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Big Pharma? Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Hennino t.

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Presentation on theme: "Big Pharma? Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Hennino t."— Presentation transcript:

1 Big Pharma? Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Hennino t

2 T EVA ’ S ID Headquarters : Petak Tikva, Israel Stock exchange : Nasdaq SEAQ International London Francfort Tel-Aviv Sector : Generics, Branded drugs, Brands One of the 20-largest pharmaceutical companies in the world Operating in ≥ 60 countries, employees

3 T EVA AND ITS CONCURRENTS

4 H ISTORY OF THE COMPANY WW II I mported medicines trough Jerusalem Teva: pharmaceutical industry only source of treatments for the local market Israel state Teva: public on the Tel Aviv Stock Exchange

5 H ISTORY OF THE COMPANY (2) July 2006 Teva Phcal Industries, Israel’s largest drugmaker Acquisition of Ikapharm, and other companies Acquisition of IVAX QVAR®, ProAirHFA® 2nd innovative drug, ttt PD

6 H ISTORY OF THE COMPANY (3) Acquisition of Barr Phtcal Dec 2008 Strategic R&D agreement with Jexys Phctls Dec 2008 Jan 2009 Joint venture with Lonza Group to market biosimilars Feb 2009 MHRA: expanded label for Copaxone + Laquinimod: « fast track » designation (FDA) Aug 2009 Launch its generic version of the birth control pill Yasmin

7 S TRATEGY Increasing generic Market Share Increase organic growth through R&D Redefining Customer Service Intellectual property Biopharmaceuticals Vertical integration Horizontal integration

8 S TRATEGY BASED ON Diversification : Products Geographical Therapeutic areas Pharmaceutical technology Management’s flexibility + ability to react to changing market conditions Dynamism

9 UNBRANDED GENERICS

10 Context : growth in generics Generic versions of biologic drugs Managed healthcare expenses + Expiration of patents on branded drugs 1984: Drug Price Competition and Patern Term Restoration Act, in generic drug manufacturers

11 E XPANDING GENERIC MARKET E XPANDING GENERIC MARKET

12 T EVA : T HE 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! o Teva ≥ 300 products within 40 factories, various areas therapeutics

13 G EOGRAPHICAL E XPANSION 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 O PPORTUNITIES FOR T EVA 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 robust generic pipeline => Big Pharma isn't happy about the way Teva operates

15 BRANDED GENERICS

16 R ESPIRATORY P RODUCTS 2005 : acquisition of IVAX QVAR® (beclomethasone dipropionate HFA): maintenance treatment of asthma ProAirHFA® (albuteral sulfate): relieves the symptoms of bronchospasms => leading competitor in the field of respiratory therapy

17 R ESPIRATORY P RODUCTS 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 therapeutic education of the patients - enhance the proper use of medicines and improve patient compliance

19 W OMEN ’ S H EALTH Barr Pharmaceutical Plan B™ OTC/Rx (levonorgestrel) emergency oral contraceptive, Enjuvia™ (synthetic conjugated estrogens, B) hormone therapy to treat moderate-to-severe vulvar and vaginal atrophy associated with menopause, Seasonique® : next generation extended-cycle oral contraceptive product continuous hormonal support

20 2009 : generic version of the birth control pill Yasmin rather than licensing it from Bayer Schering => branded generic « Ocella » Women’s Health

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 B IOPHARMACEUTICALS AND B IOGENERICS Biogenerics = important long-term growth 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

25 T EVA + S ICOR 2003 : A CQUISITION US manufacturer Sicor, for $3.4 billion =>Teva: access to Sicor’s injectable 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 T EVA + LONZA J ANUARY 2009 : S IGNED A JOINT VENTURE T EVA + C O G ENESYS 2008 : A CQUISITION

26 C O G ENESYS : 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

27 27 growth hormone and interferon alpha (by HGS and Novartis) Zablin, phase 3 ended Submits FDA licencing for hepatite C chronic Once every two weeks GLP-1 (being developed by GlaxoSmithKline under license from HGS) Albiglutid, Phase III, once a week or less B-type natriuretic peptide (BNP). CoGenesys' lead clinical candidate, Cardeva, is a long-acting form of BNP (treatment of chronic heart failure) advancing toward the clinic for outpatient. Albugranin, a long-acting form of Granulocyte Colony Stimulating Factor (GCSF), readied for clinical development, treatment of febrile neutropenia associated with chemotherapy CoGenesys: Pipeline

28 T EVA ’ S IDEAS FOR THE COMING YEARS 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

29 BRANDS

30 T EVA INNOVATIVE R&D 3 Therapeutic Fields o Central nervous system (CNS ) o Autoimmune (AI) diseases o Oncology

31 C OPAXONE 1997 : 1st major branded products : the multiple sclerosis treatment Copaxone 1st innovative drug developed in Israel that won FDA approval, Teva’s best seller

32 M ULTIPLE S CLEROSIS myelin is lost scars= scleroses (“multiple sclerosis”)

33 M ULTIPLE S CLEROSIS ( CONTINUED ) ≥ 2 million patients 4 different forms of MS ++++ : Relapsing-Remitting form manifested by relapses followed by remission (incomplete at times : disability progression)

