Appendix:
24,700
18,000
7,900
5,700
22,800
21,400
11,800
5,600
,0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
Incident cases
Drug treated
indolent 1st-line
Drug treated
follicular 1st-line
Drug treated
follicular
relapsed
Top 5 EU
US
MabThera-Rituxan/GA101:
Follicular Non-Hodgkin’s Lymphoma (NHL)
2
11,300
39,400
19,700
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
20
12
e
st
ima
tes
for
nu
mber
of
pa
tient
s
32,100
20,900
10,400
32,900
19,500
,300
,0
20,000
40,000
60,000
80,000
Incident cases
DLBCL 1st-line
DLCL relapsed
Top 5 EU
US
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
MabThera-Rituxan/GA101:
Diffuse large B-Cell Non-Hodgkin’s Lymphoma (DLBCL)
3
40,400
10,700
Drug treated
20
12
e
st
ima
tes
for
nu
mber
of
pa
tient
s
14,400
8,900
7,000
14,900
10,000
5,400
,0
20,000
40,000
Incident cases
CLL 1st-line
CLL relapsed
Top 5 EU
US
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
MabThera-Rituxan/GA101/GDC-0199:
Chronic Lymphocytic Leukemia (CLL)
4
18,900
12,400
Drug treated
20
12
e
st
ima
tes
for
nu
mber
of
pa
tient
s
Avastin: Colorectal Cancer (CRC)
5
5
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
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)
45,000
40,000
25,500
92,000
78,000
41,500
,0
30,000
60,000
90,000
120,000
150,000
mCRC
1L incidence
mCRC
1L drug treated
mCRC
2L chemo treated
Top 5 EU
US
67,000
118,000
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
6
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)
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
134,000
93,000
51,000
137,000
82,000
56,000
,0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
mNSCLC
incidence
mNSCLC
non-squamous
mNSCLC
1L non-squamous
drug treated
Top 5
EU
107,000
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
45,000
29,000
23,000
43,800
37,400
22,500
,0
20,000
40,000
60,000
80,000
100,000
mBC HER2-negative
incidence
mBC HER2-negative
1L chemo treated
mBC HER2-negative
2L chemo treated
Top 5 EU
US
Avastin
HER2-negative metastatic Breast Cancer (mBC)
7
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)
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
66,400
45,500
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
Avastin: Glioblastoma Multiforme (GBM)
8
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
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)
22,000
11,500
9,100
5,500
27,400
13,700
12,300
7,700
,0
20,000
40,000
60,000
Total diagnosed incident
brain & CNS
Total diagnosed incident
GBM
Avastin-eligible drug
treated incident GBM (1L)
Avastin-eligible drug
treated incident GBM
(Relapse)
Top 5 EU
US
21,400
13,200
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
26,500
17,700
7,000
22,000
18,300
10,000
,0
20,000
40,000
60,000
OC incidence
Front line
chemo treated
2nd line chemo treated
platinum sensitive
Top 5 EU
US
9
Avastin: Ovarian Cancer
** 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.
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 2
nd-line
platinum sensitive ovarian cancer is ~17,000 drug
treated incident Avastin naïve patients (7,000 US/10,000
Top 5 EU)
36,000
17,000
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
10
Avastin: Renal Cell Carcinoma (RCC)
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
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)
15,400
15,100
17,200
13,000
,0
20,000
40,000
Newly diagnosed all RCC
Drug treated incident
stage IV RCC
Top 5 EU
US
28,100
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
231,000
218,000
198,000
186,500
36,000
297,500
238,500
231,000
227,500
34,000
,0
100,000
200,000
300,000
400,000
500,000
600,000
Total BC
incidence
Stage I, II, III Drug treated HER2 tested
HER2+
Top 5 EU
US
Herceptin: HER2+ early Breast Cancer (eBC)
11
The target population for Herceptin in HER2+ early (adjuvant) breast
cancer is ~70,000 patients (36,000 US/34,000 Top 5 EU)
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/.
70,000
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
HER2+ metastatic Breast Cancer (mBC)
12
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)
20
12
Estima
ted
In
ci
de
nce
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
HER2+ Rx opportunities US 5 EU 2L 6,300 7,000 3L 4,700 3,200 4L 3,250 1,500 Adjuvant relapse De Novo 1L Patients (Top5 EU) 6,400 3,300 1L Patients (US) 5,400 2,800
12,000
11,300
2,800
12,000
11,500
3,300
,0
5,000
10,000
15,000
20,000
25,000
Stage IV
HER2 Tested
1L HER2+
De Novo
Top 5 EU
US
21,400
23,300
16,200
17,700
4,400
4,900
37,900
38,500
27,200
34,700
3,500
4,400
,0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2012
2017
2012
2017
2012
2017
Top 5 EU
US
Herceptin: HER2+ 1L metastatic Gastric Cancer
13
Incident advanced
stage patients
HER2 tested
Herceptin eligible
Note: HER2 Testing and eligible assumptions differ between US and 5 EU; Source: GC Forecast Model.
