Roche Investor Day - Target population data

Transcription

Appendix:
Target population data
2012 estimates for number of patients
MabThera-Rituxan/GA101:
Follicular Non-Hodgkin’s Lymphoma (NHL)
50,000
45,000
39,400
40,000
35,000
22,800
30,000
21,400
25,000
20,000
15,000
10,000
Top 5 EU
19,700
24,700
5,000
11,800
18,000
Incident cases
11,300
5,600
7,900
,0
US
Drug treated
Drug treated
indolent 1st-line follicular 1st-line
5,700
Drug treated
follicular
relapsed
Sources: Cancer Incidence in Five Continents, Vol. IX, Curado. M. P et al (2007), IARC Scientific Publications No. 160, Lyon, IARC;
World Population Prospects; 2008 revision; medium variant; MabThera patient flow model; & patient case market research Q2 2012
Estimates only; US based on Census Bureau, SEER, Mattson Jack TA data, and Q1 2012 Rituxan tracking; GNE Hematology Epi Model
2
MabThera-Rituxan/GA101:
Diffuse large B-Cell Non-Hodgkin’s Lymphoma (DLBCL)
80,000
60,000
32,900
40,000
40,400
Top 5 EU
US
19,500
20,000
32,100
10,700
20,900
,300
10,400
DLBCL 1st-line
DLCL relapsed
,0
Incident cases
Drug treated
3
MabThera-Rituxan/GA101/GDC-0199:
Chronic Lymphocytic Leukemia (CLL)
40,000
20,000
14,900
18,900
Top 5 EU
12,400
10,000
14,400
US
5,400
8,900
7,000
CLL 1st-line
CLL relapsed
,0
Incident cases
Drug treated
4
Avastin: Colorectal Cancer (CRC)
The potential target population for Avastin in first-line colorectal cancer is ~118,000 drug treated
patients (40,000 US/78,000 Top 5 EU); the potential target population in second-line colorectal
cancer is ~67,000 chemo treated patients (25,500 US/41,500 Top 5 EU)
150,000
118,000
120,000
90,000
92,000
78,000
67,000
Top 5 EU
US
60,000
41,500
30,000
45,000
40,000
mCRC
1L incidence
mCRC
1L drug treated
25,500
,0
mCRC
2L chemo treated
Source: US Team analysis and SEER Database 1975-2008. WHO mortality database 2008 http://www.who.int/whosis/whosis/;
World Population Prospects. The 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/; internal estimates
NB: EU Avastin eligibility, no cut is made for patients who are contraindicated for Avastin – all drug treated patients are assumed eligible for Avastin
5
Avastin: Non-Small Cell Lung Cancer (NSCLC)
The potential target population for Avastin in first-line non-small cell lung cancer is
~107,000 non-squamous drug treated patients (51,000 US/56,000 Top 5 EU)
350,000
300,000
250,000
200,000
137,000
150,000
82,000
100,000
50,000
134,000
56,000
93,000
,0
mNSCLC
incidence
107,000
Top 5
EU
mNSCLC
non-squamous
51,000
mNSCLC
1L non-squamous
drug treated
mNSCLC is defined as stage IIIB/IV NSCLC
Sources: SEER Database: Incidence - SEER 17 Regs Research Data (2000-2008) released April 2011; Table 1. Annual Estimates of the Resident Population by Sex and Five-Year
Age Groups for the United States: April 1, 2000 to July 1, 2009 (NC-EST2009-01). U.S. Census Bureau, Population Division. Release Date: June 2010; Table 12. Projections of the
Population by Age and Sex for the United States: 2010 to 2050 (NP2008-T12). Population Division, U.S. Census Bureau. Release Date: August 14, 2008; UHC and Medicare Claims;
1965-2005 Center for Health Statistics smoking trends data. WHO mortality database 2008 http://www.who.int/whosis/whosis/. World Population Prospects. The 2008 Revision. UN
Population Division 2009. http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits; internal estimates
6
Avastin
HER2-negative metastatic Breast Cancer (mBC)
The potential target population for Avastin in first-line HER2-negative metastatic breast cancer
is ~66,400 chemo-treated patients (29,000 US/37,400 Top 5 EU); in second-line HER2-negative
metastatic breast cancer the potential target population is ~45,500 chemo treated patients
(23,000 US/22,500 Top 5 EU)
100,000
80,000
60,000
43,800
37,400
40,000
20,000
66,400
45,500
22,500
Top 5 EU
US
45,000
29,000
23,000
mBC HER2-negative
1L chemo treated
mBC HER2-negative
2L chemo treated
,0
mBC HER2-negative
incidence
Sources: SEER Database,1994 – 2002 (raw incidence by Stage of breast cancer and overall survival rates for metastatic patients), US Census.
