HIV AND VIIV HEALTHCARE - DR DOMINIQUE LIMET, CHIEF EXECUTIVE OFFICER, VIIV HEALTHCARE DR JOHN POTTAGE, CHIEF SCIENTIFIC AND MEDICAL OFFICER, VIIV ...
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HIV and ViiV Healthcare Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare
Overview
1. ViiV Healthcare vision
2. ViiV Healthcare history and operating model
3. HIV market
4. Dolutegravir (DTG)
5. R&D strategy
6. Concluding remarks
2
ViiV Healthcare vision
An ambitious vision
Establish ViiV Healthcare as the leading company
in the HIV market in innovation, sales and reputation
4ViiV Healthcare history and operating model
A rich HIV history joined under a unique model
GSK (85%) ViiV Healthcare shareholding
2009 and Pfizer (15%)
create a joint venture
dedicated to HIV treatments
Shionogi (10%)
2012 The Japanese company
becomes new partner and
shareholder* Highly reliant External support
on GSK from Pfizer and
Dolutegravir era Strategy Shionogi
2013 infrastructure Drug discovery and
First dolutegravir (DTG)
launch in the US development
R&D Medical affairs R&D support
Manufacturing Marketing Manufacturing
Sales
ViiV Healthcare Distribution
Public affairs
2016 (Alliance markets)
acquires BMS’ HIV Global operations
pipeline and Administrative and Resource management
discovery assets functional (HR, IT,
Performance management
Legal, Finance)
*Current shareholding of ViiV Healthcare: GSK 78.3%, Pfizer 11.7%, Shionogi 10% 6End to end operation reliant on the scale and
infrastructure of large Pharma shareholders
3 15 900+ 150
regions – North America, affiliates and a presence in employees employees working in
Europe and International more than 50 countries worldwide Alliance markets*
through GSK
244 222 450+
employees working for employees working for ViiV planned, concluded and active
GSK in R&D for ViiV Healthcare through shared clinical trials since creation,
Healthcare service agreements including BMS acquisitions
*Alliance markets: Agreement with GSK in markets were ViiV Healthcare is not a legal entity 7ViiV Healthcare success to date has evolved in two
phases – First Phase: 2009 - 2013
2009 Re-energised commercial operation and R&D 2013
1. Led the Epzicom/Kivexa turnaround 2. Created an unprecedented development
programme to catapult DTG’s success
30%
25%
Global Quarterly Growth
20%
15%
10%
5%
0%
-5%
Source: GSK reported financial results 8ViiV Healthcare success to date has evolved in two
phases – Second Phase: 2013 - Today
2013 Emerging Leadership: market growth and innovation Today
1) DTG success fuelling ViiV Healthcare growth 2) Commitment to true innovation that
delivers real patient benefit
Split of ViiV Healthcare sales since 2009
Search for
2,500 Prevention Remission
cabotegravir long-acting* and Cure
2,000
Sales in £m
1,500 Long-acting Treatment Regimens
cabotegravir + rilpivirine*
1,000 New MOA
GSK3684934* previously BMS-
Dolutegravir-based Regimens 663068; attachment inhibitor
500 Tivicay and Triumeq Maturation Inhibitors*
Allosteric Integrase Inhibitors*
Combinectin*
0
2009 2010 2011 2012 2013 2014 2015 Legacy ARV Drug Portfolio DTG 2-Drug Regimens
abacavir/lamivudine, dolutegravir/rilpivirine*
maraviroc & others dolutegravir/lamivudine*
Other
Other products
products Epzicom
Epzicom/Kivexa New products
New products
Source: Reported Financial Results
* Note, therapies denoted with an (*) are investigational; safety and efficacy in treating/preventing HIV has not been established 9The HIV market
