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Insmed Incorporated Message Board

biowatchdog 30 posts  |  Last Activity: 7 hours ago Member since: Nov 13, 2004
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  • Reply to

    Response schedule guideline provided by EMA

    by biowatchdog Dec 21, 2015 11:01 AM
    biowatchdog biowatchdog 7 hours ago Flag

    Clock restarted 12/28/15.
    Next up...PRAC adoption 2/11/16.
    Then...Opinion or adoption of list of outstanding issues (LoOI) 2/25/16.

  • Reply to

    Seeds of doubt?

    by biowatchdog Dec 7, 2015 7:39 PM
    biowatchdog biowatchdog Feb 3, 2016 11:17 PM Flag

    yes...80%

  • Reply to

    Responded

    by biowatchdog Jan 13, 2016 12:24 PM
    biowatchdog biowatchdog Jan 13, 2016 11:25 PM Flag

    Delay? The CSR usually takes a month or two. So, with the follow-up completing in 3Q, "give or take" could put that near the start of 4Q, which could put the CSR completed in December. It all falls into the hands of the clinical partners anyway.

  • Reply to

    Responded

    by biowatchdog Jan 13, 2016 12:24 PM
    biowatchdog biowatchdog Jan 13, 2016 6:21 PM Flag

    Does 82% culture conversion constitute compelling data?

  • Reply to

    Responded

    by biowatchdog Jan 13, 2016 12:24 PM
    biowatchdog biowatchdog Jan 13, 2016 12:57 PM Flag

    The presentation was very quick and then we moved into another room for a little Q&A. Watch for the presentation to be posted soon…good stuff added that I would like to study further.

    We are on track for the EMA timeline I provided a week ago or so.

  • biowatchdog by biowatchdog Jan 13, 2016 12:24 PM Flag

    On time...awaiting 180 response from EMA 1Q.

    Pipeline: PAH, Sarcoidosis, NTM, MRSA, IPF

  • Reply to

    Piper Jaffray Schimmer

    by justarook04 Jan 7, 2016 4:39 PM
    biowatchdog biowatchdog Jan 8, 2016 1:15 PM Flag

    I can't imagine why this would get all the thumbs down.
    "...as well as an EMA approval decision mid-year."

  • biowatchdog biowatchdog Jan 5, 2016 3:19 PM Flag

    A discussion of the 120 LoQs almost always occurs. I can't imagine why any company would not want to vet the questions. These discussions usually include at least one rapporteur. They aren't really informal either, as the sponsor has to provide an agenda and minutes, which are verified with the EMA. At no time, however, does the EMA indicate if the intended response provided in these meetings is an acceptable answer to any question. I can say though that a prudent sponsor will eagerly try to explain and get sense of acceptance by the EMA...for example, if a question were about DRESS, we would likely point to data that shows there is no systemic exposure of amikacin and work the EMA to "understand" that DRESS specific clinical evidence would be futile. There is a lot of people reading going on in these things.

  • Reply to

    Question on timeline

    by zake1 Jan 5, 2016 9:54 AM
    biowatchdog biowatchdog Jan 5, 2016 10:35 AM Flag

    Zake,

    I posted below on the 21st. The question is did we respond as Will expected?

    This is the schedule provided by the EMA for the 120-day LoQ response.

    Submit response to 120-day LoQ on 12/25 (EMA requests submission before 12/25 to prevent any delays from a need to re-dispatch).
    Clock restarts 12/28/15.
    PRAC Rapporteur RMP Assessment Report 01/26/16.
    CHMP Rapporteur Assessment Report 2/1/16.
    Comments on RMP from CHMP and PRAC 2/1/16.
    Updated PRAC Rapporteur RMP Assessment Report 2/4/16.
    PRAC adoption 2/11/16.
    Comments on CHMP Rapporteur Assessment Report 2/16/16.
    Opinion or adoption of list of outstanding issues (LoOI) 2/25/16.