WHO, mortality database 2008 http://www.who.int/whosis/whosis/. World Population Prospects. The 2008 Revision. UN Population Division 2009.
http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits
Note: Includes 1L and 2L patient populations only
7
Avastin: Glioblastoma Multiforme (GBM)
The potential target population for Avastin in first-line GBM is ~21,400 Avastin-eligible, drug treated
incident patients (9,100 US/12300 Top 5 EU). The potential target population for Avastin in relapsed GBM
is ~13,200 Avastin-eligible, drug treated incident patients ( 5,500 US/7,700 Top 5 EU)
60,000
Top 5 EU
US
40,000
27,400
21,400
20,000
13,700
22,000
11,500
,0
Total diagnosed incident
brain & CNS
12,300
13,200
7,700
9,100
Total diagnosed incident
Avastin-eligible drug
GBM
treated incident GBM (1L)
5,500
Avastin-eligible drug
treated incident GBM
(Relapse)
Source(s): Institut de vielle sanitaire : http://www.invs.sante.fr/surveillance/cancers/default.htm,
http://www.invs.sante.fr/applications/cancers/projections2010/donnees_localisation/systeme_nerveux_central.pdf, Assoziatione Italiana Registry Tumori:
http://www.registri-tumori.it/cms/, http://info.cancerresearchuk.org/cancerstats/types/pancreas/incidence, Gemeinsames Krebsregister Jahresbericht:
http://www.berlin.de/gkr/publikationen/jahresberichte/,
SEER Cancer Stat Fact Sheet, Cancer of the Brain and Other Nervous System; Mattson Jack Brain Cancer Epidemiology, December 2007, Mattson Jack Cancer Treatment
Architecture, December 2007, Avastin Market Planning primary market research; WHO, mortality database 2008 http://www.who.int/whosis/whosis/; World Population
Prospects. The 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/; internal estimates
Note: Genentech assumes 75%-80% of incident patients are eligible for drug treatment **Avastin for relapsed GBM is not approved in EU
8
Avastin: Ovarian Cancer
The potential target population for Avastin in front
line ovarian cancer is ~36,000 drug treated incident
patients (17,700 US/18,300 Top 5 EU)
The potential target population for Avastin in 2nd-line
platinum sensitive ovarian cancer is ~17,000 drug
treated incident Avastin naïve patients (7,000 US/10,000
Top 5 EU)
60,000
40,000
22,000
36,000
Top 5 EU
18,300
17,000
20,000
26,500
17,700
US
10,000
7,000
,0
OC incidence
Front line
chemo treated
2nd line chemo treated
platinum sensitive
** EU label is FL stage IIIb-IV (GOG-218)US labels expected to reflect eligibility of ICON7 and OCEANS in 1L and 2LPS, respectively
Sources: SEER Database 1975 - 2002 . Mattson-Jack/DaVinci, Cancer!Mpact, December 2006. US Census Update 2008. WHO mortality database
2008 http://www.who.int/whosis/whosis/. World Population Prospects. The 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/.
Roche-Genentech Clinical, Patient Chart Audits, ZS Epidemiological model, 2010.
