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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • mountainmansmith mountainmansmith Mar 22, 2013 8:35 AM Flag

    Oral Formulation of Gaucher ERT

    If the ongoing Oral agent study shows adequate serum levels (study should be completed within a few months), what type of studies are needed prior to being able to produce an oral agent to sell? The drug has already been shown to be safe and effective when given intravenously and there is a cross-over study from cerezyme to Uplyso that shows this is safe. This could be a game-changer for the Gaucher community. How long would it have to take to get "approval" of an oral agent in the USA, Israel, Brazil and possibly even Europe? Also would make it much easier to reach the 5000 or so "untreated" patients that exist throughout the world. Does Pfizer "own" 60% of the oral agent market outside of Israel?
    The potential for therapeutic proteins to be given orally has much wider implications than just for Uplyso. Are any other companies close to being able to do this?
    Lets hope for a Brazil deal to help provide operating revenue (along with the US and Israel) while the company pursues these other opportunities. Or maybe another Sanofi/Genzyme disaster?!?!
    I don't think the company will be sold cheaply. This may be a longer term hold than we may have thought, but still tons of potential.
    I agree with Nuselrami that it's tough to watch the management get rich while we sit and wait, but I guess they are doing all the work and I'm sure they have much more to gain from the company's ultimate success than we do.

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    • it look like Genzyme will be ready with this oral drug before PLX. Management has a lot to loose agter they took home millions... I don't mind that they took millions I mind about pumping up hopes when they know or should have known it will take longet and harder...If you followed them closely you would have got the impression as if after FDA approval all doors will be opened... The Platform will speak to all Biotech community who will be willing to cooperate and invest.... NOTHING!!! no deal with any other drug or protein!!! NOTHING!!! so..... somebody has to pay for that.... the MOARD has to realize that something is wrong here... we are talking about somthing very big- a new platform!! where is it??? do we have indeed a new platform for various drugs? if yes why nobody put his money in this company??? the big companies are looking for new technologies.... where are they???

      • 1 Reply to nuselrami
      • Genzyme's oral gaucher's drug does have some mild cardio-vascular side-effects. It is different from Cerezyme. If PLX's oral drug is the same as the FDA approved IV drug, then PLX might be able to use the FDA 505(b)(2) NDA which references previous safety and efficacy studies. That FDA filing saves time and money.

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