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A Takeout Target Swims Along

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Amarin (Nasdaq: AMRN  ) is a perennial takeout target, but it's proceeding with the development of AMR101 nevertheless.

The company reported first-quarter earnings Tuesday -- without any revenue, they were a yawn fest of GAAP adjustments -- but management also presented an update on the company's development plans.

You'll recall that AMR101 recently passed two clinical trials: the first in patients with extremely high triglyceride levels, and a second in patients with moderate triglyceride levels. The latter group matters more, because it encompasses a lot more potential patients. Amarin estimates that 40 million people in the U.S. have triglyceride levels higher than 200 milligrams per deciliter.

Unfortunately, Amarin won't be able to gain Food and Drug Administration approval to market the drug for those moderate triglyceride levels when it submits its application in the third quarter. While the drug increases good cholesterol and lowers bad cholesterol -- something GlaxoSmithKline's (NYSE: GSK  ) Lovaza and Abbott Labs's (NYSE: ABT  ) Tricor and Trilipix don't do -- the FDA will require an outcomes study that's substantially enrolled before it will approve the drug for the less-sick patients.

The company hasn't even started the study, and it expects that it won't be substantially enrolled until the end of next year. In order to get enough outcomes -- heart attacks and the like -- it'll likely have to be a large trial. Amarin ended the quarter with about $130 million, probably not enough to run a large trial and prepare for a launch at the same time.

Raising money through a secondary offering at this point wouldn't be all that costly, but a partnership or a buyout is likely still the best option for the company.

Investors should note when valuing the company that in addition the 126 million ADSs outstanding, there are also nearly 40 million additional stock options and warrants that could be exercised. Given the large increase in share price over the last few months, it seems likely that many of those are in the money. Any potential acquirer will take into account the likelihood that they'll be exercised in the event of a takeout.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. GlaxoSmithKline is a Motley Fool Global Gains selection. The Fool owns shares of Abbott Laboratories and GlaxoSmithKline. Alpha Newsletter Account, LLC owns shares of Abbott Laboratories. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Read/Post Comments (4) | Recommend This Article (4)

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Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On May 12, 2011, at 9:32 PM, prginww wrote:

    Great insight on the stock action on amrn. It sounds like a good idea to trade this stock on run ups and pullbacks.

  • Report this Comment On May 12, 2011, at 11:55 PM, prginww wrote:

    Do I hear a slight negative tone in the article. Several key facts left out. First, an outcome study is a five year plan, meaning they do not need a bunch of money up front. Two, the NDA for the 40 million patient group can be filed with the study underway, which means they can file BEFORE the study actually begins. Three, current diluted market cap is around 2.5 billion, the possible peak sales are anywhere between 5 and 10 billion.

    You do the math. The stock will be in the 30's by December making it a 10 bagger for me.

    Just my opinion.

  • Report this Comment On May 13, 2011, at 3:55 PM, prginww wrote:

    Awfully misinformed for a Ph.D. Obviously not much background in the FDA process. AMRN will be a double from here in the next 6 months.

  • Report this Comment On May 16, 2011, at 3:05 PM, prginww wrote:

    Listen, this I have said this before and will say it again. This stock is going to be super volatile for a while at least until it gets the FDA approval for the people with the high triglycerides. Then look for another price jump putting it solidly into the 20's. That's when you look for a company to buy them out. There are companies just waiting for the approval before they make their offers. I wouldn't worry about the moderate triglyceride group too much. If the medicine works for the high group why wouldn't it work for the lower group. That might just be a matter of dosage adjusting. It just wouldn't make sense for the FDA to approve it for the high triglyceride group and not eventually get approved for the lower triglyceride groups. So, I think as soon as the FDA approves the drug look for the big Pharma players to ante up. PT between $25 and $50 by the fourth quarter.

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