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Big Pharma? Clotilde Bourdon        Olivia Scaccia  Pauline Fontaine              Antoine Henninot
Teva’s id Headquarters : PetakTikva, Israel Stock exchange : Nasdaq                                      SEAQ International London Francfort                                       Tel-Aviv Sector: Generics, Brandeddrugs, Brands One of the 20-largestpharmaceuticalcompanies in the world Operating in ≥60 countries, 38 000 employees
Teva and its concurrents
Teva: public on the Tel Aviv Stock Exchange Imported medicines trough Jerusalem only source of treatments for the local market History of the company   1901 1930 WW II 1948 1951 Teva: pharmaceutical  industry Israel state
TevaPhcal Industries, Israel’slargestdrugmaker 2nd innovativedrug, ttt PD History of the company (2)  July 2006 Acquisition of Ikapharm, and othercompanies 1960-70 1980-90 1996 2005 Acquisition of IVAX QVAR®, ProAirHFA®
MHRA: expanded label for  Copaxone + Laquinimod: « fasttrack » designation (FDA) History of the company (3)  StrategicR&D agreement with JexysPhctls Acquisition of Barr Phtcal Launchitsgeneric version of the birth control pillYasmin Joint venture withLonza Group to marketbiosimilars Jan 2009 Dec 2008 Dec 2008 Feb 2009 Aug 2009
Strategy Increasing generic Market Share Increase organic growth through R&D Redefining Customer Service Intellectualproperty Biopharmaceuticals Vertical integration Horizontal integration
Strategy based on Diversification :  ,[object Object]
Geographical
Therapeutic areas
Pharmaceutical technologyManagement’s flexibility + ability to react to changing market conditions Dynamism
UNBRANDEDGENERICS
Context : growth in generics
 Expanding generic market
Teva: The king of generic drugs Largest generic pharmaceutical manufacturer in the world 22% of all generic prescriptions in the U.S =>  Teva Pharmaceutical Industries is swallowing Big Pharma's market share! ,[object Object],[object Object]
Opportunities for Teva drugs will lose patent exclusivity (Atorvastatin Calcium – 12.4 billion in sales) Hatch-Waxman Act -> + 6 months of sales exclusivity lawyers looking for patent weaknesses => Lotrel (amlodipine) elements of the patent  => public domain => $330 million in 6 months FDA 218 applications of generics;  Teva is challenging the patents of more than half of them      => Most robustgeneric pipeline => Big Pharma isn't happy about the way Teva operates
BRANDED GENERICS
RespiratoryProducts 2005 : acquisition of  IVAX QVAR® (beclomethasonedipropionate HFA): maintenance treatment of asthma ProAirHFA®(albuteral sulfate): relieves the symptoms of bronchospasms =>  leading competitor in the field of respiratory therapy
RespiratoryProducts Asthma, COPD , Allergic rhinitis Easi-Breathe®, breath-activated inhaler (BAI),  Spiromax™/Airmax™, a multi-dose dry powder inhaler, Steri-Nebs™, the blow-fill-seal based nebulizers,  Cyclohaler®, a single dose dry powder device ,[object Object]
Match patient’s needs : ease of use and effectiveness
+++ compliance,[object Object]
Women’sHealth Barr Pharmaceutical Plan B™ OTC/Rx(levonorgestrel) emergency oral contraceptive, Enjuvia™ (syntheticconjugatedestrogens, B) hormone therapyto treat moderate-to-severe vulvar and vaginal atrophy associatedwithmenopause, Seasonique®: next generation extended-cycle oral contraceptive product continuous hormonal support
2009: generic version of the birth control pill  Yasmin ratherthanlicensingitfrom Bayer Schering      => brandedgeneric« Ocella » Women’sHealth
TEVA + IVAX
BIOSIMILARS Shlomo Yanaï,  PDG de Teva« Nous avons identifié les biosimilaires comme des relais de croissance majeurs dans notre stratégie à long terme, et nous sommes en train de consolider nos connaissances, nos capacités et nos infrastructures pour positionner Teva comme un leader de ce marché »
Biopharmaceuticals and Biogenerics Biogenerics = important long-termgrowth opportunity Cancer, Arthritis, Rare genetic disorders =  faster-growing segments of the global pharmaceutical market + major contributors to    prescription drug costs Primary biopharmaceutical products =  INF alpha 2b  GCSF(granulocyte colony-stimulating factor) hGH(human growth hormone) in the U.S. (agreement with Savient) TevaGrastim® = the 1st GCSF biosimilar marketed yesterday in UE
