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

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Presentation on theme: "Industry Trends and Tools for Generic Product Selection KATE KUHRT SHANGHAI JUNE 19-21, 2007."— Presentation transcript:

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

2 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

3 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

4 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

5 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

6 LEAGUE TABLES CONSTANTLY SHIFT - 2007 Source: TS Research

7 AVAILABILITY OF HIGH-QUALITY INDIAN & CHINESE API Source: Newport Strategies Horizon Global ™ +2 +4 +2 +7 +33 Change from 2006

8 US DMF FILINGS BY INDIAN & CHINESE API MANUFACTURERS Source: Newport Strategies Horizon Global ™

9 NUMBER OF API PLANTS INSPECTED BY THE US FDA SINCE 1990 IN INDIA $ CHINA Source: Newport Strategies Horizon Global ™

10 ANDA APPROVALS BY INDIAN GENERICS Source: Newport Strategies Horizon Global ™

11 GENERIC DRUG & API MANUFACTURERS HAVE MANY QUESTIONS… What should I develop? How big is the market? What is the patent or exclusivity situation? Where do I source the API? Who is competing with us? Do I partner or develop alone? Where should I launch? Should I focus on regulated markets?

12 THE ROLE OF INFORMATION IN THE GENERIC BUSINESS Targeting Evaluation Deal 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 months L – 8 yearsL – 7 yearsL – 6 years

13 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 Evaluation Deal Making Formulation Dev’t Registration & Review Launch *Available from Thomson Scientific

14 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 Evaluation Deal Making Formulation Dev’t Registration & Review Launch *Available from Thomson Scientific THE ROLE OF INFORMATION IN THE GENERIC BUSINESS

15 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

16 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

17 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)

18 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

19 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


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