CSL Ltd. — Investor Presentation 2010

Dec 6, 2010

R&D Briefing December 7, 2010

Agenda December 2010 R&D Briefing

8.30am: Sign in and coffee

• Welcome

• Introduction and Highlights

• Immunoglobulins

• Specialty Products

Mark Dehring Andrew Cuthbertson Andrew Cuthbertson Russell Basser

• Q&A

• 20 Minute Break

• Rec Coagulation Program

• Breakthrough Medicines

• Licensing

Simon Green Andrew Nash Andrew Cuthbertson

• Summary highlights, Q&A

Noon: Finish

Introduction and Highlights

CSL R&D Strategy

• Maintain commitment to extracting maximum value from existing assets and supporting and improving current products

Breakthrough Specialty Medicines Products

• Develop new proteinbased therapies for treating serious illnesses focusing on products that align with our technical and commercial capabilities

Immunoglobulins

Haemophilia Products

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Immunoglobulins Strategy

Supporting and enhancing current portfolio and developing new products

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developing new products
•
Yield
Breakthrough
Specialty
•
Medicines Label
Products
•
Formulation science
•
Patient convenience
Immuno-
Haemophilia
globulins Products
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Specialty Products Strategy

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Expanding use through
new markets, novel
indications and/or
modes of administration
e.g.
Breakthrough Specialty • Berinert
Medicines
Products
•
Beriplex
•
Fibrinogen
Immuno-
Haemophilia
globulins Products
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Haemophilia Strategy

Supporting and enhancing portfolio and developing new products

• Plasma products

Breakthrough Specialty Medicines Products ImmunoHaemophilia globulins Products

• Long acting rIX & rVIIa

• Patient convenience

• Coagulation research

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Breakthrough Medicines Strategy

Developing new proteinbased therapies

• Significant unmet need

Breakthrough Specialty Medicines Products ImmunoHaemophilia globulins Products

• Multiple indications, e.g.

• Reconstituted HDL

• Anti IL-3R a mAb

• Anti G-CSFR mAb

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Global R&D: Integrated R&D Facilities

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Leveraging Global Capabilities

CSL Behring CSL Limited CSL Biotherapies Organisation by site Marburg Bern K3 KoP Japan Parkville Parkville/ Broadmeadows Global project management to ensure leverage of best capabilities

Stage Gate Decision System

New Preclinical GLP Tox & Registration Product Research Product Phase I Phase II Phase III Launch Opportunity Development (FIH) Phase IV 1 2 3 4 5 6

Enter Enter Enter GLP Enter Enter Register Preclinical Research Tox & Phase I Phase II Phase III Launch Product Dev

• Robust process to support high quality investment

• Provides clarity around key criteria and deliverables

• Market environment

• Data relative to Target Product Profile

• Capabilities, capacity, ability to execute

Progress through Stage Gates in 2010

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New Preclinical GLP Tox & Registration
Product Research Product Phase I Phase II Phase III Launch
Opportunity Development (FIH) Phase IV
1 2 3 4 5 6
Enter
Enter Enter GLP Enter Enter Register
Preclinical
Research Tox & Phase I Phase II Phase III Launch
Product Dev
Privigen
antiIL-3R a Riastap
CIDP EU
Hizentra
rHDL
US, EU
rIX-FP H1N1
rVIIa-FP
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R&D Investment

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* Foreign currency impact using FY2009 exchange rates