  • Reply to

    Two MORE NEW Job Opportunities.....

    by insmhistorian Dec 28, 2015 1:26 PM
    biowatchdog biowatchdog Dec 30, 2015 8:07 AM Flag

    Seems troubling to me...or at least one here might wants us to think...that they are hiring liaisons to cover the entire U.S now when they won't have any products on the market until 2017/2018. After all, these people have advanced degrees and are paid very well.

  • This is the schedule provided by the EMA for the 120-day LoQ response.

    Submit response to 120-day LoQ on 12/25 (EMA requests submission before 12/25 to prevent any delays from a need to re-dispatch).
    Clock restarts 12/28/15.
    PRAC Rapporteur RMP Assessment Report 01/26/16.
    CHMP Rapporteur Assessment Report 2/1/16.
    Comments on RMP from CHMP and PRAC 2/1/16.
    Updated PRAC Rapporteur RMP Assessment Report 2/4/16.
    PRAC adoption 2/11/16.
    Comments on CHMP Rapporteur Assessment Report 2/16/16.
    Opinion or adoption of list of outstanding issues (LoOI) 2/25/16.

    I can provide the timeline guidance, if we move on with the 180-day LoOI.

    bwd

  • Reply to

    PJ event

    by biowatchdog Dec 14, 2015 6:35 PM
    biowatchdog biowatchdog Dec 16, 2015 9:11 PM Flag

    Another thought...conditional approvals are often preceded by expanded access programs. Hmmmm...

  • Reply to

    PJ event

    by biowatchdog Dec 14, 2015 6:35 PM
    biowatchdog biowatchdog Dec 16, 2015 9:06 PM Flag

    As an after thought it occurred to me why Terry likes to bring up that the EMA could require the 212 data. He must be alluding to the possibility of a conditional approval. After all, 7% of all submissions are conditionally approved. EMA Conditional approvals began in 2007, If I recall correctly. They are granted on lower phase data specifically for unmet medical needs and orphan indications, especially if they have compelling data. 20% of all cancer drugs under this program have been conditionally approved. The EMA requires certain conditions be met, including additional trial data (if needed) and approval is granted for 1 year which is renewable for a year. After all conditions are met, the conditional approval just gives way to a normal approval.

    Typically, from the 180 day outstanding issues they will schedule orals and if the issues can be addressed and accepted the orals will be dropped and a positive opinion granted at the same CHMP meeting.

    Gee Terry, thanks for reminding us!

    bwd

  • Reply to

    PJ event

    by biowatchdog Dec 14, 2015 6:35 PM
    biowatchdog biowatchdog Dec 14, 2015 10:57 PM Flag

    So here it is again.

    Part 2

    Regarding the barriers to entry comment, I was a little taken aback by that comment I think that is just wishful marketing of Insmed because there are clearly potential players in this market.

    Based on the data provided, using the lower 70% prevalence of MAC, Germany has the potential to provide 1 quarter revenues of about $34M. Full year revenues in the EU5 would be approximately $560M with full EU annual revenue in the neighborhood of $840M. The current standard for treatment includes a one year maintenance program. We anticipate a similar regimen for Arikayce being required (at least initially). I’ll leave to the other number crunchers the inclusion of Japan and the U.S.

    Final 212 data is expect mid-2017. The 212 was modeled using the same TB metric, 2 days after ending treatment. Unlike the earlier 28 day off cycle sampling at the end, the 2 day after required a new technique to separate the sample from the drug. This sampling measurement change actually works in favor of Arikayce and we are excited to see the results as we move forward.

    On the development front, we learned that we have several new indications currently in animal studies. As a matter of corporate policy, we do not identify any of the indications currently undergoing animal studies, but only after we have come out of these with a clear opportunity forward. The first new indication to come out of this process is PAH.

    bwd

  • Reply to

    PJ event

    by biowatchdog Dec 14, 2015 6:35 PM
    biowatchdog biowatchdog Dec 14, 2015 10:53 PM Flag

    odd that my part 2 is gone...