9
Avastin: Renal Cell Carcinoma (RCC)
The potential target population for Avastin in first-line metastatic renal cell cancer is
~28,100 drug treated incident patients (15,100 US/13,000 Top 5 EU)
40,000
28,100
17,200
20,000
13,000
Top 5 EU
US
15,400
15,100
Newly diagnosed all RCC
Drug treated incident
stage IV RCC
,0
Sources: SEER Database 1975 - 2002 . Mattson-Jack/DaVinci, Cancer!Mpact, December 2006. US Census Update 2008.
WHO mortality database 2008 http://www.who.int/whosis/whosis/; World Population Prospects. The 2008 Revision. UN Population Division
2009. http://esa.un.org/unpp/; internal estimates; Market Planning Quarterly Tracking Studies
10
Herceptin: HER2+ early Breast Cancer (eBC)
The target population for Herceptin in HER2+ early (adjuvant) breast
cancer is ~70,000 patients (36,000 US/34,000 Top 5 EU)
600,000
500,000
400,000
297,500
300,000
238,500
231,000
Top 5 EU
227,500
US
200,000
100,000
231,000
218,000
198,000
186,500
,0
Total BC
incidence
Stage I, II, III Drug treated HER2 tested
70,000
34,000
36,000
HER2+
Source: USA Breast Cancer Epi Model; Curado. M. P. et al (2007), Cancer Incidence in Five Continents, Vol. IX; World Population; HER2
Forecast Model. Prospects. The 2008 Revision. United Nations Population Division 2009. http://esa.un.org/unpp/. 11
HER2+ metastatic Breast Cancer (mBC)
The target US and Top 5 EU population for 1L HER2+
metastatic breast cancer is ~18,000 patients
(6,000 de novo and 12,000 adjuvant relapse)
The target US and Top 5 EU population for 2L-4L
HER2+ metastatic breast cancer is ~26,000
patients (~14,000 US/~12,000 Top 5 EU)
Adjuvant
relapse
De Novo
1L
Patients
(Top5 EU)
6,400
3,300
1L
Patients
(US)
5,400
2,800
2012 Estimated Incidence
25,000
Top 5 EU
20,000
12,000
15,000
11,500
US
HER2+ Rx
opportunities
10,000
5,000
12,000
11,300
,0
Stage IV
HER2 Tested
US
5 EU
3,300
2L
6,300
7,000
2,800
3L
4,700
3,200
4L
3,250
1,500
1L HER2+
De Novo
Source: USA Breast Cancer Epi Model; WHO mortality database 2008 http://www.who.int/whosis/whosis/; World Population Prospects.
The 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/; internal estimates
Stage IV=newly diagnosed cases of stage IV BC; HER2 Forecast Model
12
Herceptin: HER2+ 1L metastatic Gastric Cancer
2012/2017 estimates for number of patients
In 2017, the target population for Herceptin in HER2+ metastatic gastric cancer is
approximately 9,300 eligible patients (4,900 US/4,400 Top 5 EU)
70,000
60,000
50,000
40,000
37,900
38,500
30,000
27,200
Top 5 EU
34,700
US
20,000
10,000
21,400
23,300
2012
2017
16,200
17,700
2012
2017
,0
Incident advanced
stage patients
HER2 tested
9,300
3,500
4,400
4,400
4,900
2012
2017
Herceptin eligible
Note: HER2 Testing and eligible assumptions differ between US and 5 EU; Source: GC Forecast Model.
13
Xeloda: Metastatic Colorectal Cancer (mCRC)
The target population for Xeloda in mCRC is ~224,000 eligible drug treated incident patients (80,000
US/144,000 Top 5 EU). Of the drug treated population, the US target population in first-line and
second-line mCRC is ~40,000 and ~26,000 patients, respectively.
400,000
Top 5 EU
350,000
US
300,000
250,000
219,000
224,000
200,000
150,000
100,000
50,000
144,000
144,000
80,000
80,000
Drug treated mCRC
Xeloda eligible mCRC
US patients
3rd line+
14,000
2nd line
26,000
1st line
40,000
150,000
,0
Drug treated incident
CRC
Drug treated patients=all patients who begin a treatment in a new line of therapy
Source: US Team Analysis, SEER Database 1975 -2006; WHO mortality database 2008 http://www.who.int/whosis/whosis/. World Population Prospects.