Teva + Sicor 2003 : Acquisition US manufacturer Sicor, for $3.4 billion =>Teva: access to Sicor’sinjectable products and biosimilar development capacity expanded biopharmaceutical pipeline => take advantages of CoGenesys biological technology develop, manufacture and market a portfolio of biosimilars highly complementary companies => leading position in the emerging biosimilars market  Teva + CoGenesys 2008 : Acquisition Teva + lonzaJanuary 2009 : Signed a joint venture
CoGenesys: albumin-fusion technology  division within Human Genome Sciences Inc. (HGSI), 2005 fusing the gene that expresses human albumin +     the gene that expresses a therapeutically active protein => long-acting protein drugs => long-acting treatment options  efficacy and safety similar to or better than that of existing protein drugs more convenient dosage schedules
CoGenesys: Pipeline growthhormone and interferon alpha (by HGS and Novartis) Zablin, phase 3 ended SubmitsFDA licencing for hepatite C chronic Once everytwoweeks GLP-1 (beingdeveloped by GlaxoSmithKline underlicensefrom HGS)  Albiglutid, Phase III, once a week or less B-type natriuretic peptide (BNP). CoGenesys' leadclinical candidate, Cardeva, is a long-acting form of BNP (treatment of chronicheartfailure) advancingtoward the clinic for outpatient.  Albugranin, a long-acting form of Granulocyte ColonyStimulating Factor (GCSF), readiedfor clinicaldevelopment,  treatmentof febrileneutropeniaassociatedwithchemotherapy 27
Teva’sideas for the comingyears difficult to copy BUT  Teva is eager to produce "biogeneric" versions of drugs "The good news for us is that, because [biogenerics] require high-cost investments, we're only going to see a few competitors” (Teva's R&D chief) US : No legal way to sell generic copies of biologics BUT Teva isn't waiting idly: sells them in Europe and is ramping up production capacities
BRANDS
Tevainnovative R&D 3 TherapeuticFields ,[object Object]
Autoimmune (AI) diseases
Oncology,[object Object]
Multiple Sclerosis myelin is lost            scars= scleroses (“multiple sclerosis”)
Multiple Sclerosis (continued) ,[object Object]
4 differentforms of MS
++++ : Relapsing-Remitting form manifested by relapses followed by remission (incomplete at times : disability progression),[object Object]
Azilect®: 2ndTeva’sinnovativedrug DCI= Rasagiline 2nd generationMAO-B inhibitor treatment of idiopathic Parkinson’s Disease as:        - monotherapy        - adjunct therapy (with levodopa) in patients with end-of dose motor fluctuations Incidence: 1% people over 65
BRANDS: PIPELINE
≥ 11 innovativeprodutsexpected
StemEX ,[object Object]
Patients requiring bone marrow transplantation
Pb:  Only 15% of patients requiring bone marrow transplantation: find matching donors
 => StemEx® : Treatment of leukemia and  lymphomaStem/progenitor cells isolated from umbilical cord blood  Transplantation to patient Bonemarrowregenerationaftergraft
[object Object]
Gamida Cell:  world leader in stem cell expansion technologies and therapeutic products
Israel, 2009:  Gamida Cell-Teva Joint Venture announced :orphan designation for StemEx® for the treatment of acute lymphoblastic leukemia and acute myeloid leukemia ,[object Object],[object Object]
multiple sclerosis(MS)
Kynurenine pathway inhibitor : TRP metabolism :    neuroactive intermediate NMDA, key role in the communication between SNC and immune system =>      inflammation
Confirm the position as world leader Teva for the treatment of MSTerfluonamide (Sanofi)
Teva + MediWound, 2009    Debrase® Gel Dressing (DGD)= Bromelain based enzymatic debriding agent (mixture of proteolytic enzymes extracted from pineapple plant stem)  Dissolution (high specificity and selectivity) of eschar in burns Alternative to surgery and/or lengthy non-surgical procedures  Superior and more cost effective treatment option for burns BUTpainful phase III study, Marketing authorization in Europe during 2010
