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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • oteensdad oteensdad May 21, 2012 7:06 AM Flag

    Trials for Biosimilars

    A few thoughts, to trigger a discussion.

    In this context, IDF means Immune Defficiency Foundation, not צה"ל (Israel Defence Forces).

    IDF (the Foundation) is lobbying with the FDA for higher hurdles in clinical trials for biosimilars. "The FDA recognizes each Ig brand as unique with no generic equivalent— Ig products are not clinically interchangeable. Current science cannot demonstrate that two products will provide the exact same clinical results for a large number of patients or that switching patients from one product to another will pose no additional risks."

    I wonder whether the above statement could cancel any Enbrel patent protection...

    Also: I wonder whether the FDA could/would use the above to cause us even more grief with our future trials...

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    • sorry for the delayed response. you can find me on linkedin under my name.

    • For Jarrett or anyone else who's interested:
      Ok, glad the info was helpful as I intended ;

      As to your inquiry abt my "consulting" I wish it were more profitable than currently i.e, producing $$$ than it currently is....

      I am trying to market myself as someone who can provide Clin Research Consulting services. I got into the biosim business b/c I ran trials w/ biologics treating Autoimmune Diseases. Of course, PLX is trying to utilize the in biosim opportunity with the novel plant cell faactory approach.

      I am not sure how to communicate off-line, or even if its worth it to you to do so.

      I don't have a web site , but I am on LinkedIn.

      So, I guess if you want to continue communicating we could start connecting there.

      Just let me know what U want to do and we'll move on from there.

    • Nice knowing you remembered, jarre...

    • No, I appreciate your analysis. That wasnt meant for you. It was for that twelve tooth fool who showed up here a few weeks ago with an inability to parse people expressing legitimate concerns/frustration from senseless bashers, so he attacked me by telling me something about how his dad provided for him and he will do the same for his kids. It was pretty ridiculous and definitely highlighted the whole guy living in his parents basement stereotype. Anyway, I really appreciate your insight and patent advice. I am in the biotech world, but know nothing of the IP side. Id be curious in what consulting services you are hoping to offer in the future. Regards, Jarrett

    • oded- send this question tothe PR and ask Avuezer to respond to it

      I assume he will respond

      • 1 Reply to nuselrami
      • Well even though’ I am really down on PLX, as a highly experienced clinical research professional I did promise oteensdad (whomever that is) that I’d weigh in on the patent-biosimilar issues, specifically around the ”Enbrel” knockoff –PLX-106.

        I have 7 years work on Enbrel and another 5 on similar agents. Enbrel is at the top of this class of Rxs, at least, efficaciously. Market share wise, I think it’s #2. --- BTW, except maybe with mutual funds, I hold no position on Amgen or PFE.
        The value around Enbrel is why PLX is developing 106, instead of other related Rxs. There are also other Cos. trying to develop Enbrel as well. Finally, Amgen, who holds the US patent, also values the Rx b/c they have just obtained a new US patent replacing the orig one which expired recently.

        The new patent is reported as a product patent (, not a process patent.
        Product patents are more valuable than process: while you might be able to make the same product w/ different process but w/o a product patent U couldn’t sell it.

        As background, once a company named Immunex invented a molecule called “etanercept” (now called Enbrel). I'm a little cloudy here but I think that Roche got the original patent ca. 1994. Roche gave Immunex the patent and life time exclusivity to develop etanercept. Ca. 1997, Immunex began co-developing the Rx with Wyeth. Immunex did US and CA marketing and Wyeth ROW. They split w-w profits. Ca. 2002, Immunex was bought out by Amgen. So, Amgen got Enbrel, the orig patent and Wyeth as a partner. That lasted till '09 when PFE bought Wyeth along w/ the partnership.

        PFE has kept partnership until just recently when they announced they were exiting the deal. PFE is developing on oral Rx expected to compete with Enbrel. The Amgen deal specifies that PFE would need to split would have to split the new Rx’s $$$ with Amgen as well, since the new Rx would compete. The new Rx is expected out in late Aug—whether it will be a real threat to Enbrel is debatable—a whole story in itself. Anyway, PFE will soon not be collecting Enbrel $$$$ at least in US.

        What abt PLX-106? Well, while we PLX investors were fretting abt Elelyso’s fate; the FDA was drafting guidelines for Cos to obtain biosimilars marketing approval. Though presenting a somewhat complex approval pathway, FDA is rightfully acknowledging that biosimilars are “similar” but arguably not “identical” to orig Rxs b/c due to the complexity of the living systems that produce them. The guidelines propose extensively characterizing biosimilars molecular structure, with the intent that it should be close to that of the original Rx. But, clinical trials may also be needed. FDA is not prepared to casually provide a one size fits all approach to biosimilar development.

        The FDA guidelines are not final and many pharma Cos have commented on the draft version. But given the cautionary language in the guidance and the fact that 106 is being made by plant cells, I think there’s a there is a high probability that this agent will need clinical trials to gain approval.

        Last but certainly not least, there’s the competition. At least one Co (Hanwha) is also making etanercept and others either are doing so or plan to. On the plus side, Merck is partnering with Hanwha so, it’s a good bet that Enbrel patent challenges can be expected. But the down-side is that even with PLX plant system substantially lowering manufacturing costs, with so much competition, marketing 106 may have many challenges. That said, a larger Pharma partner or eventual buyout looks better and better to me.

        Well, I needed to collect my thoughts abt all this anyway as I am trying to build some kind of consulting gig. So, for me the chance to get this all out was helpful.

        As for the rest of U, I hope I have clarified some issues and not further clouded the waters.

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