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


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


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


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


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*


Making Formulation


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*


Making Formulation


Launch

*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

• 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

[email protected]

Industry Trends and Tools for Generic Product Selection KATE KUHRT SHANGHAI JUNE 19-21, 2007.

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