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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
BIZIMANA Charlotte

LABOULLE Caroline

MORISOT Nicolas

slide4

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

presentation of bsp
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
history of bsp
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)

history of bsp1
History of BSP

2001

1945

Acquisition of Aventis Crop Science

loss of trademarks and patents (1950)

2004

Acquisition of Roche’s OTC business

the story of the merger
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 )‏
history of products
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

history of products1
History of products

2005

Anovlar®, first oral contraceptive

FDA approves sorafenib (co-developed with Onyx Pharmaceuticals Inc)

Betaseron®, licensed in the USA

new business area
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

women s healthcare
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.
women s healthcare1
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®
primary care
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)
primary care1
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)
diagnostic imaging
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®
specialized therapeutics
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.
specialized therapeutics1
SpecializedTherapeutics
  • Neurology:
    • First compagny marketing immunomodulating treatment of remitting relapsing MS
    • Interferon beta-1b = Betaferon®
withdrawals
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)
bsp portofolio
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.

research development

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

partnerships
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

partnerships1
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

a strong pipeline1
A strong pipeline

Speciality Therapeutics

a strong pipeline2
A strong pipeline

Speciality medecine

oncology alemtuzumab
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
dosing schedule
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

epidemiology of ms
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
multiple sclerosis
Multiple sclerosis
  • Autoimmune disease that affects the

central nervous system

 demyelinization of neurons

  • 4 forms:
alemtuzumab for ms
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)

alemtuzumab for ms1
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)

alemtuzumab for ms2
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

a strong pipeline3
A strong pipeline

Speciality medecine

nexavar

NEXAVAR®

SORAFENIB

mechanism of action
Mechanism of action

Dual mechanism : antiangiogenic & Antiproliferative

nexavar1
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)
nexavar2
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)
breast cancer
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

other indications
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

a strong pipeline5
A strong pipeline

General medecine

a strong pipeline6
A strong pipeline

General medecine

xarelto

XARELTO®

RIVAROXABAN

mecanism of action
Mecanism of action

Each molecule of Factor Xa generates 1000 molecules of prothrombin

Rivaroxaban

need of anticoagulants
Need of anticoagulants
  • For acute and chronic indications
  • 6.5 million people worldwide are affected annually by venous thromboembolism (VTE)‏
      • over 500,000 deaths in Europe every year
  • 8.5 million AFIB (Atrial fibrillation) patients in Europe, Japan and U.S
    • AFIB patient has a 5-fold higher risk of stroke events
  • Venous blood clots
    • kill more people in Europe each year than AIDS, breast cancer, prostate cancer, and road traffic accidents combined
slide53

Rivaroxaban

Ideal anticoagulant

  • Oral administration
  • Fix doses
  • No monitoring
  • Security:
    • Wide therapeuticwindow
    • Fast and short activity
    • Few interactions withdrugsand food
    • Reversible
  • Direct factor Xa inhibitor (reversible)
  • Fix doses (10 mg once per dayp.o)
  • Half-life 5-9 hours (12 hours in elderly patient)
  • Few drug interactions
  • Renal and bilaryelimination
  • Biodisponibility of 80%
  • No monitoring
rivaroxaban xarelto
Rivaroxaban (Xarelto)
  • jointly developed by Bayer Schering Pharmaand Johnson & Johnson
  • Approvals in over 80 countries
  • Indication:
    • the prevention of venous thromboembolism (VTE) in adult patients undergoing elective (planned) hip or knee replacement surgery
clinical trials
Clinical trials

RECORD: VTE prevention following elective (planned) hip or knee replacement surgery (completed)

ACUTE

MAGELLAN: VTE prevention in hospitalized, medically ill patients (Phase III)

ATLAS ACS TIMI 46: Secondary prevention of acute coronary syndrome (Phase II)

CHRONIC

ROCKET AF: Stroke prevention in patients with atrial fibrillation (Phase III)

EINSTEIN: VTE treatment (Phase III)

More than 65 000 patients are expected to beenrolled !!!

slide56

Oral factor Xa inhibitors will compete in acute and chronic anticoagulant market

U.S sales

2006

3.1 B$

2014

8.4 B$

0.4B$

2.2 B$

0.5 B$

4.5 B$

<0.1 B$

0.1 B$

2.1 B$

1.5 B$

0.2 B$

estimation

a strong pipeline7
A strong pipeline

Diagnostic imaging

a strong pipeline8
A strong pipeline

Diagnostic imaging

alzheimer disease
Alzheimer disease
  • most common form of dementia
  • loss of neurons and synapses in the cerebral cortex and certain subcortical regions
  • deposits of amyloid-beta peptide
  • incurable,degenerative, and terminal disease
  • people over 65 years of age
  • more than 4 millions in USA, 880000 in France
  • predicted to affect 1 in 85 people (2050)
diagnosis imaging florbetaben
Diagnosisimaging Florbetaben
  • Positron emission tomography (PET) tracer

(BAY 94-9172)

  • Development with AC Immune
  • Indication: detection of Alzheimer’s disease

( binding to amyloid beta)

  • Positive Phase II data:
      • high specificity of over 90 percent
      • sensitivity of approximately 80 percent
  • Start of Phase III in Nov 2009…
bayer s organisation1
Bayer’s organisation

Bayer AG 2009

CA= 31168 millions €

bayer group sales by segment
Bayer Group sales by segment
  • Bayer HealthCare
  • 2006 : Increasing of 32%
  • 2006 2007 : Incresing of 21%

2005: HealthCare = 32% of Bayer CA

2009: HealthCare = 51% of bayer CA

slide71

Bayer HealthCare sales by Subgroup

  • Pharmaceuticals
  • 2006 : Increasing of 45%
  • 2006 2007 : Increasing of 27%
slide72

Growth of BSP

2005

2006

51%

63%

2007

69%

bsp sales by regions
BSP sales by regions

+ 172 %

+153%

+84%

+214%