Solvay Pharmaceuticals Performance, Priorities and Pipeline · 2018-07-03 · P H A R M A C E U T I C A LS 9 Solvay Investors Days October 1, 2008 R-POP in Gastroenterology and Women’s/Men’s

Solvay PharmaceuticalsPerformance, Priorities and PipelineWerner Cautreels, General Manager of Solvay Pharmaceuticals

SOLVAY INVESTORS DAYSOctober 1, 2008

20052005 20102010 20152015

INSPIREINSPIRE20102010

Internal FocusInternal Focus

Integration, P

erform

ance, Focus

TRANSFORMATIONTRANSFORMATION20152015

External DriversExternal DriversPipeline,Transformation, Priorities

P H A R M A C E U T I C A LSP H A R M A C E U T I C A LS

3 Solvay Investors Days October 1, 2008



• Top Line Growth• Bottom Line Growth• Delivering Efficiencies• 2010 Targets

PERFORMANCE



M EUR

1251 1249

10491167 1349

15481769 1863 1832 1745

2270

2600

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108

SALES

10 years significant growth in revenues

Annual growth+11%/y

Topline Growth

2591



205246

118 135157

134

203

263243 236

302

451

11.2% 11.6% 11.6%

8.7%

11.5%

14.1%13.3% 13.5% 13.3%

17.3% 17.6%

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 H108

REBITREBIT/Sales

M EUR

10 years REBIT growth

Bottomline Growth

457



Commercial ++ ++ + +Manufacturing + ++ ++ ++General & Administration ++ ++ + +

+

+

300275

160

80

250

5

230

2005 2006 2007 2008 est 2009 2010

28 134 59One-time costs

Cumulative annual efficiencies

expectedachieved

in M EUR

Delivering Efficiencies Reinvested in Growth & Profitability

Efficiencyprogram INSPIRE on track !

+++

47



Integrate project and product portfolio

Improve discovery platform

Consolidate development resources

Reduce overlap in sales force

Strengthen global presence

Build pan-European organization

Globalize purchasing approach

Improve plant productivity

Continue optimization of manufacturing network

Build global General & Admin functions : legal, HR, IT, Finance, Communication

Support integration of globalstrategic framework

Commercial OperationsCommercial Operations Manufacturing & SupplyManufacturing & Supply

R&DR&DGeneral & AdministrationGeneral & Administration

Integration & Transformation



R-POP in Gastroenterology and Women’s/Men’s Health stopped

One R&D organisation, one R&D portfolio

Outsourcing of certain R&D activities

Commercial OperationsCommercial Operations Global ManufacturingGlobal Manufacturing

R&DR&D

Overall reduction in sales force, shift to emerging markets

Integration of GPS/NBD into SPML

Divestment of certain C products

Global purchasing operational

Divestment of Baudette (US), Veenendaal (NL), Weesp API (NL), Synkem (Fr), Kawagoe (Jp)

Divestment Fontaine ongoing

Optimisation ongoing

Legal entities merged

Global functions integrated and fullyoperational

IT outsourcing ongoing

General & AdministrationGeneral & Administration

Integration & Transformation Execution



Integration & Transformation : FTE impact

9021917810088Total(Consolidated companies)

100581122611432Total(All companies)

200820072006

including shift of sales forces from EU to emerging markets

not including reduction of rented sales forces



by 2010

REBIT margin

Revenuesgrowth

Solvay Pharmaceuticals

Pharmaceutical Industry

PROFITABLE GROWTH

3.2 Bn EUR revenues

20% REBIT/Sales

EFFICIENCY PROGRAM

EUR 300 M stepwiseefficiency improvements

PORTFOLIO FOCUS

We stay committed to our 2010 Targets





PERFORMANCE• In Market• Therapeutic Focus

PRODUCTS



2007 Sales Breakdown

by Geographic Area

28%17%

6%

7%

11%23%

8%

28% Cardiometabolic17% Neuroscience

6% Influenza vaccines7% Pancreatic enzymes

11% Gastroenterology23% Women’s and Men’s Health

8% Others

in % of 2007 sales : EUR 2,591 M

by Therapeutic Area

45% Europe36% European Union (27)9% Other European Countries

42% The Americas40% Nafta 2% Mercosur

9% Asia-Pacific4% Rest of the world

45%

4%9%

42%



Growth in major products

-14%-25%43105Marinol®Neuroscience

TriCor sales booked by Abbott in the US in HY08 : USD 553m (+5%)

