Generics and Biogenerics


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Generics and Biogenerics

  1. 1. RESEARCH AND DEVELOPMENT OF GENERIC DRUG S Trends and R&D Impact i n Global Pharma Arena PharmaCon 2007 Dubrovnik, May 23 , 2007 Dr Aleksandar Danilovski Head of Global API R&D
  2. 2. Disclaimer This presentation expresses the opinion of the speaker and does not necessarily reflect the views or policies of PLIVA/Barr. All information pertaining to this presentation is from publications.
  3. 3. <ul><li>Historical Overview (“who we are”) </li></ul><ul><li>Pharmaceutical Market Performance </li></ul><ul><li>Generic Pharma Trends </li></ul><ul><li>Generic Differentiation Strategies  R&D (“what is in it for your”) </li></ul><ul><li>Concluding Remarks </li></ul>Presentation Outline
  4. 4. 1928 “Kaštel” d.d. moves to Zagreb <ul><li>1921 &quot;Kaštel&quot; d.d. (predecessor of PLIVA) was founded in Karlovac by two companies  “Chinoin” from Budapest and “ISIS” from Zagreb </li></ul><ul><li>Manufacturing of various drugs </li></ul><ul><li>Manufacturing of various veterinary products, agrochemicals and food stuff </li></ul><ul><li>Very close collaboration with scientific community from University of Zagreb </li></ul>PLIVA Zagreb Prilaz baruna Filipovića PLIVA Zagreb Avenija grada Vukovara Legacy PLIVA 85 Years Dedicated to Health
  5. 5. 1936 First organized research activities initiated in “Kaštel” in collaboration with Professor Vladimir Prelog (later Nobel Prize laureate for chemistry) New R&D Building opened in October 2002 V. Prelog opens first PLIVA R&D (1952) V. Prelog teaching in Zagreb (1936) Legacy PLIVA 70 Years of Continuous Scientific Activities
  6. 6. Barr Group  Barr & PLIVA Combination Global Generic Pharmaceutical Company <ul><li>Legacy Barr </li></ul><ul><ul><li>Founded in 1975 (“small private generic company”) </li></ul></ul><ul><ul><ul><li>~20-200 employees </li></ul></ul></ul><ul><ul><ul><li>Very limited R&D activities </li></ul></ul></ul><ul><ul><ul><li>~$50 million revenue (US only) </li></ul></ul></ul><ul><ul><li>2006 status prior M&A (1993 key turning point) </li></ul></ul><ul><ul><ul><li>~2 . 000 employees </li></ul></ul></ul><ul><ul><ul><li>~200 R&D scientists (only 6 scientists in 1993) </li></ul></ul></ul><ul><ul><ul><li>~$1 billion revenue (US only) </li></ul></ul></ul><ul><li>New Barr Group </li></ul><ul><ul><li>“ Founded” in late 2006 </li></ul></ul><ul><ul><ul><li>~8 . 000 employees </li></ul></ul></ul><ul><ul><ul><li>~600 R&D scientists </li></ul></ul></ul><ul><ul><ul><li>~$2.5 billion revenue (from over 30 countries across the world) </li></ul></ul></ul>
  7. 7. 200 5 Total Market Revenues Rx Drug 200 5 Revenues ($B) ~$230B ~$120B France Germany Italy Spain UK Sources: IMS Health; Marakon Associates -- Excludes some branded generics units Pharmaceutical Market Emerging Markets Growth Rates
  8. 8. R&D innovation draught <ul><li>R&D expenditures have doubled since ’99 (  $800M) </li></ul><ul><li>Time to develop has doubled since the ’60s (  15y) </li></ul><ul><li>It takes 5-10,000 compounds to result in just one approved drug and only 30 % marketed drugs recover total R&D costs </li></ul>Business Performance Big Pharma Protection Strategies are Constantly Evolving
  9. 9. Business Performance (cnt’d) Generics Outpace Big Pharma
  10. 10. Generic Pharma Trends EU Generics Market Shares
  11. 11. BRAND GENERIC Gx+ & BioGx 1.Chemistry 1.Chemistry 1.Chemistry/Biochemistry 2.Manufacturing 2.Manufacturing 2.Manufacturing 3.Controls 3.Controls 3.Controls 4.Labeling 4.Labeling 4.Labeling 5.Testing 5.Testing 5.Testing 6.Preclinical Dev. 6.N/A 6.Preclinical Dev. (abridged) 7.Clinical Dev. 7.Bioequivalance 7.Clinical Dev. (abridged) What are Generic Drugs?? First Definition Quality Safety/Efficacy GENERIC drug INNOVATOR drug bioequivalence efficacy & safety quality, efficacy, safety quality
  12. 12. Generic Pharma Trends (cnt’d) Most Analyst Expect a Decline
  13. 13. What are Generic Drugs?? Second Definition GENERIC drug Basic Patent Expired INNOVATOR drug Basic Patent Not-Expired GENERIC drug INNOVATOR drug bioequivalence efficacy & safety quality, efficacy, safety quality