The 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits; internal estimates; Curado.
14
M. P., et al (2007), Cancer Incidence in Five Continents, Vol. IX, IARC Scientific Publications No. 160, Lyon, IARC
Xeloda: Metastatic Breast Cancer (mBC)
The target population for Xeloda in metastatic breast cancer in 2012 is ~193,000 eligible drug
treated incident patients (100,000 US/93,000 Top 5 EU)
600,000
US patients
Top 5 EU
500,000
400,000
3rd line+ 1st line
31,000
38,000
US
215,000
300,000
200,000
193,000
316,000
100,000
93,000
93,000
100,000
100,000
Drug treated mBC
Xeloda eligible mBC
2nd line
31,000
,0
Drug treated BC
*Drug treated patients=all patients who begin a treatment in a new line of therapy
Adjuvant HER2- patients are drug treated while metastatic HER2- patients are chemo treated.
Source: US Team Analysis, SEER Database 1975 - 2006. WHO mortality database 2008 http://www.who.int/whosis/whosis/.
World Population Prospects, the 2008 Revision. UN Population Division 2009. http://esa.un.org/unpp/; Internal estimates; Curado. M. P., et al
(2007), Cancer Incidence in Five Continents, Vol. IX, IARC Scientific Publications No. 160, Lyon, IARC
15
Tarceva: Non-Small Cell Lung Cancer (mNSCLC)
EGFR mutation
positive ~ 11%
300,000
Top 5 EU
US
250,000
200,000
5 EU
137,000
EGFR mutation
negative ~ 89%
165,000
150,000
93,000
100,000
50,000
51,000
134,000
72,000
,0
Incidence mNSCLC*
94,000
mNSCLC
1st line drugtreated
43,000
21,000
28,000
mNSCLC
2nd line drugtreated
mNSCLC
3rd line +drugtreated
US
EGFR mutation
positive ~ 23%
EGFR mutation
negative ~ 77%
*Total metastatic NSCLC newly diagnosed or newly progressed drug treated patients
Sources: US information, SEER Annual Cancer Review 1975-2006; US Census; Mattson Jack; UHC and Medicare Claims; IntrinsiQ;
Synovate Tandem. WHO mortality database 2008 http://www.who.int/whosis/whosis/. World Population Prospects. The 2008 Revision.
UN Population Division 2009. http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits; internal estimates
16
Tarceva: Metastatic Pancreatic Cancer
2012 estimates for number of treated
newly diagnosed or progressed pancreatic
cancer patients
The potential target population for Tarceva in first-line metastatic pancreatic cancer is ~60,000 newly
diagnosed and drug treated patients (27,000 US/29,000 Top 5 EU)
70'000
56,000
60'000
50'000
35'000
29'000
40'000
Top 5 EU
30'000
US
20'000
10'000
30'000
9'000
27'000
15'000
'0
Total advanced
pancreatic patients
Advanced pancreatic Advanced pancreatic
1st line
2nd line
“Advanced”=Stage IIIB/IV in US and Stage IV in EU
UN Population Division 2009. http://esa.un.org/unpp/.; internal estimates
17
Zelboraf: 1st line metastatic Melanoma Cancer
The target population for Zelboraf in 1L BRAF mutation positive metastatic melanoma is ~9,100
drug treated patients (4,500 US/4,600 Top 5 EU)
20,000
18,000
16,000
14,000
12,000
9,200
9,100
10,000
8,000
4,600
6,000
4,000
Top 5 EU
US
8,900
4,450
2,000
,0
mM 1st line drug treated
incidence
BRAF mutation positive
Sources: US information from SEER Annual Cancer Review 1975-2008; US Census; WHO mortality database 2008
http://www.who.int/whosis/whosis/. World Population Prospects. The 2008 Revision. UN Population Division 2009.