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)
20
12
/2
01
7
estima
tes
for
nu
mbe
r
of
pa
tie
nts
9,300
150,000
80,000
80,000
219,000
144,000
144,000
,0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
Drug treated incident
CRC
Drug treated mCRC
Xeloda eligible mCRC
Top 5 EU
US
40,000
26,000
14,000
US patients
14
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.
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. M. P., et al (2007), Cancer Incidence in Five Continents, Vol. IX, IARC Scientific Publications No. 160, Lyon, IARC
2012
est
ima
tes
for
nu
mber
of
pa
tient
s
1
stline
3
rdline+
2
ndline
224,000
38,000
31,000
31,000
US patients
316,000
100,000
100,000
215,000
93,000
93,000
,0
100,000
200,000
300,000
400,000
500,000
600,000
Drug treated BC
Drug treated mBC
Xeloda eligible mBC
Top 5 EU
US
15
*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
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)
1
stline
3
rdline+
2
ndline
193,000
2012
estima
tes
for
nu
mbe
r
of
pa
tie
nts
134,000
72,000
43,000
28,000
137,000
93,000
51,000
21,000
,0
50,000
100,000
150,000
200,000
250,000
300,000
Incidence mNSCLC*
mNSCLC
1st line
drug-treated
mNSCLC
2nd line
drug-treated
mNSCLC
3rd line
+drug-treated
Top 5 EU
US
Tarceva: Non-Small Cell Lung Cancer (mNSCLC)
16
*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
22
01
2
estima
tes
for
nu
mbe
r o
f
pa
tie
nts
EGFR mutation positive ~ 11% EGFR mutation negative ~ 89%165,000
94,000
EGFR mutation positive ~ 23% EGFR mutation negative ~ 77%5 EU
US
30'000
27'000
15'000
35'000
29'000
9'000
'0
10'000
20'000
30'000
40'000
50'000
60'000
70'000
Total advanced
pancreatic patients
Advanced pancreatic
1st line
Advanced pancreatic
2nd line
Top 5 EU
US
17
Tarceva: Metastatic Pancreatic Cancer
2012
estima
tes
for
nu
mbe
r
of
tre
ated
ne
wl
y
dia
gn
ose
d
or
progresse
d
pa
ncre
atic
ca
nce
r
pa
tie
nts
“Advanced”=Stage IIIB/IV in US and Stage IV in EU
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/.; internal estimates
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)
8,900
4,450
9,200
4,600
,0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
20,000
mM 1st line drug treated
incidence
BRAF mutation positive
Top 5 EU
US
18
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)
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
9,100
20
12
e
stim
ate
s
for
nu
m
be
r
of
pa
tie
nt
s
6,600
4,100
2,100
11,700
10,000
5,000
,0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
20,000
Incidence
(stage IIc and III)
Drug treated incidence
BRAF
mutation positive
Top 5 EU
US
Zelboraf: Adjuvant Melanoma Cancer
19
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)
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
7,100
20
12
e
stima
te
s
for
nu
m
ber
of
patie
nt
s
Erivedge (vismodegib):
Advanced Basal Cell Carcinoma
20
*Basal cell carcinoma is not tracked in most cancer registries, including SEER. Prevalence is estimated from incidence rates reported in literatureand 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
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
28K
40
0
2,400
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)
1,600
2,000
1,200
1'500 K
28 K
800 K
12 K
BCC incidence
Advanced BCC incidence
Top 5 EU
US
40 K
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts (0
00
)
21
MetMAb: Non-Small Cell Lung Cancer (mNSCLC)
*Total metastatic NSCLC newly diagnosed or newly progressed patients
Sources: US information, SEER Annual Cancer Review 1975-2009; 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
20
12
e
stima
tes
for
nu
mbe
r
of
tre
ated
