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Big Pharma?

Big Pharma?. Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Hennino t. Teva’s id. Headquarters : Petak Tikva , Israel Stock exchange : Nasdaq SEAQ International London Francfort

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Big Pharma?

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  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. Strategy based on • Diversification : • Products • Geographical • Therapeutic areas • Pharmaceutical technology • Management’s flexibility + ability to react to changing market conditions • Dynamism

  9. UNBRANDEDGENERICS

  10. Context : growth in generics

  11. Expanding generic market

  12. 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! • Teva≥ 300 productswithin 40 factories, various areas therapeutics

  13. Geographical Expansion • USA • Ivax: 2005, $7.4 billion • Barr Pharmaceutical: 2008, $7.46 billion • EUROPE • 2008, US generic firm Bentley Pharmaceuticals, deal = $360 million • JAPAN • Kowa: 2008,~ $ 100 million • Taisho: 2009,~ $ 100 million • CANADA • Agreement with Novopharm

  14. 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

  15. BRANDED GENERICS

  16. 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

  17. 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 • Develop new medications not based on new molecules but based on new medical devices • Match patient’s needs : ease of use and effectiveness • +++ compliance

  18. RESPHIR operation • TEVA and PHR: campaign for asthmatic patients in France • Brands+ Unbranded generics • Two main objectives:- role of the pharmacist in the therapeuticeducationof the patients - enhance the proper use of medicines and improve patient compliance

  19. 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

  20. Women’sHealth • 2009: generic version of the birth control pill Yasmin ratherthanlicensingitfrom Bayer Schering => brandedgeneric« Ocella »

  21. TEVA + IVAX

  22. 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 »

  23. 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

  24. 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

  25. 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

  26. CoGenesys: Pipeline • growthhormone and interferon alpha (by HGS and Novartis) • Zablin, phase 3 ended • Submits FDA 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

  28. BRANDS

  29. Tevainnovative R&D 3 TherapeuticFields • Central nervous system (CNS ) • Autoimmune (AI) diseases • Oncology

  30. Copaxone • 1997 : 1st major brandedproducts : the multiple sclerosistreatmentCopaxone 1st innovativedrugdeveloped in Israelthat won FDA approval, Teva’s best seller

  31. Multiple Sclerosis • myelin is lost scars= scleroses (“multiple sclerosis”)

  32. Multiple Sclerosis (continued) • ≥ 2 million patients • 4 differentforms of MS • ++++ : Relapsing-Remitting form manifested by relapses followed by remission (incomplete at times : disability progression)

  33. Copaxone®: action on rrms • limits the formation of new lesions in the CNS • brain atrophy • the average relapse rate in people with RRMS • regulates inflammation at the site of brain lesions + controls neurodegeneration + enhances repair • slows the in the NAA (N-acetyl aspartate), marker highly correlated with progression of disability in MS

  34. 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

  35. BRANDS: PIPELINE

  36. ≥ 11 innovativeprodutsexpected

  37. StemEX • Chemotherapy : medullaraplasia • Patients requiring bone marrow transplantation • Pb: Only 15% of patients requiring bone marrow transplantation: find matching donors • => StemEx® : Treatment of leukemia and lymphoma • Stem/progenitor cells isolated from umbilical cord blood Transplantation to patient Bonemarrowregenerationaftergraft

  38. 16 Feb 05 : joint venture Teva Pharmaceutical Industries Ltd - Gamida-Cell Ltd => $25 million • 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 • StemEx: currently Phase II/III, reaching of the market in 2011

  39. Laquinimod • oral medication major therapeutic advantage compared to Copaxone, SC administration • 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 MS • Terfluonamide (Sanofi)

  40. 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

  41. 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.

  42. 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 • 1st criteria : beta cell function preservation

  43. TEVA in 2010

  44. FINANCIAL PART

  45. sales worth a record US $13,9 billion in 2009

  46. Major sales in the Neurological area

  47. Teva is the only generics maker with its own blockbuster drug CopaxoneisTEVA’sblockbuster drug While the bulk of Teva’s revenues are derived from generics, the company has one major innovative product,Copaxone

  48. "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?"

  49. Key figures • Stock increase • 1.6% since yesterday • 7.17% since 1st January 2010 • 39% for 1 year • 413% for 10 years

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