  14. 14. <ul><li>INVENTION  “doing better” & “solving a problem”  all three criteria satisfied  PATENTABLE  </li></ul><ul><li>DISCOVERY  “knowing more”  NOT PATENATBLE </li></ul>Getting a Patent What is a Patent?? NOVEL NON OBVIOUS APPLICABLE three criteria for patentability
  15. 15. Pharmaceutical Patents What can be Patented (Subject Matter)?? … USE(s) method-of-use dose, route of application, … PROCESS(es) synthesis, crystallization pharmaceutical technology,. PRODUCT(s) solid-state forms (“polymorphism”) drug product (“formulation”), dosage form,… drug substance (“basic patent”) TIME
  16. 16. i PrOH chlatrate Dihydrate PLIVA? ? Amorphous form Crystalline with non- crystalline water Stable mono-hydrate Monohydrate with residual solvents Unstable mono-hydrate Ethanolate Stable anhydrous form Anhydrous solvates New crystalline hydrate (di?) (pilars) RELATED PATENTS (14) September 2001 SOLID-STATE FORMS RELATED PATENTS (30) (Sept. 2001 - Oct. 2005) PURITY ANHY- DROUS MONO- HYDRATE SOLVATES DIHYDRATE PLIVA Stabilized by antioxidant Impurities High purity mono-hydrate Improved stability in impermeable Al containers Tetragonal anhydrous (cryst. ) Stable mono-hydrate Mono with lower hygr. by compaction Ethanolate Azi-hydrates 1,2-propylene-glycol clathrates 2 Novel iPr-solvates Propanolate 1pat. +1appl. Sesquihydr. & monoclinic & ortho-rhombic solv. 5 appl. Monoclinic solvates & Process for dihydrate Single step process for dihydrate Process for non-hygroscopic dihydrate Process for dihydrate (t-BuOH) Dihydrate polymorphs Amorphous via Ortho- rhombic solvates Granted Improved process for monohydrate Anhydrous (by azeotr. dest. - 2 appl. Ethanolate formulation Azi from Cryst. DHL & EtOH/water Degradation products Pfizer Ercros Apotex TEVA Hanmi Chimica Sintetica TEVA Lab. Silanes Wockhardt Pfizer Biochemie Alembic ADAMED Astur Pharma Sandoz Alembic Jubilant Hanmi Chemi Spa.
  17. 17. Atorvastatin Example (exp.2010) Status in 2005 - 557 patent families Second Example ATORVASTATIN (Lipitor ® ) 1 basic 39+36 polymorphs (salts) + processes 91 drug product (formulation); pharmaceutical technology 390 methods-of-use, dosing regimes, …
  18. 18. Proven solid-state expertise: from patents to commercial products PLIVA Generic R&D Know-How Generic Drugs are NOT COPIES!!!
  19. 19. Generic Pharma Differentiation Approaches  M&A Consolidation
  20. 20. <ul><li>Differentiation Approaches  adding value by focusing on any kind of market exclusivity </li></ul><ul><ul><li>Target the correct and sustainable product selection paradigms </li></ul></ul><ul><ul><li>Value-added generics  “barrier-to-entry products” (“specialty generics” & “supergenerics”) </li></ul></ul><ul><ul><li>Vertical integration  API availability </li></ul></ul><ul><ul><li>Proactive IP positioning </li></ul></ul><ul><ul><li>Quality, speed and accuracy in effective R&D execution </li></ul></ul>Generic Pharma Differentiation Approaches  R&D is the Future!!
  21. 21. Being First is Everything ! !! <ul><li>Speed to develop </li></ul><ul><li>Appetite/readiness for risk </li></ul><ul><li>API availability  internal (R&D) vs. sourcing strategies </li></ul><ul><li>Speed to market </li></ul><ul><li>Capabilities / technical and business fit </li></ul><ul><li>Ultra low cost </li></ul><ul><li>IP awareness and proactive approach </li></ul>KSF ! Generic Pharma Key Success Factors (KSF)
  22. 22. Origin Paradigm Pharmaceutical Sciences Molecule Size “ Small” “ Big” Molecule Synthesis “ Chem” “ Biotech” “ Traditional” drugs (chemistry) “ Recombinant” drugs (molecular biology & biotechnology) pharmacy
  23. 23. PLIVA R&D (Zagreb site only) Resources Breakdown in Dec.2006 (total of 186 scientists) FBF; 41; 22% PMF; 60; 31% FKIT; 39; 21% PBF; 27; 15% Medicina; 5; 3% Veterina; 2; 1% FER; 2; 1% Ostali HR; 5; 3% Ostali svijet; 5; 3%
  24. 24. <ul><li>Science and technology </li></ul><ul><li>Educated and motivated people (committed, dedicated and accountable) </li></ul><ul><li>Modern techniques and technologies </li></ul><ul><li>Goal oriented </li></ul><ul><li>Speed and accuracy (“being first is everything”) </li></ul><ul><li>Team work </li></ul><ul><li>Effective resource management </li></ul>Strategy for Success The Best R&D Paradigm
  25. 25. Thank You! “ As soon as you find the key to success, somebody always changes the lock” Tracey Ullman