-7%-9%4083Luvox®Neuroscience

+21%+21%63106Teveten®Cardiometabolic

+49%

+7%

+4%

+57%

+3%

+7%

-7%

+6%0%

HY08 vs HY07

Women’s & Men’s health

Gastroenterology

Influenza vaccines

Neuroscience

Pancreatic enzymes

Women’s & Men’s health

CardiometabolicPHARMACEUTICALS

Net sales (EUR m)

+7%5199Duphalac®90

127

150

198

308

4332,591

2007

+15%221Fenofibrates

+7%149Androgel®

mainly in H2Influvac®

45

81103

1,249

HY08

+8%

+3%

+14%

+5%

HY08 vs HY07(constantexchange

rates)

Duphaston®

Serc®

Creon®



SPECIFIC MEDICAL NEEDSSustain and build on market leadershipNew products by in-licensing & acquisition

With Full R&DNew influenza vaccine technologiesNew pancreatic enzyme replacements

MARKETING EXCELLENCESustain and build on market excellence & leadershipNew products by in-licensing & acquisition

No R to POPWith development possibilities

KEY FOCUS AREASSustain and build on market leadershipNew products by in-licensing & acquisition

With Full R&DIn range of biological targets and indications

Therapeutic focus

CardioMetabolic

NeuroScience

Influenza Vaccines

GastroEnterology

Women’s/Men’s Health

PancreaticEnzymes



Therapeutic focus

CardioMetabolic

NeuroScience

Influenza Vaccines

PancreaticEnzymes

SLV319260.31,703A8A (Anti-Obesity)

SLV31991.912,996A10B (Oral Antidiabetics)

2007

Mill. USD MS % +/- % US$

Solvay Pharmaceuticals portfolio

Worldwide 671,687 100.0 10

CNS 111,764 16.6 10

N5A (Antipsychotics) 20,758 3.1 14 Bifeprunox, SLV313, SLV314,

N4A (Anti-Parkinson) 3,740 0.6 19 DUODOPA®, SLV308

Cardiovascular 100,998 15.0 2

C10A (Lipid-Regul.) 30,480 4.5 -8 Zolip, FDC

C10A2 (Lipid-Regul.) 2,287 0.3 10 TriCor, TriLipix

Source: IMS Health, IMS World Review 2008



CARDIO-METABOLIC

NEURO-SCIENCE

PANCREATIC ENZYMES

INFLUENZAVACCINES

Our Areas of Focus

Psychosis

Bipolar Disorder

Parkinson’s Disease

Traumatic Brain Injury

Bioengineered Enzymes

New delivery systems

Adjuvants

Dyslipidemias

Obesity

Type 2 Diabetes

Acute Heart Failure

Diabetic Nephropathy

Pulmonary hypertension

Atherosclerosis

+ exploratory platforms, such as Alzheimer, cognition





• Geographical expansion• Manufacturing & Supply• Industry Drivers• Innogenetics

PRIORITIES



Evolution of net sales in emerging markets (% of total net sales)

GeographicalExpansion

0

5

10

15

20

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

0

200

400

600

800

1000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

EU

USA

ROW

Evolution of net sales in main regions (MEUR)

Today the Emerging Markets represent about 1/5th of total sales



0

20

40

60

80

100

120

140

Brazil Russia India China Turkey Mexico Australia Poland

199720022007

Evolution of sales (MEUR)

Geographical Expansion : a few examples



■ Manufacturing and Supply organization is in the middle of a transformation process to enable it to contribute to the overall success of Solvay Pharmaceuticals

