Synthon, The Value Chain of a specialty pharmaceutical company

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Synthon, Dirk Pamperin, health Valley Event 2010

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Synthon, The Value Chain of a specialty pharmaceutical company

  1. 1. The value chain of a specialty pharmaceutical company<br />March 17, 2010<br />Dirk Pamperin<br />
  2. 2. Synthon at a Glance<br />Past and future success<br />Building on a history of success in Generic Small Molecules<br />Facts & figures<br />Shaping the future – A compelling strategy<br />Climbing the Pharmaceutical Industry Ladder<br />Life cycle products<br />Biosimilars and New Biological Entities<br />Our Expertise<br />
  3. 3. Building on a history of success in Generic Small Molecules<br />
  4. 4. Building on a history of success <br />Key milestones of Synthon’s journey to success<br />1994 Opening of R&D departments in Prague the Czech Republic<br />1998 Opening of office in Australia<br />1993 Introduction of first product: generic dobutamine<br />1997 Opening of office in North Carolina , USA<br />1998 Acquisition of DP production facility in Spain<br />2003 Introduction simavastatine<br />1991 Founded in The Netherlands<br />2000 Acquisition of DS production facility and offices in Blansko CZ<br />2001 Acquisition of DS production facility and offices in Argentina<br />2006 Introduction tamsulosine<br /> 2007<br /><ul><li>Acquisition of Labs Rider, Chile
  5. 5. New line of business: biopharmaceuticals
  6. 6. Opening of new R&D and production unit in Czech Republic
  7. 7. Opening of office in Russia
  8. 8. Acquisition of Nafar in Mexico</li></ul>2009 - 2010<br />1991<br />1992<br />1993<br />1994<br />1995<br />1996<br />1997<br />1998<br />1999<br />2000<br />2001<br />2002<br />2003<br />2004<br />2005<br />2006<br />2007<br />2008<br />2009<br />
  9. 9. Building on a history of success <br />We are present in key markets worldwide<br />2<br />8<br />6<br />5<br />1<br />9<br />3<br />7<br />4<br />8<br />1<br /><ul><li>1250 employees in 9 countries
  10. 10. 330 employees in Nijmegen</li></ul>7<br />6<br />5<br />4<br />3<br />2<br />
  11. 11. Building on a history of success <br />Turnover<br />In € million<br />
  12. 12. Building on a history of success<br />R&D expenditure has created a strong portfolio<br /><ul><li>Products on the market: 28
  13. 13. Molecules in development: 54 (10 under registration)
  14. 14. More than 130 patent families file (average 12.7 annually)</li></li></ul><li>Building on a history of success<br />Our portfolio continues to be well positioned in Europe<br />
  15. 15. Building on a history of success<br />Value Chain<br />
  16. 16. portfolio<br />selection<br />Building on a history of success<br />Value Chain<br /><ul><li>Focus on specialty generics and biopharmaceuticals
  17. 17. Opportunity evaluation of 100% of marketed products
  18. 18. Strong market knowledge and business intelligence</li></li></ul><li>research /<br />development<br />portfolio<br />selection<br />Building on a history of success<br />Value Chain<br /><ul><li>From active pharmaceutical ingredient (API) to finished product
  19. 19. Own in house development of APIs
  20. 20. Expertise in a wide range of complex dosage forms
  21. 21. First to Market Strategy: Launch as soon as possible
  22. 22. Meeting the need of partners: Early entry and main launch waves</li></li></ul><li>Building on a history of success<br />Value Chain<br />Value Chain<br />research /<br />development<br />portfolio<br />selection<br />intellectual<br />property<br />Map R&D path in IP landscape<br />Patent own developments<br />Develop and support IP launch strategy<br />Ensuring full exploration of IP possibilities<br />
  23. 23. Building on a history of success<br />Value Chain<br />research /<br />development<br />portfolio<br />selection<br />registration<br />intellectual<br />property<br /> Capable of running complex procedures<br /> 30+ countries, 30+ regulatory systems<br /> Worldwide expertise, except Japan<br />95% of our partners rely on our expertise<br /> Strong relationships with authorities<br />Number of Marketing authorizations:<br />Synthon: 600+ in 25 countries<br />Partners: 2000+ in 30 countries<br />
