Sumitomo Pharma Co.ltd. · TSE:4506
Sumitomo Pharma Co.ltd — Technical Presentation (January 2011)
36 slides from Sumitomo Pharma Co.ltd's technical presentation, Jan 25, 2011
Slide 1: LATUDA Clinical Development Update
LATUDA Clinical Development Update LATUDA Meeting (Tokyo) January 2011 Antony Loebel, MD Executive Vice President Clinical Research and Medical Affairs Sunovion Pharmaceuticals Inc.
Slide 2: Agenda
Agenda LATUDA Label Overview • Approval timeline • Label highlights Schizophrenia Program • Overview of results of PEARL studies • Highlights from the PEARL Safety study • Ongoing and planned studies in schizophrenia Bipolar Depression Development Program • Overview of PREVAIL program LATUDA
Slide 3: Successfully Launch LATUDA and Maximize the Molecule Across Its Lifecycle
Successfully Launch LATUDA and Maximize the Molecule Across Its Lifecycle LATUDA Schizophrenia Bipolar Depression Expand into Foundational Additional Markets 2
Slide 4: LATUDA US FDA Approval
LATUDA US FDA Approval First atypical antipsychotic to receive a first-cycle US FDA approval 10 Month Standard FDA Review • NDA filed: December 30, 2009 • FDA Approval: October 28, 2010 One of only 21 products approved by the FDA in 2010 • The only Psychiatric Products division NME approved in
Slide 5: LATUDA Label Highlights
LATUDA Label Highlights Label Reflects Favorable Product Profile Indication • LATUDA is indicated for the treatment of patients with schizophrenia Doses • 40 or 80 mg/d recommended, no titration needed; once daily with food (350 cal min) Contraindications/Warnings • Contraindicated for hyperse
Slide 6: LATUDA Label Highlights
LATUDA Label Highlights Label Includes Substantial Safety and Efficacy Database 4 efficacy data studies included • Phase 2a (006): LATUDA 40 and 120 mg/d • Phase 2b (196): LATUDA at 80 mg/d • PEARL 1 (229): LATUDA at 80 mg/d • PEARL 2 (231): LATUDA at 40 and 120 mg/d and olanzapine 2,096 patient
Slide 7: Agenda
Agenda LATUDA Label Overview • Approval timeline • Label highlights Schizophrenia Program • Overview of results of PEARL studies • Highlights from the PEARL Safety study • Ongoing and planned studies in schizophrenia Bipolar Depression Development Program • Overview of PREVAIL program LATUDA
Slide 8: LATUDA Phase 2 and 3 Schizophrenia Trials
LATUDA Phase 2 and 3 Schizophrenia Trials LATUDA mg/d Active N 40 mg 80 mg 120 mg 160 mg Control Study 006 149 40 120 Study 196 180 80 Study 229 500 40 80 120 (PEARL 1) Study 231 Olanz 478 40 120 15 (PEARL 2) Study 233 Quet XR 488 80 160 600 (PEARL 3) 7
Slide 9: PEARL 2 (Study 231): Study Design
PEARL 2 (Study 231): Study Design Open-Label Double-Blind Phase Extension Phase LATUDA 40 mg/d Screening LATUDA 120 mg/d Baseline LATUDA 40-120 mg/d Olanzapine 15 mg/d (active control) Placebo 6 weeks 6 months Olanzapine 15 mg/d was included as an active control for assay sensitivity Data were analy
Slide 10: Results: PANSS Total (MMRM)
PEARL 2 Results: PANSS Total (MMRM) Day Wk Wk Wk Wk Wk Wk 6 Baseline 4 1 2 3 4 5 Endpoint 0 LS Mean Change from Baseline -5 * ** -10 ** ** -15 ** ** ** -20 ** ** ** ** * -25 ** ** ** ** -30 ** Placebo (n=114) 40 mg/d LATUDA (n=118) 120 mg/d LATUDA (n=118) 15 mg/d Olanzapine (n=121) *p<0.05; **p<0.01
Slide 11: Results: CGI-S (MMRM)
PEARL 2 Results: CGI-S (MMRM) Day Wk Wk Wk Wk Wk Wk 6 Baseline 4 1 2 3 4 5 Endpoint 0.0 LS Mean Change from Baseline -0.5 * * * * ** -1.0 ** * ** ** ** ** ** ** -1.5 ** ** ** Placebo (n=114) 40 mg/d LATUDA (n=119) 120 mg/d LATUDA (n=118) 15 mg/d Olanzapine (n=122) *p<0.05; **p<0.01 H. Meltzer et al.