The HIV epidemic remains a substantial challenge
of our time
36.7 m
people living with
HIV worldwide1
2.1m infections and 1.1m ADULTS WOMEN CHILDREN (A highly dynamic market
HIV market valued at £16 billion in 2015
Reported reason for patients switching to a new therapy as
reported by physicians (N=246)
Dynamic Segment
~15-35% of the market per year 1% Simplification
3% 2% Toxicity
8%
4% Clinical trial inclusion
32% Virological failure
6%
Drug-drug interaction
Initiation (naive) ~5-10%
Patient decision
13%
Lack of adherence
Switch ~10-25%
Pregnancy
31%
Other
Stable segment ~65-85%
Source: IMS MIDAS Database, Ipsos and IMS NBRx, and GSK internal analysis. Carrero-Gras A, et al. J Int AIDS Soc 2014;17(Suppl 3):19819 12The market has been receptive to innovation
and remains a strong opportunity for growth
£16B
£12.7B Tivicay
Prezista
Isentress
3rd agents £5.4B Isentress
3rd agents £5.0B Prezista
Sustiva
Triumeq
STRs Atripla
Atripla
STRs Stribild £5.9B Genvoya
Odefsey
£3.5B Complera
NRTI backbone £4.1B Epzicom/Kivexa NRTI backbone £4.5B Epzicom/Kivexa
Descovy
Truvada Truvada
Generics Generics
2013 2015
Source: IMS MIDAS Database 13Guideline updates drive market evolution
2013 2014 2015 2016
October 2013 DHHS October
November 20142013 recommends
November 2015 integrase July 2016
DHHS inhibitor-based
EACS added DTG regimens including
WHO added DTGDTG IAS
recommends + Epzicom/Kivexa
+Epzicom or +Truvadaas alternative first for ART
as preferred recommends
integrase inhibitor- or +Truvada for
naive patients line treatment initial regimens
based regimens ART naive patients consisting of an
including DTG integrase
+Epzicom or inhibitor plus two
+Truvada as NRTIs
preferred for ART
naive patients
14We have now entered the integrase inhibitor era
INIs represent 46% of the TRx market, a figure that will continue to grow
Core Agent share of US TRxs INI dynamic
(Core Agents only, STRs allocated to Core Agent class) share >70%
Atripla Tivicay in the US and
100% Isentress Complera Stribild Triumeq Genvoya
Launch Launch growing
Launch Launch Launch Launch Launch
90%
80%
Odefsey
70% Launch
60%
50%
40%
30%
20%
10%
0%
Protease inhibitors Non-nucleoside inhibitors Entry inhibitors Integrase inhibitors
Source: IMS NPA Monthly Jul 2016 15Dolutegravir
Amongst integrase inhibitors, DTG stands out
Unprecedented and unmatched clinical Unique product characteristics
trial results
efavirenz Rapid and potent antiviral activity
raltegravir darunavir atazanavir
dolutegravir SUPERIOR SUPERIOR SUPERIOR SUPERIOR
Drug-Drug interactions (DDIs)
High barrier to resistance
(experienced) (naive) (women / naive) In vitro findings supported by Phase III
(naive) data
Few clinically significant DDIs,
Unboosted
DOLUTEGRAVIR Long binding to
wild type integrase
NON INFERIOR Dissociation from mutant IN-
DNA complexes slower vs RAL
(naive) or EVG
Well tolerated
Few discontinuations
Breadth and depth
of clinical trial data
elvitegravir / NON INFERIOR SUPERIOR due to AEs in INI-naïve
DTG superior vs EFV and DRV/r in
clinical trials
cobicistat (naive) (women / naive) treatment-naïve subjects and RAL in
treatment-experienced subjects
NON INFERIOR NON INFERIOR Long half-life;
raltegravir (naive)
(naive) low variability in exposure
DTG (50 mg QD) exposures
19-fold above IC90
SINGLE, FLAMINGO, SPRING 2, SAILING and ARIA were non-inferiority studies with a Long ‘tail’ - drug plasma concentrations