  24. 24. research /<br />development<br />portfolio<br />selection<br />registration<br />production<br />intellectual<br />property<br />Building on a history of success<br />Value Chain<br />Value Chain<br /><ul><li>Own production capabilities for API (Czech Republic, Argentina)
  25. 25. Production site for solid finished dosage (Spain)
  26. 26. Strong and long lasting partnerships with CMOs all over the world</li></li></ul><li>Building on a history of success<br />Value Chain<br />research /<br />development<br />marketing /<br />sales<br />portfolio<br />selection<br />registration<br />production<br />intellectual<br />property<br /><ul><li>Our costumers are partners
  27. 27. We are in business with 90% of generic companies</li></li></ul><li>Building on a history of successOur integrated model delivers for our customersWe support our customers with a strong comprehensive solution<br />World wide regulatory expertise<br />IP expertise<br />Reliable integrated supply<br />R&D excellence<br />Synthon Products<br />
  28. 28. A Compelling Strategy<br />
  29. 29. Ifyoudon’t go forwards, you go backwards<br />
  30. 30. A Compelling Strategy<br />Three dimensions for future success<br />Marketing and Sales activities in emerging market<br />Focus on therapeutic areas<br />Climbing the pharmaceutical ladder<br />
  31. 31. A Compelling Strategy -<br />Climbing the Pharmaceutical Ladder<br />
  32. 32. Climbing the Pharmaceutical Ladder<br />Synthon is founding its new technology platforms form generic small molecule business<br />
  33. 33. Life cycle products <br />Benefit for Patient and health care professional<br />Focus on products in interesting therapeutic areas<br />
  34. 34. Biosimilars– New BiologicalEntities<br />Antibody (glycoprotein) 200-500 timeslargerthenSimvastatin<br />
  35. 35. Biosimilars– New BiologicalEntities<br />Full development versus biosimilar<br />New biopharmaceutical<br />Repeat for every new indication<br />Discovery<br />POC & Safety<br />Dose finding<br />Efficacy & side-effects<br />Full NDA<br />Target discovery and optimization<br />Pre-clinical development<br />Clinical development<br />Phase I<br />Clinical development<br />Phase II a & b<br />Clinical development<br />Phase III<br />Registration<br />Equivalent efficacy<br />Equivalent safety<br />Submission<br />Similarity & Safety<br />Biosimilar<br />One study may be sufficient to obtain approval for all registered indications <br />
  36. 36. Biosimilars<br />Established Infrastructure in Nijmegen<br />Cell line<br />development<br />+<br />Cell banking<br />(MCB, WCB)<br />Single modified cell<br />(best producing cell selected)<br />Transformation<br />USP<br />Expansion<br />Production (bioreactor)<br />Optimized for highest production<br />Cells from WCB<br />DSP<br />Separation (centrifuge / filter)<br />Purification (chromatography)<br />Highest purity, minimal losses<br />
  37. 37. Our expertise<br />
  38. 38. Research and Development<br />Our expertise<br />Chemical and Pharmaceutical Development<br />Pre-clinical development<br />Clinical development<br />Phase I<br />Clinical development<br />Phase II a & b, III<br />Registration<br /><ul><li>Experiences with more than 50 Phase I studies
  39. 39. Large network of experts for numerous indication
  40. 40. Strong operational clinical team
  41. 41. Various technologies
  42. 42. Up scaling and GMP production from small to large scale
  43. 43. Well established relation with US and EU authorities also for scientific advice
  44. 44. Team of experts specialized in preclinical development
  45. 45. Research in Chemistry
  46. 46. Upscaling of synthetic routes
  47. 47. Small, intermediate and large scale production under GMP</li></li></ul><li>Climbing the Pharmaceutical Ladder <br />Yourideamightfit<br /><ul><li>Synthon is an established pharmaceutical company
  48. 48. Brought range of technologies available
  49. 49. Strong teams in all phases of drug development
  50. 50. Open for collaboration</li></li></ul><li>www.synthon.com<br />Synthon BV<br />Microweg 22<br />P.O. Box 7071<br />6503 GN Nijmegen <br />T (+31) 243 727 700<br />pr@synthon.nl<br />The Netherlands<br />

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