Slide 1: R&D Briefing December 6, 2012
For personal use only R&D Briefing December 6, 2012
Slide 2: Legal Notice: Forward looking statements
Legal Notice Forward looking statements For personal use only The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL’s financial results and estimates, business prospects and products in research, all of which involve substan
Slide 3: Agenda December 2012 R&D Briefing
Agenda December 2012 R&D Briefing • Welcome Mark Dehring For personal use only • Introduction & Highlights Andrew Cuthbertson • Immunoglobulins & Specialty Products • Clinical Development Russell Basser • Commercial Opportunities Lutz Bonacker • Q&A • Break • Coagulation/Haemophilia • Introduction &
Slide 4: Introduction and Highlights
For personal use only Introduction and Highlights
Slide 5: CSL R&D Strategy
CSL R&D Strategy For personal use only • Maintain commitment Breakthrough to extracting maximum Medicines value from existing assets and supporting and improving current products Specialty Immunoglobulins Products • Develop new protein-based therapies for treating serious illnesses focusing Haemophi
Slide 6: Immunoglobulins Strategy
Immunoglobulins Strategy For personal use only Maintaining leadership position through focus on: • Patient convenience • Yield • Label Immunoglobulins • Formulation science • Specialty Igs 6
Slide 7: Specialty Products Strategy
Specialty Products Strategy For personal use only Leveraging high quality, broad product portfolio through: • New markets • Novel indications Specialty • Novel modes of Products administration 7
Slide 8: Haemophilia Strategy
Haemophilia Strategy For personal use only Supporting and enhancing plasma products and developing novel recombinant portfolio with focus on: • Scientific and product innovation • Patient benefit Haemophilia Products 8
Slide 9: Breakthrough Medicines Strategy
Breakthrough Medicines Strategy For personal use only Leveraging clinical and technical insight in developing Breakthrough novel protein-based therapies Medicines • Significant unmet need • Multiple indications Optimising value of IP portfolio and assets • Partner high opportunity products 9
Slide 10: Leveraging Global Capabilities
Leveraging Global Capabilities For personal use only Global project management Recombinant protein manufacturing capabilities 10
Slide 11: R&D Investment
For personal use only 11 R&D Investment
Slide 12: Global R&D Portfolio December 2011
Global R&D Portfolio December 2011 For personal use only Immunoglobulins Haemophilia Specialty Products Influenza Vaccine Fibrinogen Fibrinogen Privigen®CIDP EU Biostate® EU Hizentra® US New Indications Aortic Surgery Zemaira® EU Berinert ® Hizentra® ® EU PCC Self Admin FXIII US Beriplex ® US New In
Slide 13: Progress through Stage Gates in 2012
Progress through Stage Gates in 2012 For personal use only Hizentra rVIIa-FP Hizentra CIDP Canada, EU Berinert rVIII-SC rIX-FP Self Admin Fibrinogen CSL362 Aortic EU Hizentra Berinert Japan Subcut Privigen CIDP CSL112 EU Biostate EU Beriplex US Bleeding 13
Slide 14: Global R&D Portfolio December 2012
Global R&D Portfolio December 2012 For personal use only Immunoglobulins Haemophilia Specialty Products Influenza Vaccine Privigen® CIDP Hizentra® CIDP Hizentra® US/EU EU Biostate® EU Fibrinogen Berinert ® New Indications Zemaira® EU Beriplex® US Self Admin PCC Fibrinogen Berinert® SC New Indication
Slide 15: Immunoglobulins
For personal use only Immunoglobulins
Slide 16: Immunoglobulins
Immunoglobulins For personal use only Maintaining leadership position through focus on: • Patient convenience • Yield • Label Immunoglobulins • Formulation science • Specialty Igs Key Focus • Hizentra® • Privigen® 16
Slide 17: Innovation to Drive Growth
Innovation to Drive Growth For personal use only • Efficient and competitive cost structure • Ig yield improvements • Product differentiation • Patient convenience • Clinical Use and Indications • Clinical efficacy • Expansion into Neurology • Alzheimer’s Disease opportunity • Prevention of vertical