http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits; internal estimates
18
Zelboraf: Adjuvant Melanoma Cancer
The target population for Zelboraf in BRAF mutation positive stage IIc and III melanoma is
~7,100 drug treated patients (2,100 US/5,000 Top 5 EU)
20,000
18,000
16,000
14,000
12,000
11,700
10,000
10,000
8,000
6,000
4,000
2,000
6,600
US
5,000
4,100
,0
Incidence
(stage IIc and III)
7,100
Top 5 EU
Drug treated incidence
2,100
BRAF
mutation positive
Sources: US information from SEER Annual Cancer Review 1975-2008; US Census; WHO mortality database
Roche-Genentech Clinical, Patient Chart Audits; internal estimates
19
Erivedge (vismodegib):
Advanced Basal Cell Carcinoma
2012 estimates for number of patients (000)
The target population for Erivedge in metastatic and locally advanced basal cell carcinoma is
~40,000 patients (28,000 US/ 12,000 Top 5 EU)
2,400
2,000
800 K
1,600
1,200
Top 5 EU
1'500 K
US
40 K
40
12 K
28K
28
K
0
BCC incidence
Advanced BCC incidence
*Basal cell carcinoma is not tracked in most cancer registries, including SEER. Prevalence is estimated from incidence rates reported in literature
and primary market research.
Source: US BCC Market Sizing Study, W4 2012 & EU5 Market Sizing Study, 2011. Lucas RM et al: Global burden of disease from solar ultraviolet
radiation. In: Prüss-Üstün et al (eds.) Environmental Burden of Disease Series No 13. Geneva: WHO 2006; WHO mortality database
Roche-Genentech Clinical, Patient Chart Audits; internal estimates
20
2012 estimates for number of treated newly
diagnosed or progressed NSCLC patients
MetMAb: Non-Small Cell Lung Cancer (mNSCLC)
350'000
Top 5 EU
300'000
US
250'000
200'000
137'000
47,500
150'000
100'000
50'000
24,500
93'000
51'000
134'000
72'000
'0
Incidence
mNSCLC*
mNSCLC
1st line
drug treated
43'100
25'500
22'000
21'000
28'300
10'500
14'150
mNSCLC
2nd line
drug treated
mNSCLC
2nd line
Met Dx+
mNSCLC
3rd line+
drug treated
mNSCLC
3rd line
Met Dx+
*Total metastatic NSCLC newly diagnosed or newly progressed patients
UN Population Division 2009. http://esa.un.org/unpp/. Roche-Genentech Clinical, Patient Chart Audits; internal estimates
21
Lucentis:
Age-related Macular Degeneration (AMD)
Of the ~560k patients with wet AMD (wAMD), our potential U.S. target patient population is ~280k
patients in 2012
600,000
500,000
562,000
Existing patients
174,000
400,000
333,000
300,000
200,000
New patients
109,000
388,000
100,000
279,000
86,000
224,000
193,000
Presenting/
diagnosed
population
Treated
population
,0
wAMD
population
Source: Klein R et al. Fifteen-year cumulative incidence of age-related macular degeneration: the Beaver Dam Eye Study. Ophthalmology 2007
Feb;114(2):253-262; Klein R et al. Prevalence of age-related macular degeneration in the US population. Arch Ophthalmol 2011 Jan;129(1):75-80;
US Census; Roche-Genentech Clinical, Patient Chart Audits, 2007 wAMD Buying Process; internal estimates
22
Lucentis: Diabetic Macular Edema (DME)
Of the ~700k patients with DME, we believe our Lucentis U.S. target population is ~170k patients in 2012
700,000
600,000
700,000
New patients
Existing patients
234,000
500,000
408,000
400,000
163,000
300,000
200,000
466,000
245,000
100,000
241,000
96,000
170,000
68,000
145,000
102,000
Presenting/
diagnosed
Treated
population
,0
DME
population
Vision loss
Sources: Bressler NM, Varma R, Doan Q, et al. Prevalence of Visual Impairment from Diabetic Macular Edema and Relationship to Eye Care from
the 2005-2008 National Health and Nutrition Examination Survey (NHANES) extrapolated to 2012; The Retina Society 45th Annual Scientific
Meetings, Washington, DC; October 4−7, 2012 (accepted for presentation); Eye Diseases Prevalence Research Group (EDPRG) paper April 2004;
2008 DME Buying Process; Roche-Genentech Clinical, Patient Chart Audits; internal estimates
23
Lucentis: Retinal Vein Occlusion (RVO)
• Of the ~290k patients with CRVO, our potential U.S.