ne
wl
y
dia
gn
ose
d
or
progresse
d
NSC
LC
pa
tie
nts
134'000
72'000
43'100
22'000
28'300
14'150
137'000
93'000
51'000
25'500
21'000
10'500
'0
50'000
100'000
150'000
200'000
250'000
300'000
350'000
Incidence
mNSCLC*
mNSCLC
1st line
drug treated
mNSCLC
2nd line
drug treated
mNSCLC
2nd line
Met Dx+
mNSCLC
3rd line+
drug treated
mNSCLC
3rd line
Met Dx+
Top 5 EU
US
47,500
24,500
Lucentis:
Age-related Macular Degeneration (AMD)
22
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
Of the ~560k patients with wet AMD (wAMD), our potential U.S. target patient population is ~280k
patients in 2012
388,000
224,000
193,000
174,000
109,000
86,000
,0
100,000
200,000
300,000
400,000
500,000
600,000
wAMD
population
Presenting/
diagnosed
population
Treated
population
New patients
Existing patients
562,000
333,000
279,000
20
12
e
sti
m
ate
s
for
nu
m
be
r
of
pa
tie
nts
Lucentis: Diabetic Macular Edema (DME)
23
Of the ~700k patients with DME, we believe our Lucentis U.S. target population is ~170k patients in 2012
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
466,000
245,000
145,000
102,000
234,000
163,000
96,000
68,000
,0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
DME
population
Vision loss
Presenting/
diagnosed
Treated
population
New patients
Existing patients
408,000
170,000
241,000
700,000
20
12
e
sti
m
ate
s
for
nu
m
be
r
of
pa
tie
nts
246,000
30,000
24,300
18,100
42,400
36,000
29,200
21,500
,0
100,000
200,000
300,000
CRVO population Rate of vision loss Presentation/ Diagnosis rate Treatment rateLucentis: Retinal Vein Occlusion (RVO)
2012 estimates for BRVO target population
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
2012 estimates for CRVO target population
•
Of the ~290k patients with CRVO, our potential U.S.
target patient population is 40k patients in 2012
•
Of the ~870k patients with BRVO, we believe our
potential U.S. target patient population is 50k
patients in 2012
288,000
66,000
54,000
40,000
719,600
52,200
27,800
20,600
151,200
83,200
44,200
32,700
,0
200,000
400,000
600,000
800,000
1000,000
BRVO population Rate of vision loss Presentation/ Diagnosis rate Treatment rateExisting patients
New patients
871,000
135,000
72,000
53,000
Rituxan and Actemra:
TNF-IR Rheumatoid Arthritis
25
Our global target population for MabThera/Rituxan
and Actemra in rheumatoid arthritis is ~900k bio
eligible patients.
*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
2012 estimates for target population
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)
1.9
1.5
1.3
0.70
2.0
1.3
1.1
0.19
0
1
2
3
4
Diagnosed
RA
patients
Mod-to-Sev
RA patients
Mod-to-Sev
treated
RA patients
Biologic
treated
US
Top 5 EU
327,000
85,000
371,000
103,400
,0
300,000
600,000
900,000
US
Top 5 EU
BIO-IR (2L+)
DMARD-IR (1L)
(in millions)
20
12
e
stima
tes
for
nu
mbe
r
of
pa
tie
nts
Actemra:
Systemic Juvenile Idiopathic Arthritis (sJIA)
26
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
Sources: US: Q4 2011sJIA Market Research, 2010 sJIA ad-board, CDC NHANES, Global Epi Group, EU5: GHEP Epidemiology
2012 US potential target population
6,000
5,700
5,950
1,480
,0
2,000
4,000
6,000
8,000
10,000
12,000
Prevalent population
Diagnosed and treated
US
EU5
1L ~2.6K 2L ~2.1K 3L ~1.1KUS patients per line
~7,200
20
12
e
stim
ate
s
for
nu
m
be
r
of
pa
tie
nt
s
Rituxan: ANCA-Associated Vasculitis
27
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
2012 US potential target population
41K
Diagnosed
7K
CS
15K
MPA
19K
WG
20K
In
remission
3K Active Tx CS
18K
Active Tx
WG/MPA
Diagnosed AAV patients
in US 2012
Patients by
disease type
Actively treated vs.