Slide 18: Cytogam
Cytogam® For personal use only The only registered CMV immunoglobulin in the US indicated for the prevention of CMV disease associated with transplantation • CMV infection is the leading known cause of birth abnormalities in developed countries • Partnership with US National Institutes of Health (NI
Slide 19: Hizentra
Hizentra® For personal use only The first 20% high concentration low volume SCIG for convenient self administration providing steady-state Ig levels and an established long-term safety record with chronic administration Global Introductions Continue • Launched in US since 2010 • Broad approvals in E
Slide 20: Alternate schedules for Hizentra
Alternate schedules for Hizentra® For personal use only • Hizentra® is indicated weekly for patients with PID • Enhancing patient options through provision of additional schedules • Efficacy expected to be maintained • Safety not expected to be different 20
Slide 21: Chronic Inflammatory Polyneuropathy (CIDP)
Chronic Inflammatory Polyneuropathy (CIDP) • A chronic peripheral nerve For personal use only disease with progressive muscle weakness and loss of sensation, usually occuring in elderly patients • Most common chronic autoimmune neuropathy 21
Slide 22: Potential benefits of Hizentra in Patients with CIDP
Potential benefits of Hizentra® in Patients with CIDP For personal use only Current maintenance therapies Oral IVIG Plasma Hizentra® steroids Exchange • Avoids drawbacks of i.v. route • Reduced volume Adverse Less convenience Invasive therapy • Increases patient autonomy effects with long term usee
Slide 23: The PATH Trial: Hizentra in CIDP
The PATH Trial: Hizentra® in CIDP For personal use only • 150 patients • 2 doses vs placebo • Study approved by FDA, EMA, PMDA • Recruiting in US & EU 23
Slide 24: Privigen
Privigen® For personal use only The first and only 10% liquid intravenous immunoglobulin (IVIg) therapy that is proline stabilised with room temperature storage up to 36 months Building Capacity to Address Patient Needs Globally • Privigen approved broadly in US, Europe, South America • New Ig manuf
Slide 25: Privigen in CIDP: Rate of Response
Privigen® in CIDP: Rate of Response For personal use only 100 90 80 70 Responder rate (%) 60 50 40 77% 30 47% 61% 20 10 0 Total IVIg pretreated IVIg untreated
Slide 26: Specialty Products
For personal use only Specialty Products
Slide 27: Specialty Products
Specialty Products Leveraging high quality, For personal use only broad product portfolio through: • New markets • Novel indications • Novel modes of Specialty administration Products Key Focus • Beriplex® • Fibrinogen • Zemaira® • Berinert® 27
Slide 28: Beriplex
Beriplex® • Prothrombin Complex Concentrate = PCC For personal use only • vitamin K-dependent coagulation factors (FII, FVII, FIX, FX) Seeking approval for use of Beriplex® to reverse the effects of vitamin K antagonists for: • Bleeding related to over-anticoagulation • Patients needing surgery 2 la
Slide 29: Fibrinogen
Fibrinogen® For personal use only The first and only treatment approved by the US FDA for acute bleeding episodes in patients with congenital fibrinogen deficiency Europe • Peri-/post-operative control of coagulopathic bleeding • REPLACE Phase III study • 200 subjects – recruitment commenced Jan 201
Slide 30: Zemaira
Zemaira® For personal use only Zemaira is the first highly purified alpha-1 augmentation therapy approved by the FDA for chronic augmentation and maintenance therapy of adults with Alpha-1 and emphysema Seeking to broaden commercial reach through launch in EU, Canada, Brazil • EU requires demonstrat
Slide 31: Berinert
Berinert® For personal use only Plasma derived, pasteurised & nanofiltered concentrate of C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adults and adolescents 31
Slide 32: What Happens to Patients?