target patient population is 40k patients in 2012
2012 estimates for CRVO target population
300,000
288,000
• Of the ~870k patients with BRVO, we believe our
potential U.S. target patient population is 50k
patients in 2012
2012 estimates for BRVO target population
1000,000
871,000
42,400
800,000
151,200
200,000
600,000
246,000
400,000
100,000
66,000
36,000
30,000
,0
CRVO
population
Rate of
vision loss
54,000
29,200
24,300
40,000
21,500
18,100
Presentation/ Treatment rate
Diagnosis rate
719,600
200,000
,0
BRVO
population
Existing patients
135,000
72,000
83,200
52,200
53,000
44,200
27,800
32,700
20,600
Rate of
vision loss
Presentation/ Treatment rate
Diagnosis rate
New patients
BRVO=Branch Retinal Vein Occlusion; CRVO=Central Retinal Vein Occlusion.
Source: Klein R et al. The 15-year cumulative incidence of retinal vein occlusion: the Beaver Dam Eye Study. Arch Ophthalmol 2008 Apr;126(4):513-518; Klein R
et al. The epidemiology of retinal vein occlusion: the Beaver Dam Eye Study. Trans Am Ophthalmol Soc 2000;98:133-141; discussion 141-143; The Branch Vein
Occlusion Study Group. (1984). Am J Ophthalmol, 98(3), 271-82; 2008 RVO Buying Process Research; Roche-Genentech Clinical, Patient Chart Audits; internal
estimates
24
Rituxan and Actemra:
TNF-IR Rheumatoid Arthritis
Our global target population for MabThera/Rituxan
and Actemra in rheumatoid arthritis is ~900k bio
eligible patients.
Top 5 EU: Target population for MabThera is Bio-IR
(2L+: 85k), for ACTEMRA it is all biologics (~190k)
US: Target Population for Rituxan and Actemra* is BIO IR
(2L+: ~330k)
2012 estimates for target population
(in millions)
4
3
US
900,000
BIO-IR (2L+)
DMARD-IR (1L)
Top 5 EU
2.0
600,000
1.3
2
371,000
1.1
300,000
1
1.9
1.5
1.3
0.19
327,000
103,400
85,000
US
Top 5 EU
0.70
0
,0
Diagnosed
RA
patients
Mod-to-Sev Mod-to-Sev
RA patients
treated
RA patients
Biologic
treated
*1st line indication pending FDA approval in October 2012
US Sources: 2011 Equinox EPI Research and Modeling, 2011 survey of published RA epidemiology literature including 2010 US based study,
2011 literature review of most recent sources (2008-2010), primary market research 2010-2011 (Rheum ATU, GfK rheum report, Synovate Chart
Audit, Adelphi, Decision Resources, etc.), Claims data analysis (2011); Updated for BP2012
5EU Sources: RA Bio-Population alignment (based on BlackSwan assessment); RA Tracker Adelphi & Genactis 2011 and 2012
25
Actemra:
Systemic Juvenile Idiopathic Arthritis (sJIA)
US: The target sJIA patient population is estimated to be ~5,700 who are eligible for treatment with
Actemra – the first and only FDA approved therapy
EU5: The bio eligible sjIA sjIA target population is estimated to be ~1,500 patients
2012 US potential target population
US patients per line
12,000
2L
~2.1K
US
10,000
5,950
8,000
EU5
~7,200
1L
~2.6K
3L
~1.1K
1,480
6,000
4,000
6,000
5,700
Prevalent population
Diagnosed and treated
2,000
,0
Sources: US: Q4 2011sJIA Market Research, 2010 sJIA ad-board, CDC NHANES, Global Epi Group, EU5: GHEP Epidemiology
26
Rituxan: ANCA-Associated Vasculitis
• Actively treated patients may enter remission
• Label from FDA indicated
for GPA and MPA only
19K
WG
41K
Diagnosed
Eligible
for
Rituxan
18K
Active Tx
WG/MPA
3K Active Tx CS
15K
MPA
7K
CS
Diagnosed AAV patients
in US 2012
• Patients in remission may re-enter „actively
treated‟ upon disease flare-up
Patients by
disease type
20K
In
remission
Actively treated vs.
