Merck and Endocyte withdraw regulatory apps

Merck (MRK +0.9%) and development partner Endocyte (ECYT -0.5%) withdraw their conditional marketing authorization applications from the European Medicines Agency for vintafolide and companion imaging components, imaging agent etarfolatide and IV folic acid, for the treatment of adults with folate receptor-positive , platinim-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin. The companies' action is based on further analyses of interim data from the Proceed clinical trial. Earlier this month, The Data Safety Monitoring Board recommended stopping the trial due to the lack of efficacy.

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Comments (5)
  • TruffelPig
    , contributor
    Comments (4207) | Send Message
    I was waiting for this shoe to drop. Any more bad news possible from this failed phase III? Or are we done for now?
    19 May 2014, 06:09 PM Reply Like
  • biochemist
    , contributor
    Comments (761) | Send Message
    Well, there is the Phase 2 TARGET study on-going which is for a 2nd line indication in non-small cell lung cancer. Looks like ECYT and MRK will wait for those results.
    19 May 2014, 08:05 PM Reply Like
  • docrog123
    , contributor
    Comments (150) | Send Message
    T>P>;I agree with your questions 1&2, but u could have saved a few type strokes by asking, "..Are we done?". To me this news is quite a let down.
    20 May 2014, 01:32 AM Reply Like
  • William Heller
    , contributor
    Comments (4) | Send Message
    ECYT is scheduled to present two papers at a conference June 2. If they were to withdraw these presentations it would signal problems. But if they continue with them it would seem to indicate that the above reported withdrawal is a reasonable action given the issues surrounding the drug trial. Remember, Merck invested $1 billion in ECYT.
    19 May 2014, 08:40 PM Reply Like
  • ECapo
    , contributor
    Comments (735) | Send Message
    biochemist is right. This news is of no surprise and the drop seems like a knee jerk reaction. As anyone is aware they are not only applied to Ovarian Cancer. They would have been better served to have made this announcement much earlier as the original news articles came out. Poor advise by their board and their relations executives.
    20 May 2014, 11:37 AM Reply Like
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