What Happens to Patients? For personal use only • Recurrent episodes of swelling, sometime with a rash • Unpredictable and occur anywhere in the body • Life-threatening if laryngeal swelling • Attacks caused by stress, infection, menstruation, some drugs, unknown causes 32
Slide 33: Berinert
Berinert® For personal use only Plasma derived, pasteurised & nanofiltered concentrate of C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adults and adolescents US and European approved label expansion for self administration o
Slide 34: Overcoming Challenges in Long-term Prophylaxis of HAE Attacks
Overcoming Challenges in Long-term Prophylaxis of HAE Attacks For personal use only Current prophylactic therapies Oral Intravenous High concentration androgens C1-INH subcutaneous (sc) Berinert® • Limited by • Inconvenience • Avoids drawbacks of i.v. adverse and risks of • Low volume for s.c. admin
Slide 35: Berinert Subcutaneous Prophylaxis Program
Berinert® Subcutaneous Prophylaxis Program For personal use only • Study ongoing in US and Germany - due to complete 1H Safety and 2013 pharmacokinetic study • Select safe and efficacious dosing for clinical efficacy trial - due to commence 2H 2013 35
Slide 36: Commercial Opportunities and Activities
For personal use only Commercial Opportunities and Activities
Slide 37: Immunoglobulins
For personal use only Immunoglobulins
Slide 38: The Immunoglobulin Market is attractive
The Immunoglobulin Market is attractive For personal use only The 2012 IG market is a > $6 B opportunity • Market includes IVIG, SCIG and Hyperimmunes CSL • Growing Market • CSL is well positioned 38
Slide 39: CSL's Immunoglobulin Portfolio
For personal use only CSL’s Immunoglobulin Portfolio Specific IG • Globalise portfolio SCIG • Expand into neurology Privigen • Increase convenience IVIG Other $US1,722M 39
Slide 40: Ig Portfolio Positioning
Ig Portfolio Positioning For personal use only First and only Proline-stabilised IVIG • High purity 10% liquid IVIG • Optimal dimer formulation throughout shelf life for improved tolerability First and only 20% Proline-stabilised SCIG • Low administration volume increases efficiency • Convenient – f
Slide 41: Globalise Portfolio
Globalise Portfolio Privigen & Hizentra (PL) For personal use only Privigen & Hizentra (HU) Privigen (BR) Privigen (TW) Privigen & Hizentra (CZ) Privigen (TR) Privigen (MY) Privigen (SG) Privigen (MX) Privigen (RU) Hizentra (BR) Hizentra (TR) Hizentra (AR) Privigen (HK) Hizentra (JAP) Hizentra (MX)
Slide 42: Expand into Neurology
Expand into Neurology For personal use only Hizentra 20% Privigen 10% CIDP CIDP (EU) (EU, CH, CAN) Hizentra 20% CIDP (US) 2012 2013 2014 2015 2016+ • Strengthen presence in neurological segment • Launch Privigen® in CIDP in the EU • Develop Hizentra® in CIDP in the US, the EU and RoW 42
Slide 43: Increase Convenience
Increase Convenience Privigen 40g Presentation For personal use only (US, CH, EU) Hizentra Convenience Initiatives Hizentra 10g (US, EU) 2012 2013 2014 2015 • Increase dosing flexibility • Differentiate through convenience launches: • 10 g vial Hizentra® • 40 g vial Privigen® • Ongoing convenience i
Slide 44: Hizentra Infusion Steps
Clean surface Sanitize your hands Inspect each vial For personal use only of Hizentra Gather your supplies Prepare syringe Infusion Steps 4 preparation steps per vial Prepare syringe Reducing number of vials (continued) increases convenience Write in your journal Prepare syringe (continued) Start in
Slide 45: Cytogam