teva + oncogenex :  2009  OGX-011 = custirsen sodium ;  	=> adjunct therapy to enhance the effectiveness of chemotherapy  Blocksclusterin production(cell survival protein) overproduced in several cancers Multiple Oncology Indications: 2010: global Phase III :Metastatic Castrate Resistant Prostate Cancer (CRPC) 	 Phase III :1st-Line, in association, treatment of Advanced, Unresectable Non-Small Cell Lung Cancer (NSCLC) : initiated by early 2011. key component of  Teva branded oncology medicines franchise.
Diapep 227 Treatment of  Type I Diabetes modulates immune response Synthetic analog of diabetes epitope HSP 60 in beta cells (Diapep 24AA (437-460 HSP 60)) Phase 3 on going, 300 patients 1stcriteria : beta cell function preservation
TEVA in 2010
FINANCIAL PART
sales worth a record US $13,9 billion in 2009
Major sales in the Neurological area
CopaxoneisTEVA’sblockbuster drug Teva is the only generics maker with its own blockbuster drug While the bulk of  Teva’s revenues are derived from generics, the company has one major innovative product,Copaxone
"One of the biggest concerns on Wall Street is, When does Teva become the Pfizer of generics?" asks Ken Cacciatore, an analyst at Cowen & Co. "When does it become too big to grow?"
Key figures Stock increase 1.6% since yesterday 7.17% since 1st January 2010 39%  for 1 year 413% for 10 years
January 11 2010, 28th annual J.P Morgan HealthcareConference :
THREATS ?
  Dark sides generic drug market => price = main differentiating factor -> competition   ->    profit margins Teva enjoys : ++ competitive advantages => continue earnings excess returns + able to purchase competitors at a low price
A generic of Copaxone – a hazard for Teva? patent end : 2012 BUT Continued growth: RRMS gold standard therapy Pure generic of Copaxoneunlikely + significant studies Proprietary injection device Limited competition: slow penetration of competitors 2009 :  MHRA : expanded label => treatment of patients withclinicalisolated syndrome suggestive of multiple sclerosis
2009: FDA blocks approval of a generic version of its Copaxone Momenta Pharmaceuticals Inc. and Mylan Inc.  Petition : to slow the approval process + prolong market exclusivity  FDA -> no generic version of Copaxonein U.S. market until 2011
Competitors? Novartis:  biogeneric version of Pfizer's Genotropin (a human growth hormone), Japan Merck: plans to develop biogenericsBioVentures => "Teva is going to be competing with the big boys,“ says Sanford Bernstein analyst Ronny Gal Big Pharma : join the generic market:  - Pfizer would expand its portfolio of generics          - GSK: partnership with Indian generic company
Israel: threat? Inaccessible market such as Iran…. Political, military conflict

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Big Pharma Giant Teva's Strategy and Pipeline

  • 1. Big Pharma? Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Henninot
  • 2. Teva’s id Headquarters : PetakTikva, Israel Stock exchange : Nasdaq SEAQ International London Francfort Tel-Aviv Sector: Generics, Brandeddrugs, Brands One of the 20-largestpharmaceuticalcompanies in the world Operating in ≥60 countries, 38 000 employees
  • 3. Teva and its concurrents
  • 4. Teva: public on the Tel Aviv Stock Exchange Imported medicines trough Jerusalem only source of treatments for the local market History of the company 1901 1930 WW II 1948 1951 Teva: pharmaceutical industry Israel state
  • 5. TevaPhcal Industries, Israel’slargestdrugmaker 2nd innovativedrug, ttt PD History of the company (2) July 2006 Acquisition of Ikapharm, and othercompanies 1960-70 1980-90 1996 2005 Acquisition of IVAX QVAR®, ProAirHFA®
  • 6. MHRA: expanded label for Copaxone + Laquinimod: « fasttrack » designation (FDA) History of the company (3) StrategicR&D agreement with JexysPhctls Acquisition of Barr Phtcal Launchitsgeneric version of the birth control pillYasmin Joint venture withLonza Group to marketbiosimilars Jan 2009 Dec 2008 Dec 2008 Feb 2009 Aug 2009
  • 7. Strategy Increasing generic Market Share Increase organic growth through R&D Redefining Customer Service Intellectualproperty Biopharmaceuticals Vertical integration Horizontal integration
  • 8.