■ This process will lead to a stronger and more sustainable organization

Manufacturing & Supply



Manufacturing & Supply

Purchasing Processes

Plant Performance

Supply Chain Improvement

Network Restructuring

4 Main Areas of Improvement



Supply Chain Projects

■ Reduce our stock from raw material to the finished products

■ Implement a performance measurement system based on 4 KPIs (inventory level / OTIF / forecast accuracy / throughput time) to track our performance level

■ Optimize worldwide distribution network

■ Integrate products and markets



From 18 to 11 sites in three years

Canlac(CA)

Baudette(US)

Mexico (MX)

Solvay Pharma (BR)

Weesp (NL) Olst (NL) Veenendaal (NL) Neustadt(DE)

Kawagoe (JP)

Cork (IR)

Peptisyntha(BE)

Parets(ES)

Giraud(FR)

Châtillon(FR)

Synkem(FR)

Fontaine(FR)

Organics (US)

FPP

API

Sy. Factory

May 2005




Canlac(CA)

Mexico (MX)

Solvay Pharma (BR)

Weesp (NL) Olst (NL) Neustadt(DE)

Cork (IR)

Parets(ES)

Châtillon(FR)

Fontaine(FR)

Organics (US)

FPP

API

May 2008



Network restructuring

Q4-08SellFontaine

√DownsizeNeustadt

√

√

√

√

√

Q2-08

√

√

SoldSynkem

Downsize / SellChatillon – Foch

Sold

Sold

Sold

Closed

Transferred

Transferred

Type of decision

Kawagoe

Baudette

API outsouring Weesp

Giraud – API outsourcing

Veenendaal

Peptisyntha

Manufacturing site




Canlac(CA)

Mexico (MX)

Solvay Pharma (BR)

Weesp (NL) Olst (NL) Neustadt (DE)

Cork (IR)

Parets (ES)

Châtillon(FR)

Organics (US)

Closure / Sale intention announced

Site impacted by restructuring

FPP

API

May 2008Fontaine

(FR)



INSPIRE2010

Industry Drivers



Regulatory paradigm shift

INSPIRE 2010

Industry Drivers

Resource allocation shift



■ Stakeholder impact→ Payers and public will play an increasingly critical role

■ Transparency■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift

Industry Drivers



Stakeholder Impact

TRADITIONAL CORE CUSTOMERS

• KOLs

• Regulatory agencies

• Physicians

• Payers • Politicians• Dept. of Health &

Human Services• Media

• Patients• State & Fed Gvmnts

• Advocacy groups • Professional

societies• Pharmacists

• Wholesalers• Pharmacy chains• Actuaries and benefits

consultancies

CUSTOMERS WHO COULD BECOME MORE IMPORTANT

NEW CUSTOMERS

Traditional customers are joined by new

influencers

Traditional customers are joined by new

influencers



… however today’s M&S spend is still focused on traditional core

20 25

10

20

5

25

65

30Physician –traditional core

Consumers

Government

Payor/managed care organizations

Today Tomorrow

Decision maker’s influence is evolving …

Physicians and patients

New customers

90-95%

5-10%

Customer interaction model will require change

Stakeholder Impact



■ Stakeholder impact■ Transparency

→ Public awareness and societal demands

■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift

Industry Drivers



Transparency

Fair value

Focus on medical need

Constant innovation

Fair influence

Affordability limitsExcessive prices and profits

Lifestyle products favoredDeveloping world diseases neglected

R&D productivity collapseThe dilemma of incremental innovation

Excessive lobbying: profits before patients

SOCIETY’S EXPECTATIONS SOCIETY’S PERCEPTIONS



■ Stakeholder impact■ Transparency■ Personalized medicine

→ Therapeutic segmentation→ Combination of therapeutics & diagnostics

■ Regulatory paradigm shift■ Resource allocation shift

Industry Drivers



Personalized Medicine

Near term (5 years?)

Medium term (5-10 years?)

Long term (10+ years?)

