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Emisphere Technologies, Inc. Message Board

  • davidbiotechinvestor davidbiotechinvestor Nov 21, 2011 11:14 AM Flag

    So why didn't Novartis cancel the program?

    And why is Novo pushing the OA MRI data? Why didn't they just cancel it and move on?

    Thoughts anybody?

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    • In my opinion... The reason why Novartis didn't cancel the program is because the compound did have efficacy, i.e. increased bone density, but did not meet the primary endpoint, which was reduction in the number of fractures versus placebo.

      Novartis did mention that the overall number of total fractures was low, which means that any therapeutic benefit may be hinden, as not enough fractures occurred to differentiate the two groups.

      I do have Big Pharma knowledge of OP drug trials, and the biggest problem in the long term study is not having enough overall fractures. i.e. You have to wait for enough people to develop fractures to see if there is any therapeutic effect, if only a few people develop fractures, you won't see any difference, since the endpoint is the number of reduced fractures versus placebo.

      My guess is Novartis will extend the trial for another year or two, to see if a therapeutic effect will be observed. i.e. wait for more people to develop fractures.

      Always do your own DD.

      • 3 Replies to gt95ab
      • Is it possible that the same goes for OA, they found some therapeutic effect but perhaps the sample was not large enough and they need MRI data accepted? Maybe that's the reason they continue to examine those results and publish papers.

      • Thanks for the insight.

        I'm hoping that because they did see increased lumbar spine bone mineral density, the program still has some hope.

        Looking at the summary of the clinical data in the product insert for Miacalcin (nasal salmon calcitonin) and UGNE's phase III data, the primary end point in those studies was the increase in lumbar spine/vertebral BMD. Also, those studies had a lot less patients (less than 600) compared to the 4500 patient study done by Nordic A/S. The pharmacokientic data for the oral formulation is also much better than Miacalcin.

        Given all that, it seems like if the trial's primary end point was just increase in BMD, the study would have been a success. Do you think there's any chance NVS will go ahead and try to get approval?

      • Thank you for your insights. If Novartis does opt to extend the trials, what does this mean for Emisphere? Are they entitled to any additional milestone payments?

    • I guess there is a slimmer of hope that Novartis might have some positive takeaway from OA/OP which could move this higher
      The last resort is B12 which should atleast push it to a dollar range. we could only hope that the further results come out sooner than later

    • A reason for hope but of course the company is on life support.

      • 1 Reply to wmimi12
      • I agree it's not a pretty picture. But the facts here are a lot better then many other biotech start ups. They have a proven drug delivery system that can do things that nobody else has done yet. They have one proven application of it in B12 should they ever get around to putting it on the market. And potentially there are many other applications for their Eligen system. They, obviously can't afford to do the trials themselves, but they can partner them out and wait. How much money does it cost to run a Company that needs to do nothing unless they want to sell B12 themselves?

 
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