pre-specified analysis for superiority up to 216h post dose
Chart shows primary endpoint outcomes
References: 1. Min S, et al. AIDS 2011;25:1737–45, 2. Walmsley S, et al. N Engl J Med 2013;369:1807–18, 3. Clotet B, et al. Lancet 2014;383:2222–31, 4. Cahn P, et al. Lancet 2013;382:700–8, 5. Raffi F, et
17
al. Lancet,013;381:735–43, 6. Kobayashi M, et al. Antiviral Research 2008;80;213–22, 7. Kobayashi M, et al. Antimicrob Agents Chem 2011;55(20):813-821, 8. Hightower KE, et al. Antimicrob Agents
Chemother 2011;5:4552–9, 9. van Lunzen J, et al. IAS 2011. Abstract TUAB0102, 10. van Lunzen J, et al. Lancet Infect Dis 2012;12:111–8, 11. Elliot E, et al. IWCPHIV 2015. Abstract 13Dolutegravir leads the market as the #1 core agent
Weekly US TRx market share (STR + core agent) – since Tivicay launch
30%
25%
DTG total 19.7%
20%
Competitor
franchise 17.7%
15% Competitor
franchise 15.6%
10% Competitor
Franchise 9.1%
5%
0%
Source: IMS data to 2 September 2016 18
#1 meaning most prescribedAnd the #1 agent in dynamic share in the US
New* Patient Shares by Product Switch/Add Patient Shares by Product
30% (STR+Core agent) 60% (STR+Core agent)
DTG total EXCLUDING conversions1
25% 27% 50%
Competitor DTG total 38%
franchise
20% 22% 40%
Competitor
franchise
15% 30% 34%
Triumeq
13% Triumeq 21%
Tivicay
10% 13% 20%
Tivicay 18%
5% 10%
0% 0%
1 Conversions = switches from Truvada+Sustiva to Atripla, Truvada+Edurant to Complera, Tivicay+Epzicom to Triumeq, Prezista to Prezcobix, Reyataz to Evotaz, Stribild
19
to Genvoya, Complera to Odefsey. ** IMS “New” metric is a proxy for naïve patients. It represents a longitudinal IMS panel of patients with no prior HIV therapy RX in the
last 12 months, and overstates true naïve volume slightly.
Source: IMS NBRX Custom HIV Report 26 August 2016. #1 meaning most prescribed.Already #1 agent in dynamic share in many other
key markets
# 1 in Naïve # 1 in Switch
France
Germany
Italy
Spain
UK
Canada
Japan
Sources: IMS NBRX Custom HIV Report 08/19/2016 (US), Ipsos Scope Aug 2016 (FR, IT, SP, UK, JP), Lemon Wave 4 - June-July 2016 (GER), IMS Rx Dynamics (CA)
20
#1 meaning most prescribedViiV Healthcare is the only company with increasing growth
in HIV over the past 12 months (from +34% to +53%)
HIV Market Growth 12%
70% Global HIV market by value
60%
MAT Market Share
Competitor 1
£9.1bn
Key
54% MAT sales
50% +14% Market share
MAT growth
40% ViiV Healthcare
£3.1bn
30% 18%
Competitor 2 +53%
Competitor 3 £1.7bn
20% Competitor 4 £1.1bn 10%
Competitor 5 £0.9bn 6% +5%
£0.5bn 5% -7%
10% 3% -16%
-22%
0%
-40% -20% 0% 20% 40% 60% 80%
MAT Sales Growth
Source: IMS Health MAT June 2016R&D strategy
Committed to innovation and leadership in HIV
Search for
Prevention Remission
cabotegravir long-acting* and Cure
Long-acting Treatment Regimens
cabotegravir + rilpivirine*
New MOA
GSK3684934* previously
Dolutegravir-based Regimens BMS-663068; attachment inhibitor
Tivicay and Triumeq Maturation Inhibitors*
Allosteric Integrase Inhibitors*
Combinectin*
Legacy ARV Drug Portfolio DTG 2-Drug Regimens
abacavir/lamivudine, dolutegravir/rilpivirine*
maraviroc & others dolutegravir/lamivudine*
*Note, therapies denoted with an (*) are investigational; safety and efficacy in treating/preventing HIV has not been established 23Our belief in the market evolution
2 NRTI backbone Core Agent Core Agent
3rd agent 2 NRTI backbone 1 partner agent
PAST PRESENT FUTURE
24Why can 2-drug regimens (2DR) succeed?