  • 11. Pharmaceutical technologyManagement’s flexibility + ability to react to changing market conditions Dynamism
  • 13. Context : growth in generics
  • 15.
  • 16. Opportunities for Teva drugs will lose patent exclusivity (Atorvastatin Calcium – 12.4 billion in sales) Hatch-Waxman Act -> + 6 months of sales exclusivity lawyers looking for patent weaknesses => Lotrel (amlodipine) elements of the patent => public domain => $330 million in 6 months FDA 218 applications of generics; Teva is challenging the patents of more than half of them => Most robustgeneric pipeline => Big Pharma isn't happy about the way Teva operates
  • 18. RespiratoryProducts 2005 : acquisition of IVAX QVAR® (beclomethasonedipropionate HFA): maintenance treatment of asthma ProAirHFA®(albuteral sulfate): relieves the symptoms of bronchospasms => leading competitor in the field of respiratory therapy
  • 19.
  • 20. Match patient’s needs : ease of use and effectiveness
  • 21.
  • 22. Women’sHealth Barr Pharmaceutical Plan B™ OTC/Rx(levonorgestrel) emergency oral contraceptive, Enjuvia™ (syntheticconjugatedestrogens, B) hormone therapyto treat moderate-to-severe vulvar and vaginal atrophy associatedwithmenopause, Seasonique®: next generation extended-cycle oral contraceptive product continuous hormonal support
  • 23. 2009: generic version of the birth control pill Yasmin ratherthanlicensingitfrom Bayer Schering => brandedgeneric« Ocella » Women’sHealth
  • 25. BIOSIMILARS Shlomo Yanaï,  PDG de Teva« Nous avons identifié les biosimilaires comme des relais de croissance majeurs dans notre stratégie à long terme, et nous sommes en train de consolider nos connaissances, nos capacités et nos infrastructures pour positionner Teva comme un leader de ce marché »
  • 26. Biopharmaceuticals and Biogenerics Biogenerics = important long-termgrowth opportunity Cancer, Arthritis, Rare genetic disorders = faster-growing segments of the global pharmaceutical market + major contributors to prescription drug costs Primary biopharmaceutical products = INF alpha 2b GCSF(granulocyte colony-stimulating factor) hGH(human growth hormone) in the U.S. (agreement with Savient) TevaGrastim® = the 1st GCSF biosimilar marketed yesterday in UE
  • 27.