Cytogam® For personal use only The only registered CMV immunoglobulin in the US indicated for the prevention of CMV disease associated with transplantation Center for Disease Control1: Potential Opportunity • CMV is the most common viral infection that infants are born with Assuming Screening at wee
Slide 46: Specialty Products
For personal use only Specialty Products
Slide 47: Specialty Products
For personal use only Specialty Products Wound Healing Other Specialty Products Tachocomb Beriplast Kybernin Berinert Zemaira Fibrogammin Streptase Beriplex Perioperative Bleeding $US618 M Riastap • Increase clinical data set • Add indications • Expand regionally 47
Slide 48: Beriplex
For personal use only Beriplex® In the US 3.8 M patients are on warfarin1 with a major bleeding rate of 3.1-3.6%2 per year • In US launch in warfarin reversal indication • US surgical indication: Patients requiring emergency surgery needing urgent reversal of warfarin • Understand the use in Factor
Slide 49: Blood Products vs. Concentrates
Blood Products vs. Concentrates For personal use only FFP Fibrinogen concentration at ≈2.3g / L Not virus inactivated Frozen, requires time (<50 minutes) to thaw Red Blood Cells Need to be matched to blood type Not virus inactivated Concentrated, virus inactivated, room temperature storage, Fibrinog
Slide 50: Fibrinogen
Fibrinogen® For personal use only • Obtain WEU & US acquired label • Initiate acquired label expansion • Generate, publish & communicate data 50
Slide 51: Bring to Europe
Bring to Europe For personal use only Pivotal trial objective: Zemaira slows the progression of emphysema Demonstration of a clinical outcome (disease modification) • Publish data in 2013: • American Thoracic Society • European Respiratory Society • Recognition in treatment guidelines • Demonstrate
Slide 52: Berinert
Berinert® For personal use only Berinert treats the fundamental cause of HAE symptoms by providing C1- INH deficient patients with the missing human protein1. Berinert has demonstrated that it provides fast relief of pain and swelling within 30 minutes2 • Obtain Prophylaxis indication • Increase con
Slide 53: Berinert - Current Life Cycle Activities
Berinert® - Current Life Cycle Activities For personal use only • Low-volume, high Product improvement concentration, formulation • Short-term prophylaxis, Expand 2013 (EU/Can) indication • Further initiatives ongoing New method of • Prophylaxis Indication use with s.c. formulation 53
Slide 54: Q&A
For personal use only Q&A
Slide 55: Break
For personal use only Break
Slide 56: Haemophilia Products
For personal use only Haemophilia Products
Slide 57: Haemophilia
Haemophilia Supporting and enhancing plasma products and developing For personal use only novel recombinant portfolio with focus on: • Scientific and product innovation • Patient benefit Key Focus Haemophilia • Long acting rIX-FP Products • Long acting rVIIa-FP • rVIII-Single Chain • Research into l
Slide 58: Innovation to Drive Growth
Innovation to Drive Growth For personal use only • Patient convenience primary Scientific Edge driver of innovation • Albumin fusion technology Improved half life, rAlbumin Precise engineering extended as fusion of specially • rIX-FP, rVIIa-FP, rVWF-FP dosing platform designed interval linker • Fact
Slide 59: rIX-FP (CSL654)
For personal use only 59 rIX-FP (CSL654)
Slide 60: rIX-FP (CSL654) Clinical Program
rIX-FP (CSL654) Clinical Program For personal use only PUP study Phase Phase 1/2 Phase 2/3 Phase 3 Paediatric 1 PK PK PK Long-term safety Long-term safety 7d prophylaxis 7-14d prophylaxis Extension safety On-demand On-demand Surgical prophylaxis 60
Slide 61: Compared with in market rFIX
