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DAVID HARDING CPhI 2008 SHANGHAI JUNE 24–26, 2008 Product Selection for API Manufacturers and Generic Pharmaceutical Companies:A Tool for Success * AGENDA About Thomson Reuters Trends in the global generic and API industry Newport Horizon Premium?: an industry standard for API product selection * 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 RD and Regulatory Affairs API Sourcing Patents Intellectual Property Relied upon by the majority of the world’s generic pharmaceutical companies and API manufacturers * 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 * 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! * 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