Industry Trends and Tools for Generic Product
Selection
KATE KUHRT
SHANGHAI
JUNE 19-21, 2007
AGENDA
• About Thomson Scientific
• Trends in the global generic and API industries
• The role of information in generic product
development
• Horizon Global™: an industry standard for generic
product selection
ABOUT HORIZON GLOBAL
• An industry standard product selection tool for generic
pharmaceutical companies and API manufacturers.
• High quality, “must have” information for people in:
– Strategy, Planning & Product Targeting
– Business Development & Licensing
– Competitive & Business Intelligence
– R&D & Regulatory Affairs
– API Manufacturing & Sourcing
– Patents & Intellectual Property
GENERICS: A $90B GLOBAL
OPPORTUNITY
Western Europe
$17bn
US, Canada: $50bn
Eastern Europe &
Russia: $10bn
China: $3bn
Japan: $4bn
Rest of World: $4bn
Latin America: $2bn
Total World Pharmaceutical Sales: $600bn
Source: TS Research, IMS Health, VOI PharmaHandbook
FORCES AFFECTING THE WORLD
GENERICS MARKET TODAY
• A growing pressure for brand to generic substitution
• A small number of products coming off patent and a
growing number of competing generic companies
• The rapid increase of mergers and acquisitions
• India: low-cost, high quality finished dose products
• China: low-cost, high quality API and intermediates
• Pipeline growth is now as dependent on licensing as it
is on in-house development
• Early access to API => speed to market => generic
success
LEAGUE TABLES CONSTANTLY SHIFT - 2007
Teva
Sales $M Focus
HQ
8400
Global
Israel
Sandoz
5960
Global
Austria
Hospira
3480
Global
US
Barr
3032
Global
US
Watson
2550
US
US
Merck KGaA
2200
Global
ratiopharm
2000
EU
Germany
Actavis
1835
US
US
Stada
1400
EU
Mylan
1260
Global
US
Ranbaxy
1170
Global
India
Perrigo
1024
US
US
Apotex
770
Global
Canada
Cipla
740
Global
India
Endo
650
US
US
GedeonRichter
600
EU
Hungary
Krka
600
EU
Slovenia
Dr Reddy’s
550
Global
India
Acquired Mayne
Acquired Pliva
Acquired Andrx
Germany Purchase by Mylan expected to close H2 07
Lost Bid for Pliva
Germany Sold US Business
Majority stake in Matrix; Acquiring Merck KGaA
Acquired Betapharm
Source: TS Research
Number of Corporate Groups
AVAILABILITY OF HIGH-QUALITY INDIAN &
CHINESE API
+33
104
120
100
Change from
2006
+7
74
80
India
China
60
40
20
+4
18
+2
25
+2
8
-1
17
0
Established
Less Established Potential Future
Source: Newport Strategies Horizon Global ™
US DMF FILINGS BY INDIAN & CHINESE API
MANUFACTURERS
350
Number of Type II DMFs
306
300
271
250
199
200
150
134
100
50
0
India
China
83
15
26
54
58
41
45
14
86
95
38
28
13
32
44
49
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Source: Newport Strategies Horizon Global ™
NUMBER OF API PLANTS INSPECTED BY THE
US FDA SINCE 1990 IN INDIA $ CHINA
80
70
68
60
60
51
45
50
Indian Ownership
Chinese Ownership
Other Ownership
40
30
18
20
14
10
0
Sites
Groups
Source: Newport Strategies Horizon Global ™
ANDA APPROVALS BY INDIAN GENERICS
120
100
80
Tentative
Final
60
40
20
0
1997
1998 1999
2000 2001
2002 2003
2004 2005
2006
Source: Newport Strategies Horizon Global ™
GENERIC DRUG & API MANUFACTURERS HAVE
MANY QUESTIONS…
What is the patent
or exclusivity
situation?
Who is competing
with us?
What should I develop?
Where do I source
the API?
How big is the market?
Do I partner or
develop alone?
Where should I launch?
Should I focus on
regulated
markets?
THE ROLE OF INFORMATION IN THE
GENERIC BUSINESS
Targeting
L – 8 years
Evaluation
L – 7 years
Deal
Making
Formulation
Dev’t
Registration
& Review
Launch
L – 18 months
L – 6 years
Launch
Target possible candidates for development
Research product candidates in detail
Find the right partners
Make products quickly and safely
Get first approval
Deliver to the customer!
THE ROLE OF INFORMATION IN THE
GENERIC BUSINESS
Targeting
Evaluation
Deal
Making
Formulation
Dev’t
Registration
Launch
& Review
Information Needs - Data
• Sales*
• Dose Form and Strength*
• Patents, Patent Challenges*
• Labeling
• Chemistry, Synthesis
• Data Exclusivity*
• Market Exclusivity*
• Approvals
• API Sources*
• Company Data*
• Manufacturing Capabilities*
• Bioequivalence
• Stability
• Pharmacodynamics
• Toxicity
• Country Regulations*
• Pack Pricing*
• Reimbursement
*Available from Thomson Scientific
THE ROLE OF INFORMATION IN THE
GENERIC BUSINESS
Targeting
Evaluation
Deal
Making
Formulation
Dev’t
Registration
Launch
& Review
Business Needs - Functionality
• Access global market, intellectual property and product info*
• Predict key data in advance (e.g. competitiveness, generic launch date)*
• Flexible, fast searching across multiple, exacting criteria*
• Identify early, viable source of API supply and backup sources*
• Spot in- and out-licensing capabilities*
• Identify potential partner companies with multiple, exacting criteria*
• Keep a watchful eye on potential acquisition targets, track competitors*
*Available from Thomson Scientific
API MANUFACTURERS’ INFO NEEDS
The key question for API Manufacturers:
Which products will generics develop over the next 10+ years?
Data needs
• Market size in kg
• API competitive landscape*
• Manufacturing capabilities*
• Routes of synthesis*
• Intermediates**
• Patents*
• Potential dose partners*
*Available from Thomson Scientific
** Currently in development by Thomson Scientific
HORIZONS GLOBAL: A GENERIC
INDUSTRY STANDARD
• First launched in December 2002
– Version 3.5 released December 2006
– Version 4.0 targeted for summer 2007
• Used by at least 3 of the top 5 companies in every
generic market
– 100+ companies
– 2,500+ users
• Used by API manufacturers to strategically target
products for development, find partners, and attract
customers
HORIZONS GLOBAL: A GENERIC
INDUSTRY STANDARD (cont)
• Designed to meet key generic business needs:
–
–
–
–
–
Target products and companies
Evaluate products and companies
Find early API sources
Identify licensing opportunities
Track competitive developments
• Searchable content includes:
– 10,000 launched APIs
– 18,000 corporate groups and 3,500 API manufacturing
sites
– 92 patent countries
• Incorporates unique intelligence and analysis on
API development
HORIZON GLOBAL IN CHINA
• Horizon Global is already being used at API and
Dose companies in China
• A recent, informal survey of customers in China
revealed:
– Most customers said they used Horizon Global “very
often”, and some said they used Horizon Global “daily”
– The precise search capabilities of Horizon Global help
them:
• Select new projects for development
• Identify new markets and global partners
• Analyze competition
THANK YOU!
Kate Kuhrt
Director, Generics and API Intelligence
Thomson Reuters
215 Commercial Street
Portland, Maine 04101
USA
+ 1 (207) 871-9700 x26
kate.kuhrt@thomsonreuters.com