 Global R&D Pipeline

December 2009

Humate® P Zemaira® US Privigen®

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New IndicationsFibrinogen Aortic SurgeryFibrinogen Privigen® CIDP EUHizentra®EU Hizentra®US Rhophylac® US
Berinert® US
PCC Zemaira® EU Beriplex® EU
New Indications Riastap® US
Beriplex ® US
Riastap® EU Afluria® US
Biostate® EU
Afluria/Enzira® EUAfluria®
Rec Coagulation CSL689 rVIIa-FP
Factors
CSL654 rIX-FP
Novel Plasma
Proteins
Vaccines– Merck Vaccines– Merck Vaccines– Merck Partnered Vaccine
Vaccines – Pfizer Programs
Vaccines– Pfizer
Vaccines– Abbott
P gingivalis POD CSL444 H5N1 CSL425
CRC-OHS/Sanofi * ISCOMATRIX® Flu 2009 H1N1 Flu
CSL112 CAM3001
reconstituted HDL GM-CSFR - AZ CSL401 CSL401
H5N1 Flu H5N1 Flu
CSL362 IL-3R CSL412
Discovery CSL324 G-CSFR ISCOMATRIX® Flu
Projects IL-13R
Core Capabilities Plasma Proteins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Partnered Projects
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 Global R&D Pipeline  December 2010

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Humate® P
Zemaira® US
Privigen®
Rhophylac® US
Afluria®
Fibrinogen Fibrinogen Privigen®CIDP EU Hizentra® EU Hizentra® US
New Indications Aortic Surgery
Zemaira® EU Beriplex® EU Berinert® US
PCC
New Indications Beriplex ® US Riastap® US
Biostate® EU Riastap® EU
Rec Coagulation CSL689 rVIIa-FP
Factors
CSL654 rIX-FP
Novel Plasma
Proteins
Vaccines– Merck Vaccines– Merck Vaccines– Merck Partnered Vaccine
Vaccines – Pfizer Programs
Vaccines– Pfizer
Vaccines– Abbott
P gingivalis POD CSL425
CRC-OHS/Sanofi * 2009 H1N1 Flu
CSL112 CAM3001
CSL401
reconstituted HDL GM-CSFR - AZ
H5N1 Flu
CSL362 IL-3R
CSL324 G-CSFR
Discovery
Projects IL-13R
Core Capabilities Plasma Proteins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Partnered Projects
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Expected Progress in next 12 months

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New Preclinical GLP Tox & Registration
Product Research Product Phase I Phase II Phase III Launch
Opportunity Development (FIH) Phase IV
1 2 3 4 5 6
Enter
Enter Enter GLP Enter Enter Register
Preclinical
Research Tox & Phase I Phase II Phase III Launch
Product Dev
Fibrinogen Hizentra
anti IL-3R a
Aortic EU
Berinert Hizentra
anti GCSFR
SC ROW
rHDL FXIII
Beriplex
rIX-FP
US
rVIIa-FP
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Immunoglobulins

Immunoglobulins Strategy

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Supporting and
enhancing
current portfolio and
developing new products
•
Yield
Breakthrough
Specialty
Medicines •
Products Label
•
Formulation science
•
Immuno- Patient convenience
Haemophilia
globulins Products
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Privigen[®]

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• Only room temperature stable IVIG (36 months)

• IgLab Module2 comes on-line 2011 (submitted to the FDA 25 Nov)

• Privigen approved and launched in US, Europe, Australia, Canada and other countries, with additional registrations underway

• European Phase III study in CIDP initiated

Hizentra[®]

• First 20% SCIg launched in US

• FDA approval March 2010

• Expected to be the first 20% SCIg launched in Europe, Canada, Switzerland, Japan and other geographies

• Review in progess: EMA, Switzerland, Canada

• Launches expected in 2011

• Japan Phase III study initiated Sept 2010

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Specialty Products

Specialty Products Strategy

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Expanding use through
new markets, novel
indications and/or
modes of administration
e.g.
•
Breakthrough Specialty Berinert
Medicines
Products
•
Beriplex
•
Fibrinogen
Immuno-
Haemophilia
globulins Products
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Improving Treatment for Hereditary Angioedema Berinert[®] Program

Hereditary Angioedema (HAE)

• C1-esterase inhibitor is the primary control protein of activation of mediators of vascular permeability

• HAE results from deficiency or dysfunction due to gene mutation

• i.e. life-long condition

What Happens to Patients?

