Amarin's shares are trading up since we last checked in, but there are several upcoming catalysts that could dramatically affect this stock. Let's run through the latest news:
That old NCE issue...
Amarin shareholders were left out in the cold again this month. The Food and Drug Administration's Orange Book update on Nov. 16 was widely expected to put a definitive end to the suspense surrounding Vascepa's NCE status. However, it looks like the government agency still hasn't made up its mind, and we'll have to wait until mid-December (at least) to find out what happens.
In the meantime, Amarin looks determined to reinforce the patents for its flagship drug. Currently, the company has 10 patents for Vascepa and is pursuing several more. While this is important for long-term protection against generic pharma companies, the drug's NCE designation remains the biggest catalyst for this stock today. The next Orange Book update should happen around Dec. 14, so mark your calendars!
A new suitor?
Investors have been aware of AstraZeneca's interest in Amarin since the end of October, but a new player has thrown its hat into the ring. There has been speculation that Teva Pharmaceutical, one of the biggest drugmakers in the world, is interested in making a bid. Teva, which has both generic and branded drug divisions, recently tried to muscle into the hypertriglyceridemia market by challenging the patents for GlaxoSmithKline and ProNova Biopharma's Lovaza. The drug's patents held up in court, however, so an Amarin buyout could be Teva's best bet if this market remains central to its strategy.
In any case, investors shouldn't expect a buyout or partnership agreement to happen until the NCE issue is settled.
Delay of a different kind
In the Q3 conference call, Amarin's management stated that it would be launching Vascepa in the first quarter of 2013, but would hold off on whether it would actually hire a sales team until the end of November. In a recent announcement, the company informed investors that it has put the brakes on this issue until mid-December, and that was probably done to realign its commercialization strategy with a potential NCE decision. At this point, it looks like a positive NCE decision will result in a buyout. If the FDA doesn't decide in Amarin's favor, however, it's difficult to predict what Amarin will do. Of course, if the company is faced with another month of NCE indecision, I'm guessing it will have no choice but to march into the lipid-lowering market and get Vascepa to patients on its own in early in 2013.
Max Macaluso owns no shares of the companies mentioned. The Motley Fool owns shares of Abbott Laboratories.