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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
Big Pharma?

Clotilde Bourdon Olivia Scaccia Pauline Fontaine Antoine Henninot

teva s id
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
slide4

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
slide5

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®
slide6

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
Strategy
  • Increasing generic Market Share
  • Increase organic growth through R&D
  • Redefining Customer Service
  • Intellectualproperty
  • Biopharmaceuticals
  • Vertical integration
  • Horizontal integration
strategy based on
Strategy based on
  • Diversification :
  • Products
  • Geographical
  • Therapeutic areas
  • Pharmaceutical technology
  • Management’s flexibility + ability to react to changing market conditions
  • Dynamism
teva the king of generic drugs
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
geographical expansion
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
opportunities for teva
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
respiratory products
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
respiratory products1
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
resphir operation
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

women s health
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
slide20

Women’sHealth

  • 2009: generic version of the birth control pill Yasmin ratherthanlicensingitfrom Bayer Schering

=> brandedgeneric« Ocella »

biosimilars

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
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
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
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
slide27

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
teva s ideas for the coming years
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
teva innovative r d
Tevainnovative R&D

3 TherapeuticFields

  • Central nervous system (CNS )
  • Autoimmune (AI) diseases
  • Oncology
copaxone
Copaxone
  • 1997 : 1st major brandedproducts : the multiple sclerosistreatmentCopaxone

1st innovativedrugdeveloped in Israelthat won FDA approval, Teva’s best seller

multiple sclerosis
Multiple Sclerosis
  • myelin is lost scars= scleroses (“multiple sclerosis”)
multiple sclerosis continued
Multiple Sclerosis (continued)
  • ≥ 2 million patients
  • 4 differentforms of MS
  • ++++ : Relapsing-Remitting form manifested by relapses followed by remission (incomplete at times : disability progression)
copaxone action on rrms
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
azilect 2 nd teva s innovative drug
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
slide38

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

slide39

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
laquinimod
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)
teva mediwound 2009
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
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
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
copaxone is teva s blockbuster drug

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

slide49

"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
Key figures
  • Stock increase
    • 1.6% since yesterday
    • 7.17% since 1st January 2010
    • 39% for 1 year
    • 413% for 10 years
dark sides
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
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
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
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
Israel: threat?
  • Inaccessible market such as Iran….
  • Political, military conflict
what about the futur
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!
talampanel

End of phase III, 2012

Talampanel
  • Glutamat receptor antagonist, orphan drug
  • Monoclonal antibody against Pd1 protein=> inhibcelular apoptosis

CT 011

pipeline products in development
Pipeline products in development

Cf Barr acquisition : prevent epidemics of an acute respiratory disease to armed forces personnel/market it to immunosuppressed patients