• 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

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HAE Treatment Guidelines

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1. Bowen , et al, Ann Allergy Asthma Immunol. 2008

2. Gompels et al, Clin Exp Immunol . 2005

Berinert[®] - Effective Treatment for HAE

• Long clinical use in Europe

• Orphan drug status for treatment in US in 2009

• Currently given via intravenous administration

• A&E or self-administration

• High quality manufacturing process

• Strong safety record

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Berinert[®] Development Program

• Improving Convenience

• Developing a high concentration, low volume formulation

• More rapid and easier subcutaneous administration

• Improving Options

• Program to gain indication for prevention for sufferers with frequent attacks

• Launch when prevention indication for Berinert[®] is available in US

• Expanding Indications

• Exploring opportunities for new medical uses

Treating the Bleeding Patient

Acquired Bleeding Disorders

• Coagulation factor deficiencies can occur because of multiple factors

• Current treatment options

• Donated blood products – platelets, fresh frozen plasma (FFP), cryoprecipitate

• Specific products such as those in CSL portfolio

• Problems with donated blood products

• Sensitivity reactions

• Large volume

• Time taken to administer

• Storage not straightforward

• Consume a lot of donated blood

• Limited lifespan

Beriplex[®] to reverse anti-coagulation with Vitamin K antagonists (e.g. warfarin)

Challenges with Anti-Coagulation

• Vitamin K antagonists are the most commonly prescribed oral anti-coagulants to prevent clotting for people who are at risk, i.e. previously had a clot, artificial heart valves, etc

• Potential problems

• Over anti-coagulation can be a consequence of other medications, illness, other factors

• Need to urgently reverse if trauma, surgery immediately required

What is Beriplex[®] ?

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• Highly purified preparation containing vitamin K- dependent coagulation factors

• FII, FVII, FIX, FX

• 2 viral inactivation steps

• Specific antidote to vit K antagonists (anti-coagulants)

• provides rapid normalisation of clotting

• Used in Europe for >10 years with excellent safety record

• Current program to expand geographical usage

Program to licence Beriplex[®] in US

• Seeking approval for use of Beriplex[®] to reverse the effects of vitamin K antagonists for

• Bleeding related to over-anticoagulation

• Patients needing surgery

• 2 large randomised, controlled clinical trials

• Bleeding study completed and analysis currently underway

• BLA submission planned for 2011

Fibrinogen Concentrate for Major Cardio-Aortic Surgery

Aortic Aneurysm – a Potentially Lethal Problem

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Fibrinogen in Aortic Surgery

• Patients go on cardiopulmonary bypass and 

• coagulation factors are consumed bleeding

• Concept – a quickly administered, fast acting, low volume medicine to microvascular bleeding that will substantially reduce the need for donated (allogeneic) blood products

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Pilot Experience in Hannover

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Proof-of-Concept Study in Aortic Repair

• Prospective, randomized, double-blind, placebocontrolled, single-center study

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Standardised Approach

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Standard transfusion protocol
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Fibrinogen Reduced Amount of Blood Transfused

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50
p < 0.0001
40
30
20
10
0
Fibrinogen Placebo
N = 29 N = 31
Units of allogeneic blood products
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Fibrinogen Reduced Proportion of Patients Requiring Transfusion

Proportion of subjects Administration of donated blood Fibrinogen Placebo products (N = 29) (N = 31) No 45% 0% Yes 55% 100% p<0.0001

Fibrinogen in Aortic Surgery Program

• Next 12 months

• Confirm findings in multi-centre trials in Europe to commence in 2011

• Longer term Outlook

• Obtain extended approvals in EU

• Obtain indication approval in US

Q&A

Break

Haemophilia

Haemophilia Strategy

Supporting and enhancing portfolio and developing new products

• Plasma products

Breakthrough Specialty Medicines Products ImmunoHaemophilia globulins Products

• Long acting rIX & rVIIa

• Patient convenience

• Coagulation research

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Recombinant Coagulation Factors with extended half-life