In remission
at any given time
•Label from FDA indicated for GPA and MPA only
•Actively treated patients may enter remission
•Patients in remission may re-enter „actively treated‟ upon disease flare-up
Eligible for Rituxan
Xolair: Chronic Idiopathic Urticaria (CIU)
US potential target population
28
2014 U.S. Xolair eligible patients seen by Target MDs = ~78,500 patients
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
961,020
672,714
605,443
441,973
125,078
78,549
,0
200,000
400,000
600,000
800,000
1000,000
Diagnosed CU
Idiopathic
Age 12+
RX treated
Non-responsive
to RX therapy
Seen by
biologic
prescriber
20
14
e
sti
m
ate
s
for
nu
m
be
r
of
pa
tie
nts
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
Xolair: Allergic asthma
2012 U.S. Xolair eligible patients seen by Target MDs = ~382,000 patients
2012 US potential target population
18,552
10,078
4,031
2,217
1,330
,891
,382
,0
5,000
10,000
15,000
20,000
Diagnosed
Asthmatics
(12+)
Treated
Asthmatics
Moderate
and Severe
Uncontrolled
Allergic
Within dosing
table
Seen by ALs,
PUDs, and
select PCPs
Treated 54% Moderate/Severe 40% Uncontrolled 55% IgE Mediated 60% 67% 43%29
Lebrikizumab:
Severe uncontrolled adult asthma
30
Forecasted estimates for target population
10,152
1,442
,793
13,023
4,428
1,204
,0
5,000
10,000
15,000
20,000
25,000
Treated asthmatics
Treated w
high dose ICS
Uncontrolled
Top 5 EU
US
* 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
Schizophrenia
31
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)
Pa
tie
nts (0
00
s)
The target population of diagnosed Schizophrenic patients with residual symptoms is ~2.4M patients
(1,323M US/1,080M EU)
2,375
2,197
1,889
1,323
1,986
1,847
1,588
1,080
,0
1,000
2,000
3,000
4,000
5,000
Schizophrenic
prevalence
Schizophrenics
diagnosed
Treated
schizophrenics
Schizophrenics with
Neg and/or Pos
symptoms
Top 5 EU
US
2012 potential target population
Target patient
population
32
2nd generation anti-CD20:
Relapsing Multiple Sclerosis (RMS)
2012
estima
tes
for
nu
mbe
r
of
pa
tie
nts
Potential target population for 2nd generation anti-CD20 for Relapsing Multiple Sclerosis (RMS)
is ~475,000 patients (250,300 US/223,000 EU)
306,000
250,300
294,000
223,000
,0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
Diagnosed prevalence
Treated population
Top 5 EU
US
~475,000
33
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)
2012
estima
tes
for
nu
mbe
r
of
pa
tie
nts
38,200
18,400
65,000
20,000
,0
20,000
40,000
60,000
80,000
100,000
120,000
Prevalence
Treated population
Top 5 EU
US
~38,400
Alzheimer’s Disease
US target population
Source: Plassman (2007), IMS Claims Data, Internal Roche/GNE Data
No.
of
Pa
tie
nts in 2
01
2
(0
00
s)
The target population of diagnosed, treated Mild, Moderate and Severe Alzheimer‟s patients is ~1,200,000
1,356
,609
,330
1,003
,708
,537
,352
,324
,292
2,711
,0
,500
1,000
1,500
2,000
2,500
3,000
Prevalent
population
Mild & moderate
population
Dx'd
population
Tx'd
population
Alzheimer's
Severe
Moderate
Mild
2012 potential US target population
34
1.2m
Alzheimer’s Disease
5EU target population
35
Source: Plassman (2007), IMS Claims Data, Internal Roche/GNE Data
No.
of
Pa
tie
nts in 2
01
2
(0
00
s)
The target population of diagnosed, treated Mild, Moderate and Severe Alzheimer‟s patients is ~1,200,000
1,403
,630
,341
1,038
,733
,555
,365
,336
,302
2,806
,0
,500
1,000
1,500
2,000
2,500
3,000
Prevalent
population
Mild & moderate
population
Dx'd
population
Tx'd
population
Alzheimer's
Severe
Moderate
Mild
2012 potential EU5 target population
Source: WHO Hepatitis B Department of Communicable Diseases Surveillance and Response Report, WHO/CDS/CSR/LYO/2002.2: Hepatitis B.
HBsAg Prevalence
8% - High
2-7% - Intermediate
<2% - Low
WHO estimate ~350 million global chronic HBV infections
Global prevalence of chronic HBsAg infection
Chronic HBsAg prevalence in Developed
Markets (France, Germany, Italy and USA)
37
Ch
ronic
HBsA
g
pa
tie
nts
(N)
2.5m
2.0m
0.7m
0.8m
,0.0
,0.5
,1.0
,1.5
,2.0
,2.5
,3.0
2010
2025
Chronic anti-HBsAg
Diagnosed chronic anti-HBsAg
Chronic HBsAg prevalence in Emerging
Markets (China [urban], Brazil, Turkey)
Ch
ronic
HBsA
g
pa
tie
nts (N)
88m
51m
41m
24m
,0.0
,20.0
,40.0
,60.0
,80.0
,100.0
2010
2025
Chronic anti-HBsAg
Diagnosed chronic anti-HBsAg
39
Aleglitazar
Objective:
Reduction of CV mortality, non-fatal MI, stroke, following a recent ACS in adults with concomitant T2D.
Number
of
pa
tie
nts wi
th
A
CS
&
T2
D
(e
xclud
ing
CHF
stage
II-IV
, 0
00
‟s
)
Source: Internal Roche and Genentech forecasts using National Center for Health Statistics NHANES (US) and country-specific data (ex-US)