Slide 12: Results: Weight Change (LOCF)
PEARL 2 Results: Weight Change (LOCF) 5 4.2 Mean Change from Baseline (kg) 4 3 2 1.0 1.1 1 0.6 0 Placebo LATUDA 40 mg/d LATUDA 120 mg/d Olz 15 mg/d n=115 n=119 n=118 n=122 J. Meyer et al. Poster presented at ACNP meeting, December 2009 11
Slide 13: Results: Lipid Profile
PEARL 2 Results: Lipid Profile 25 24.0 20 Median Change (mg/dL) 15 9.0 10 7.0 5 0.0 1.0 0 -1.0 -1.0 -5 -2.0 -5.0 -4.0 -5.0 -10 -7.0 -15 Cholesterol HDL LDL Triglycerides Placebo (n=116) LATUDA (n=237) Olanzapine (n=122) LOCF endpoint values; all subjects fasting per protocol J Meyer et al. Poster pr
Slide 14: Results: Glucose (LOCF)
PEARL 2 Results: Glucose (LOCF) 5 Median Change from Baseline (mg/dL) 4 3.0 3 2 1.0 1 0 -1 -1.0 -1.0 -2 Placebo LATUDA 40 mg/d LATUDA 120 mg/d Olz 15 mg/d n=100 n=107 n=94 n=111 All subjects fasting per protocol J. Meyer et al. Poster presented at ACNP meeting, December 2009. 13
Slide 15: Results: Insulin (LOCF)
PEARL 2 Results: Insulin (LOCF) 10.0 Mean Change from Baseline (mg/dL) 5.9 5.0 0.0 -1.3 -2.4 -3.2 -5.0 Placebo LATUDA 40 mg/d LATUDA 120 mg/d Olz 15 mg/d n=114 n=119 n=115 n=121 All subjects fasting per protocol J. Meyer et al. Poster presented at ACNP meeting, December 2009. 14
Slide 16: PEARL 3 (Study 233): Study Design
PEARL 3: Study Design Double-Blind Phase Double-Blind Short-Term Phase Extension Phase LATUDA 80 mg/d LATUDA 160 mg/d Screening Baseline LATUDA 40-120 mg/d Quetiapine XR 200-800 mg/d Placebo Quetiapine XR 600 mg/d 6 weeks 12 months Note: The data for 160 mg/day dose of LATUDA have not yet been submi
Slide 17: PEARL 3: Subject Disposition
PEARL 3: Subject Disposition LATUDA LATUDA 160 Quet XR 80 mg/d mg/d 600 mg/d Placebo Number of Subjects 125 121 120 122 Randomized (n=488) Discontinuations 36 (29%) 28 (23%) 23 (19%) 48 (39%) Insufficient Clinical Response 16 (13%) 12 (10%) 6 (5%) 28 (23%) Adverse Event 5 (4%) 4 (3%) 4 (3%) 5 (4%) W
Slide 18: Results: PANSS Total (MMRM)
PEARL 3 Results: PANSS Total (MMRM) Day Wk Wk Wk Wk Wk Wk 6 Baseline 4 1 2 3 4 5 Endpoint 0 *p<0.05 LS Mean Change from Baseline * **p<0.01 -5 *** ***p<0.001 * *** -10 *** *** *** -15 *** *** *** -20 *** *** *** *** *** *** *** -25 *** *** *** -30 *** Placebo (n=120) 80 mg/d LATUDA (n=125) 160 mg/d
Slide 19: Results: CGI-S (MMRM)
PEARL 3 Results: CGI-S (MMRM) Day Wk Wk Wk Wk Wk Wk 6 Baseline 4 1 2 3 4 5 Endpoint 0.0 *p<0.05 LS Mean Change from Baseline ** **p<0.01 * ***p<0.001 -0.5 ** *** *** *** *** -1.0 *** *** *** *** *** *** *** -1.5 *** *** *** *** *** -2.0 Placebo (n=120) 80 mg/d LATUDA (n=125) 160 mg/d LATUDA (n=121)
Slide 20: Results: Metabolic Weight Change and Triglycerides
