Transcript Japan ppt - Brian Tempest

Why Generic Companies should enter the
Innovator Space
Dr. Brian W Tempest
www.briantempest.com
The Global Generic Summit – Barcelona, Spain
5th March 2009
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Asia’s Share of World GDP (at PPP)
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Asia the Answer for Development Costs
Early discovery leads from USA, Europe or Singapore
Molecular optimisation from India
Toxicology from China, Central Europe, Singapore
Electronic Data Capture India
API Manufacture India
Drug Formulation Manufacture India, USA
Phase 1 Clinical Trials Europe
Phase 2,3 heavy use of India
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Corporate back office India
Indian Companies feel Confident..
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..in a Global Match with USA & China
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Economic Deregulation
source IMF, World Bank
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The Rise of the Indian Middle Class
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Leveraging of Indian Companies
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Innovation & BRICs
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Filings with a Chinese or Indian Inventor
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Pfizer Productivity Plans in 2004
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Pfizer Outsourcing
Year
Plants
R&D % Man O/s
2004A
78
15
8%
2007A
57
10
17%
2009E
44
30%
Source May 2008 Citigroup
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Discovery Services in India
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Manufacturing Units in India
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CTs Worldwide source NIH
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CT Recruitment Attractiveness
index
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Speed of Clinical Trials in India
Patients
Sites
Time
EU
India
85
22
36m
650
5
18m
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Neck Cancer CT
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300 patients, 30 sites
$5.6m EU/USA vs. $ 1.8m plus
30% faster at $800K per day
savings
In 2007 Pfizer carried out 44
CTs at 143 sites in India
involving 1800 patients in
oncology, infectious diseases,
CVS, psychiatry, respiratory
and metabolic diseases . On
par with China.
Source Dr Mattina President R&D
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Sources: CT Outsourcing Conference, 24th July 2007, Mumbai
No. of USA investigators:
2001
2006
26,000
18,000
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Electronic Data Capture in India
% Trials in EDC
Accuracy
2005
2007
- 300 GSK Staff
25%
45%
- 2.2m Clinical Data sheets
- 450 Trials
Savings
Paper
EDC
- No data security issues
$2.8m
$ 0.5m
- Error rate <0.01 / 100k
2004 data
Sources: CT Outsourcing Conference,
24th July 2007, Mumbai
Source: BCG report “Looking Eastward, Sept’2006”
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Toxicology in India
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A Global Deal on Different IP Regions
USD
Per Capita Expenditure on Healthcare 2002
6000
5000
4000
3000
2000
1000
0
USA
Brazil
Thai
China
India
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Sources: World Health Report 2005
16 Indian Healthcare Companies
•Sales Growth 2Q +30% , 3Q +28%
•CRAMS focused companies perform best
•Higher regulatory filings continue
•China supplies reverted to normal cost levels
•M&A activity continues in Europe, Japan, Latam
•Citigroup sees best as Cadila, Cipla, Lupin, Piramal
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The Real Patent Issues in India
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In 2007/8 35,000 patents were filed
By Dec 2008 11,500 patents pending & 15,000
granted
By March 2009 45,000 more patents filed
Ranked 11th in World Patent filings
3rd in PCT filings after S Korea & China
In 2008 number of patent examiners fell from
150 to 118 with 318 vacancies
Lack of patent training institutions
Patent office now hiring 1500 staff
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PCT Filings from Asia in 2006
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Huawei - China
LG – S Korea
Samsung – S Korea
LG – S Korea
Elec Telecom – S Korea
2TE – China
STR – Singapore
Ranbaxy – India
CSIR – India
NHN – S Korea
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Different Global Generic Market Sizes $b
Region
Sandoz
2006
IMS
2008
USA
23
68
West Europe
14
19
East Europe
13
NA
Japan
3
3
Latam/Canada
10
3 (Canada only)
ROW
37
7
Total
100
100
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Emerging Markets $b
Novartis Presentation
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Branded Generics- the analyst’s view
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“Branded Generics are the most
profitable place to be in generics and
there are a few markets with better
branded characteristics than those of
…”
Frances Cloud Nomura September 14 2007
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Downsides to the Asian Scenario
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Potential Challenge – Infrastructure
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Access to Renewable Water
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Indian Beaurocracies a Civil Servant’s office in Patra, India
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In Summary
Asia is an answer to lower development costs
Generic Companies are interested in Innovation
Big Pharma Companies are interested in BRICs
India is particularly strong in Innovation & CTs
CRAMS Indian Companies are more profitable
Branded generics are allied to NCE Promotion
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Thank You
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