No News Equals Bad News for Amarin Investors

Well, it looks like Amarin (Nasdaq: AMRN  )  investors will have to wait a little bit longer -- again -- to discover whether the FDA grants the company's hypertriglyceridemia drug Vascepa New Chemical Entity (NCE) status. The FDA updated its database of approved drugs today, and many believed that Vascepa would either be given or denied the NCE designation. This issue has kept Amarin in neutral during the past few months, and negotiations with possible partners or acquirers, such as AstraZeneca (NYSE: AZN  ) and Teva (NYSE: TEVA  ) , have stalled.

In this video, health-care analysts David Williamson and Max Macaluso discuss this ongoing delay, and how it impacts Amarin's plans going forward.

 

The biotech space can make or break investors overnight and, while Amarin might not disappear into thin, the success of its new triglyceride-lowering drug is key to the company's future success or failure. The company has huge potential, but don't invest a dollar before reading everything you need to know about Amarin. You can start now with top Fool.com analyst Max Macaluso's premium research report. Click here now to keep reading.


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  • Report this Comment On November 18, 2012, at 8:23 PM, CappinQ wrote:

    Ok, on November 16th the Electronic Orange Book appeared to have changed from "Updated through September" to "Updated through October" which is why everyone thought there was NO news this month.

    BUT WAIT.........

    On November 18, the Orange Book appeared to have changed BACK to read, "Updated through September."

    (Check link to FDA Orange Book below)

    http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail....

    It appears that the November Update has not yet occurred. NCE announcement of a decision for Vascepa might still be coming in November!

    The "Orange Book Data Update Date" that you based your "No News" headline on has gone back to pre-Friday status. Perhaps the finalized update is yet to come?

    Remember their is a reference to the Friday of the second full work week of a Month in the Orange Book Update faq.

    The Friday of the second full work week in November didn't land on the 16th. With the recognition of Veterans' Day on Nov. 12th and Thanksgiving on Nov. 22, technically the Friday of the second full work week in November lands on the 30th. Check your official FDA Holiday Calendar. Now I don't think they will wait for the 30th, but it does seem to open up the possibility of the update being finalized this coming week or the week after.

    I am guessing NCE status will be granted.

    I can't wait to see what happens next.

  • Report this Comment On November 18, 2012, at 9:25 PM, yazzbro wrote:

    An FDA spokesperson sayed that the FDA was not ready to make a decision at this time. So to think that a decision on Vascepa will appear next week is really wishful thinking. Most likely decision on NCE will be next month.

  • Report this Comment On November 18, 2012, at 9:41 PM, CappinQ wrote:

    yazzbro,

    For some reason, I don't recall that announcement. I've been reading everything, everywhere and never saw such a declaration. Do you have a link? Please post it.

    Until the Orange Book reads "Updated through October" I will hold out hope that the October update is still yet to be released. Since November has no update yet, my guess is that it is still coming either this coming week, or the week after that.

    TODAY THE ORANGE BOOK SHOWS: Orange Book Data Updated Through September, 2012

    It will read, "Data Updated Through OCTOBER, 2012 when the November update occurs.

    The monthly EOB update goal is by the end of the following month’s second work week (e.g., November’s EOB will be updated by the end of the second full work week in December).

    Exclusivity information updated monthly and current to the date of the monthly EOB update date.

    Get ready!

  • Report this Comment On November 19, 2012, at 8:53 AM, NoPanicBill wrote:

    Everyone is writing about NCE as the reason AMRN has not been sold. That is rediculus. Joe Z is as smart as they come. He has everything to gain by not selling AMRN until mid to late next year. In his earnings report he stated that the NDA (new drug application) for the Anchor study >200<500 would be presented to the FDA before the end of February. This places approval before the end of the year. That will enhance the value of the company to over $8 billion from just under $2 billion from the Marine study >500 only. The NCE is not important for the sale because of the extension of time from each new drug application that is approved by the FDA. The Anchor study will extend eclusitivity from 3 to 4 years. Then there is the Reduce-it study for Statins. This study was requested from AMRN by the FDA at a cost of $125 million to completion. This will not be accomplished until well into 2015. Approval would not happen until some time in 2016. Add 3 years to that and you now have sole exclusive rights for 7 full years. So the real catalyst is not NCE. It is the first positive report on Reduce-it that will ignight big pharm. into action. Look for that to happen mid to late next year. This will propel AMRN to extraordinary and proper price ranges that Joe Z will sell the company. There are 2 ways to play it. Buy the stock unmargined and ride the ups and downs for the duration or buy call options starting at a June 15 strike price and if there is not a deal by then, roll it over into a January 2014 $15 call. The key is patience and good results from Reduce-it not NCE on Marine, but I would like to add that the longer the FDA takes the better it is for AMRN as a positive sign that it will be granted NCE and that approval would help stabilize the price. Just remember that the key is Reduce-it for the optimum selling price.

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