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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • alternatepatel alternatepatel Mar 3, 2012 7:47 AM Flag

    Protalix shows Pfizer the way

    Dave Simmons - Pfizer Inc. - President & General Manager
    ''...The next point I want to make, and this ties still -- goes back to expand the portfolio, I want to talk about the Protalix partnership
    and the in licensing deal we had for taliglucerase because we've had progress since that deal has been signed. A couple points on this.

    First, the FDA has given us a first-quarter 2011 PDUFA date, so that's secured and in hand now and we're waiting for the FDA to finish their review of the NDA application. Also, as we know, despite Shire coming into the market, there are still supply shortages in the Gauchers market.

    We've secured temporary use protocol with the government of France and we're supplying patients in need in France with
    Gauchers disease and we're negotiating with other countries ex-US -- I can't disclose the detail until the contracts are done -- but the point is we're making progress with taliglucerase even before the NDA application has been completely reviewed by the US government.

    Finally, our experience working with Protalix has really informed our own thinking about biosimilars as a market opportunity.

    We have finalized our internal biosimilar strategy and we've already started developing a portfolio of monoclonal antibodies leveraging the great capabilities that have come in from Wyeth.

    So pre Wyeth, we looked at this area as maybe requiring too much capital intensive investment to really make sense of it. Once Wyeth came in this removed a lot of barriers of capital requirements. We've been able to immediately leverage their development capabilities and they're so good, their yields are best in class worldwide. So the production yields that come out of their processes are extremely high. So we're very, very bullish on the biosimilar front and our learnings in working with Protalix have been instrumental.

    i dont see a reason why pfizer would not acquire PLX

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