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.
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