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
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
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
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
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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
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
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48. Gamida Cell: world leader in stem cell expansion technologies and therapeutic products
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
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
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
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!
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
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
135next 3 years : $89 billion worth of
estradiol for 84 consecutive days, followed by seven days of low-dose estrogen (0.01 mg of ethinylestradiol) SEASONIQUE
daily sub-cutaneous injections of 20 mg. well tolerated (common problems= itching and inflammation, flushing, weakness, nausea)
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)
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.
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”
(=medicines and healthcareproductsregulatoryagency)