Oncology Infectious dis.OsteoporosisCystic Fibrosis

OncologyCardiovascularRheumatologySchizophreniaAsthmaCOPDSepsis/ ARDSInfertilityDiabetesObesity

CNSCVMore challenging

indications inOncologyOphthalmologyRheumatology

• Sequence determined by the relative market opportunity

• Significant uncertainty around time frames



■ Stakeholder impact■ Transparency■ Personalized medicine■ Regulatory paradigm shift

→ More patients in clinical trials, both before and after approval

→ Risk management programs→ Start with small indications before later expansions→ Focus on innovative products

■ Resource allocation shift

Industry Drivers



Regulatory Paradigm Shift

More Safety ■ More patients required in more clinical trials pre- and post-

approval■ Demonstration of comparative safety of NCE■ Controlled launch programs ■ Establishment of open access patient safety registries■ More emphasis on long-term safety data / pharmacovigilance

Increased focus on safety and data



Regulatory Paradigm Shift

More Data ■ Extensive research and documentation of the NCE's mechanism

of action■ Clinical studies designed to evaluate safety & efficacy in various

genotypes/phenotypes of patients as classified by genetic screening of patient populations→ Extensive safety screening using highly sensitive biomarkers

■ More detailed regulatory guidance and requirements for clinical trials in differentiated groups:→ Age: pediatrics, elderly→ Specific risk groups→ Specific target groups

→ No data = no labeling



■ Stakeholder impact■ Transparency■ Personalized medicine■ Regulatory paradigm shift■ Resource allocation shift

→ R&D expenditures: → SG&A expenditures:→ Cost of Goods :

Industry Drivers




Industry Drivers & Solvay actions

Processes, interfaces, relationships

Trial registration

Publication of trial results

Innogenetics acquisition

Biomarker approach in clinical developmentAdaptation of R&D activities

to new requirements

Use of external expertise (advisory panels)

Inspire project

Further increase R&D and product sourcing spend

Solvay actions Solvay actions




Acquisition of Innogenetics

■ Total enterprise value of EUR 206 million (100% of the outstanding shares + indebtedness on Dec. 31, 2007)

■ Acquisition financed by available resource of the Solvay group■ 84.3% of the shares have been offered offer is accepted by

Solvay■ Extension of the tender offer from Sept 23 to Oct 14, 2008■ An opportunity for Solvay Pharmaceuticals:

→Accelerate the development of Solvay’s therapeutic pipeline Expand biomarker technologies and enter progressively into the field of personalized medicine

→Expand the diagnostic activities Reinforce existing commercial operationsContinue the development of Innogenetics’ diagnostics pipeline



endorses Innogenetics’ recent decision to focus on diagnostics activities and to divest GENimmune (assets from therapeutics activities)

Solvay Pharmaceuticals’ strategic vision :■ Preserve the operational autonomy of Innogenetics ■ Continue the expansion of the diagnostic activities■ Leverage both companies R&D competences

Solvay Pharmaceuticals’strategic vision



Solvay Pharmaceuticals and Innogenetics

Solvay Pharmaceuticals

Solvay Solvay PharmaceuticalsPharmaceuticals

R&D therapeutics

R&D R&D therapeuticstherapeutics

COMMERCIAL THERAPEUTICS

InnogeneticsInnogeneticsInnogenetics

COMMERCIAL DIAGNOSTICS

R&D diagnostics

R&D R&D diagnosticsdiagnostics

■ Biomarkers→ improved molecule

selection→ surrogate markers for

clinical studies■ Companion diagnostics

→ personalized medicine

■ Biomarkers→ improved molecule

selection→ surrogate markers for

clinical studies■ Companion diagnostics

→ personalized medicine



About Innogenetics

International biotechnological company that develops and markets diagnostic products to improve therapy management and patient health

Products sold in 90+ countries through its 6 subsidiaries and a large number of distributors

Listed on Euronext Brussels (INNX)