For personal use only Compared with in market rFIX • 5.3-fold longer half-life (92hrs) • ~ 45% higher incremental recovery • ~7-fold larger AUC • ~7-fold slower clearance 61
Slide 62: Efficacy of rIX-FP in Phase 1/2 Trial
Efficacy of rIX-FP in Phase 1/2 Trial • 13 subjects treated weekly for up to 48 weeks For personal use only • previously on prophylaxis o no increase in weekly FIX consumption • switched from on-demand to weekly prophylaxis o >90% reduction in bleeding rate • Subjects treated on-demand (85 bleeds) •
Slide 63: rIX-FP (CSL654) Safety Data
rIX-FP (CSL654) Safety Data For personal use only • Excellent safety profile in completed studies • Well tolerated • No inhibitors • No adverse events related to CSL654 63
Slide 64: rIX-FP (CSL654) Further Development
rIX-FP (CSL654) Further Development For personal use only • Enrolment of Phase 2/3 study due to be completed early 2013 • Paediatric study has commenced • Prolonged half life o exploring treatment intervals longer than every second week 64
Slide 65: rVIIa-FP (CSL689)
For personal use only 65 rVIIa-FP (CSL689)
Slide 66: Development of rVIIa-FP (CSL689)
Development of rVIIa-FP (CSL689) • Phase 1 in 40 healthy volunteers For personal use only • First-in-man dose escalation study in healthy volunteers completed • No SAEs, one related mild AE • Pivotal Phase 2/3 Trial in Hemophilia A & B patients with Inhibitors • Dose finding, Safety and Efficacy on-
Slide 67: Phase 1 Study of rVIIa-FP in Healthy Volunteers
Phase 1 Study of rVIIa-FP in Healthy Volunteers For personal use only Lines represent different doses of CSL689 (no placebo) Half-life 3-4 fold longer than rFVIIa 67
Slide 68: Potential of rVIIa-FP (CSL689)
Potential of rVIIa-FP (CSL689) • For patients with inhibitors For personal use only • Single dose for treatment of bleeding • Prevention of bleeding in patients undergoing surgery • Prophylaxis • Other indications • Congenital Factor VII deficiency • Acquired hemophilia • Glanzmann's thrombasthenia
Slide 69: rVIII-SingleChain (CSL627)
rVIII-SingleChain (CSL627) For personal use only 69
Slide 70: rVIII-SingleChain: approach for improved FVIII
rVIII-SingleChain: approach for improved FVIII • FVIII’s physiological partner in plasma is von Willebrand For personal use only factor (vWF) • FVIII/vWF complex is important role in the physiological activity and clearance of FVIII • Aim - improve binding to VWF • FVIII is an unstable molecule in t
Slide 71: rVIII-SingleChain: high affinity for vWF
rVIII-SingleChain: high affinity for vWF For personal use only Binding to plasma-derived (pd) VWF Comparison of VWF affinity constants 250 20 18 200 Affinity constant (1/(nm) 16 14 Relative units 150 12 10 100 8 6 4 50 2 Single chain rFVIII (CSL627) Full length rFVIII 0 rVIII-SingleChain Full length
Slide 72: rVIII-SingleChain: PK profiles in rodents
rVIII-SingleChain : PK profiles in rodents For personal use only PK in haemophilia A mice PK in rats 5 6,000 FVIII:C plasma level (IU/mL) 5,000 4 FVIII:Ag (mIU/mL) 200 IU/kg FVIII:C 100 IU/kg FVIII:C 4,000 n=3/timepoint 3 geometric means ± SD n=5/timepoint 3,000 geometric means ± SD 2 2,000 1 1,000
Slide 73: rVIII-SingleChain Phase 1/3 Study Design
rVIII-SingleChain Phase 1/3 Study Design Interim analysis For personal use only Planned Dec 2012 Part 1 Part 2 CSL627 & Octagog alfa CSL627 repeat-dose, on-demand or Extension study single-dose PK (n=30) prophylaxis (n=30) Part 3 CSL627 repeat-dose, on-demand or prophylaxis (n=78 evaluable subjects)
Slide 74: Recombinant Coagulation Portfolio Summary
