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UBS New York September 2007

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Innovative research and smart drug development. UBS New York September 2007. 6 ... Drug therapy totalled US$900 million in 2003(2) ... – PowerPoint PPT presentation

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Title: UBS New York September 2007


1
UBSNew York September 2007
  • Alice Huxley, CEO
  • Konrad P Wirz, CFO
  • Professor Hans Rudolf Brunner,
    Acting Medical Director
  • Frank LaSaracina, Managing Director Speedel USA

2
Disclaimer
  • This document on SPEEDEL HOLDING AG (SPEEDEL
    HOLDING or the Company) contains
    forward-looking statements that involve
    substantial risks and uncertainties. These
    forward-looking statements are based on the
    Company managements current expectations and
    projections about future events. All statements,
    other than statements of historical facts,
    regarding our strategy, future operations, future
    financial position, future revenues, projected
    costs, prospects, plans and objectives of
    management are forward-looking statements. The
    words may, plans, will, and similar
    expressions are intended to identify
    forward-looking statements, although not all
    forward-looking statements contain these
    identifying words. We may not actually achieve
    the plans, intentions or expectations described
    in these forward-looking statements and you
    should not place undue reliance on them. There
    can be no assurance that actual results of our
    research and development activities and our
    results of operations will not differ materially
    from these expectations. Factors that could cause
    actual results to differ from expectations
    include, among others our or our partners
    ability to develop safe and efficacious products
    our or our partners ability to achieve positive
    results in clinical trials our or our partners
    ability to obtain marketing approval and market
    acceptance for our product candidates our
    ability to enter future collaboration and
    licensing agreements the impact of competition
    and technological change existing and future
    regulations affecting our business changes in
    governmental oversight of pharmaceutical product
    development the future scope of our patent
    coverage or that of third parties the effects of
    any future litigation general economic and
    business conditions, both internationally and
    within our industry, including exchange rate
    variations and our future financing plans.

3
SWX SPPN
  • Biopharmaceutical company developing innovative
    therapies for cardiovascular and metabolic
    diseases, the largest pharmaceutical market
    segment
  • Creating value for patients, partners and
    investors
  • One of Europes top tier biopharmaceutical
    companies
  • 2007 start of recurring revenues SPP100
    (Tekturna/Rasilez) in US / EU

4
Wall Street Journal Gold Award For Innovation
UBS Global New York 25 September 2007 Alice Huxley
4
at the heart of value creation
5
First-in-class Opportunity
  • Focus on therapeutic areas with significant unmet
    medical need and high commercial potential
  • At forefront of medicinal innovation with
  • Renin inhibitors for various cardiovascular
    diseases
  • Endothelin A receptor antagonist in Diabetic
    Nephropathy
  • Direct thrombin inhibitor for prevention of
    Vascular Graft Occlusion
  • Innovative research and smart drug development

6
Mature and Diverse Pipeline Q3 2007
Disease
Approved US
Registration US
Originator
Lead Identification
Lead optimisation
Phase 0
Phase II
Phase I
Phase III
Approved EU
Hypertension
Novartis
SPP100
Renin Inhibitor monotherapy
Hypertension
Novartis
SPP100HCTZ
Renin Inhibitor diuretic
Hypertension
Novartis
SPP100valsartan
Renin Inhibitor ARB
Hypertension
Novartis
SPP100ramipriI
Renin Inhibitor ACE-I
Hypertension
Novartis
SPP100amlodipine
Renin Inhibitor CCB
SPP100HCTZ (fixed dose)
Hypertension
Novartis
Renin Inhibitor diuretic
Diabetic Hypertension
SPP100ramipriI
Novartis
Renin Inhibitor ACE-I

Diabetic Nephropathy
Novartis
SPP100
Renin Inhibitor
Left Ventricular Hypertrophy
Novartis
Renin Inhibitor
SPP100
Heart Failure
Novartis
SPP100
Renin Inhibitor
SPP100 means co-administration with other drug
7
First-in-class in Renin Inhibition
8
SPP100 (Tekturna/Rasilez) Positioning
  • First new treatment for hypertension in over 10
    years
  • Double digit drops in blood pressure as
    monotherapy
  • Blood pressure control beyond 24 hours
  • Durability and persistence of control
  • Additional benefits in combination with other
    antihypertensives
  • Placebo-like safety and tolerability
  • Potential for end-organ protection