PEARL 3 Results: Metabolic Weight Change Triglycerides 5.0 10.0 8.0 Mean Change from Baseline (kg) 8.0 4.0 6.0 Median Change from 4.0 Baseline (mg/dL) 2.0 3.0 0.0 2.1 -2.0 2.0 -4.0 -2.0 -6.0 1.0 0.6 0.6 -8.0 0.1 -10.0 -9.0 -9.0 0.0 -12.0 Placebo LATUDA LATUDA Quet XR Placebo LATUDA LATUDA Quet XR 80
Slide 21: Results: Epworth Sleepiness Scale
PEARL 3 Results: Epworth Sleepiness Scale 1.0 LS Mean Change (ANCOVA LOCF) *** 0.6 0.5 0.0 -0.5 -0.7 -1.0 -0.9 -1.1 -1.5 -2.0 Placebo LATUDA 80 mg/d LATUDA 160 mg/d Quet XR 600 mg/d n=114 n=119 n=116 n=112 A. Loebel et al. Poster presented at ACNP meeting, Dec 8th, 2010 ***p<0.001 20
Slide 22: PEARL 3: Selected Common AEs for LATUDA and Quetiapine XR
PEARL 3: Selected Common AEs for LATUDA and Quetiapine XR LATUDA LATUDA Quet XR 80 mg/d 160 mg/d 600 mg/d Placebo Adverse Event (n=125) (n=121) (n=119) (n=121) Akathisia 10 (8.0%) 9 (7.4%) 2 (1.7%) 1 (0.8%) Nausea 10 (8.0%) 9 (6.6%) 4 (3.4%) 4 (3.3%) Parkinsonism 7 (5.6%) 8 (6.6%) 4 (3.4%) 0 Dizzine
Slide 23: Long Term Safety Study: Study Design
PEARL Safety trial (LTSS: Long Term Safety Study): Study design Open-Label Double-Blind Phase Continuation Phase LATUDA 40-120 mg/d n=400 Screening Baseline LATUDA 40-120 mg/d Risperidone 2-6 mg/d n=200 12 months 6 months 22
Slide 24: LTSS Safety Results: Weight Change
LTSS Safety Results: Weight Change (Observed Case) D Wk Wk Wk Mo Mo Mo 7 3 6 12 6 9 12 LS Mean Change from Baseline (kg) 5 4 3 2 1 0 -1 -2 LATUDA Risperidone BL Day 7 Wk 3 Wk 6 Wk 12 Mo 6 Mo 9 Mo 12 LATUDA n= 419 406 359 337 282 216 173 150 Risperidone n = 202 196 175 162 135 122 106 98 23
Slide 25: LTSS Safety Results: Triglycerides
LTSS Safety Results: Triglycerides (LOCF) LATUDA Risperidone n=354 n=169 0.0 Median Change from Baseline (mg/dL) -1.0 -2.0 -4.0 -3.5 -6.0 -8.0 -10.0 24
Slide 26: LTSS Safety Results: Glucose
LTSS Safety Results: Glucose (LOCF) Median Change from Baseline (mg/dL) 5.0 4.0 3.0 3.0 2.0 1.0 0.0 -0.5 -1.0 *** LATUDA Risperidone n=354 n=171 ***p= 0.001 25
Slide 27: LTSS Safety Results: Prolactin
LTSS Safety Results: Prolactin (LOCF) 10.0 9.10 Median Change from Baseline (ng/mL) 8.0 6.0 4.0 2.0 ** 0.10 0.0 LATUDA Risperidone n=378 n=176 **p=0.001 26
Slide 28: LTSS: Selected Common AEs for LATUDA and Risperidone
LTSS: Selected Common AEs for LATUDA and Risperidone LATUDA Risperidone Adverse Event (n=419) (n=202) Nausea 16.7 % 10.9 % Akathisia 14.3 7.9 Vomiting 10.0 3.3 Weight Increased 9.3 19.8 Somnolence 13.6 17.8 Psychotic Disorder 5.0 7.4 Constipation 1.9 6.9 Dystonia 3.1 5.9 Parkinsonism 4.3 5.4 27
Slide 29: Long Term Safety Trial Summary
