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quantifeye 3 posts  |  Last Activity: Jun 13, 2014 2:51 PM Member since: Aug 23, 2011
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  • quantifeye quantifeye Jun 13, 2014 2:51 PM Flag

    Thank you. Good find and well founded extrapolation!

    Sentiment: Strong Buy

  • quantifeye by quantifeye Jun 12, 2014 12:19 AM Flag

    First biosimilar infliximab to report American College of Rheumatology ACR20 response comparison at early time points:
    - No meaningful differences observed in safety or immunogenicity
    Data presented at EULAR Annual Conference 2014
    Epirus Switzerland GmbH, a subsidiary of Boston-based Epirus Biopharmaceuticals focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced clinical data from a Phase 3 study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis (RA). Jonathan Kay, MD and Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School, presented the results of this trial at (EULAR).

    This study in severe RA patients was designed as an equivalence trial comparing BOW015 to Remicade. BOW015 achieved a week sixteen ACR20 response rate of 89.8%, compared to 86.4% for Remicade, an outcome which met its pre-specified statistical endpoint. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with RA, indicating a 20% improvement across a series of diagnostic parameters.

    The study also included ACR20 comparisons at two, six, and fourteen weeks. No other clinical trial of a biosimilar infliximab has demonstrated and reported response to treatment at these earlier time points in advance of the sixteen week plateau phase.

    Key secondary objectives of the study were to assess long-term efficacy, safety, tolerability, and immunogenicity.
    **** No meaningful differences were observed between BOW015 and Remicade. Results of the open label phase, including one year immunogenicity, one year safety, and long-term responder rates, are expected to be available in the third quarter of 2014.**** !!!!

    Sentiment: Strong Buy

  • Zalicus's new owner (pre merger) has just revealed that their clinical trial level IIIb drug candidate for the treatment of Rheumatoid Arthritis ( an 8.7 Billion dollar market currently serviced by only 2 players) as now been shown to show parallel efficacy, if not outright superiority over Johnson and Johnsons 6 BILLION dollar drug, Remicade. Prior to todays release of the data, this comparison was not widely known.

    Sentiment: Strong Buy

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