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Novo Nordisk A focused global healthcare company with biotech expertise Investor Presentation November 2001

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Title: Novo Nordisk A focused global healthcare company with biotech expertise Investor Presentation November 2001


1
Novo NordiskA focused global healthcare
company with biotech expertise Investor
PresentationNovember 2001
2
Novo Nordisk today
  • Consistent, strong organic growth
  • Focused on few therapeutic areas with large unmet
    medical needs
  • Leadership in diabetes and most extensive
    diabetes pipeline in the industry
  • Becoming an established player in general
    haemostasis management
  • Proven biotech and drug delivery capabilities
  • Strong intellectual property portfolio
  • Low exposure to patent expirations
  • Track record of delivering on promises

3
Novo Nordisk Future Key Drivers
Coagulation disorders
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Human growth hormone
Intellectual property
HRT
4
Turnover by Therapy first nine months 2001
Key observations
HRT
Growth driven by sales of insulin and continued
growth in sales of NovoNorm /Prandin High
growth in the US supported by increasing sales in
Europe and Rest of World Solid growth in Europe
and US, but Japan hit by inventory adjustments
and depreciation of JPY in 2001 Growth in Europe
supported by Pharmacia's US launch mid-2000
hGH
12
3
Coagulation disorders
42
Diabetes care
15
Total turnover of DKK 17,316 mn (16)
5
Turnover by Region first nine months 2001
Key observations
Strong insulin market growth and continued
penetration of NovoSeven and Norditropin
SimpleXx
RoW
15
Japan
Strong insulin market growth and continued
penetration of NovoNorm and NovoSeven
Europe
-5
18
Growth affected by depreciation of JPY and
inventory adjustments
USA
36
Primarily driven by Diabetes care and NovoSeven
sales
Total turnover of DKK 17,316 mn (16)
6
Novo Nordisk Future Key Drivers
Coagulation disorders
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Human growth hormone
Intellectual property
HRT
7
A high growth therapeutic area
Key Novo Nordisk features
Continued high growth
  • More than 75 years of experience within diabetes
  • Dominant position in insulin markets of Europe
    and Japan
  • Strong growth in the US
  • 2,000 dedicated employees in Diabetes RD
  • Most comprehensive Type 2 diabetes pipeline in
    the industry

Diabetes care
25

CNS
20
Cancer
Respiratory
15
Cardiovascular
CAGR 1995-1999
Arthritis
Gastrointestinal
10
Infectious disease
5
0
0
5
10
15
20
25
CAGR 2000-05
Source SG Cowen estimates
8
Towards more intensive/flexible treatment
Novo Nordiskmarket share 2001
39
Short-acting
52
Premixed
Short-acting market growth 11.8 CAGR since
1996 Premixed market growth 9.1 CAGR since
1996 Long-acting market growth 0.5 CAGR since
1996 Total market growth 6.1 CAGR since 1996
41
Long-acting
Note All figures are based on MAT Q2 volumes,
industrialised world only.
9
Insulin market overview(01/ 00 MAT Q2 Volumes)
Novo Nordisk market share
Market growth (01/00)
market size
USA
26
- 0.3
43
Europe
58
9.5
47
Japan
7.8
80
4
RoW
60
10.5
6
World
46
4.8
100
Notes Industrialised world only. WalMart
figures not included. Growth in Europe
effected both positively and negatively by
conversion of formulation.
10
Adding Value to Volume
Worldwide analogue penetration
Worldwide pen penetration
1997
1997
1998
1998
1999
1999
2000
2000
2001
2001
0
50
50
0
50
50
Unit value
Unit value
Notes All numbers are MAT Q2
11
Key insulin market observations
  • Volume
  • No. of people with diabetes expected to double by
    2025
  • Increased diagnosis rate
  • Intensified therapy
  • Product upgrades
  • Insulin analogues
  • Insulin delivery systems

5 to annual growth
5 to annual growth

12
Insulin etc
Sales by quarter
  • Key observations
  • Growth of 13 in 9M 2001 vs 9M 2000 and growth of
    12 in Q3 2001 vs Q3 2000
  • In the US sales growth is driven by market share
    gain, primarily via major contracts
  • NovoLog launched in the US in September
  • Sales growth in Europe primarily due to high
    market growth
  • NovoRapid approved in Japan in October 2001