Half-life Improvement for Coagulation Products

Products with improved half-life will be beneficial to patients

• Less frequent injections

• Improved compliance

• May enable prophylaxis

Albumin as a Carrier Protein

• Albumin has a naturally long half-life (~20 days)

• Proof of principle data for FVIIa and FIX

Coagulation factor + short half-life

Albumin long half-life

Albumin = half-life extension

Albumin fusion extends the half life of rFIX

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rIX-Albumin Fusion Protein
3 Dimensional Model
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Pharmacokinetics in Rabbits
rIX-FP: average curves
2048
Pharmacokinetics in Monkeys
1024
512
100 U/kg
•
256
128 •
50 U/kg
64
•
32
0 1 2 3 4 5 6 7 8
Day
Factor IX (IU/L) above background
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• Pre clinical toxicology completed • Phase I commenced Oct 2010 • Data available in ~12 months

Extended half life suitable for once per week dosing

Albumin fusion extends the half life of rVIIa

Pharmacokinetics in Rats

Haemostatic Efficacy in FVIII Deficient Mice

NovoSeven rVIIa-FP 0.9 mg/kg

• Pilot scale manufacturing process developed

• Proceeding to pre clinical toxicology, Q1 2011

Manufacturing for Rec Coagulation Products

Phase I / II Process Development GMP Manufacture

CSL Parkville Melbourne Australia

Phase III & Launch

Technical Transfer

Contract Manufacturing

Contract Manufacturing CSL’s purification expertise CMO CSL Behring, Marburg Intermediate Transportation Cell Culture Intermediate Purification to Finished Product

Large Scale Biotech Facility

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2009 2010 2011 2012 2013 2014 2015 2016 2017
Design Construction Operations
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• Support large scale manufacturing for CSL’s R&D portfolio

Broadmeadows, Melbourne, Australia

• Highly flexible to accommodate range of biotechnology manufacturing processes.

• Compliant to FDA, EMA and TGA requirements

• Construction commenced November 2010

Utilising Marburg’s Coagulation Expertise

• Facility for purification and formulation of recombinant coagulation proteins

• Renovation of existing FDA compliant recombinant facility

• Utilise existing knowhow of plasma coagulation factors

• Opened November 2010

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Breakthrough Medicines

Breakthrough Medicines Strategy

Developing new proteinbased therapies

• Significant unmet need

Breakthrough Specialty Medicines Products ImmunoHaemophilia globulins Products

• Multiple indications, e.g.

• Reconstituted HDL

• Anti IL-3R a mAb

• Anti G-CSFR mAb

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Reconstituted HDL (CSL112)

• Compelling opportunity

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• Significant investment and risk in late stage development

• Phase I study progressing well

• Phase IIa to commence in 2011

Optionality of rMAb Programs

• Establish paradigm

• Opportunity for multiple medical indications

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Autoimmune Arthritis
Other Blood
Respiratory
Malignancies
Relapsed CF exacerbations
Refractory AML
CSL362 CSL324
IL-3R a G-CSF
AML, MRD Vasculitis
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*Possible clinical indications only

CSL362 Acute Myeloid Leukemia

CSL362 - AML

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KA Thornton, M Levis . NEJM 2007. 357:1639
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AML

• most common acute leukaemia in adults

• incidence increases with age

• untreated AML fatal: 3 - 4 mo

• chemotherapy  50-75% CR

• ~70% will relapse

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100
Study Years 1989-1997, n=553
80 Median Survival = 3.2 months
5-Year Survival = 12%
60 Study Years 1983-1986, n=142
Median Survival= 6.3 months
5-Year Survival =13%
40
Study Years 1973-1979, n=293
Median Survival= 3.5 months
20
5-Year Survival = 6%
0
0 5 10 15 20
Years
Survival %
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• 5-year OS = 21% (2008) < 55 yrs ~ 40%