DTG/CAB uniquely positioned for 2DRs
Scientifically viable
Encouraging clinical data
Long term treatments with improved adverse event profile
Unmet medical need
Ageing HIV patient population with co-morbidities
Persistent interest in 2DR research
Market demand
Market receptive to new treatment advances
2DRs have the potential to challenge therapy standard
25ViiV Healthcare integrase inhibitors at the forefront
of the 2DR paradigm shift
Establish DTG as the Challenge the three
leading core agent
in the market drug paradigm
DTG+ DTG+
3TC RPV
CAB+
RPV LA
26Cabotegravir LATTE and LATTE-2 Studies
Durable virologic suppression with oral and long-acting (LA) 2DR
LATTE (oral CAB+RPV) LATTE-2 (LA inj. CAB+RPV)
Week 96 Virologic Outcomes Week 48 Virologic Outcomes
*
Reference: Margolis et al, Lancet Inf Dis 2015;15(10):1145-1155 Margolis D et al., 21st IAC, abstract THAB0206LB, 2016
27
*Cabotegravir + abacavir + lamivudine oralInvestigator initiated 2DR studies
PADDLE
ASPIRE DOLATAV
GARDEL SALT DUALIS
LAMIDOL
ACTG 5353
LPV/r+3TC ATV/r + 3TC DTG+ DRV/r
DTG+ATV/r
DTG+3TC
LPV/r = lopinavir boosted with ritonavir ; DRV/r = darunavir boosted with ritonavir ; ATV/r = atazanavir boosted with ritonavir 28DTG + RPV
Phase III started May 2015
SWORD 1 and 2
Indication Maintenance therapy for adult patients with HIV-1 infection
Number of patients 1,000 virologically suppressed patients
Study design Phase III, randomised, open-label study to assess the safety and efficacy of
switching to DTG + RPV versus continuing current antiretroviral regimen
Primary endpoint The primary endpoint is proportion of patients with plasma HIV-1 RNADTG + 3TC
Phase III started August 2016
GEMINI 1 and 2
Indication Treatment for HIV-1 infection in adults who have not received prior antiretroviral
therapy
Number of patients 1,400 naive patients
Study design Phase III, randomised, multicentre, non-inferiority studies to evaluate the
efficacy, safety, and tolerability of DTG + 3TC QD versus DTG + TDF/FTC FDC
over 148 weeks
Primary endpoint The primary endpoint for these studies is non-inferior antiviral activity measured
by the proportion of participants with plasma HIV-1 RNAA growing body of evidence to support 2DR
2016 2017 2018
INTERNAL STUDIES
SWORD 1 & 2 ▲
GEMINI 1 & 2 ▲
ISS STUDIES*
PADDLE 96 weeks ▲
ACTG 5353 ▲
ASPIRE ▲
DUALIS ▲
LAMIDOL ▲
DOLATAV ▲
Next available congress presentation = ▲
Forward-looking, dependant on data availability
*ISS abstract are best estimates only and subject to change based on investigator decision
31Why innovation should remain a priority in HIV
Maturation
Fusion inhibitor
inhibitor
Protease
inhibitor
CCR5
antagonis
t Protease inhibitor
Attachment RT inhibitor
inhibitor
Integrase Protease
inhibitor inhibitor
Reference: Lataillade et al. CROI 2015, Abstract 114LB 32Concluding remarks
Our strategic priorities to ensure near and long term
success
Continue to drive share in traditional 3 drug regimens through strength of DTG
Create a new paradigm in oral treatment through 2DR
Create a new paradigm in treatment through long-acting therapy
Continue to lead HIV innovation with research that delivers new mechanisms
offering new options for patients most in need
34Q&A
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