Appendix: Target population data
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Appendix:
Target population data
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
EU107,000
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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 2nd-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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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)
2012 E
stim
ate
d Incid
ence
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)
2012/2
017 e
stim
ate
s fo
r num
ber
of
patients
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 e
stim
ate
s fo
r num
ber
of
patients
1st line
3rd line+
2nd line 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)
1st line 3rd line+
2nd line
193,000
2012 e
stim
ate
s fo
r num
ber
of
patients
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
22012 e
stim
ate
s fo
r num
ber
of
patients
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 e
stim
ate
s fo
r num
ber
of
treate
d
new
ly d
iagnose
d o
r pro
gre
ssed p
ancre
atic
cancer
patients
“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)
56,000
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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 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
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
2012 est
imate
s fo
r num
ber
of
patients
(000)
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
2012 e
stim
ate
s fo
r num
ber
of
treate
d n
ew
ly
dia
gnose
d o
r pro
gre
ssed N
SC
LC
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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
2012 est
imate
s fo
r num
ber
of
patients
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 rate
Lucentis: 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 rate
Existing patients New patients
871,000
135,000 72,000 53,000
24
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)
2012 est
imate
s fo
r num
ber
of
patients
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
EU51L
~2.6K
2L
~2.1K
3L
~1.1K
US patients per line
~7,200
2012 est
imate
s fo
r num
ber
of
patients
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
2014 est
imate
s fo
r num
ber
of
patients
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
~2,000*
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)
Patients
(000s)
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
~2.4m
32
2nd generation anti-CD20:
Relapsing Multiple Sclerosis (RMS) 2012 e
stim
ate
s fo
r num
ber
of
patients
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
Source: Genentech/Roche internal assumptions
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 e
stim
ate
s fo
r num
ber
of
patients
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
Source: Genentech/Roche internal assumptions
Alzheimer’s Disease
US target population
Source: Plassman (2007), IMS Claims Data, Internal Roche/GNE Data
No. of
Patients
in 2
012 (0
00s)
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
Patients
in 2
012 (
000s)
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
1.2m
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
36
Chronic HBsAg prevalence in Developed
Markets (France, Germany, Italy and USA)
37
Chro
nic
HB
sAg p
atients
(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
2012 potential target population
Chronic HBsAg prevalence in Emerging
Markets (China [urban], Brazil, Turkey) C
hro
nic
HB
sAg p
atients
(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
2012 potential target population
39
Aleglitazar
Objective:
Reduction of CV mortality, non-fatal MI, stroke, following a recent ACS in adults with concomitant T2D.
Num
ber
of
patients
with A
CS &
T2D
(exc
ludin
g C
HF s
tage II-
IV, 000‟s
)
Source: Internal Roche and Genentech forecasts using National Center for Health Statistics NHANES (US) and country-specific data (ex-US)
0
100
200
300
400
500
600
700
800
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Top 5EU
US
Related Documents