• 55-65 yrs < 10%

• 65 yrs < 5%

CSL362 - AML

CD123 is a target expressed on AML blasts and leukemic stem cells

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Transforming
mutations
AML Blasts and LSC 100 CD34+38+
Express CD123 80
10000
HSC LSC 60
40
(CD123+) 1000
20
100
0
1 10 100 1000 10000
CD123
Normal blood 10 100 CD34+38-
cell formation 80
1
60
1 10 100 1000 10000
CD34
(basophils and CD34 40
pDC CD123+)
20
0
1 10 100 1000 10000
Leukemic blast cells CD123
CD123
(CD123+)
CD38
% of Max
% of Max
CD38
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CSL362 - AML

a CSL362 – a second generation mAb targeting CD123 (IL-3R )

• retains (cf. CSL360) the ability to potently inhibit IL-3 activity

• humanised for reduced immunogenicity

• optimised for enhanced tumour killing activity

• in-licensed proprietary technologies

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Fc  RIII NK
AML
CD123 Target cell killing
Fc  RI/II/III M
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CSL362 - AML

CSL362 shows potent killing activity in vitro

• blood basophils and pDC

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no mAb CSL362 (10mg/mL) Down regulation of CD16 on activated NK cells
10 [4] 10 [4]
100
10 [3] 10 [3] 80
1.94 4.44e-4
60
10 [2] 10 [2]
40
10 [1] 10 [1]
20
10 [0] 10 [0] 0
10 [0] 10 [1] 10 [2] 10 [3] 10 [4] 10 [0] 10 [1] 10 [2] 10 [3] 10 [4] 10 [0] 10 1 10 2 10 [3] 10 4
CD123 PE CD123 PE PBMC Donor 3
10 [4] 10 [4]
CD16
10 [3] 10 [3]
Count = 240 Count = 0
Freq. of Total = 0.067% Freq. of Total = 0% No CSL360 CSL362
10 [2] 10 [2]
antibody 10mg/mL 10mg/mL
10 [1] 10 [1]
10 [0] 31.6 10 [0] 0
10 [0] 10 [1] 10 [2] 10 [3] 10 [4] 10 [0] 10 [1] 10 [2] 10 [3] 10 [4]
CD123 PE CD123 PE
CD123
whole blood , 48hrs
IgE
basophils
NK cells (CD3-, CD56+)
pDC
CD11c APC
IgE FITC IgE FITC
CD11c APC CD11c APC
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CSL362 - AML

CSL362 shows potent killing activity in vivo I • basophils and pDC in non-human primates

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Basophil depletion Time course analysis of cell depletion
CSL362: 10mg/kg 3 NHP’s / grp, CSL362: 10mg/kg
10 [4]
Day -2
0.523
10 [3]
Basophils
10 [2]
10 [1]
10 [0]
10 [0] 10 [1] 10 [2] 10 [3] 10 [4]
PE-A
10 [4]
6 Hour
5.38e-3
10 [3]
pDC
10 [2]
10 [1]
10 [0]
10 [0] 10 [1] 10 [2] 10 [3] 10 [4]
PE-A Time point
CD123
FITC-A
IgE
% maximum cell number
FITC-A
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CSL362 - AML

CSL362 shows potent killing activity in vitro II

• tumour cell lines and primary AML cells

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CD123+ve CTLEN Primary AML, RMH048
100
90
80
70
CSL362
60
50
CSL362
40
30
CSL360
20
10
CSL360
0 -10
0.0001 0.001 0.01 0.1 1 10 0.0001 0.001 0.01 0.1 1 10
Antibody (mg/ml) Antibody (mg/ml)
(Donor PBMC effectors, E:T = 100:1) (Enriched NK effectors, E:T = 25:1)
% Specific lysis
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CSL362 - AML

CSL362 shows potent killing activity in vivo II

• primary AML cells in NOD/SCID mice

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AML
sample
mAbs,
CSL360
300mg, 3x/wk,
CSL362v1
4 weeks
4 weeks
CSL362v2
P = 0.0007 comparing CSL360 and CSL362 V1
4 weeks P = 0.0002 comparing CSL360 and CSL362
(LGD between these groups =12-15 days)
Engraftment measured by % human
CD45+ cells in peripheral blood (>20% =
event).
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CSL362 - AML

