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Industry Trends and Tools for Generic Product Selection KATE KUHRT SHANGHAI JUNE 19-21, 2007.
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Transcript of Industry Trends and Tools for Generic Product Selection KATE KUHRT SHANGHAI JUNE 19-21, 2007.
Industry Trends and Tools for Generic Product SelectionKATE KUHRT
SHANGHAIJUNE 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
Total World Pharmaceutical Sales: $600bn
US, Canada: $50bn
Latin America: $2bn
Western Europe
$17bn
Rest of World: $4bn
Eastern Europe & Russia: $10bn
Source: TS Research, IMS Health, VOI PharmaHandbook
Japan: $4bn
China: $3bn
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
Source: TS Research
Global IsraelTeva 8400
Global AustriaSandoz 5960
Global GermanyMerck KGaA 2200
EU SloveniaKrka 600
Global USMylan 1260
EU Germanyratiopharm 2000
Global IndiaRanbaxy 1170
EU GermanyStada 1400
Global IndiaCipla 740
US USPerrigo 1024
Global CanadaApotex 770
US USWatson 2550
Global USBarr 3032
EU HungaryGedeonRichter 600
Focus HQSales $M
Global USHospira 3480
Global IndiaDr Reddy’s 550
US USActavis 1835
US USEndo 650
Purchase by Mylan expected to close H2 07
Sold US Business
Lost Bid for Pliva
Acquired MayneAcquired Pliva
Acquired Andrx
Acquired Betapharm
Majority stake in Matrix; Acquiring Merck KGaA
AVAILABILITY OF HIGH-QUALITY INDIAN & CHINESE API
Source: Newport Strategies Horizon Global ™
74
2518
817
104
0
20
40
60
80
100
120
Established Less Established Potential Future
Nu
mb
er o
f C
orp
ora
te G
rou
ps
India
China
+2+4
+2-1
+7
+33
Change from 2006
US DMF FILINGS BY INDIAN & CHINESE API MANUFACTURERS
Source: Newport Strategies Horizon Global ™
14 13
83
134
199
271
306
583841
2645
86
494432
95
28
5415
0
50
100
150
200
250
300
350
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Nu
mb
er o
f T
ype
II D
MF
s
India
China
NUMBER OF API PLANTS INSPECTED BY THE US FDA SINCE 1990 IN INDIA $ CHINA
Source: Newport Strategies Horizon Global ™
1814
45
68
6051
0
10
20
30
40
50
60
70
80
Sites Groups
Indian Ownership
Chinese Ownership
Other Ownership
ANDA APPROVALS BY INDIAN GENERICS
Source: Newport Strategies Horizon Global ™
0
20
40
60
80
100
120
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Tentative
Final
GENERIC DRUG & API MANUFACTURERS HAVE MANY QUESTIONS…
What should I develop?
How big is the market?
What is the patentor exclusivity
situation?
Where do I sourcethe API?
Who is competingwith us?
Do I partner ordevelop alone?
Where should I launch?
Should I focus on regulated markets?
THE ROLE OF INFORMATION IN THE GENERIC BUSINESS
Targeting EvaluationDeal
Making Formulation
Dev’t Registration & Review
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!
LaunchL – 18 monthsL – 8 years L – 7 years L – 6 years
THE ROLE OF INFORMATION IN THE GENERIC BUSINESS
Information Needs - Data
• Manufacturing Capabilities*• Bioequivalence• Stability• Pharmacodynamics• Toxicity• Country Regulations*• Pack Pricing*• Reimbursement
• Sales*• Dose Form and Strength*• Patents, Patent Challenges*• Labeling• Chemistry, Synthesis• Data Exclusivity*• Market Exclusivity*• Approvals• API Sources*• Company Data*
Targeting EvaluationDeal
Making Formulation
Dev’t Registration & Review
Launch
*Available from Thomson Scientific
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*
Targeting EvaluationDeal
Making Formulation
Dev’t Registration & Review
Launch
*Available from Thomson Scientific
THE ROLE OF INFORMATION IN THE GENERIC BUSINESS
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
• 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
HORIZONS GLOBAL: A GENERIC INDUSTRY STANDARD (cont)
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