Recombinant Coagulation Portfolio Summary Target Launch Dates CSL654 (rIX-FP) For personal use only • Pivotal Phase II/III study commenced 2015 • h Phase I data demonstrate >5x half life extension • r Orphan drug status granted by US FDA CSL627 (rVIII-SingleChain) 2016 • Phase I/III trial commenced
Slide 75: Commercial Opportunities and Activities
For personal use only Commercial Opportunities and Activities
Slide 76: Coagulation Sales
For personal use only Coagulation Sales Helixate pd Coag $US1,058M • Launch rIX-FP in 2015 • Launch rVIII-SingleChain as bio-better in 2016 • Grow pd FVIII 76
Slide 77: Coagulation: Total Market Size
Coagulation: Total Market Size Key Market Segments and Products For personal use only • Beriate • Helixate • Factor X P Hem A FX P ~ $5B ~ $3M pd ITT management • Biostate Inhibitor bleed ~ $300M treatment Target • Haemate P ~ $1B Segments • Mononine VWD Hem B • Berinin • Biostate ~$500M ~$700M • Ha
Slide 78: Coagulation: Key Market Segments and Products
Coagulation: Key Market Segments and Products. • Beriate For personal use only • Helixate NexGen/FS/81 • Factor X P Hem A • rVIII-Single ~ $5B Chain FX P ~ $ 3M pd ITT management • Biostate • rVIIa-FP Inhibitor bleed ~ $300M treatment Target • Haemate P ~ $1B Segments • Mononine • Biostate EU VWD He
Slide 79: Recombinant Coagulation Portfolio
Recombinant Coagulation Portfolio 2012/13 For personal use only & • Differentiate recombinant albumin fusion platform and launch rIX-FP • Differentiate and launch rVIII-SingleChain • Strong support for Helixate and growth of rVIII-SingleChain 79
Slide 80: rIX-FP (CSL654) & rVIIa-FP (CSL689)
rIX-FP (CSL654) & rVIIa-FP (CSL689) For personal use only Scientific Edge Improved half Recombinant Specifically life, extended Albumin as designed dosing fusion linker interval partner 80
Slide 81: rIX-FP: The Scientific Edge
rIX-FP: The Scientific Edge For personal use only Phase 1 data rIX-FP 1 rFIX- PEGylated 2 rFIX-Fc fusion 3 (CSL Behring – Albumin Fusion) Half life x 5.3 x5 ~ x3 extension vs rFIX • Half life supports dosing every 2+ weeks 1 Santagostino et al, Blood. 2012; 120 (12): 2405 – 2411 2 Negrier et al., Bl
Slide 82: rVIIa-FP: The Scientific Edge
rVIIa-FP: The Scientific Edge T/2 extension rVIIa-FP For personal use only (CSL Behring-Albumin Fusion) Phase 1 being analysed Half life vs rFVIIa x 3-4 • The only half life extension technology currently in clinical development which enhances the duration of effect of native rFVIIa • Half life supp
Slide 83: rVIII-SingleChain (CSL627)
rVIII-SingleChain (CSL627) For personal use only Me++ A1 A2 B A3 C1 C2 Commercial Covalent bond Scientific Edge Edge Improved Improved High VWF financial molecular affinity contribution stability Opportunity for Extended Dosing Interval 83
Slide 84: Presenting Data: Active Scientific Presence
Presenting Data: Active Scientific Presence For personal use only 30 25 20 15 10 5 0 Albumin Fusion rVIIa-FP rVIII-SingleChain rIX-FP Technology Abstract/Poster Publication 84
Slide 85: Breakthrough Medicines
For personal use only Breakthrough Medicines
Slide 86: Breakthrough Medicines
Breakthrough Medicines For personal use only Leveraging clinical and technical insight in developing Breakthrough novel protein-based therapies Medicines • Significant unmet need • Multiple indications Key Focus • CSL112 (Apo AI) • CSL362 (anti-IL-3R mAb) • CSL346 (anti-VEGF-B mAb) 86
Slide 87: CSL112 (Apolipoprotein A-I)
CSL112 (Apolipoprotein A-I) For personal use only • CSL112 is natural apolipoprotein A-I (apoA-I) the chief protein component of HDL • Rapidly and robustly enhances capacity of plasma to promote cholesterol efflux • Global Phase 2b development program to initiate mid-2013 • Potential to address sign