DKK million
4,500
4,000
3,500

3,000
2,500
2,000
1,500
1,000
500
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
13
Diabetes pipeline - insulins
Phase 1
Phase 2
Phase 3
  • NN1998 (AERx iDMS)
  • NN304 (Basal analogue)
  • NN414 (Insulin secretion)
  • NN4201 (Hepatic glucose regulator)
  • NN622 (Dual-acting sensitiser)
  • NN2344 (Insulin sensitiser)
  • NN1215 (LABI)
  • NN2211 (GLP-1 analogue)

14
NN304 versus NPH insulin
  • Key observations
  • Soluble at neutral pH
  • No re-suspension required
  • Mixable with other insulin products
  • Novel mechanism of protraction
  • Predictable action profile
  • Low intra-patient variability
  • Contributes to low risk of hypoglycaemia
  • Safety
  • Reduced risk of hypo- glycaemic events versus NPH
  • Hypoglycaemic events

26
50
36
40
30
Number of episodes
39
62
20
10
0
2230-
0800-
1200-
Time
0800
1200
2200
unknown
NN304
NPH insulin
Note Findings from EASD 2001
15
From diet and exercise to insulin
Insulin 14
OAD and insulin 3
Diet and exercise 50
OAD 33
Type 2 patients diagnosed
16
NovoNorm/Prandin
Sales by quarter
DKK million
  • Key observations
  • Growth of 44 in 9M 2001 vs 9M 2000
  • Growth of 34 in Q3 2001 vs Q3 2000
  • Continued market penetration in Europe
    contributed to growth
  • Growth in the US via strong underlying market
    growth
  • Sales in Q3 affected by inventory adjustments in
    Q2 2001 in the US and large orders to the Russian
    Ministry of Health in H1 2001

450
400
350
300
250
200
150
100
50
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
17
Growth opportunities in OAD
Growth in USD 6.2 bn OAD market
Key observations Novo Nordisk
Sales development in USD CAGR 27
  • Experience in the OAD market from NovoNorm
    /Prandin
  • Broad pipeline of innovative approaches for Type
    2 diabetes
  • NN622 has just entered clinical Phase 3 trials

No. of treated patients CAGR 13
18
Diabetes pipeline non-insulins
Phase 1
Phase 2
Phase 3
  • NN1998 (AERx)
  • NN304 (Basal analogue)
  • NN414 (Insulin secretion)
  • NN4201 (Hepatic glucose regulator)
  • NN622 (Dual-acting sensitiser)
  • NN2344 (Insulin sensitiser)
  • NN1215 (LABI)
  • NN2211 (GLP-1 analogue)

19
Attractive late stage diabetes pipeline
Note Expected profiles
20
NN622 adding lipid control to glucose regulation
  • Key observations
  • Lipid abnormalities much more common in people
    with Type 2 diabetes than in people without
    diabetes
  • Cardiovascular disease is accountable for 75 of
    all deaths in people with Type 2 diabetes

Estimated 50-70 of people with Type 2 deabetes
have abnormal lipid values
  • Hypertriglyceridaemia and a reduced HDL level are
    the most common lipid abnormalities among people
    with Type 2 diabetes
  • Existing therapies are not efficacious and have
    consequently not reached widespread use
  • NN622 will benefit most people with Type 2
    diabetes as there is no lipid threshold to
    cardiovascular disease risk

OAD market estimated to be USD 6.2bn in 2001
close to 1/3 being sensitisers
21
NN622 a competitive profile
HbA1C
-2
  • Definitions
  • NN622
  • Sensitisers
  • Fibrates
  • Statins