In remission
at any given time
GPA=Granulomatosis with polyangiitis, MPA=Microscopic polyangiitis, CS=Churg-Strauss syndrome, ANCA=antineutrophil cytoplasmic antibodies
Source: Triangulation and analysis using multiple published studies and primary market research, including:
Watts, et al. Epidemiology of ANCA-associated Vasculitis. Rheumatic Disease Clinics of North America. 2010, August; 36 (3): 447-461;
Koldingsnes, et al. Epidemiology of ANCA associated vasculitis. Norsk Epidemiologi 2008; 18 (1): 37-48; Rituxan AAV Forecast Research, January 2011;
Rituxan GPA/MPA Opportunity Assessment, February 2012
27
Xolair: Chronic Idiopathic Urticaria (CIU)
US potential target population
2014 U.S. Xolair eligible patients seen by Target MDs = ~78,500 patients
1000,000
961,020
800,000
672,714
600,000
605,443
441,973
400,000
200,000
125,078
78,549
,0
Diagnosed CU
Idiopathic
Age 12+
RX treated
Non-responsive
to RX therapy
Seen by
biologic
prescriber
Sources include: CIU Market Research with physicians (Q2 2012), Genentech Burden of Illness Report (2010), Greaves (2007), Tong (1997),
Kaplan (2002), Najib (2009), Xolair team input
28
Xolair: Allergic asthma
2012 U.S. Xolair eligible patients seen by Target MDs = ~382,000 patients
20,000
18,552
Treated
54%
15,000
10,078
10,000
Moderate/Severe
40%
4,031 Uncontrolled
5,000
55%
2,217
IgE Mediated
60%
1,330
67%
,891
43%
,382
,0
Diagnosed
Asthmatics
(12+)
Treated
Asthmatics
Moderate Uncontrolled
and Severe
Allergic
Within dosing Seen by ALs,
table
PUDs, and
select PCPs
Sources include: US Department of Health & Human Services, Vital & Health Statistics, Dec 2006, Trends in Asthma Morbidity &
Mortality, August 2007, REACT, AAAAI, TENOR, IMS Dx. Updated prevalence based on CDC Data Jan 2011
29
Lebrikizumab:
Severe uncontrolled adult asthma
Forecasted estimates for target population
25,000
20,000
15,000
13,023
Top 5 EU
US
10,000
5,000
10,152
4,428
1,442
,0
Treated asthmatics
Treated w
high dose ICS
~2,000*
1,204
,793
Uncontrolled
* Lebrikizumab eligible patients (periostin high) are a subset of this population
Sources: US Department of Health & Human Services, Vital & Health Statistics, Dec 2006, Trends in Asthma Morbidity & Mortality, August 2007,
REACT, AAAAI, TENOR, IMS Dx. Updated prevalence based on CDC Data Jan 2011, Phase II MLLY trial, January 2011 Market Research
30
Schizophrenia
The target population of diagnosed Schizophrenic patients with residual symptoms is ~2.4M patients
(1,323M US/1,080M EU)
2012 potential target population
5,000
Target patient
population
Patients (000s)
4,000
1,986
3,000
1,847
1,588
2,000
1,000
~2.4m
1,080
2,375
2,197
1,889
Top 5 EU
US
1,323
,0
Schizophrenic
prevalence
Schizophrenics
diagnosed
Treated
schizophrenics
Schizophrenics with
Neg and/or Pos
symptoms
Sources: Decision Resources, Data Monitor, Roche Epidemiology Group
US Sources: McGrath et. al., 2008 (Prevalence); Adelphi time to mortality data (Diagnosed); WK PLD Analysis 2010, Adelphi Database 2010,
Weiden & Olfson et al., 1990, ECA, 1991, Internal Patient Flow Model (Treatment Rate); Internal Schizophrenia Chart Audit (residual symptoms)