  • 28. Teva + Sicor 2003 : Acquisition US manufacturer Sicor, for $3.4 billion =>Teva: access to Sicor’sinjectable products and biosimilar development capacity expanded biopharmaceutical pipeline => take advantages of CoGenesys biological technology develop, manufacture and market a portfolio of biosimilars highly complementary companies => leading position in the emerging biosimilars market Teva + CoGenesys 2008 : Acquisition Teva + lonzaJanuary 2009 : Signed a joint venture
  • 29. CoGenesys: albumin-fusion technology division within Human Genome Sciences Inc. (HGSI), 2005 fusing the gene that expresses human albumin + the gene that expresses a therapeutically active protein => long-acting protein drugs => long-acting treatment options efficacy and safety similar to or better than that of existing protein drugs more convenient dosage schedules
  • 30. CoGenesys: Pipeline growthhormone and interferon alpha (by HGS and Novartis) Zablin, phase 3 ended SubmitsFDA licencing for hepatite C chronic Once everytwoweeks GLP-1 (beingdeveloped by GlaxoSmithKline underlicensefrom HGS) Albiglutid, Phase III, once a week or less B-type natriuretic peptide (BNP). CoGenesys' leadclinical candidate, Cardeva, is a long-acting form of BNP (treatment of chronicheartfailure) advancingtoward the clinic for outpatient. Albugranin, a long-acting form of Granulocyte ColonyStimulating Factor (GCSF), readiedfor clinicaldevelopment, treatmentof febrileneutropeniaassociatedwithchemotherapy 27
  • 31. Teva’sideas for the comingyears difficult to copy BUT Teva is eager to produce "biogeneric" versions of drugs "The good news for us is that, because [biogenerics] require high-cost investments, we're only going to see a few competitors” (Teva's R&D chief) US : No legal way to sell generic copies of biologics BUT Teva isn't waiting idly: sells them in Europe and is ramping up production capacities
  • 33.
  • 35.
  • 36. Multiple Sclerosis myelin is lost scars= scleroses (“multiple sclerosis”)
  • 37.
  • 39.
  • 40. Azilect®: 2ndTeva’sinnovativedrug DCI= Rasagiline 2nd generationMAO-B inhibitor treatment of idiopathic Parkinson’s Disease as: - monotherapy - adjunct therapy (with levodopa) in patients with end-of dose motor fluctuations Incidence: 1% people over 65
  • 43.
  • 44. Patients requiring bone marrow transplantation
  • 45. Pb: Only 15% of patients requiring bone marrow transplantation: find matching donors
  • 46. => StemEx® : Treatment of leukemia and lymphomaStem/progenitor cells isolated from umbilical cord blood Transplantation to patient Bonemarrowregenerationaftergraft
  • 47.
  • 48. Gamida Cell: world leader in stem cell expansion technologies and therapeutic products
  • 49.
  • 51. Kynurenine pathway inhibitor : TRP metabolism : neuroactive intermediate NMDA, key role in the communication between SNC and immune system => inflammation
  • 52. Confirm the position as world leader Teva for the treatment of MSTerfluonamide (Sanofi)
  • 53. Teva + MediWound, 2009 Debrase® Gel Dressing (DGD)= Bromelain based enzymatic debriding agent (mixture of proteolytic enzymes extracted from pineapple plant stem) Dissolution (high specificity and selectivity) of eschar in burns Alternative to surgery and/or lengthy non-surgical procedures Superior and more cost effective treatment option for burns BUTpainful phase III study, Marketing authorization in Europe during 2010
  • 54. teva + oncogenex : 2009 OGX-011 = custirsen sodium ; => adjunct therapy to enhance the effectiveness of chemotherapy Blocksclusterin production(cell survival protein) overproduced in several cancers Multiple Oncology Indications: 2010: global Phase III :Metastatic Castrate Resistant Prostate Cancer (CRPC) Phase III :1st-Line, in association, treatment of Advanced, Unresectable Non-Small Cell Lung Cancer (NSCLC) : initiated by early 2011. key component of Teva branded oncology medicines franchise.
  • 55. Diapep 227 Treatment of Type I Diabetes modulates immune response Synthetic analog of diabetes epitope HSP 60 in beta cells (Diapep 24AA (437-460 HSP 60)) Phase 3 on going, 300 patients 1stcriteria : beta cell function preservation
  • 58. sales worth a record US $13,9 billion in 2009
  • 59. Major sales in the Neurological area
  • 60. CopaxoneisTEVA’sblockbuster drug Teva is the only generics maker with its own blockbuster drug While the bulk of Teva’s revenues are derived from generics, the company has one major innovative product,Copaxone
  • 61. "One of the biggest concerns on Wall Street is, When does Teva become the Pfizer of generics?" asks Ken Cacciatore, an analyst at Cowen & Co. "When does it become too big to grow?"