9
SPP100 (Tekturna/Rasilez) All Data Demonstrate
Consistent Double Digit Blood Pressure Response
Blood pressure reduction (sitting, mmHg) with
Tekturna 300mg
Placebo
Tekturna
Placebo
Tekturna
Placebo
Tekturna
Placebo
Tekturna
Placebo
Tekturna
0
sys
systolic
-2
-4
-6
-8
-10
-10
-12

-12



-14

-14
-16



-16


-18
n130
n130
n176
n175
n115
n113
n163
n166
n192
n180
-18
Study 2203
Study 1201
Study 2308
Study 2201
Study 2204
Systolic
plt0.05 vs. placebo for study 2201 plt0.05
vs. placebo for study 2203 plt0.0001 vs.
placebo for study 1201 plt0.0001 vs. placebo for
study 2308 plt0.05 vs. placebo for study
2204 Source Studies Novartis A2201, A2203,
A1201, A2308 and A2204
Diastolic
10
High Blood Pressure Can Start a Progression
Toward Vital Organ Damage
Damage tocirculatory system
Organ damage
Heart and blood vessel injury
Enlarged heart
Heart failure, kidney failure and stroke
Blood vessel and kidney malfunction
End-stage organ failure
Abnormal blood vessel function
Renin System
Risk factors diabetes, high blood pressure
Death
Adapted from Dzau V, et al. Am Heart J
1991121124463
11
SPP100 (Tekturna/Rasilez ) ALOFT Phase II Study
Overview
  • Heart failure is common and leading cause of
    hospitalization and death1
  • Despite effective therapies morbidity and
    mortality remain high and new treatments are
    needed
  • Speedel Phase IIa study 2002 established proof of
    concept of SPP100 in congestive heart failure
    patients
  • ALOFT2 Efficacy assessed by measuring change
    in plasma biomarker Brain Naturietic Peptide
    (BNP, NT-pro BNP)
  • 12 weeks treatment
  • SPP100 150mg once per day given in addition to
    standard therapy
  • 302 patients with stable heart failure

1. Heart Disease and Strokes Statistics 2007
update. American Heart Association 2. McMurray J,
et al. Latebreaker presentation at ESC Congress
2007
12
Reductions in Brain Naturietic Peptide Levels
Linked to Improved Mortality in Heart Failure
Patients
  • Cardiac production and blood BNP1 and NT-pro BNP2
    levels increase when the heart is damaged and
    stressed
  • Higher the levels of BNP and NT-pro BNP in blood
    mean worse prognosis
  • Reductions in BNP and NT-pro BNP are associated
    with an improved outcome in heart failure patients

1 BNP Brain Natriuretic Peptide 2 NT-pro BNP
N-Terminal Pro-B-Type Natriuretic
Peptide Source Bibbins-Domingo K, et al. JAMA
2007297169-176
Source Novartis Business Review Sept 12 2007
13
SPP100 (Tekturna/Rasilez ) ALOFT Phase II
Significant Reduction in BNP Levels
meanSEM
0
n137
n148
-10
-20
-30
-12.2
-40
Change from baseline (pg/mL)
-50
-60
-70
-80
p0.0160
-61
-90
Optimal HF therapy placebo
Optimal HF therapy aliskiren 150 mg
McMurray J, et al. Latebreaker presentation at
ESC Congress 2007
14
Heart Failure Trials Perspective
ALOFT 3 months
A-HeFT 6 months
Val-HeFT 4 months
RALES 3 months
10
2 n1890
0
n137
n148
n1850
n51
n50
n340
n343
-10
- 6
-8
-12
-15
-20
p0.02
-30
Change in BNP (pg/mL)
-34
-40
-39
plt0.0001
p0.05
-50
-60
-61
p0.016
-70
Baseline BNPconcentration(pg/mL)
291
181
70
300
Placebo
Aliskiren
Spironolactone
Valsartan
Hydralazine-isosorbide dinitrate
McMurray J, et al. Latebreaker presentation at
ESC Congress 2007
15
SPP100 (Tekturna/Rasilez ) ALOFT Phase II Study
Results
  • Good tolerability when added to standard heart
    failure treatment
  • Significant improvement in key indicators of
    heart failure severity
  • Future studies with SPP100 in heart failure are
    needed to evaluate if it can improve clinical
    outcomes

