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Generics and Biogenerics
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Generics and Biogenerics



PharmaCon 2007

PharmaCon 2007



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Generics and Biogenerics Generics and Biogenerics Presentation Transcript

  • 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
  • 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.
    • Historical Overview (“who we are”)
    • Pharmaceutical Market Performance
    • Generic Pharma Trends
    • Generic Differentiation Strategies  R&D (“what is in it for your”)
    • Concluding Remarks
    Presentation Outline
  • 1928 “Kaštel” d.d. moves to Zagreb
    • 1921 "Kaštel" d.d. (predecessor of PLIVA) was founded in Karlovac by two companies  “Chinoin” from Budapest and “ISIS” from Zagreb
    • Manufacturing of various drugs
    • Manufacturing of various veterinary products, agrochemicals and food stuff
    • Very close collaboration with scientific community from University of Zagreb
    PLIVA Zagreb Prilaz baruna Filipovića PLIVA Zagreb Avenija grada Vukovara Legacy PLIVA 85 Years Dedicated to Health
  • 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
  • Barr Group  Barr & PLIVA Combination Global Generic Pharmaceutical Company
    • Legacy Barr
      • Founded in 1975 (“small private generic company”)
        • ~20-200 employees
        • Very limited R&D activities
        • ~$50 million revenue (US only)
      • 2006 status prior M&A (1993 key turning point)
        • ~2 . 000 employees
        • ~200 R&D scientists (only 6 scientists in 1993)
        • ~$1 billion revenue (US only)
    • New Barr Group
      • “ Founded” in late 2006
        • ~8 . 000 employees
        • ~600 R&D scientists
        • ~$2.5 billion revenue (from over 30 countries across the world)
  • 200 5 Total Market Revenues Rx Drug 200 5 Revenues ($B) ~$230B ~$120B France Germany Italy Spain UK Sources: IMS Health; Marakon Associates -- Excludes some branded generics units Pharmaceutical Market Emerging Markets Growth Rates
  • R&D innovation draught
    • R&D expenditures have doubled since ’99 (  $800M)
    • Time to develop has doubled since the ’60s (  15y)
    • It takes 5-10,000 compounds to result in just one approved drug and only 30 % marketed drugs recover total R&D costs
    Business Performance Big Pharma Protection Strategies are Constantly Evolving
  • Business Performance (cnt’d) Generics Outpace Big Pharma
  • Generic Pharma Trends EU Generics Market Shares
  • 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
  • Generic Pharma Trends (cnt’d) Most Analyst Expect a Decline
  • 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
    • INVENTION  “doing better” & “solving a problem”  all three criteria satisfied  PATENTABLE 
    • DISCOVERY  “knowing more”  NOT PATENATBLE
    Getting a Patent What is a Patent?? NOVEL NON OBVIOUS APPLICABLE three criteria for patentability
  • 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
  • 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.
  • 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, …
  • Proven solid-state expertise: from patents to commercial products PLIVA Generic R&D Know-How Generic Drugs are NOT COPIES!!!
  • Generic Pharma Differentiation Approaches  M&A Consolidation
    • Differentiation Approaches  adding value by focusing on any kind of market exclusivity
      • Target the correct and sustainable product selection paradigms
      • Value-added generics  “barrier-to-entry products” (“specialty generics” & “supergenerics”)
      • Vertical integration  API availability
      • Proactive IP positioning
      • Quality, speed and accuracy in effective R&D execution
    Generic Pharma Differentiation Approaches  R&D is the Future!!
  • Being First is Everything ! !!
    • Speed to develop
    • Appetite/readiness for risk
    • API availability  internal (R&D) vs. sourcing strategies
    • Speed to market
    • Capabilities / technical and business fit
    • Ultra low cost
    • IP awareness and proactive approach
    KSF ! Generic Pharma Key Success Factors (KSF)
  • Origin Paradigm Pharmaceutical Sciences Molecule Size “ Small” “ Big” Molecule Synthesis “ Chem” “ Biotech” “ Traditional” drugs (chemistry) “ Recombinant” drugs (molecular biology & biotechnology) pharmacy
  • 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%
    • Science and technology
    • Educated and motivated people (committed, dedicated and accountable)
    • Modern techniques and technologies
    • Goal oriented
    • Speed and accuracy (“being first is everything”)
    • Team work
    • Effective resource management
    Strategy for Success The Best R&D Paradigm
  • Thank You! “ As soon as you find the key to success, somebody always changes the lock” Tracey Ullman