Source : Innogenetics, company presentation, www.innogenetics.com, 2008



Key figures FY07 and H108

FY07 H108

Company revenues (consolidated) €54.1m €30.6m + 12%

Diagnostics product sales €47.0m €25.8m + 8%Diagnostics revenues €50.9m €28.8m + 12%Diagnostics gross profit €30.0m €17.1m + 13%Gross margin stable 55.5% 54.6%

Operating result inDiagnostics €0.1m €0.9m

EBITDA in Diagnostics €7.0m €4.2m + 45%

Cash position €23.5m €15.7m

Diagnostics product sales: driver for sustained future growth

Source: Innogenetics, company presentation: www.innogenetics.com, 2008

H107/H108



Key Diagnostic Product Areas

Infectiousdiseases

HLA

Genetictesting (GT)

Neuro-degenration

Oncology

• 47% of total 2007 product sales• Virology market with HCV, HBV, HIV and HPV• Partnerships with Roche, Bayer and TWT

• 15% of total 2007 product sales• Currently developing assays using the 4-MAT™

microarray platform

• 14% of total 2007 product sales• Cystic fibrosis (CF), MBL2, Apo E• Leading supplier of CF testing in Europe

• Access to AdnaGen’s CE labelled products for breastand colon cancer

• 6% of total 2007 product sales• Alzheimer’s disease : early and differential

diagnosis, therapy monotoring

Source : Innogenetics, company presentation, www.innogenetics.com, 2008



Solvay – Innogeneticscollaboration

■ 1st period (1997-2002): Target discovery & identification

■ 2nd period (2003-2005): Target validation

■ 3rd period (2006-present): Potential biomarkers & Compagnion diagnostics

→ Neurology programTraumatic brain injury (SLV334)Parkinson’s disease (SLV357)Schizophrenia

→ Cardiometabolic programDiabetic nephropathy (SLV306)Acute heart failure (in preparation)

■ Future : join competencies to accelerate pipelines in diagnostics and therapeutics





• Promising Projects in R&D Pipeline

PIPELINE

R&D Pipeline Overview and Key Developments

CLAUS STEINBORNGlobal R&D Head Solvay Pharmaceuticals



R&D pipeline

FEMOSTON® low dose

ANDROGEL® low volume

ANDROGEL®

pediatric US

EE/MT USWomen’s & Men’s Health

CREON® USCREON® JPNSLV339SLV340Pancreatic enzymes

GRIPPOL® PlusINFLUVAC® TC EU

GRIPPOL® TC

H5N1 egg

Seasonal TC US

Adjuvants,

H5N1 TCInfluenza vaccines

bifeprunox

pardoprunox

DUODOPA® US

SLV 313

SLV 334

Anatibant (+Xytis)

SLV314SLV338, SLV351,

SLV354, SLV357Neuroscience

TriLipix™ USPULZIUM® intravenous (EU)

Zolip

PULZIUM®

intravenous (US)

SLV319

Daglutril (SLV306)

SLV320

SLV337, SLV338,

SLV341

SLV342, SLV344,

SLV352, SLV 356Cardiometabolic

Filed/Approved

Phase IIIPhase IIPhase IPreclinical

Discontinued : Synordia, dronabinol MDI

Approved : Luvox IR/CR (US)

P H A R M A C E U T I C A LS


PULZIUM® Intravenous (atrialarrhythmias)

PRECLINICAL PHASE I PHASE II PHASE III FILED APPROVED

TriLipix®(next generation fenofibrate)

TriLipix® + Crestor®(Abbott/AstraZeneca)

Zolip (fenofibrate + statin)

Daglutril (SLV306) (pulmonary hypertension)

SLV320 (acute heart failure)

SLV 319 (obesity/diabetes)

Research & Development CARDIOMETABOLIC

2007 R+D Investments: EUR 139M (33% of total Pharma R&D)



Bifeprunox (schizophrenia)

SLV314 (schizophrenia)


DUODOPA® (Parkinson)

Pardoprunox (SLV308) (Parkinson)

SLV313 (schizophrenia)

SLV334 (traumatic brain injury)


Research & Development NEUROSCIENCE



GRIPPOL® Plus (Egg-Based AdjuvantedSeasonal Vaccine)


