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BIZIMANA Charlotte LABOULLE Caroline MORISOT Nicolas

BIZIMANA Charlotte LABOULLE Caroline MORISOT Nicolas. Bayer’s organisation. Distribution of the sales (2009). Distribution of the R&D. BAYER 2009 BSP 2009 CA: 31 Billions € CA: 10 Billions € R&D: 2,75 Billions € R&D: 1,572 billion €.

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BIZIMANA Charlotte LABOULLE Caroline MORISOT Nicolas

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  1. BIZIMANA Charlotte LABOULLE Caroline MORISOT Nicolas

  2. Bayer’s organisation

  3. Distribution of the sales (2009)

  4. Distribution of the R&D BAYER 2009 BSP 2009 CA: 31 Billions € CA: 10 Billions € R&D: 2,75 Billions € R&D: 1,572 billion € Bayer Schering pharma CA account for 33% of Bayer income. 58% of R&D investment is devoted to Bayer Schering Pharma

  5. Presentation of BSP • One of the ten largest specialty pharmaceutical companies in the world • Products marketed in more than 100 countries • Headquarter: Berlin • Employees: 38000 members worlwide ( 5900 in R&D) • Production locations: Europe, United States, Latin America and Asia • Main research locations: Berlin and Wuppertal in Germany; Berkeley, USA

  6. World grading of pharmaceutical compagnies (2009) 13

  7. History of BSP Ernst Scheringpurchased a chemist's shop ("Green Pharmacy“) Friedrich Bayer and Johann Friedrich Weskott establish a dyestuffs factory in Barmen 1929 Schering Corporation founded in New York ( first US subsidiary) 1943 1939 bombing raid totally destroyed the main administration building and main stores (Berlin) Gerhard Domagk is awarded the Nobel Prize in Medicine (Prontosil)

  8. History of BSP 2001 1945 Acquisition of Aventis Crop Science loss of trademarks and patents (1950) 2004 Acquisition of Roche’s OTC business

  9. The story of the Merger • 13/03/06: → € 14,6 billions bid for Schering AG • 24/03/06: → public takeover of € 16,3 billions for Schering 29/12/2006:  Acquisition of Schering by Bayer • March 2008: the BSP headquarter in Lille (Euralille + Lys lezlannoy)‏ • First quarter 2009: the new headquarter in Eurasanté (Lille )‏

  10. What are the interests of the merger

  11. History of products 1890 1888 first pharmaceutical product: Phenacetin first pharmaceutical speciality: Piperazin 1928 first hormone preparation for climacteric complaints Aspirin ® is registered as a trademark 1930 the first injectable renal contrast medium Launch of Levitra

  12. History of products 2005 Anovlar®, first oral contraceptive FDA approves sorafenib (co-developed with Onyx Pharmaceuticals Inc) Betaseron®, licensed in the USA

  13. New business area June 2005 June 2007 • Oncology • Cardiology • Hematology • Women’s healthCare • Primary Care • Diagnostic Imaging • Specialized Therapeutics • Oncology • Gynecology • Andrology • Dermatology • Immunology • Diagnostic Imaging

  14. Women’sHealthCare • Discovery of the first birth control pill: 1961 • Worldwide leader concerning contraception. • Oral femalecontraception: • Gestodenebased-products :→Meliane® → Mélodia® • Drospirenonebased-products: → Jasmine® → Yaz® • Dienogest and estradiolvaleratebased-products: → Qlaira® • A « natural » birth control pillwithoestrogenderivedfromnaturalhumanestradiolwaiting for AMM.

  15. Women’sHealthCare • intrauterine system for long term contraception • Levonorgestrel based-product:→ Mirena® • Hormone substitutive treatment for menopause and endometritis • Drospiterone based-product: → Angeliq® • Dienogestbased-product: → Visanne®

  16. Primary Care • More than 70 years experiment concerning infectiology • Ciprofloxacine = Ciflox® (fluoroquinolones) • Moxifloxacine = Izilox® • Josamycine =Josacine®(macrolides) • Present since the beginning in cardiology with aspirin • Nifedipine = Chronodalate®(calcic inhibitor) • Telmisartan = Pritor®(Angiotensin II antagonists)

  17. Primary care • Anticoagulant: first oral direct factor Xainhibitor • Rivaroxaban = Xarelto® • Evolution regardingveinousthrombosisprevention • Othertherapy areas: • Pneumology: Iliprost = Ventavis® (prostacyclinanalog) • Erectile dysfunction: vardenafil = Levitra®(PDE 5 inhibitor) • Diabetes: acarbose = Glucor®(alpha-glucosidasesinhibitor)

  18. Diagnostic Imaging • Leads to : • Better diagnosis → better choice of treatment • Better medical supervision • World wide leader concerning development and marketing contrast product • X-rays: iopromide = Ultravist® • IRM: • gadobutrol = Gadovist® • Dimeglumine gadopentetate = Magnevist®

  19. SpecializedTherapeutics • Oncology: • 2005: launch of sorafenib : Nexavar®(Anticancerprotein kinase inhibitors) for advancerenalcarcinoma • 2007: extend indication for hepatocellularcarcinoma. • June 2008:«Prix Galien »because of it’s ratio benefit / risk in liver cancer • Hemophilia: • Antihemophilic recombinant VIII factor = Kogenate® + perfusion system Bioset® • Formation and education plan to improvecoverage of the disease.