Long Term Safety Trial Summary Discontinuation rate was higher for LATUDA vs. risperidone • LATUDA completer rate: 34% • Risperidone completer rate: 44% Effects on weight and glucose for LATUDA suggest benefits from a metabolic risk perspective Minimal elevation in prolactin in LATUDA-treated
Slide 30: Current and Planned LATUDA Studies in Schizophrenia
Current and Planned LATUDA Studies in Schizophrenia Study Timing Purpose Post-Marketing Provide info on impact on patients switching Switch Study in Initiated in Q3 2010 from one atypical Schizophrenia antipsychotic therapy to LATUDA Supports efforts to obtain maintenance Schizophrenia Maintenance S
Slide 31: LATUDA Switch Study in Schizophrenia
LATUDA Switch (Study 289 and 290) in Schizophrenia Open-Label LATUDA 40 LATUDA 40 LATUDA 40-120 mg/d mg/d mg/d (n=70) Screening 6-Month LATUDA 40 LATUDA 80 LATUDA 40-120 mg/d Extension mg/d mg/d (n=70) (Open- Label) LATUDA 80 LATUDA 80 LATUDA 40-120 mg/d mg/d mg/d (n=70) Previous Antipsychotic 50% 0
Slide 32: Agenda
Agenda LATUDA Label Overview • Approval timeline • Label highlights Schizophrenia Program • Overview of results of PEARL studies • Highlights from the PEARL Safety study • Ongoing and planned studies in schizophrenia Bipolar Depression Development Program • Overview of PREVAIL program LATUDA
Slide 33: Bipolar Depression Development Plan: PREVAIL Studies
Bipolar Depression Development Plan: PREVAIL Studies PREVAIL: PRogram to EValuate Antidepressant Impact of LATUDA Ongoing global clinical trials for LATUDA in Bipolar Depression will evaluate effectiveness of LATUDA as • Monotherapy • Adjunct therapy • Maintenance therapy Lower, flexible dose
Slide 34: Agenda
Agenda LATUDA Label Overview • Approval timeline • Label highlights Schizophrenia Program • Overview of results of PEARL studies • Highlights from the PEARL Safety study • Ongoing and planned studies in schizophrenia Bipolar Depression Development Program • Overview of PREVAIL program LATUDA
Slide 35: LATUDA Global Development Plan
LATUDA Global Development Plan United States • Launch in early February 2011 for Schizophrenia • Bipolar depression sNDA planned for 1H/2012 • Other indications under consideration: – Bipolar maintenance: study initiation 3rd Q 2011 (12 months to complete) – MDD with mixed features: study initiati
Slide 36: Disclaimer Regarding Forward-looking Statements
Disclaimer Regarding Forward-looking Statements The statements made in this presentation material are forward-looking statements based on management’s assumptions and beliefs in light of information available up to the day of announcement, and involve both known and unknown risks and uncertainties.
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