CSL362 shows potent killing activity in vitro III

• primary patient AML blasts with autologous remission NK cells

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No Antibody CSL362
10 4 10 4
6.35 1.31
10 3 10 3
10 2 10 2
10 1 10 1
10 0 10 0
10 0 10 1 10 2 10 3 10 4 10 0 10 1 10 2 10 3 10 4
CD45 FITC CD45 FITC
CD45 FITC
CD33 PE CD33 PE
CD33 PE
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NK and blast cells from RMH076 mixed at a ratio of 3:1. CSL362 added to a final conc. of 10ug/mL and the cultures incubated for 24h at 37[o] C.

CSL362 – AML

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FIH, Phase I/IIa study of CSL362 in AML patients AML
(24,300)
- remission / early relapse
Primary objectives:
Best
• Induction Supportive
safety and tolerability of escalating doses Care
•
PK; immunogenicity
Fail 1 [st] line
Achieve CR
Secondary objectives: therapy
(12,300)
• (8,900)
MTD (if exists within range)
• anti-leukaemic activity Patients with Patients with 2nd line
high or No further
low risk of induction
intermediate
(clinical response rate) therapy
risk of relapse relapse therapy
•
biological effect on CD123+
LSC and blasts
Achieve Fail
Relapse
• CR therapy
biologically effective dose
& schedule
Relapse
Next milestone: commence GLP Toxicology in 2011
commence clinical studies early 2012
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CSL362 – Longer Term Potential for SLE

pDC and basophils support the progression of SLE

• SLE is characterised by an IFN a signature and pDC are the major source of IFN a in SLE

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CSL360
CSL362
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• mAb added for 18 hr to deplete pDCs, CpG (5 uM)

• added for 24 hr to stimulate IFN- a production.

CSL 324 Acute and Chronic Inflammation

CSL324 – Acute and Chronic Inflammation

Neutrophils and inflammatory disease

• most abundant WBC, ~10[9] cells / kg body weight

• leave the bone marrow (BM) per day

• key effectors of the innate response to infection

• but...

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COPD exacerbations
•
excessive production and persistence within
CF exacerbations
tissues leads to chronic inflammation and tissue
destruction ARDS
Rheumatoid
G-CSF G-CSF
arthritis
neutrophils
CSF’s, cytokines
Vasculitis
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CSL324 – Acute and Chronic Inflammation

The role of G-CSF in mouse models of inflammatory disease

• anti-G-CSF mAb inhibits disease progression in mouse models of arthritis

Collagen-induced arthritis

Anti-collagen Ab – induced arthritis

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12 Control control
10 aG-CSF anti-G-CSF G-CSF gene
8 knockout
aTNF anti-TNF a
6
4
2
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
control
Anti-CII LPS Day of disease induction
mAbs
daily mAb therapy
Clinical score
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CSL324 – Acute and Chronic Inflammation

The role of G-CSF in mouse models of inflammatory disease

• anti-G-CSF mAb inhibits disease progression in a mouse model of COPD

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Cigarette smoke
3 times/day @ 2 cigarettes/exposure
D.-5 -4 -3 -2 -1 0 1 2 3
G-CSF mAb Diluent or G-CSF mAb Dissection
or isotype influenza or isotype
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Lung neutrophils (Day 3)
750000
500000
250000

0
ShamSmk + Dil + isotypeSmk + DilSmk+Dil+anti-GCSFSmk + Flu + isotypeSmk + FluSmk+Flu+anti-GCSF
Total neutrophils in lung lavage
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CSL324 – Acute and Chronic Inflammation

Identification and characterisation of a lead candidate mAb

• options available included:

