1 Amarin Catalyst to Watch

Amarin's drug Vascepa, a treatment for high triglyceride levels, was approved by the Food and Drug Administration this summer. While the company was able to successfully jump over this regulatory hurdle, it is currently trying to obtain New Chemical Entity, or NCE, status for its flagship drug. An NCE designation would give Vascepa five years of market exclusivity, while failure to obtain this status would result in only three years of protection. Fool.com health care bureau chief Brenton Flynn and analyst Max Macaluso discuss the potential impact of this decision on Amarin going forward.

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Brenton Flynn and Max Macaluso have no positions in the stocks mentioned above. The Motley Fool has no positions in the stocks mentioned above. 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.


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  • Report this Comment On September 22, 2012, at 10:07 AM, skm1965 wrote:

    Max;

    Your Video shows one dimensional view.

    NCE gives you exclusivity--but if you did not have strong patents--it is not worth much.

    Example: Generics like Apotech etc. tried to challenge CRESTOR patents--and their lawyer argued that the patent was fraudly obtained.The judge dimissed the lawsuit with fines for Apotech in 2010.

    Second: You fail to talk about the most important study: OUTCOME or REDUCE-IT study for 8000 patients worldwide.This study started in Dec.2011 and expects to enroll most patients by Dec.2012. Now why this is important?

    Reason: JELIS study was done for 18645 patients in Japan from 1999-2005 and it proved that EPADEL lowered Cardiac events.

    Astra Zeneca did JUPITER study in 2007--but found in 2009 (2 years into study of 6 years) that certain subgroups benefitted tremendously.So they filed early for expanded labeling.FDA panel rules in favor by majority and FDA gave its approval in 2010. Sales of CRESTOR jumped from 4.5 bil.$ in 2009 to 6.5 bil.$ in 2011.

    By the way-Astra Zeneca faced the same problem on NCE with FDA.-that is why Generics tried to challenge patent.

    Amarin has far more patents and stronger than Astra Zeneca.

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