Fasting plasma glucose (FPG)
Plasma insulin
-60
-60
0
Note The slide is constructed for illustrative
purpose including findings from the NN622 12
weeks phase 2 studies. The relative comparison to
sensitisers, fibrates and statins are all
indicative. Also note that there is only little
evidence regarding statins and fibrates effect on
the FFA levels and therefore values for those are
not included.
-60
-60
Free fatty acids (FFA)
Triglyceride
60
HDL cholesterol
22
Protein Delivery Systems
Devices
  • Key observations
  • A new research and development unit
  • Leveraging on key core competences
  • Innovative and superior drug delivery
  • Focus on next generation of insulin delivery

Proteins
Endocrinology
23
Novo Nordisk Future Key Drivers
Coagulation disorders
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Human growth hormone
Intellectual property
HRT
24
Coagulation disorders (NovoSeven)
  • Key observations
  • Growth of 42 9M 2001 YoY and 36 Q3 2001 YoY
  • Increased use in surgical procedures for
    inhibitor patients
  • Increased use for patients with acquired
    haemophilia
  • Sales are positively affected by increased
    investigational use
  • Investing in a new NovoSeven factory

Sales by quarter
900
DKK million
800
700
600
500
400
300
200
100
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
25
Advantages of NovoSeven
FVIIa/NovoSeven
Tissue factor
26
Beyond haemophilia treatment
  • NovoSeven in bleeding conditions
  • Coagulation factor deficiencies
  • Platelet defects
  • General haemostasis
  • Reduction of blood and plasma transfusions
  • No product offers this safety and efficacy
    profile
  • Increasing supportive data from investigational
    use
  • NovoSeven is a life saving drug

Haemostasis Management
Haemophilia Treatment
27
NovoSeven indication expansions
Coagulation Factor Deficiency
PlateletDisorder
GeneralHaemostasis
Spontaneous bleeding
Single Factor
Multiple Factors
Surgical bleeding
Lack of platelets
Defective platelets
Haemophilia with inhibitors
Intra-cerebral bleedingsTraumatology
Upper gastrointestinal bleedings )
Orthotopic liver transplantations ) Liver
resection )
Stem cell transplantation
Liver resection
Vitamin K-antagonists
) Patients with chronic liver disease
28
Building Strong Scientific Evidence
Clinical area Status on project
Orthotopic liver transplantation Ongoing Ph 2/3
project Upper GI bleeds Ph 2 study has been
initiated Liver resection Ph 2 study has been
initiated Liver resection Exploratory Ph 2
study has been initiated Bone marrow
transplantations Ph 2 study has been
initiatedIntra-cerebral bleeds Exploratory Ph 2
study has been initiated Reversal of
anti-coagulantia therapy Ph 2 study expected to
start later this year Traumatology Ph 2 study
expected to first half next year
Patients with chronic liver disease.
29
Novo Nordisk Future Key Drivers
Coagulation disorder
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Human growth hormone
Intellectual property

HRT
30
Human growth hormone sales
  • Key observations
  • Growth of 3 in 9M 2001 YoY and decrease of 3 in
    Q3 2001 YoY
  • Reported sales in Japan impacted by negative
    currency and wholesalers inventory adjustments
  • Market share gains from continued roll-out of
    Norditropin SimpleXx in both Europe and the US

Sales by quarter
DKK million
700
600
500
400
300
200
100
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
31
Novo Nordisk Future Key Drivers
Coagulation disorder
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Intellectual property
Human growth hormone
HRT

32
Hormone Replacement Therapy
  • Key observations
  • Growth of 12 9M 2001 YoY and growth of 6 Q3
    2001 YoY
  • Activelle and Vagifem main contributors to
    growth in Europe
  • Growth supported by Pharmacias launch of
    ActivellaTM and Vagifem mid-2000

