredients in both AMR101 and Lovaza are omega-3 fatty acids EPA and DHA. AMR101 contains more EPA and less DHA than Lovaza, but whether that's enough to consider AMR101 a new chemical entity is up for debate and a matter that FDA will decide.
Which brings us back to the June 22 meeting. According to the FDA's web site, FDA officials in attendance included Chief Counsel Elizabeth Dickinson and her top assistant counsel Mustafu Unlu. Denise Esposito, FDA's deputy director for policy and Keith Webber, deputy director in the FDA's Office of Pharmaceutical Science, were also present, as were several other agency lawyers.
Amarin's representatives at the meeting included the company's top lawyer Joseph Kennedy, Steve Ketchum, president of research and development, Paresh Soni, senior vice president, head of development, and Barbara Kurys, senior director for intellectual property management. Attorneys from Amarin's outside law firms were also involved in the meeting.
Asked to comment on what was discussed at the June 22 meeting, company spokesperson David Schull responded, "Amarin is unable to comment because the company is operating in a quiet period in advance of its PDUFA date for AMR 101." [PDUFA date is FDA jargon for the date on which drug approval decisions are announced.]The timing of the June 22 meeting -- essentially one month ahead of the FDA's approval decision date for AMR101 -- raises hope that the agency has already decided to approve the drug. That's the good news. The bad news, potentially, is that Amarin asked to meet with top FDA officials on June 22 because the agency had told the company that NCE status for AMR101 was in doubt. In other words, this meeting was perhaps an attempt by Amarin to convince FDA to change its mind about the market exclusivity of AMR101. All this is speculation, obviously, until FDA makes its formal decision known on July 26. Speaking at an investor conference last January, Amarin CEO Joe Zakrzewski expressed optimism that FDA would grant AMR101 NCE status because the drug was fundamentally different from Glaxo's Lovaza. "To my knowledge, an outcomes study has never being requested for a drug that didn't get NCE status," said Zakrzewski, in reference to an FDA requirement that Amarin conduct a post-approval cardiovascular outcomes study of AMR101 that is expected to cost $120 million and enroll 8,000 patients. This study is already underway. --Written by Adam Feuerstein in Boston.
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