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ImmunoGen, Inc. Message Board

chinesehamsters 6 posts  |  Last Activity: Apr 16, 2014 3:26 PM Member since: Sep 24, 1999
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  • Reply to

    Oral Presentation

    by paintball_is_stellar Jan 21, 2014 8:09 AM
    chinesehamsters chinesehamsters Jan 21, 2014 12:29 PM Flag

    On page 27 of the agenda they show a time line for the various stages of the approval process. Assuming we are at the 180/181 day point where outstanding questions are addressed, it is approximately another 30 days until the CHMP issues it's opinion, then another 67 days for the official stamp of approval from the EC. It looks like they have questions from March 2013 and then additional items from November 2013 and they would like some Enodcyte folks on hand to discuss any items they may not have addressed to their satisfaction, thus the possible oral explanation. I don't know that we will see any news at all out of this meeting today.

    Not a very fast process for an orphan drug is it.

    Chinese Hamsters

  • Reply to

    Yesterday's CHMP/EMA Outcome?

    by jmlregoog Jan 22, 2014 10:08 AM
    chinesehamsters chinesehamsters Jan 22, 2014 1:03 PM Flag

    After looking at some of the meeting minutes published from last year it looks like the CHMP will post their opinions the day after the close of their 4-day meetings. So we might expect to hear the outcome on the 24th of this week, if they continue to follow the pattern they had in 2013.

    Chinese Hamsters

  • Reply to

    Per PR, Sounds like another 3 months

    by fib1_1_2_3_5 Jan 24, 2014 7:35 AM
    chinesehamsters chinesehamsters Jan 24, 2014 11:39 AM Flag

    My take on all of this. ECYT apparently has some significant questions from the regulators they have not yet addressed. ECYT is trying to pretend that this the expected course of action when it is not. It was quite clear in looking at the CHMP agenda that Vintafolate and the diagnostic were being discussed for a positive or negative opinion. You can also see via the archives the CHMP has where they have requested information from ECYT last year, I think in March and again in November. What is really bothersome in ECYT's press release is they give no indication what so ever on what the outstanding issue is, so I can only conclude from that deafening silence that it is pretty significant. This is enough of a big red flag for me to run far far away from ECYT until they sort this out, if they sort this out.

    Chinese Hamsters

  • chinesehamsters chinesehamsters Mar 3, 2014 5:36 PM Flag

    I think Roche is more likely to buy out Immunogen than Seattle Genetics for a couple of reasons. First is that they would just save themselves the trouble of paying the royalty stream to Immunogen on Kadcyla for the next 18 or so years. Second, Immunogen actually has another wholly owned ADCC that gets little mention, IMGN 529. This one is in early clinical testing, but the primary indication is non-Hodgkins B cell lymphoma. Roche has another huge blockbuster drug called Rituxan, which is also going off patent soon. This might be a way of keeping that revenue in-house. I am not aware of what Roche is doing to preserve that market once Rituxan goes off patent. IMGN 529 is not a timely solution for that however, but I do not know of a relevant biosimilar that is in the works by anyone either. TEVA was but squashed their program due to concerns about return on investment.

    Chinese Hamsters

  • chinesehamsters chinesehamsters Mar 4, 2014 11:43 AM Flag

    IDEC did develop Rituxan, and Genentech inked a deal early on (1995) to take on commercial manufacturing in exchange for a royalty arrangement. The royalty in retrospect was pretty small, but for IDEC at the time a piece of something was better than nothing at all. Then Roche of course owned the majority share of of Genentech (late just bought them), thus Rituxan sales globally are not reflected in their earnings.

    Thus my speculation that Roche might be thinking about buying Immunogen if they come up with a potential Rituxan replacement. As I said earlier, IMGN 529 is still in a very early stage of development, so maybe wishful thinking.

    Chinese Hamsters

  • Reply to

    IMGN started at BUY

    by bioimmunomabman Apr 16, 2014 9:28 AM
    chinesehamsters chinesehamsters Apr 16, 2014 3:26 PM Flag

    Finally an analyst with a calculator did the math. They are still a bit short on their forecast of Kadcyla sales however. It will approach closer to $9 billion than the $7 they are predicting. I have been saying that for the last two years. Kadcyla is why I bought this stock and stick with it. Anything else that comes out of the pipeline is just gravy.

    Chinese Hamsters

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