Sales by quarter
400
DKK million
350
300
250
200
150
100
50
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
33
Novo Nordisk Future Key Drivers
Coagulation disorders
Primarygrowth drivers
Diabetes care
Secondary valuedrivers
Human growth hormone
Intellectual property
HRT
34
No major patent expirations
60
of 2000 sales with patents expiring in 2001-2005
50
40
30
20
10
0
JJ
AHP
BMS
GSK
AstraZ.
Pfizer
Abbott
Merck
Roche
Amgen
Eli Lilly
Aventis
Novartis
S-Plough
Pharmacia
Novo Nordisk
Source Nordea Securities
) Except NovoSeven in Japan, which expires in
2008
35
Financials
36
Financial results first nine months
DKK million 2001 2000 change
Net turnover 17,316 14,936 16 Operating profit
as reported 4,130 3,457 19 Financial
items 334 (27) N/A Profit
before tax 4,464 3,430 30 Net profit 2,857
2,136 34 Earnings per share (DKK) -
diluted 8.21 6.09 35 Earnings per ADR
(USD)) 1.01 0.75 35 ) Translated for
convenience at the end of September 2001 exchange
rate of USD 100 DKK 811.82
37
Updated outlook for 2001
  • Growth in operating profit of 15 is expected
  • Net financial income is expected to be approx DKK
    375 million
  • Tax rate expected at the level of 36
  • Investments expected around DKK 3.5 billion
  • Above outlook is based on the assumption that
    exchange and interest rates remain at the current
    level (6 November 2001)

38
Adding shareholder value at Novo Nordisk
A holistic view on value creation
  • Four long-term financial targets
  • EBIT growth of 15 per annum
  • EBIT margin of 25
  • ROIC of 25 per annum
  • Cash to earnings of 60

Economically viable
Socially responsible
Environmentally sound
Supported by shareholder value creating
initiatives
  • Demerger of Novozymes
  • Spin-offs
  • Share splits
  • Cancellation of own shares
  • Steady increase in pay-out ratio
  • Use of share buy-back programmes
  • Management invested in Novo Nordisk
  • Option based incentive programmes

39
Novo Nordisk Key Drivers
Diabetes care
Coagulation disorders
  • Estimated market potential for current NovoSeven
    indication of USD 350 million
  • Entering 6 new clinical areas with 8 new studies
  • Strategy for making NovoSeven the first general
    haemostatic agent
  • Patent protection in Europe and the US until
    2011, in Japan until 2008
  • World leader with steady growth for more than 75
    years
  • 2/3 of business (insulin) growing gt10 pa
  • Growth platform in the US
  • The most comprehensive insulin and insulin device
    portfolio one new device per year
  • Sensitisers (NN622 and NN2344)
  • GLP-1 analogue (NN2211)

Primarygrowthdrivers
Secondary valuedrivers
Human growth hormone
Intellectual property
HRT
40
Forward-looking statements
This presentation contains forward-looking
statements as the term is defined in the US
Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are subject to
risk and uncertainties that may cause actual
results to differ materially from expectations,
including unexpected developments in the
international currency exchange and securities
markets, government-mandated or market-driven
price decreases for Novo Nordisk's products in
the company's major markets and the introduction
of competing products within Novo Nordisk's core
businesses. These and other risks and
uncertainties are further described in reports
filed with the US Securities and Exchange
Commission (SEC) by Novo Nordisk and readily
available to the public, including the company's
Form 20-F, which was filed on 27 April 2001.
41
Investor Information
  • Investor Relations contactsNovo Nordisk A/S
    Investor Relations Novo Allé DK2880
    BagsværdDenmark
  • Fax (45) 4444 2314 Peter HaahrPhone (45)
    4442 1207 E-mail pehr_at_novonordisk.com
  • Palle Holm Olesen
    Phone (45) 4442 6175 E-mail
    phoo_at_novonordisk.com
  • Rasmus JorgensenPhone (1) 212 867 0123
    E-mail rrhj_at_novonordisk.com

