Synthon, Dirk Pamperin, health Valley Event 2010

1. The value chain of a specialty pharmaceutical company March 17, 2010 Dirk Pamperin

2. Synthon at a Glance Past and future success Building on a history of success in Generic Small Molecules Facts & figures Shaping the future – A compelling strategy Climbing the Pharmaceutical Industry Ladder Life cycle products Biosimilars and New Biological Entities Our Expertise

3. Building on a history of success in Generic Small Molecules

5. New line of business: biopharmaceuticals

6. Opening of new R&D and production unit in Czech Republic

7. Opening of office in Russia

8. Acquisition of Nafar in Mexico2009 - 2010 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

10. 330 employees in Nijmegen7 6 5 4 3 2

11. Building on a history of success Turnover In € million

13. Molecules in development: 54 (10 under registration)

15. Building on a history of success Value Chain

17. Opportunity evaluation of 100% of marketed products

19. Own in house development of APIs

20. Expertise in a wide range of complex dosage forms

21. First to Market Strategy: Launch as soon as possible

23. Building on a history of success Value Chain research / development portfolio selection registration intellectual property Capable of running complex procedures 30+ countries, 30+ regulatory systems Worldwide expertise, except Japan 95% of our partners rely on our expertise Strong relationships with authorities Number of Marketing authorizations: Synthon: 600+ in 25 countries Partners: 2000+ in 30 countries

25. Production site for solid finished dosage (Spain)

28. A Compelling Strategy

29. Ifyoudon’t go forwards, you go backwards

30. A Compelling Strategy Three dimensions for future success Marketing and Sales activities in emerging market Focus on therapeutic areas Climbing the pharmaceutical ladder

31. A Compelling Strategy - Climbing the Pharmaceutical Ladder

32. Climbing the Pharmaceutical Ladder Synthon is founding its new technology platforms form generic small molecule business

33. Life cycle products Benefit for Patient and health care professional Focus on products in interesting therapeutic areas

34. Biosimilars– New BiologicalEntities Antibody (glycoprotein) 200-500 timeslargerthenSimvastatin

35. Biosimilars– New BiologicalEntities Full development versus biosimilar New biopharmaceutical Repeat for every new indication Discovery POC & Safety Dose finding Efficacy & side-effects Full NDA Target discovery and optimization Pre-clinical development Clinical development Phase I Clinical development Phase II a & b Clinical development Phase III Registration Equivalent efficacy Equivalent safety Submission Similarity & Safety Biosimilar One study may be sufficient to obtain approval for all registered indications

36. Biosimilars Established Infrastructure in Nijmegen Cell line development + Cell banking (MCB, WCB) Single modified cell (best producing cell selected) Transformation USP Expansion Production (bioreactor) Optimized for highest production Cells from WCB DSP Separation (centrifuge / filter) Purification (chromatography) Highest purity, minimal losses

37. Our expertise

39. Large network of experts for numerous indication

40. Strong operational clinical team

41. Various technologies

42. Up scaling and GMP production from small to large scale

43. Well established relation with US and EU authorities also for scientific advice

44. Team of experts specialized in preclinical development

45. Research in Chemistry

46. Upscaling of synthetic routes

48. Brought range of technologies available

49. Strong teams in all phases of drug development