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Product Selection for API Manufacturers and Generic Pharmaceutical Companies: A Tool for Success

Product Selection for API Manufacturers and Generic Pharmaceutical Companies: A Tool for Success. DAVID HARDING CPhI 2008 SHANGHAI JUNE 24–26, 2008. AGENDA. About Thomson Reuters Trends in the global generic and API industry

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Product Selection for API Manufacturers and Generic Pharmaceutical Companies: A Tool for Success

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  1. Product Selection for API Manufacturers and Generic Pharmaceutical Companies:A Tool for Success DAVID HARDING CPhI 2008 SHANGHAI JUNE 24–26, 2008

  2. AGENDA • About Thomson Reuters • Trends in the global generic and API industry • Newport Horizon Premium™: an industry standard for API product selection

  3. ABOUT THOMSON REUTERS – HEALTHCARE & SCIENCE • Part of the Thomson Reuters Corporation • Acquired Newport Strategies in 2004 • A unique research focus: tracking global generic API development and manufacturing activities • High quality, “must have” information for people in • Strategy, Planning and Product Targeting • Business Development & Licensing • Competitive & Business Intelligence • R&D and Regulatory Affairs • API Sourcing • Patents & Intellectual Property • Relied upon by the majority of the world’s generic pharmaceutical companies and API manufacturers

  4. CONSOLIDATION IN THE INDUSTRY • Current consolidation efforts may affect API manufacturers as more dose companies are becoming backward integrated into API manufacture • Example: Barr’s acquisition of Pliva • Biogenerics • New dose forms • Presence in emerging markets • Access to API • Result: Industry will likely be dominated by a handful of global players plus many small, focused players

  5. EFFECTS OF BACKWARD INTEGRATION INTO API • More control over cost and access to API • Different parts of the value chain may make money in different products • Faster response times • No one plant can make all APIs required by a typical generic • Making just enough for captive use often not economical • Other dose companies wary of buying API from a competitor There is still a need for 3rd party API suppliers!

  6. IMPORTANCE OF API IN PATENT CHALLENGES • Risk of supplier failure is high for companies involved with patent challenges • Even one day of delay can cost the company FTF status • Risk is also high for API manufacturers • Generics may settle with innovators or do deals with other generics who use other API sources • If dose company is backward integrated into API, may switch to internal API source when convenient • If development starts too early, product may be withdrawn from market • Backward integration into API can provide advantages • Coordinated API and dose development • Coordinated regulatory submissions • Speedy addressing of any issues • Improved knowledge of polymorphs

  7. NEWPORT HORIZON PREMIUM: A GENERIC INDUSTRY STANDARD • Launched on March 10, 2008 • NEW version released on June 2, 2008 with Routes of Synthesis covering over 2600 products • Expressly designed to meet key generic business needs • Targeting & evaluating products and companies • Identifying licensing opportunities • Tracking competitive developments • Finding early opportunities! • Covers 10,000 launched products, 12,000 companies and 92 patent countries • Incorporates unique API development intelligence and analysis with Sales, Consumption (kg/IU), Patents and Launched formulations

  8. THANK YOU! David Harding Newport Sales Support Specialist Thomson Reuters 215 Commercial Street Portland, Maine 04101 USA + 1 (207) 871-9700 x27 david.harding@thomsonreuters.com

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