Gsk Plc · LSE:GSK
Gsk — ViiV Healthcare — IAC Analyst Presentation 2012
22 slides from Gsk's conference presentation, Jul 27, 2012
Slide 1: IAC Analyst Presentation
IAC Analyst Presentation David Redfern Chairman, ViiV Healthcare Chief Strategy Officer, GSK July 27, 2012 1
Slide 2: ViiV Healthcare
ViiV Healthcare Dr Dominique Limet CEO, ViiV Healthcare July 27, 2012 2
Slide 3: ViiV Healthcare at a glance
• Equity split of 85% GSK and 15% Pfizer • 100% focused on HIV • £1.6 billion sales in 2011 • 10 HIV medicines across 5 drug classes • 4 compounds currently in Phase II/III • 16 compounds under investigation for development • 530 staff in 18 countries worldwide 3
Slide 4: A Sustainable Business
A Sustainable Business • £1.6 bn of sales in 2011 (CER 1%) • Kivexa/Epzicom (+15% in H1 2012) – Reinstated as preferred initial NRTI-backbone in the IAS-USA Guidelines • Celsentri/Selzentry (+24% in H1 2012) – Continued growth ahead of the 3rd agent market • Selzentry + Epzicom = 57% total (H1 2012)
Slide 5: Our Partnership Approach
Our Partnership Approach • With Shionogi on innovative development programme for integrase inhibitors dolutegravir and ‘744 LAP (Long Acting Formulation) • With the research community – IAS Industry Collaborative Group on HIV Cure – Collaboration for HIV/AIDS Immunological Therapy (CHAIT) • With the
Slide 6: ViiV Healthcare
ViiV Healthcare Dr John Pottage Chief Scientific and Medical Officer ViiV Healthcare July 27, 2012 6
Slide 7: Our Approach to R&D
Our Approach to R&D The Theory The Practice • More consistent flow of new medical entities (NMEs)/ fixed dose Strategy & combinations (FDCs) thanks to 2 Commercial- isation combined pipelines • 2 R&D ‘engines’ • Additional drive to build new GSK Dev Pfizer Dev alliances/business development opportun
Slide 8: Shionogi-ViiV Healthcare Dolutegravir Pivotal Studies
Shionogi-ViiV Healthcare Dolutegravir Pivotal Studies Patient population Headline Data Results DTG regimen non- Treatment naive Reported 2 April 2012 inferior to RAL Presented at IAC 2012 ABC/3TC FDC enabling Reported 11 July 2012 DTG regimen superior to Atripla* INI-resistant 2012 N/A Treatment exp
Slide 9: SPRING-2 data
SPRING-2 data Presented at IAC, Washington DC on 26 July 2012 9
Slide 10: SPRING-2 (ING113086) Study Design
SPRING-2 (ING113086) Study Design ● Phase III, randomized, double-blind, double-placebo, multicenter, parallel- group, non-inferiority study, ART-naive patients ● All arms include 2 NRTI backbone given once daily (ABC/3TC or TDF/FTC) ● Primary endpoint: % <50 c/mL at 48 weeks (“snapshot”) , non-infe
Slide 11: Baseline Characteristics
Baseline Characteristics DTG 50 mg QD RAL 400 mg BID n=411 n=411 Age Median (y) 37 35 Gender Male 85% 86% Race White 84% 86% African American/African heritage 12% 9% Other 4% 5% Baseline HIV-1 RNA Median (log10 c/mL) 4.52 4.58 >100,000 c/mL 28% 28% Baseline CD4+ Median (cells/mm3) 359 362 <200 cells
Slide 12: Virologic Success Over Time
Virologic Success Over Time 100 DTG 88% 90 Proportion <50 c/mL (%) 80 RAL 85% 70 60 50 40 30 20 10 DTG 50 mg QD 0 RAL 400 mg BID BL W4 W8 W12 W16 W24 W32 W40 W48 Week Median (IQR) Change From Baseline CD4+ Cell Count (cells/mm3) W4 W24 W48 DTG 50 mg QD 87 (26, 149) 183 (100, 295) 230 (128, 338) RAL
Slide 13: Treatment Differences (95% CI) at Week 48 by Strata
Treatment Differences (95% CI) at Week 48 by Strata No difference between backbone treatments DTG 50 mg QD RAL 400 mg BID Difference in n=411 n=411 Proportion (95% CI) (DTG - RAL) Number of Responders/Total Assessed Baseline Plasma HIV-1 RNA 267 / 297 (90%) 264 / 295 (89%) 0.4 (-4.5, 5.3) ≤100,000 c
Slide 14: Protocol-Defined Virologic Failure (PDVF)
Protocol-Defined Virologic Failure (PDVF) No Integrase Inhibitor nor NRTI mutations in DTG arm ● Amongst DTG-treated subjects, no integrase nor NRTI mutations were detected through Week 48 DTG 50 mg QD RAL 400 mg BID n=411 n=411 Subjects with PDVF 20 (5%) 28 (7%) IN genotypic results at BL and 8 18
Slide 15: Select Summary of Adverse Events
Select Summary of Adverse Events DTG 50 mg QD RAL 400 mg BID n=411 n=411 n (%) n (%) Grade 2-4 Drug-Related Events 24 (6) 27 (7) Grade 3 2* 5*** Grade 4 2** 0 Serious Adverse Events 29 (7) 31 (8) Drug related 3 5 Arrythmia, hypersensitivity, Convulsion (2), Aphasia, hepatitis hypersensitivity/hepati
Slide 16: Laboratory Results
Laboratory Results Maximum Post-Baseline Emergent Toxicity DTG 50 mg QD RAL 400 mg BID N=411 N=411 Grade 3 – 4 n (%) n (%) Creatine Phosphokinase (CPK) 20 (5) 14 (3) Aspartate Aminotransferase (AST) 11 (3) 9 (2) Alanine Amino Transferase (ALT) 9 (2) 7 (2) Lipase 7 (2) 14 (3) Total Bilirubin 2 (<1) 1
Slide 17: Renal Safety
Renal Safety ● No withdrawals due to renal events ● Small increase in creatinine due to blockade of Cr secretion1 ● DTG does not affect actual glomerular filtration rate (GFR)1 Change in serum creatinine, Mean (+/- SD) Change in creatinine clearance, Mean (+/- SD) Mean change from baseline Mean chan
Slide 18: Summary
Summary ● In this well powered, double blind-double placebo study, once daily DTG was as effective as twice daily RAL, when co-administered with 2 NRTIs over 48 weeks – 88% on DTG were virologically suppressed (<50 c/mL) vs 85% on RAL – DTG is noninferior to RAL with 95% CI: -2.2% to +7.1%; lower en
Slide 19: SINGLE headline data
SINGLE headline data Announced 11July 2012 19
Slide 20: Headline Data from SINGLE trial
Headline Data from SINGLE trial ● SINGLE trial demonstrated superiority of the DTG-based regimen compared to Atripla at 48 weeks* – 88% of study participants on DTG-based regimen were virologically suppressed (<50 copies/mL) vs. 81% on the single tablet regimen Atripla® [difference and 95% CI; 7.4%
Slide 21: Clinical perspective on the SPRING-2 trial
Clinical perspective on the SPRING-2 trial Prof. François Raffi Professor of Infectious and Tropical Diseases, Nantes Medical University Principal Investigator, SPRING-2 July 27, 2012 21
Slide 22: Q&A
Q&A ViiV Healthcare