Surveyed U.S. Psychiatrists Would Prescribe EnVivo Pharmaceuticals' Encenicline to 25 Percent of their Patients with Cognitive

     Surveyed U.S. Psychiatrists Would Prescribe EnVivo Pharmaceuticals'
    Encenicline to 25 Percent of their Patients with Cognitive Impairment
                        Associated with Schizophrenia

Surveyed Psychiatrists and Payers Identify Improved Efficacy on Patient
Function as a Pressing Unmet Need, According to Findings from Decision
Resources Group

PR Newswire

BURLINGTON, Mass., March 31, 2014

BURLINGTON, Mass., March 31, 2014 /PRNewswire/ --Decision Resources Group
finds that surveyed U.S. psychiatrists would prescribe EnVivo
Pharmaceuticals/Bayer HealthCare/Mitsubishi Tanabe Pharma's encenicline to 25
percent of their patients with cognitive impairment associated with
schizophrenia (CIAS). Assuming its promising—albeit preliminary—clinical
profile is confirmed in ongoing Phase III studies, encenicline could become
the first-ever therapy approved to treat this condition, fulfilling a major
unmet need in the clinical management of schizophrenia. Surveyed psychiatrists
also project patient shares of up to 20 percent for other emerging CIAS drugs,
including AbbVie's ABT-126, Omeros's OMS-824, and Avineuro Pharmaceuticals'

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Other key findings from the Decision Base report entitled Cognitive Impairment
Associated with Schizophrenia: What Clinical Attributes Will Be Most
Persuasive for Psychiatrists and Payers Regarding the First Novel Drugs in
this Highly Underserved Arena?:

  oUnmet need: Surveyed U.S. and European psychiatrists ascribed the highest
    level of unmet need for a therapy offering an improved effect on patient
    function, among queried efficacy attributes. Furthermore, 55 percent of
    surveyed U.S. payers expressed a high degree of willingness to grant
    favorable formulary coverage to such a therapy. These data align with an
    FDA mandate that novel therapies must demonstrate efficacy on a co-primary
    functional end point, such as the University of California San Diego
    Performance-Based Skills Assessment, in order to obtain approval for CIAS.
  oPayers receptive, but demanding: Surveyed U.S. managed care organization
    pharmacy directors are receptive to novel drugs offering greater
    improvement from baseline on the Measurement and Treatment Research to
    Improve Cognition in Schizophrenia Consensus Cognitive Battery (MATRICS
    MCCB) than current off-label therapies (e.g., Eisai/Pfizer's Aricept,
    other brands, generics) occasionally prescribed for the treatment of CIAS,
    but hold high expectations for the effect-size gains that would motivate
    formulary coverage.
  oPsychiatrists' willingness for trade-offs: Based on the results of a
    conjoint analysis, surveyed U.S. psychiatrists appear unwilling to make
    significant concessions in dosing frequency or price per day for a therapy
    that achieves even the maximum tested performance in improving CIAS
    patients' cognitive and functional outcomes.

Comments from Decision Resources Group Analyst John Crowley, Ph.D.:

  o"A clear opportunity exists for drug development in CIAS, owing to the
    current lack of approved or meaningfully effective off-label therapies
    coupled with psychiatrists' recognition of and desire to treat CIAS in
    their patients. However, interviewed experts cite several hurdles to be
    overcome in this arena, including the need for well-validated, druggable
    targets, and defining the optimal enrollment criteria for CIAS patients in
    clinical trials."
  o"Of interest, our findings show that a novel CIAS therapy that also offers
    an improved effect on positive and negative psychiatric symptoms presents
    the greatest opportunity for drug developers, based on the relatively high
    level of unmet need and high importance to prescribing choice that
    surveyed U.S. and European psychiatrists assigned to this attribute."

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Decision Resources Group
Christopher Comfort


SOURCE Decision Resources Group

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