Share informationNovo Nordisks B shares are
listed on the stock exchanges in Copenhagen and
London. Its ADRs are listed on the New York Stock
Exchange under the symbol "NVO". For further
company information, visit Novo Nordisk on the
Internet at http//www.novonordisk.com
42
Appendix
43
Margin Development
6000
Development in gross- andEBIT-margin 1997-2000
Production costs
5000
4000
DKK million
3000
2000
1000
0
1997
1998
1999
2000
7000
RD costs
6000
SD costs
Adm. costs
5000
4000
DKK million
30.1
3000
2000
Note EBIT margin as reported
27.9
16.3
17.4
1000
9.0
12.1
0
1997
1998
1999
2000
44
Profit Loss 1998-2000
DKK million 1998 1999 2000
Net turnover 13,647 16,423 20,811
Y/Y growth 8.4 20.3 26.7
Gross profit 9,896 12,196 15,767
EBIT 2,933 3,527 4,816
EBIT-margin 21.5 21.5 23.1
Net finance 243 -178 24
Pre-tax profit 3,176 3,349 4,840
Tax rate 36.5 40.3 36.2
Net profit 2,016 2,001 3,087
45
Diabetes RD at Novo Nordisk Sources of
innovation
  • Clinical research
  • Steno Diabetes Centre
  • Oxford Diabetes Centre
  • Clinical research centres worldwide
  • Basic research
  • Hagedorn Research Institute
  • Oxford and Steno Diabetes Centre
  • Academic collaborations
  • Consortia
  • Evidence-based medicine
  • NN disease mgt programmes
  • Outcomes data from gt 100.000 individuals with
    diabetes

RD projects
  • Molecular diversity design
  • Protein chemistry since 23
  • Medicinal chemistry since 68
  • Computational chemistry since 75
  • Rational drug design since 83
  • Combinatorial chemistry since 93
  • Drug target screening
  • Molecular biology since 80
  • HT screening Amersham since 92
  • Chemoinformatics since 95
  • Dundee MRC consortium since 98
  • Ultra HT Screening since 00
  • Trinomics
  • Genomics Incyte since 95
  • Proteomics CPA since 97
  • Metabonomics since 99

46
Diabetes drug candidates in development at Novo
Nordisk
  • Genotype

Insulin Resistance Dyslipidaemia
Obesity
Type 2 diabetes
Failure of oral drugs
Phenotype
Diet and exercise NN education programme
Sensitizers and lipid-lowering agents NN2344
NN622
ß-cell agents NovoNorm NN2211, NN414 Hepatic
glucose regulators NN4201
Insulins NovoRapid, NovoMixTM, AERx, insulin
detemir, LABI
Appetite regulation NN2211
  • Type 2 diabetes is preceded by impaired glucose
    tolerance and occurs when the beta-
  • cell fails. It may also be seen in the absence
    of obesity and insulin resistance.

47
Type 2 Diabetes the Metabolic Syndrome
NN622
NN622
Genetic Acquired Glucotoxicity Lipotoxicity
Insulin deficiency
Insulin deficiency
Impaired beta cell function
Hepatic glucose production
Glucose-induced insulin secretion
Post receptor defect
Hyperglycemia
Tissue response to insulin
Glucose uptake
Basal hyper- insulinemia
NN622
Glucose transport
Insulin resistance
Insulin resistance
Insulin binding
Genetic Acquired Obesity Age
48
Pharmaceutical needs in diabetes
  • Type 1
  • Intervention in ?-cell
  • destruction
  • Blood glucose regulation
  • Type 2
  • Blood glucose regulation
  • Regulation of energy balance (diabetes-associated
    obesity)
  • Reduction of triglycerides, FFA and LDL/HDL ratio
    (diabetic dyslipidaemia)

Including, but not restricted to, new
pharmaceuticals
49
Insulin detemir versus NPH insulin Night-time
glucose profile
BG (mM)
Insulin detemir showed reduced variability
compared to NPH
N 21
9
8
N 52
7
6
5
11pm
3am
7am
Treatment
Insulin detemir
NPH insulin

Findings Predictable glucose profiles over night
with detemir
J. L. Selam et al. Oral presentation EASD 2001
50
Profile of the ideal basal insulin
  • Desirable properties
  • Solubility
  • Soluble at neutral pH
  • Mixable with other insulins
  • Absorption
  • Predictable
  • Glucose lowering effect
  • Peakless with low variability
  • Safety profile
  • Low risk of hypoglycaemia at all times
  • Injection site
  • No local reactions
  • Limitations of current insulins
  • Solubility
  • Most current basal insulins require re-suspension
  • Absorption
  • Highly variable
  • Glucose lowering effect
  • Not predictable
  • Safety profile
  • Risk of hypoglycaemia
  • Injection site
  • Injection pain with acidic insulin