34 C OPAXONE ®: 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

35 A ZILECT ®: 2 ND T EVA ’ S INNOVATIVE DRUG DCI= Rasagiline 2nd generation MAO-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

36 BRANDS: PIPELINE

37 ≥ 11 innovative produts expected

38 StemEX Chemotherapy : medullar aplasia 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 Bone marrow regeneration after graft

39 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

40 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) L AQUINIMOD

41 T EVA + M EDI W OUND, 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 BUT painful phase III study, Marketing authorization in Europe during 2010

42 TEVA + ONCOGENEX : 2009 OGX-011 = custirsen sodium ; => adjunct therapy to enhance the effectiveness of chemotherapy Blocks clusterin 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 key component of Teva branded oncology medicines franchise.

43 D IAPEP 227 Treatment of Type I Diabetes modulates immune response Synthetic analog of diabetes epitope HSP 60 in beta cells (Diapep 24AA ( HSP 60)) Phase 3 on going, 300 patients 1 st criteria : beta cell function preservation

44 TEVA IN 2010

45 FINANCIAL PART

46 SALES WORTH A RECORD US $13,9 BILLION IN 2009

47 M AJOR SALES IN THE N EUROLOGICAL AREA

48 C OPAXONE IS TEVA’ S BLOCKBUSTER DRUG While the bulk of Teva’s revenues are derived from generics, the company has one major innovative product, Copaxone Teva is the only generics maker with its own blockbuster drug

49 "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?"

50 K EY FIGURES Stock increase 1.6% since yesterday 7.17% since 1 st January % for 1 year 413% for 10 years

51 J ANUARY , 28 TH ANNUAL J.P M ORGAN H EALTHCARE C ONFERENCE : Date06/01/1007/01/1008/01/1011/01/1012/01/10 Dernier (c) (c) (c) (c) (c) USD Variation+0.25%-0.63%+4.40%-0.62%-0.54% Volume

52 THREATS ?

53 D ARK 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

54 A GENERIC OF C OPAXONE – A HAZARD FOR T EVA ? patent end : 2012 BUT Continued growth: RRMS gold standard therapy Pure generic of Copaxone unlikely + significant studies Proprietary injection device Limited competition: slow penetration of competitors 2009 : MHRA : expanded label => treatment of patients with clinical isolated syndrome suggestive of multiple sclerosis

55 2009: FDA BLOCKS APPROVAL OF A GENERIC VERSION OF ITS C OPAXONE Momenta Pharmaceuticals Inc. and Mylan Inc. Petition : to slow the approval process + prolong market exclusivity FDA -> no generic version of Copaxone in U.S. market until 2011

56 C OMPETITORS ? Novartis: biogeneric version of Pfizer's Genotropin (a human growth hormone), Japan Merck: plans to develop biogenerics BioVentures => "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

57 I SRAEL : THREAT ? Inaccessible market such as Iran…. Political, military conflict

58 PERSPECTIVES

59 W HAT ABOUT THE FUTUR ? $31 billion in 2015 net income of $6.8 billion in 2015 generics: $135 to $150 billion by 2015 government reforms: cost savings + $150 billion worth of brand name drugs losing 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!

60 International expansion

61 Growth in biosimilars

62 M IX OF GENERICS AND BRANDED REMAINS CONSTANT

63 SWOT StrengthsWeaknesses Teva-Barr is the largest global generics company Growing position in CNS with branded products Expertise in patent challenges Acquisition of Barr limits scope for further large M&A in the near term OpportunitiesThreats Make use of economic woes to generate support for favorable biosimilar legislation in the US Further expansion into ex-US markets Use of financial strength to launch at risk Shift manufacturing to lower cost countries Early arrival of generic Copaxone Increasing strength of competing generics companies Maturation of US and other key markets Declining number of branded drugs to target

64 W HAT ABOUT JOINING TEVA ?

65

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67 T ALAMPANEL Glutamat receptor antagonist, orphan drug Monoclonal antibody against Pd1 protein=> inhib celular apoptosis E ND OF PHASE III, 2012 CT 011

68 ProjectIndicationClinical phasePartnerFormulation LaquinimodMSIIIActive biotechOral TV-1102MSIIa completedAntisense therapeutics Inc Inj PagoclonePersistent developmental stuttering IIbEndo pharmaceuticals Oral TalampanelAmyotrophic lateral sclerosis IIOral TalampanelGlioblastomaII completedOral Adenovirus vaccines Respiratory diseases IIIUS department of defense inj Cf Barr acquisition : prevent epidemics of an acute respiratory disease to armed forces personnel/market it to immunosuppressed patients P IPELINE PRODUCTS IN DEVELOPMENT

69 P ROJECTS IN WHICH THEY HAVE AN INTEREST ProjectIndicationClinical phasePartnerInvestment Million $ StemExHematological malignancies IIIGamida cell25 CT-011Solid tumors and hematologicl malignancies IICuretech10.5 DebraseRemoval of burn- ijured tissue III in EuropeMediWound15 Diapep-277Type I diabetesIIIAndromeda biotech10


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