• humanisation of in-licensed mouse mAbs against the huG-CSGR

• de novo generation of fully human mAbs utilising Dyax phage display

• technology (G-CSF and / or G-CSFR specific)

CSL324

• fully human mAb directed against the human G-CSFR

• high affinity for target – 257pM at the cell surface

• potent antagonist of G-CSF activity in a variety

• of assay systems

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1.4
1.2
1
0.8
0.6
anti-G-CSFR I (human)
0.4 anti-G-CSFR II 5D11 IgG4 (human)
C1.2 IgG4
anti-G-CSFR 711/H71 IgG1(humanised)
0.2
0
1000 100 10 1 0.1 0.01 0.001
antibody conc. (nM) Antibody Concentration nM
Absorbance 490nM
Absorbance 450 nM
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CSL324 – Acute and Chronic Inflammation

CSL324 is a potent inhibitor of G-CSF action in vitro

• inhibition in of G-CSF mediated neutrophil production from HSC

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mAb	IC50 (nM)
C1.2	0.016
RO5F6	ND

Each point represents the mean +/- range of duplicate measurements

CSL324 – Acute and Chronic Inflammation

CSL324 is a potent inhibitor of G-CSF action in vivo

• inhibition of PEG-G-CSF induced neutrophilia in NHP’s

• 2 groups (3 animals per group)

• s.c PEG-GCSF on Day 1

• single i.v infusion of CSL324 12 hrs later

CSL324 – Acute and Chronic Inflammation

Concluding comments

• CSL324:

• fully human monoclonal antibody directed against the G-CSFR

• a potent antagonist of G-CSF activity in in vitro and in vivo assays systems

• does not induce acute neutropenia in NHP’s (role of G-CSF in homeostasis vs. acute or chronic inflammation)

• opportunities for clinical development in a number of inflammatory indications

• potential for small parallel Phase IIa studies

• Next milestone: commence preclinical tox studies late 2011

Licensing

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ISCOMATRIX[®] Adjuvant

Business Plan: Pillars for Success

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Value
• •
Increased Flexible capacity
interest from with long term
major partners Broad Exclusive supply
Licenses Manufacture
•
~30 fields
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Merck Sharp & Dohme Corp.

• Merck Sharp & Dohme Corp. continues to show confidence in ISCOMATRIX[®] adjuvant for vaccine development programs

• Additional Licences

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• Broader research interest

High Quality Scientific Research

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Internal research
Partners (Merck, Genentech)
High quality academics (WEHI) Mechanisms
FDA
Investigator led
clinical studies
(NCI)
Biomarkers
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Partnered Projects

Partnered Projects

a CAM3001 (GM-CSFR )

• Medimmume/AstraZeneca commenced Phase II study in Rheumatoid Arthritis Feb 2010

Periodontal disease vaccine

• Research agreement with Sanofi pasteur

• Option to an exclusive worldwide license

GARDASIL[®]

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Summary

 Global R&D Pipeline  December 2010

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Humate® P
Zemaira® US
Privigen®
Rhophylac® US
Afluria®
Fibrinogen Fibrinogen Privigen®CIDP EU Hizentra® EU Hizentra® US
New Indications Aortic Surgery
Zemaira® EU Beriplex® EU Berinert® US
PCC
New Indications Beriplex ® US Riastap® US
Biostate® EU Riastap® EU
Rec Coagulation CSL689 rVIIa-FP
Factors
CSL654 rIX-FP
Novel Plasma
Proteins
Vaccines– Merck Vaccines– Merck Vaccines– Merck Partnered Vaccine
Vaccines – Pfizer Programs
Vaccines– Pfizer
Vaccines– Abbott
P gingivalis POD CSL425
CRC-OHS/Sanofi * 2009 H1N1 Flu
CSL112 CAM3001
CSL401
reconstituted HDL GM-CSFR - AZ
H5N1 Flu
CSL362 IL-3R
CSL324 G-CSFR
Discovery
Projects IL-13R
Core Capabilities Plasma Proteins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Partnered Projects
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Q&A