31
2nd generation anti-CD20:
Relapsing Multiple Sclerosis (RMS)
Potential target population for 2nd generation anti-CD20 for Relapsing Multiple Sclerosis (RMS)
is ~475,000 patients (250,300 US/223,000 EU)
700,000
600,000
500,000
400,000
~475,000
294,000
223,000
300,000
200,000
100,000
Top 5 EU
US
306,000
250,300
,0
Diagnosed prevalence
Source: Genentech/Roche internal assumptions
Treated population
32
2nd generation anti-CD20:
Primary Progressive Multiple Sclerosis (PPMS)
Potential target population for 2nd generation anti-CD20 for Primary Progressive Multiple Sclerosis
(PPMS) is ~ 38,400 patients (18,400 US/20,000 EU5)
120,000
100,000
80,000
65,000
Top 5 EU
60,000
~38,400
40,000
US
20,000
20,000
38,200
18,400
,0
Prevalence
Source: Genentech/Roche internal assumptions
Treated population
33
Alzheimer’s Disease
US target population
The target population of diagnosed, treated Mild, Moderate and Severe Alzheimer‟s patients is ~1,200,000
2012 potential US target population
No. of Patients in 2012 (000s)
3,000
Alzheimer's
,352
2,500
2,000
1,500
Severe
Moderate
1,003
2,711
1,000
,324
1.2m
,708
,292
1,356
,500
,537
,609
,0
Prevalent
population
Mild & moderate
population
Source: Plassman (2007), IMS Claims Data, Internal Roche/GNE Data
Mild
Dx'd
population
,330
Tx'd
population
34
Alzheimer’s Disease
5EU target population
The target population of diagnosed, treated Mild, Moderate and Severe Alzheimer‟s patients is ~1,200,000
2012 potential EU5 target population
No. of Patients in 2012 (000s)
3,000
,365
2,500
2,000
1,500
Alzheimer's
Severe
Moderate
1,038
2,806
1,000
,336
1.2m
,733
,302
1,403
,500
,555
,630
,0
Prevalent
population
Mild & moderate
population
Source: Plassman (2007), IMS Claims Data, Internal Roche/GNE Data
Mild
Dx'd
population
,341
Tx'd
population
35
Global prevalence of chronic HBsAg infection
HBsAg Prevalence
8% - High
2-7% - Intermediate
<2% - Low
WHO estimate ~350 million global chronic HBV infections
Source: WHO Hepatitis B Department of Communicable Diseases Surveillance and Response Report, WHO/CDS/CSR/LYO/2002.2: Hepatitis B.
36
Chronic HBsAg prevalence in Developed
Markets (France, Germany, Italy and USA)
Chronic HBsAg patients (N)
,3.0
,2.5
2.5m
2.0m
,2.0
,1.5
,1.0
0.7m
0.8m
,0.5
,0.0
2010
Chronic anti-HBsAg
2025
Diagnosed chronic anti-HBsAg
37
Chronic HBsAg prevalence in Emerging
Markets (China [urban], Brazil, Turkey)
Chronic HBsAg patients (N)
,100.0
88m
,80.0
,60.0
,40.0
51m
41m
24m
,20.0
,0.0
2010
Chronic anti-HBsAg
2025
Diagnosed chronic anti-HBsAg
Aleglitazar
Number of patients with ACS & T2D
(excluding CHF stage II-IV, 000‟s)
Objective:
Reduction of CV mortality, non-fatal MI, stroke, following a recent ACS in adults with concomitant T2D.
800
700
600
500
400
300
Top 5EU
US
200
100
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Source: Internal Roche and Genentech forecasts using National Center for Health Statistics NHANES (US) and country-specific data (ex-US)
39

Roche Investor Day - Target population data

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