51
Insulin profiles in type 1 diabetic patients
treated with NovoRapid or human insulin
52
AERx iDMS Pulmonary insulin administration
  • Pulmonary insulin opportunity
  • Non-invasive insulin delivery
  • Mainly poorly controlled Type 2 diabetes patients
  • Expanded insulin sales
  • Product requirements
  • Accuracy, precision, dose adjustment
  • Patient friendly device interface
  • Scaleable manufacturing
  • Aradigm is the ideal partner
  • Liquid insulin formulation
  • Breath control
  • Increment of single insulin units
  • Performance monitoring

53
Pulmonary insulin delivery Competition
Aradigm Inhale Alkermes
Speciality Systemic local delivery Systemic delivery Systemic
Device Single dose, liquid aerosol Single dose -
Size Portable, not pocket-sized Portable, not pocket-sized Portable, pocket sized
Formulation Liquid, disposable unit dose Dry powders, disposable unit dose Dry powders
Breath Control Yes, patient training device None Breath activated device
Comments Phase II, Novo Nordisk Phase III, Pfizer/Aventis Phase I, Eli Lilly
54
The AERxiDMS in patients with asthma PK results
8000
Mean SE
6000
Insulin (pMkg)
4000
2000
0
0
50
100
150
200
250
300
350
400
Time (minutes)
Results are C-peptide body weight adjusted.
Henry R et al Diabetologia Vol 44 (Sup 1) OP2
(9) Aug 2001
55
The AERxiDMS Findings on EASD
  • Rapid onset of action
  • Similar duration of action as SC
  • Linear dose response (one AERxUnit increments)
  • Smoking alters PK profile
  • No provocation of bronchospasm in asthmatic
    patients
  • Low intra-subject variability
  • Proven safety in all pre-clinical studies

56
The insulin market Overall findings
  • Insulin products
  • Actrapid, Insulatard, Monotard,
    Mixtard, Ultratard, Velosulin, Novolin,
    NovoRapid, NovoMix (registration), Insulin
    detemir (Phase 3), LABI (Phase 1)
  • Insulin delivery systems
  • NovoPen, NovoLet, PenMate, Innovo,
    InnoLet, In-Duo, FlexPen, AERx/NN1998 (Phase 2)
  • Committed to 1 new device per year
  • Both Type 1 and 2 diabetes
  • Mainly specialist driven, but GPs very important
    in US
  • Few players, large volumes
  • Inexpensive and reimbursed treatment
  • Necessitates multiple daily injections and
    glucose monitoring
  • Patients start too late on insulin
  • Devices increasingly important
  • Need for education on importanceof treating more
    assertively

57
NN2211 Effect on fasting and post-prandial blood
glucose in type 2 patients
GLP-1 effects Insulin ? ?-cell
survival ? Glucagon ? Appetite
? GI-emptying ?
12
Placebo
11
NN2211
10
9
(mmol/l)
Mean glucose profiles
8
7
6
Insulinpulseanalysis
Standardmeal
5
Dosing
4
-2
0
2
4
6
8
10
12
14
16
18
Time (hours)
From abstract published at EASD 2001
58
Metabolic abnormalities associated with diabetes
59
Findings from the Phase 2 studies (efficacy)
  • Blood glucose control
  • HbA1c decrease within the range of 1-1.5-points
  • Fasting plasma glucose (FPG) decrease in the area
    of 23-35
  • Plasma insulin decrease of approx 50
  • Control of diabetic dyslipidaemia
  • HDL-cholesterol increase of 18-30
  • Triglyceride decrease of 35-55
  • Free fatty acids (FFA) decrease of 35-45
  • Note All numbers are placebo-adjusted

60
Findings from the Phase 2 studies (safety)
  • Weight
  • Dose-dependent increase as reported with other
    PPAR agonists
  • Oedema
  • Dose-dependent occurrence as reported with other
    PPAR agonists
  • Liver
  • No effect on any parameter
  • Haemotology
  • Dose-dependent effects as reported with other
    PPAR agonists
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