  • 62. Key figures Stock increase 1.6% since yesterday 7.17% since 1st January 2010 39% for 1 year 413% for 10 years
  • 63. January 11 2010, 28th annual J.P Morgan HealthcareConference :
  • 65. Dark sides generic drug market => price = main differentiating factor -> competition -> profit margins Teva enjoys : ++ competitive advantages => continue earnings excess returns + able to purchase competitors at a low price
  • 66. A generic of Copaxone – a hazard for Teva? patent end : 2012 BUT Continued growth: RRMS gold standard therapy Pure generic of Copaxoneunlikely + significant studies Proprietary injection device Limited competition: slow penetration of competitors 2009 : MHRA : expanded label => treatment of patients withclinicalisolated syndrome suggestive of multiple sclerosis
  • 67. 2009: FDA blocks approval of a generic version of its Copaxone Momenta Pharmaceuticals Inc. and Mylan Inc. Petition : to slow the approval process + prolong market exclusivity FDA -> no generic version of Copaxonein U.S. market until 2011
  • 68. Competitors? Novartis: biogeneric version of Pfizer's Genotropin (a human growth hormone), Japan Merck: plans to develop biogenericsBioVentures => "Teva is going to be competing with the big boys,“ says Sanford Bernstein analyst Ronny Gal Big Pharma : join the generic market: - Pfizer would expand its portfolio of generics - GSK: partnership with Indian generic company
  • 69. Israel: threat? Inaccessible market such as Iran…. Political, military conflict
  • 71. What about the futur ? $31 billion in 2015 net incomeof $6.8 billion in 2015 generics: $135 to $150 billion by 2015 governmentreforms: costsavings+ $150 billion worth of brand namedrugslosing patent protection in the next 5 years boost profits by 14% annually for the next 5 years, compared with flat earnings at the five biggest pharmaceutical companies So far the drugmaker is on target to reach that goal!
  • 74. Mix of generics and branded remains constant
  • 75. SWOT
  • 77.
  • 78.
  • 79. Talampanel Glutamat receptor antagonist, orphan drug Monoclonal antibody against Pd1 protein=> inhibcelular apoptosis End of phase III, 2012 CT 011
  • 80. Pipeline products in development Cf Barr acquisition : prevent epidemics of an acute respiratory disease to armed forces personnel/market it to immunosuppressed patients
  • 81. Projects in whichthey have an interest

Editor's Notes

  1. According to Pharmalot.com, in 2008 more than 60% of prescription market volume wasdispensed as genericAs more brand namedrugs go off patents in comingyears, genericdrugmanufacturers’ profits are likely to increaseGenerigdrugcompanies have alsobranched out intogeneric versions of biologicdrugs
  2. 135next 3 years : $89 billion worth of
  3. estradiol for 84 consecutive days, followed by seven days of low-dose estrogen (0.01 mg of ethinylestradiol) SEASONIQUE
  4. daily sub-cutaneous injections of 20 mg. well tolerated (common problems= itching and inflammation, flushing, weakness, nausea)
  5. 80-90% of patients with Parkinson’s disease are treated with levodopa (30% of them asMonotherapy : 26 000-40 000 patients receiving levodopa therapy alone)
  6. In accordance with EMEA. Teva Innovative Ventures currently has about 20 portfolio companies.DGD dissolves the burn eschar within four hours of application, providing an effective, selective, fast and safe alternative to current debriding means, such as surgery and non-surgical methods.
  7. The first company to introduce a new generic drug often captures market share that persists even when more generic drugs are introduced. Even under very severe competition, Teva would be “the last man standing”
  8. (=medicines and healthcareproductsregulatoryagency)