McMurray J, et al. Latebreaker presentation at
ESC Congress 2007
16
SPP100 (Tekturna/Rasilez ) Extensive Organ
Protection Program Expected to Demonstrate
Benefits Beyond BP Control
Source Novartis Business Review Sept 12 2007
17
Mature and Diverse Pipeline Q3 2007
Disease
Originator
Lead Identification
Registration US
Lead optimisation
Phase 0
Phase II
Phase I
Phase III
Registration EU
Graft Occlusion in Chronic Haemodialysis
SPP200
Abbott
Direct Thrombin Inhibitor

Diabetic Nephropathy
Roche
Endothelin A Receptor Antagonist
SPP301
(on hold)
Hypertension End Organ Protection
Speedel
Renin Inhibitor
SPP635
Hypertension End Organ Protection
Speedel
Renin Inhibitor
SPP1148
Hypertension End Organ Protection
Speedel
Renin Inhibitor
SPP600 Series
Hypertension End Organ Protection
Speedel/Locus
Renin Inhibitor
SPP800 Series
Hypertension End Organ Protection
Speedel
Renin Inhibitor
SPP1100 Series
18
Next Generation Renin Inhibitors
19
Goals for the Next Generation of Renin Inhibitors
  • Increase bioavailability in humans for greater
    efficiency in dosing (increase absorption)
  • Extensive tissue distribution leading to further
    improved end organ protection (larger volume of
    distribution)
  • Prolonged half-life supporting once-a-day dosing
    and night-time efficacy (long half-life)
  • Slow progression of renal deterioration in animal
    studies (good tissue penetration)

20
SPP635 Phase IIa Results June 2007 Treatment of
Mild to Moderate Hypertensive Patients for 4 Weeks
  • Study Overview
  • 35 patients, single centre, double-blind,
    placebo-controlled
  • 4 week once daily treatment with placebo or
    SPP635
  • To assess the effect of SPP635 once daily
    treatment for 4 weeks on
  • sitting and ambulatory blood pressure
  • plasma renin activity (PRA)
  • To assess the safety and tolerability of SPP635
    in patients with mild to moderate hypertension

20
21
SPP635 Phase IIa Demonstrates Double Digit
Response on Ambulatory Blood Pressure
Change from Baseline (mmHg)
plt0.05 vs. Baseline Source Speedel SPP635CRD04
22
SPP635 Phase IIa Mean Ambulatory Blood Pressure
Following 4 weeks Treatment
23
SPP635 Phase IIa Hypertension Clinical Summary
  • Once daily treatment for 4 weeks provides
    sustained significant decreases in sitting
    systolic and diastolic BP
  • Sustained 24-hour BP control both day and night
  • PRA inhibition over 24 hours
  • Safe and well tolerated in this study

23
23
24
SPP1148 Speedels Next Generation Renin
Inhibitor
Product overview
  • Animal studies showed
  • Nanomolar potency against human Plasma Renin
    Activity
  • Improves oral bioavailability in animals
  • Exceptional protection of renal function in the
    double transgenic rat model
  • 24-hour BP reduction in the double transgenic rat
    model
  • Developed in house by Speedel Experimenta
  • SPP1148 started Phase 1 Q1 2007, first results
    expected Q4 2007

History
Current Status
25
First-in-class in Diabetic Nephropathy
26
Diabetic Nephropathy Market Overview
  • Diabetes is a global health problem(1)
  • Affected 171 million people in 2000
  • Diabetic Nephropathy is a life threatening
    complication of diabetes that results in the
    deterioration of kidney function and premature
    death
  • Diabetic Nephropathy high unmet medical need
    with 7.9 million diagnosed diabetics with
    nephropathy in 2003 in 7 key markets(2)
  • Drug therapy totalled US900 million in 2003(2)
  • If the 7.9 million patients were treated with
    ARBs only market size would be US3-4bn