  • biowatchdog by biowatchdog Dec 14, 2015 6:35 PM Flag

    For those of you who have not really listened to the PJ event or perhaps were only keen to certain statements…

    Part 1:

    The extension for the 120 LoQ response was not due to data needed to answer the questions. We could have responded to all of the questions with the data available, but after seeing the compelling interim data of the 112, we wanted to include the 112 data in our response. The 112 data shows more than 80% remain culture negative for 1 year. While the sample size is small, this durability is compelling for an indication where an effective treatment does not exist. Since the EMA could ask to wait on the 212 data, the durability of the culture conversions seen in the 112 only serves to strengthen the application, mitigating an EMA need for the 212 data.

    We expect an EMA answer in the first half of 2016. The answers to the 120 LoQ will be submitted by year end and we could have the initial response by the February CHMP meeting and the final decision by mid-2016. The initial response is, of course, the CHMP opinion. “Could” by February alludes to the EMA 180 day milestone where the CHMP provides a list of outstanding issues or issues an opinion.

    When the EMA does eventually approve, Germany is well on their way to be ready to launch. In fact, launch could be in the 4Q16 if the EMA approves by mid-2016 (1H16). Annual cost for treatment with Arikayce will be about $60K in the EU with the median about $40K. (This could be largely attributable to the UK where I once read cost would be in the neighborhood of $20K but that was under the CF indication…we shall see.) The launch will be very quick as Insmed is already in the clinics (this is also a barrier to any possible competitor studies, frankly Insmed does not see any competition on the horizon). We have been seeing an 70-80% MAC NTM in the clinics.

  • Reply to

    Not on the CHMP December agenda

    by visionquest08 Dec 14, 2015 11:14 AM
    biowatchdog biowatchdog Dec 14, 2015 6:30 PM Flag

    If they respond by Wednesday, they could be in sections 3.4-6 but I think it is a given that we should not expect specific mention until the February meeting at the earliest now. However, I noticed the EMA is looking to revise their guidelines for inhaled medical products with members submitted for the committee’s formation in the January meeting. I don’t know of anything in the industry driving this, so that could be interesting.

  • Reply to

    Seeds of doubt?

    by biowatchdog Dec 7, 2015 7:39 PM
    biowatchdog biowatchdog Dec 11, 2015 9:24 AM Flag

    Slide 11 on December presentation:

    "14/17 (82.4%) demonstrated durable negative cultures off-LAI"...and more to come.

    bwd

  • biowatchdog by biowatchdog Dec 7, 2015 7:39 PM Flag

    All this talk about a delay, pushing the timeline out, and planting the seeds of doubt as to the success of the CONVERT and the EMA filing is going to surprise any who bite on it or truly take stock in the negatives of the message.

    "...we have most of our sites up and running now. So we have a lot more data and visibility. What we have tried to do with this guidance is provide a broad range of where we may land in terms of ultimate timing. And as time goes forward here and we get to our next quarterly call, I think we’re going to be making an effort to narrow this guidance a bit further as more data comes in, enrollment continues and the performance of sites becomes more steady state."
    Translation: We have now provided a very conservative time frame that we truly expect to bring in, not push out that guidance.

    "Now that we have that one-year data and it is so compelling, it’s really critical that we get that final data included in the CSR. So when we originally went back to the EMA, we requested the six months to be able to submit by the end of the calendar year so that we could include that CSR from the 112 study. That’s a really important point. Everything else is ready to go. That particular CSR has got to be in the dataset."
    Translation: Really no need to translate, as it is right there. The data "...IS SO COMPELLING." Don't be surprised, if the conversion rate is upwards to 80%.

    bwd

  • biowatchdog by biowatchdog Dec 2, 2015 11:56 AM Flag

    I am not sure about Insmed since Terry brought up Amylin. There is a real concern here because Bristol-Myers Squibb only bought Amylin for $5.3 billion and AstraZeneca only paid $3.5 billion for a portion of the profits from Amylin’s drugs.

    We had better bail!

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