DecisionBase PDFs

March 2010

Schizophrenia: Emerging Atypical Depot Formulations Must Meet Psychiatrists’ High Expectations to Be Successful in a Generically Threatened Market

Introduction:

The late-stage pipeline of emerging therapies for the treatment of schizophrenia continues to be dominated by atypical antipsychotics and several depot formulations of atypical antipsychotics. Because most of these emerging schizophrenia therapies are expected to offer only modest advantages in safety, tolerability, and delivery over existing drugs, significant unmet need remains in this market for more-effective medications with minimal metabolic side effects. In the past, market opportunity for “me too” atypical antipsychotics has been sustained by the individualized patient response to drugs and the frequent drug-switching that takes place in this indication. However, the increasing number of generic atypical antipsychotics will result in a more stringent reimbursement environment, putting increasing pressure on emerging therapies to differentiate themselves from competitors to obtain favorable reimbursement status.

Questions Answered in This Report:

  *   Reducing the global, positive, and negative symptoms are key goals in the treatment of schizophrenia. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European psychiatrists weight specific efficacy end points and other drug attributes in their prescribing decisions for schizophrenia?

  *   Olanzapine (Eli Lilly’s Zyprexa) was the 2008 major-market sales leader for schizophrenia. Do thought leaders expect emerging therapies to offer significant improvements in safety, tolerability, and/or delivery over olanzapine? Which emerging therapies pose the greatest threat to olanzapine’s status as a benchmark therapy?

  *   By 2013, the paliperidone palmitate depot (Janssen’s Invega Sustenna) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the current therapies evaluated in this study. On what clinical attributes is paliperidone palmitate most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by paliperidone palmitate?

Scope:

Key drug development opportunity tested in our target product profiles for schizophrenia: an atypical antipsychotic depot associated with a lower incidence of clinically significant weight gain than risperidone depot at 12 weeks

Physicians surveyed for this study: 60 U.S. and 30 European psychiatrists.

Comprehensive List of Therapies Included in Our Research and Modeling

Current Therapies

- Olanzapine (Eli Lilly’s Zyprexa)

- Quetiapine (AstraZeneca’s Seroquel)

- Aripiprazole (Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify)

- Paliperidone (Janssen’s Invega)

- Risperidone depot (Janssen’s Risperdal Consta)

Emerging Therapies

- LY-2140023 (Eli Lilly)

- Lurasidone (Dainippon Sumitomo)

- Olanzapine pamoate (Eli Lilly’s Zyprexa Relprevv/Zypadhera)

- Paliperidone palmitate (Janssen’s Invega Sustenna)

- Aripiprazole depot (Otsuka Pharmaceutical)

Search Reports

Mentioned in this report:

  • Companies:
  • - Astellas Pharma
  • - AstraZeneca
  • - Bristol-Myers Squibb
  • - Dainippon Sumitomo Pharma
  • - Eli Lilly
  • - Janssen
  • - Johnson & Johnson
  • - Novartis
  • - Otsuka Pharmaceutical
  • - Pfizer
  • - Vanda Pharmaceuticals