BEDMINSTER, NJ ( TheStreet) -- The commercial future of Amarin's ( AMRN) prescription fish-oil pill AMR101 may have been decided at a meeting between top company executives and officials from the U.S. Food and Drug Administration on June 22. The subject of the June 22 meeting between Amarin and FDA was "Orange Book Discussion," according to a calendar posted on the FDA's web site. Details of the meeting and its outcome aren't publicly known and Amarin won't comment. But based on the subject and the people who participated, the marketing exclusivity of AMR101 -- how many years Amarin will get to sell the fish-oil pill before generic drug makers can file a challenge to enter the market -- was the likely topic. Amarin shares fell 6% to $14.40 on Tuesday and were down almost 10% intraday as awareness and worries about this June 22 meeting spread around Wall Street. The FDA's decision over whether or not to grant AMR101 so-called New Chemical Entity (NCE) status -- and the five years of market exclusivity that goes with it -- is almost as important to Amarin as getting the drug approved on July 26. If FDA grants NCE status to AMR101, Amarin will have five years of market exclusivity, regardless of the patent situation.
Recent patent grants and allowances are likely to extend protection through 2030. With NCE status for AMR101, generic drug makers are also prohibited from submitting so-called paragraph 4 filings to FDA (challenges to existing drug patents) for four years. Without NCE status, AMR101's market exclusivity shrinks to three years and generic drug makers can file paragraph 4 challenges immediately after approval. These extra two years of market exclusivity and restrictions on paragraph 4 filings are important in determining the long-term profitability of AMR101. Without the maximum market exclusivity, AMR101's commercial value may be diminished -- the drug might be incapable of generating the billion dollars in sales or more that investors have come to expect because cheaper, generic versions could enter the market sooner. Large pharmaceutical companies possibly interested in partnering with or even acquiring Amarin may stay away. FDA is expected to issue an approval decision on AMR101 on or before July 26. The decision on the drug's NCE status should be announced at the same time. If FDA approves AMR101 but doesn't grant the drug NCE status, Amarin's stock price could fall on fears that generic drug makers will immediately file paragraph 4 challenges in an effort to invalidate AMR101's patents.
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. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com. Follow TheStreet on Twitter and become a fan on Facebook.