(1) World Health Organization (2) Source
Estimate, Decision Resources. United States,
France, Germany, Italy, Spain, United Kingdom,
Japan
Source World Health Organization
27
SPP301 Phase III ASCEND Clinical Trial Stopped
12/2006
  • ASCEND Phase III clinical trial in diabetic
    nephropathy (diabetic kidney disease) started in
    July 2005
  • Company stopped trial December 2006 following
    recommendation from the Data Safety Monitoring
    Board and Steering Committee in interest of
    patient safety
  • Safety concerns caused by imbalance in fluid
    retention between patients on drug compared to
    those on placebo
  • Fluid retention not unusual in this patient
    population but considered to be an additional
    burden for fragile patients with severe diabetic
    kidney disease

28
SPP301 Next Steps
  • Steering Committee, DSMB and company remain
    confident about compounds potential in diabetic
    nephropathy
  • Significant unmet medical need
  • Fast Track Status from FDA
  • Proven efficacy (lowering proteinuria) in Phase
    IIb
  • ASCEND Phase III data to be evaluated and
    announcement expected early Q4 2007
  • Results of unblinded data analysis will help us
    explore
  • Alternative trial designs for DN
  • Compounds potential in other indications

29
A novel approach for treating ESRD patients

30
SPP200 Update
  • Phase II trial in US in 127 patients undergoing
    chronic haemodialysis via a PTFE graft with data
    from over 9,000 haemodialysis sessions reported
    results August 2006
  • Designed to assess safety profile and obtain
    first efficacy data
  • Compared to unfractionated heparin (UFH), gold
    standard anti-coagulant
  • Active dialogue with FDA to establish clinical
    and technical requirements for development and
    registration
  • Needs further dose exploration
  • Re-assessing commercial opportunity
  • Next steps decision early Q4 2007

31
Financials
32
Key Financials Fully Financed Through 2008
Estimated and accrued as per IAS
18 Note Numbers may not add due to
rounding (1) Includes cash and cash equivalents
and financial assets held at fair value through
profit and loss (2) Includes borrowings, finance
lease payable and convertible loans (3) Cash-burn
is defined as the difference in liquid assets
between the beginning and end of the period,
minus any cash inflow during the period
33
Financial Results Second Quarter 2007 / Outlook
2007
  • CHF 1 million recognised as first recurring
    revenue for SPP100
  • Managements best estimate, accrued as per IAS
    18, subject to revision
  • Cash-burn of CHF 27.0m Q2 2007 vs CHF 16.5m Q2
    2006
  • Guidance full year 2007 cash-burn CHF 75-85m
  • Excludes any revenues from SPP100 sales or other
    licensing activities
  • Sufficient funds to finance current pipeline
    through end 2008
  • Liquid assets of CHF 134.8m as of 30 June 2007
  • 2005 CHF 70.0m loan fully converted into shares

34
Summary
35
Milestones Achieved 2007
  • SPP1148 next generation renin inhibitor start
    Phase I
  • CHF55.5 million gross proceeds convertible bond
  • SPP100 Start of secondary prevention clinical
    trial (ASPIRE)
  • SPP100 Approval by FDA
  • SPP100 Launch by Novartis and start of recurring
    revenues
  • SPP100 Filing with FDA of fixed dose combination
    with diuretic
  • SPP100 Approval in Switzerland
  • SPP635 Phase IIa results hypertension
  • SPP100 EU approval
  • SPP100 First clinical results from end organ
    protection study (ALOFT in CHF
    patients)

36
Milestones Remaining 2007
  • SPP100 Clinical results available from end organ
    protection studies (AVOID in diabetic patients)
  • SPP100 Start of primary prevention clinical
    trials (ALTITUDE)
  • SPP200 decision next steps
  • SPP301 Analysis of ASCEND Phase III data and
    decision next steps
  • SPP635 Start Phase IIa in diabetic patients
  • SPP1148 Phase I results

37
Building a Sustainable Profitable Business
Self sustaining revenues
Commercial operations
Mid-long term
New CVM modes of action in clinic
Family of renin inhibitors partnered
SPP100 on the market generating revenues
SPP301 Phase III SPP200 Phase II
Today-
short term
De Novo compounds in clinic
World leadership in renin inhibition
Significant partnerships
In-house research unit generating clinical
candidates
38
Questions
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