Gsk Plc · LSE:GSK
Gsk — ERS Investor & Analyst Event 2014
27 slides from Gsk's conference presentation, Sep 9, 2014
Slide 1: ERS Investor & Analyst Event
ERS Investor & Analyst Event Munich Tuesday 9th September 2014
Slide 2: Darrell Baker, SVP, Global Head of Respiratory
Darrell Baker SVP, Global Head of Respiratory
Slide 3: Agenda
Agenda GSK’s Respiratory Portfolio Darrell Baker, Global Head of Respiratory at 13:45 – 14:00 GSK Eosinophils Research in COPD Professor Neil Barnes, Respiratory Franchise 14:00 – 14:10 Medical Head at GSK Eosinophils – Clinical Professor Ian Pavord, University of Oxford 14:10 – 14:25 Experience in
Slide 4: Respiratory portfolio in transition – new portfolio provides platform for continued market leadership
Respiratory portfolio in transition – new portfolio provides platform for continued market leadership £21bn global respiratory market Breo Ellipta approved & launched Anoro Ellipta approved & launched Incruse Ellipta approved Arnuity Ellipta approved 5 additional products in late stage development •
Slide 5: Breo Ellipta / Relvar Ellipta launches underway
Breo Ellipta / Relvar Ellipta launches underway – Approved in over 50 markets globally – Launched in 19 markets including US (for COPD only), Japan (asthma only), UK, Germany, Denmark, Sweden, Mexico, Chile, Brazil. US BREO NBRx Share 14.0% 12.0% US access building as at July: 10.0% – Commercial: ~5
Slide 6: Anoro Ellipta launches underway
Anoro Ellipta launches underway The first once-daily dual bronchodilator in US for treatment of COPD – Approved in 38 markets globally – Launched in 8 markets including US, Canada, UK, Germany, Chile, Denmark & Japan US ANORO NBRx Share 0.12 0.1 US access building as at July: 0.08 – Commercial: ~75%
Slide 7: Upcoming catalysts in our respiratory franchise
Upcoming catalysts in our respiratory franchise – Incruse approved in US and Europe – launch anticipated by end of the year – Arnuity approved in US – launch anticipated in 2015 – Mepolizumab severe asthma filing by end of 2014 – Phase 3 studies commenced in Eosinophilic Granulomatosis with Polyangi
Slide 8: Seretide comparator study DB2116134: Anoro Ellipta vs. Seretide
Seretide comparator study DB2116134 Anoro Ellipta vs. Seretide – A 12-week, randomised, double-blind, double- Patients and treatment1 dummy, multi-centre study to evaluate the efficacy – Patients were randomised to Anoro Ellipta 55/22mcg or Seretide 500/50mcg in a 1:1 ratio and safety of Anoro Ellip
Slide 9: Anoro Ellipta significantly improved FEV1 compared with Seretide
Anoro Ellipta significantly improved FEV1 compared with Seretide Primary endpoint: WM FEV1 (0–24h) on Least squares mean changes in WM FEV1 (0–24h) Day 84 from baseline on Day 841 – Anoro Ellipta showed a statistically significant improvement in mean change from baseline WM FEV1 (0–24h) compared wit
Slide 10: Patient profiles for the new portfolio
Patient profiles for the new portfolio 10
Slide 11: Steven Yancey, Medicine Development Leader, mepolizumab
Steven Yancey Medicine Development Leader, mepolizumab
Slide 12: Objectives/design of the Phase III asthma programme
Objectives/design of the Phase III asthma programme MEA115588 (MENSA) To evaluate the efficacy of mepolizumab 75 mg intravenous (i.v.) or 100 mg subcutaneous (SC) every 4 weeks versus placebo on the frequency of clinically significant exacerbations in adult and adolescent subjects with severe eosino
Slide 13: Asthma and eosinophilic inflammation
Asthma and eosinophilic inflammation Over-expression of eosinophils 13