Slide 88: CSL362 (anti-IL-3R mAb)
CSL362 (anti-IL-3RD mAb) • Initial indication: Acute myeloid leukaemia For personal use only • Enhanced recruitment of tumour killing NK cells • Targeting patients in CSL362 - Improved killing of patient leukaemia cells with autologous NK cells remission with high risk of relapse • Phase I trial in
Slide 89: CSL346 (anti-VEGF-B mAb)
CSL346 (anti-VEGF-B mAb) • Type 2 Diabetes For personal use only • Fat accumulation within tissues leads to insulin resistance and failure to control blood glucose • Most patients progress to insulin dependence CSL346 treatment preserves E cell • VEGF-B controls fat uptake into tissues insulin produ
Slide 90: Licensing and Collaborations
For personal use only Licensing and Collaborations
Slide 91: Licensing
Licensing For personal use only Optimising value of IP Portfolio and assets Breakthrough Breakthrough Medicines Medicines • Partner high opportunity products • GARDASIL® Specialty Immunoglobulins Specialty Immunoglobulins Products • Mavrilimumab (GM- Products CSFRD - Medi/AZ) Haemophilia • Periodont
Slide 92: GARDASIL
GARDASIL® • Impact of Australian HPV Vaccination Program For personal use only • 93% reduction in genital warts in females less than 21 years • Adolescent male funding • Extension to Australian NIP to include 12-13 yr males, with 2 year catch up for Year 9 males, from 2013 • Long term protection • N
Slide 93: Mavrilimumab (GM-CSFR)
Mavrilimumab (GM-CSFRD) Phase II EARTH Study completed For personal use only • 264 subjects with moderate-to-severe RA • bi-weekly dosing for 12weeks (10, 30, 50, 100mg) • Primary endpoint • DAS28-CRP decrease >1.2 at wk12 • Secondary endpoints • DAS28-CRP remission • ACR20/50/70 & HAQ-DI • Safety p
Slide 94: ISCOMATRIX Adjuvant Partnering Activities
ISCOMATRIX® Adjuvant Partnering Activities • Major partners continue to advance vaccine development For personal use only programs • Merck Research Laboratories initiated Dengue clinical study • Strong neutralising antibodies against all 4 serotypes in NHPs even at low antigen doses 10000 LiCor 50 M
Slide 95: Summary
For personal use only Summary
Slide 96: Global R&D Portfolio December 2012
Global R&D Portfolio December 2012 For personal use only Immunoglobulins Haemophilia Specialty Products Influenza Vaccine Hizentra® CIDP Privigen® CIDP Hizentra® US/EU Biostate® EU Fibrinogen Berinert ® New Indications Zemaira® EU Beriplex® US Self Admin PCC Fibrinogen Berinert® SC New Indications A
Slide 97: Expected Progress in next Months
Expected Progress in next 12 Months For personal use only rVWF-FP rVIIa-FP Zemaira EU Beriplex Beriplex P gingivalis Japan Surgery US Partnered vaccine P Privigen CIDP programs EU Berinert EU rVIII-SC Prophylaxis Berinert Beriplex SC Bleeding US 97
Slide 98: Significant Short-Midterm Target Launch Dates
Significant Short-Midterm Target Launch Dates For personal use only >2016 2013 2014 2015 2016 2017 CSL654 CSL627 CSL689 rIX-FP rFVIII rVIIa-FP Berinert® Beriplex® US Beriplex® US SubCut EU Berinert® Bleeding Surgical SubCut US Fibrinogen EU Aortic Surgery Zemaira® Z i ® EU Privigen® CIDP Hizentra® H
Slide 99: Q&A
For personal use only Q&A
Slide 100: For website and printed version
For personal use only For website and printed version
Slide 101: Mavrilimumab: Most Common Adverse Events
Mavrilimumab Safety profile - Most Common Adverse events (≥3%) For personal use only 101
Slide 102: Mavrilimumab: Serious Adverse Events
Mavrilimumab Safety profile – serious adverse events For personal use only 102