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Shire soars more than 6% on trial results for dry eye treatment

Discussion in 'Market News' started by Lily, Oct 27, 2015.

  1. Lily

    Lily Forum Member

    Aug 29, 2015
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    Company hopes to put in new US application early next year after new update

    Shire shares are soaring after positive trial results for lifitegrast, its treatment for dry eye disease.

    The treatment met its primary and secondary targets, and Shire now plans to re-submit an application to the US Food and Drug Administration in the first quarter of 2016.

    If approved by the FDA, this keeps us on track fro a potential US launch next year.

    We are also planning to use these data, in conjunction with the existing comprehensive clinical data set, for regulatory filings for lifitegrast in other markets outside the US.

    We continue to assume lifitegrast will be approved in the third quarter of 2016, partly because FDA has effectively indicated the only other prescription drug on the market (Restasis) has marginal efficacy, setting a relatively low bar. We estimate 2016 and 2017 lifitegrast sales of $25m and $152m, respectively. Our lifitegrast net present value contributes around 210p a share (7%) assuming a 70% probability and $1bn peak potential.

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