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AmpliPhi Biosciences Corporation Message Board

  • p25162 p25162 Jul 4, 2013 1:30 PM Flag

    Glybera 1st patient anyday now, 400 to 500 eligible Europe alone, $323k US per patient/annum

    The first patient to receive the commercial product will be treated in Germany around the middle of 2013 (anyday now). Potential US launch, based on Glybera's FDA Orphan Drug status, in 2014.

    APHB is ridiculously undervalued as a security because Glybera royalties are pure profit streams for years on end, plus the EU marketing approval milestone that APHB has most likely already received. MYDICAR is approx. 2 years out for a $5 milllion milestone, and as an FDA Orphan Drug could come to market with a successful Phase 2b.

    uniQure estimated there are 400 to 500 patients in Europe eligible to receive Glybera. The addressable market for Glybera is larger than I originally knew, plus the treatment is actually administered every 5 years. Approx. $323k US per year per patient.

    CEO Aldag expects there will be three clinical centers in Germany administering the product, with others in Turkey, the UK, France, Italy and elsewhere in Europe.

    Now that it has European Medicines Agency approval for Glybera, uniQure intends to engage with the FDA, with the aim of a U.S. launch in 2014. I don't know at this point if the FDA will need any more data. As this is an ultra-rare orphan disease, I hope they won't request further trials. Most of the patients [in the submitted studies] were dosed in North America, in Canada," Aldag said.

    Sentiment: Strong Buy

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