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Expert Interview

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Discussing the Market Potential of Neurocrine's (NBIX) Ingrezza for Tardive Dyskinesia After April 11th PDUFA

Ticker(s): NBIX, TEVA, VRX

Who's the expert?

Name: Blinded Doctor

Institution: Hofstra Northwell School of Medicine | Zucker Hillside Hospital

  • Professor Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine & Medical Director of the Recognition and Prevention program at the Zucker Hillside Hospital.
  • Involved in the care of over 100 psychiatric patients per month in outpatient and inpatient settings; monthly treats ~20 patients with schizophrenia and depression (~7 bipolar), and ~6 with Tardive Dyskinesia per month.
  • Principal Investigator or Steering Committee member of several large, federally funded grants for antidepressants and novel mechanism agents for schizophrenia, bipolar disorder, major depressive disorder, and anxiety disorders.

Interview Questions

Please describe your background and experience treating patients with TD. How many patients with TD do you currently see?

Added By: pjloria

What is the current treatment protocol for patients with Tardive Dyskinesia? How would you describe the effectiveness of current treatments? 

Added By: pjloria

There are no other approved products for TD, but Valeant's tetrabenazine, benzodiazepines, clozapine, or botulinum toxin injections also may be tried in treatment. How would you describe the effectiveness of tetrabenazine, and these other forms of treatment that are sometimes used? 

Added By: pjloria

What is the market potential of Ingrezza in TD? NBIX identified a possible patient population of 500,000; is this an accurate number? 

Added By: pjloria

How does Ingrezza compare in efficacy and safety to tetrabenazine? Which drug do you see controlling the market going forward?

Added By: pjloria

Are there any other drugs currently being developed that could disrupt the market for TD drugs? 

Added By: pjloria

The label for Ingrezza is very clean and benign vs. Austedo.  Was this something you expected or did you anticipate seeing other warnings, restrictions, etc...

Added By: user2323

How aware of Ingrezza's approval are psychiatrists or providers that typically treat TD?  Is this a physician group that is generally conservative or are they receptive of new therapies?

Added By: user2323

If we assume Ingrezza's sales force will be highlighting the lack of dose titration, faster onset, once a day dosing, lack of food requirement, tolerability of the drug, etc... Please discuss how meaningful these attributes will be in the real world setting.  

Added By: user2323

Ingrezza does not require a black box warning, unlike Teva's Austedo, which has a PDUFA in TD in August 2017.

  • If given the choice, would there be any reason a physician would put patients on Teva’s deuterated product vs. Ingrezza, given the boxed safety warning and inferior efficacy and dosing regimen?
  • How do you think this will this affect the commercialization and market share of both products?

Added By: pjloria

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