Slide 14: MENSA: Design and patient identification
MENSA: Design and patient identification Primary Run-in period Efficacy Week -1 to -6 Investigational Product Administered Endpoint Week 0 4 8 12 16 20 24 28 32 40 Visit 2 3 4 5 6 7 8 9 10 Follow-up Visit 2 Visit 1 Random Screen Assignment 1:1:1 Mepolizumab 75mg IV and Placebo SC Mepolizumab 100mg S
Slide 15: Results: Primary Endpoint – Reduction in Exacerbations
Results: Primary Endpoint Reduction in Exacerbations Placebo mepolizumab 75 mg IV mepolizumab 100mg SC Cumulative number of exacerbations p<0.001 Time (weeks) 15
Slide 16: Secondary Endpoint: Changes in Pre-BD FEV1
Secondary Endpoint Changes in Pre-BD FEV1 Placebo mepolizumab 75 mg IV mepolizumab 100mg SC p<0.001 FEV1 (liters) Time (weeks) Errors bars represent 95% CI 16
Slide 17: Secondary Endpoint: Changes in St George's Respiratory Questionnaire
Secondary Endpoint Changes in St George’s Respiratory Questionnaire Placebo 75 mg IV 100 mg SC 0 2 Change from baseline in SGRQ score 4 6 8 9 10 12 14 15.4 16 16 18 6.4 points difference * *p<0.001 7.0 points difference* 17
Slide 18: Key Results by Higher Blood Eosinophil Counts (≥500 cells/µL)
Key Results by Higher Blood Eosinophil Counts (≥500 cells/µL) 18
Slide 19: Summary of Adverse Events
Summary of Adverse Events Placebo mepolizumab mepolizumab IV SC N=191 N=191 N=194 All AEs, n (%) 158 (83) 161 (84) 152 (78) Non-asthma events 157 (82) 161 (84) 152 (78) Asthma worsening 29 (15) 18 (9) 13 (7) Drug-related* 30 (16) 33 (17) 39 (20) Led to withdrawal 4 (2) 0 1 (<1) SAEs, n (%) On-treatm
Slide 20: SIRIUS: Design and patient identification
SIRIUS: Design and patient identification Primary Efficacy Endpoint assessed at week 24 Investigational Product SC every 4 weeks (Exit Visit) Visit 1 Week 0 4 8 12 16 20 24 Visit 2 Visit 3 4 5 6 7 8 9 OCS Optimisation Induction Maintenance OCS Reduction Phase Phase Phase Phase -8 to -3 weeks mepoliz
Slide 21: Results: Primary endpoint of OCS reduction
Results: Primary endpoint of OCS reduction % Reduction 0 10 20 30 40 50 60 100-90 % Reduction Strata <90-75 <75-50 OR= 2.39 (95% CI, 1.25-4.56) P= 0.008 <50-0 Other Placebo Mepolizumab Other: no decrease in OCS dose, or lack of control during weeks 20-24 or withdrawal from treatment 21
Slide 22: Results: Median OCS reduction during the study
Results: Median OCS reduction during the study Placebo Maintenance Median OCS change from baseline (%) phase mepolizumab 100mg SC Optimized dose * 0 4 8 12 16 20 24 Weeks * P=0.007 22
Slide 23: Changes in Asthma Control Questionnaire
Changes in Asthma Control Questionnaire Placebo mepolizumab 100mg SC p=0.004 Mean ACQ-5 Score Time (weeks) 23
Slide 24: Reduction in Exacerbations
Reduction in Exacerbations 32 % reduction* 2.5 Exacerbation rate per year 2 2.2 * P=0.042 1.5 1.4 1 0.5 0 Placebo mepolizumab 24
Slide 25: Summary of Adverse Events
Summary of Adverse Events Number (%) of Patients Adverse Event Type Placebo mepolizumab N=66 N=69 All AEs 61 (92) 57 (83) Non-asthma events 60 (91) 57 (83) Asthma worsening 8 (12) 2 (3) Drug-related* 12 (18) 21 (30) Led to withdrawal from study 3 (5) 3 (4) SAEs On-treatment 12 (18) 1 (1) Fatal 1 (2)
Slide 26: Conclusions – Asthma
Conclusions – Asthma mepolizumab: PhIII data demonstrated potential as an add-on therapy in patients with severe eosinophilic asthma, producing a clinically and statistically significant (~50%) reduction in the exacerbation rate compared with placebo MENSA mepolizumab produced a similar treatment ef
Slide 27: Q&A
Q&A