  20. SpecializedTherapeutics • Neurology: • First compagny marketing immunomodulating treatment of remitting relapsing MS • Interferon beta-1b = Betaferon®

  21. Withdrawals • cardiology: • 2001: cerivastatine = Baycol®→ 52 death (rhabdomyolysis) • 2 reasons: • association with Gemfibrozil (Fibrate : increase risk of rhabdomyolysis) • Bayer launched strong high dose (US & UK) 80mg • Anticoagulant • Aprotinin = Trasylol®(antifibrinolytic: plasmin inhibition) • 2008: withdrawn because increased the risk of death (BART study)

  22. BSP portofolio Best-Selling products in 2009 (millions euros) Women’s HealthCare Specialized Therapeutics Primary Care Diagnostic Imaging •Schering brought a range of products that complement Bayer's portfolio to BSP.

  23. Research and Development

  24. Berlin Wuppertal Berkeley Research & Development R&D expenditure • Oncology • Women’s Health • Diagnostic Imaging • Cardiology • Oncology • Applied research and life cycle management in Hemophilia and MS

  25. Partnerships With biotechnology firm in 2009: • access to five cancer-related targets for therapeutic development and in-vivo diagnostic imaging • Cession to : Alemtuzumab concerning oncology indication Co- development in MS • Collaboration and agreement with develop bi- specific antibodies technology concerning solid tumors

  26. Partnerships • Agreement with to develop Tyrosin-Kinase inhibitor especially concerning MEK receptor • Purchase of preclinical Anti cancer plan from With public institution: • 2009: German clinical cancer research center: → Both invest 1.75 € million

  27. Pipeline

  28. A strong pipeline

  29. A strong pipeline Speciality Therapeutics

  30. A strong pipeline Speciality medecine

  31. Alemtuzumab

  32. Oncology Alemtuzumab • Marketed as Campath or MabCampath (2001) ( co-development with Genzyme) • Mechanism of action: humanized monoclonal antibody directed against the glycoprotein CD52 • Indication: treatment of fludarabine-refractory B-cell chronic lyphocytic leukemia (CLL) • 2007: first line therapy for CLL

  33. Dosing Schedule • IV infusion over 2 hours • Recommended Dosing Regimen: - escalation to the maximum recommended single dose of 30 mg ( 3, 10 and 30 mg) • Total duration of therapy (including dose escalation) : 12 weeks • Main adverse events: cytopenias, infusion reactions, infections

  34. Epidemiology of MS • Highest prevalence in white populations in temperate regions • 2.5 million worldwide ( 400,000 in the USA) • 2 women/ 1 man • 1st cause of handicap amongyoung people • Between 20 and 50 years (average onset: 34 years) • Uncurableandinvaliding

  35. Multiple sclerosis • Autoimmune disease that affects the central nervous system  demyelinization of neurons • 4 forms:

  36. Alemtuzumab for MS? 2008: Positive Phase II results A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis (RRMS)

  37. Alemtuzumab for MS? Primary Outcome Measures: - Sustained Accumulation of Disability (SAD) - Relapse • Alemtuzumabwas more effective thaninterferon beta-1a (Rebif) with - sustained accumulation of disabilitythreeyearsafter the last course - durable reductions in relapse rate Observed adverse events: • thyroiddisorders (23% vs 3%) • infections (66% vs 47%) • Immune thrombocytopenic purpura (3% vs 1%) (in 3 patients whom 1 died)

  38. Alemtuzumab for MS? Phase 3 trial ongoing… CARE-MS: Comparison of Alemtuzumab and RebifEfficacy in Multiple Sclerosis Purpose: to establish the efficacy and safety of twodifferent doses of alemtuzumab as a treatment for RRMS, in comparisonwithRebif® Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

  39. A strong pipeline Speciality medecine

  40. NEXAVAR® SORAFENIB

  41. Mechanism of action Dual mechanism : antiangiogenic & Antiproliferative

  42. Nexavar ® • Developed and marketed in collaboration with • Indications: • 2005 : approved by FDA for treatment of advanced renal cell carcinoma (after failure of α-interferon or IL-2 treatment) • 2007 : approved by FDA for treatment of hepatocellular carcinoma • 2008 : first disappointment • Small cells lung cancer : Sorafenib doesn’t prolong progression-free survival in patients (Bayer stops clinical trials during phase III)

  43. Nexavar ® • Adverse effects • Diarrhoea, rash, alopecia, hand-foot skin reaction ,HTA • Manageable side-effect profile, well-suited for combination therapy • Dosage • 200mg tablets: 800mg /day • Price: 3898.11 € (120 tablets)

  44. New estimated cases in the world 2010

  45. Breast Cancer Nexavarexciting First resultsfrom 2 Phase II • Paclitaxel+/- Nexavar • 237 patients (first line) • Combination Nexavar + paclitaxel demonstrated a positive trend towards improvement of progression free survival (p=0.09) • No new toxicities observed with the combination • Capecitabine+/- Nexavar • 229 patients (first and second line) • Combination Nexavar + capecitabine significantly improved median progression free-survival by 74% vs capecitabine + placebo (6.4 months vs 4.1 months) • Combination did not result in any new side effects Randomized, double-blind, placebo-controlled Phase 2 trials HER-2 negative, locally advanced or metastatic breast cancer → Phase III in breast cancer to be initiated in 2010

  46. Other indications Phase II • Colorectal cancer • 1st line treatment in combination with FOLFOX • Ovarian or peritoneal cancer • Maintenance treatment after 1st line treatment • Breast cancer Phase III • Non-small cell lung cancer • 1st line combination therapy with gemcitabine and cisplatin (Nexus trial) • Thyroid cancer • Nexavar monotherapy • Liver cancer • Adjuvant therapy vs Placebo → More than 200 active trials exploring Nexavar anti-tumor potential

  47. A strong pipeline

  48. A strong pipeline General medecine

  49. A strong pipeline General medecine

  50. XARELTO® RIVAROXABAN

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