INFLUVAC®TC EU (Cell-Based Seasonal Vaccine)

GRIPPOL® TC (Cell-Based Adjuvanted Seasonal Vaccine)

INFLUVAC® TC US (Cell-Based Seasonal Vaccine)

Pandemic egg (H5N1 Egg Based Vaccine)


Research & Development INFLUENZA VACCINES




CREON® US

CREON® JPN

SLV339 (non animal sourced enzymes)


Research & Development PANCREATIC ENZYMES



Main cardiometabolicindications

METABOLICSYNDROME

DIABETES DYSLIPIDEMIACARDIO-

VASCULAR PREVENTION

TriLipix™next generation

fenofibrate

LIPANTHYL®

fenofibrate

TriCor®/LIPANTHYL® NFENo food-effect fenofibrate

fenofibrate & statin fixed dose combinationsABBOTT & ASTRAZENECA co-develop for USA

SOLVAY project ZOLIP for rest of world

SLV319Obesity/type 2 diabetes

SIMCOR®(Niaspan®/simvastatin)



Success factors of ourfenofibrate franchise

0

500

1000

2004 2005 2006 2007

M USD

TriCor® sales* evolutionin the US

* booked by Abbott

+56%

Positive long term use wellestablishedAddresses residualcardiovascular risk on statins Current flagship product :

important clinical benefits of 145 mg NFEbeing introduced in all major markets by 2008 (incl. Russia)IP formulation protection untilJan. 2023 in US and 2018 in Europe – patent litigation vs Teva ongoing

Ongoing discussions of EMEA recommendation concerningclass review of fibrates



0

50

100

150

200

US European Union 30

Asia Pacific & Middle

East & Ca

Japan Eastern Europe. & Lat.Am.

Aug 06 – Aug 07Aug 07 – Aug 08

+13%

+11%

-19% +106%

+9%

USEurope 30

Eastern Europe & Lat.Am.

Asia Pacific & Middle East &

CAJapan

Fenofibrate franchise : worldwide growth

Sales evolution (MEUR)Worldwide sales distribution

(Aug 07 – Aug 08)



TriLipix™

■ Next generation fenofibrate■ Regulatory exclusivity & IP ■ Specifically developed for

combination with statins■ Submitted in the US (Q4/07)■ Regulatory submission files

for ROW are being prepared■ Improved Therapeutic Benefit

clinical programs ongoing

■ Phase III studies presented at scientific congresses (HY08)

Submitted US



TriLipix™Phase III studies

■ Three phase III studies presented at the scientific congresses (March & May 2008)

■ TriLipix™, in combination with statins :

→ primary end points reached

→ significant improvement in all 3 key lipids :HDL and TG, compared to statin therapy alone

LDL, compared to TriLipix™

→ safety similar to TriLipix™ or statin monotherapies(no rhabdomyolysis or unexpected liver, kidney or muscle safety signals identified)



■ Developed by Abbott/AstraZeneca■ Fixed dose combination for US■ Phase III program ongoing■ Rosuvastatin : fastest growing

branded statin in US(CRESTOR®/AstraZeneca)

■ Convenient single pill for comprehensive lipid treatment

■ Today only 5% of US statin users get a fibrate co-prescribed,further growth potential for fixed combination

■ IP protected

TriLipix™ + Crestor®

Launch date:2010 US

Phase III



Simcor®

■ Fixed combination of Niaspan® and simvastatin

■ Effectively targets all three key lipids (LDL, HDL, TG) →reduction of residual risk

■ Phase III data showed greater improvement of three key lipids compared to simvastatin alone

■ Co-promotion with Abbott (US territory)

■ Launched in April 2008

Launched US



Zolip

■ Fenofibrate NFE & simvastatin fixed dose combination for EU & ROW

■ Phase III clinical program close to completion

■ Convenience, compliance and stronger lipid effects

■ IP to 2018 with possible extensions

■ Data exclusivity EU 10 years from approval

■ ACCORD* NIH study results expected 2010

* Action to Control Cardiovascular Risk in Diabetes

Submission date: Q3/2009

Peak sales potential EU/ROW:

100-250 MEUR



SLV319

■ Cannabinoid 1 receptor antagonist

■ Inhibits both central and peripheral CB1 receptors

■ Preclinical profile supports further development

■ Phase II PoP in obesity completed, results support continuation

■ Further discussions on prioritization of indications

■ Worldwide rights back to Solvay

Phase II



SLV319 Phase II results

Percent change from baseline in body weight over time

Phase II

Off drug treatment

weeks

P=0.0002

P=0.0017

P=0.0203



Phase II


12,5% 14,9%6,1%

15,1%20,0%

31,3%

10,6%

44,7%

42,9%

49,1%

54,0%37,5%

59,6%

31,3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

P LAC E BO 5mg/d 25/5 mg/d 10mg/d 25mg/d 50mg/d 100mg/wk

S ubjects With >5% R eduction from Baseline

S ubjects With >10% R eduction from Baseline

Percentage of Subjects Reaching 5% and 10% Weight Loss




■ Placebo controlled dose finding study

■ Efficacy→ weight reduction shown already after 12 weeks→ effect continues for highest dose even after

discontinuation of study drug→ relatively high placebo effect

■ Safety→ predominant adverse events : gastro-intestinal

symptoms, CNS→ no seizures→ too small sample size to draw definite conclusions on

incidence of adverse events



Pulzium® Intravenous

■ Mixed potassium channel blocker

■ Recent onset atrialfibrillation/flutter

■ Approved in EU (UK, Sweden, Spain)

■ Non approvable letter in US

■ Available for worldwide out-licensing

■ IP 2012 (EU 10 years dossier excl, US 5 years dossier excl)

Approved Europe

Submitted US 2006 Q4

Peak sales potential under 100 MEUR



daglutril (SLV306)

■ First in class “lutril” = dual endopeptidase inhibitor NEP & ECE

■ Improves impaired cardiac function

■ IP 2016 + possible extensions

■ Preparing phase II in pulmonary hypertension

■ Phase II in arterial hypertension did not support continuation in this indication

Phase II



SLV320

■ Adenosine 1 antagonist

■ Intravenous formulation

■ Innovative compound for patients with acute heart failure (AHF)

■ Proof of concept in AHF, PoPstudies ongoing

■ IP 2019 + possible extensionsPhase II

Cardio-Metabolic

NeuroscienceNeuroscience

Influenza Vaccines

Pancreatic Enzymes



■ Partial dopamine agonist+ additional serotonin 1A activity

■ Schizophrenia

■ Activities in EU continue, together with Lundbeck→Phase III trials ongoing

■ All development activities for US territory are on hold→requested clinical trials could

lead to substantial delays, limiting the benefit for patients and the commercial opportunity

■ IP 2017 + 5y (US) and 10y (EU) dossier protection

Bifeprunox

Phase III



Duodopa®

■ Levodopa & carbidopa combination

■ Novel, microprocessor controlled administration system, delivering through indwelling tube directly into small bowel

■ Programmable external pump under patient control

■ Registered in 34 countries, launched in 20 countries

■ US phase III studies ongoing

■ IP 2013 and orphan status EU 10 years and US 7 years

Launch date 2004

Peak sales potential100 to 250 MEUR



Pardoprunox (SLV308)

■ Mixed partial agonist dopamine, noradrenaline, serotonin

■ Early and advanced Parkinson’s Disease

■ Phase III results partially available


■ Potential differentiation in dyskinesia and other CNS symptoms

Submission date: 2011

Peak sales potentialabove 250 MEUR



Phase III study in early Parkinson (monotherapy)

Mean change from baseline UPDRS, part 3 (LOCF)

-12.0

-10.0

-8.0

-6.0

-4.0

-2.0

0.0

2.0

0 5 10 15 20 25 30 35 40

< titration > < ----maintenance 24 weeks -------------> Endp

6 mg12 mg12-42 mgplacebo

end of titration

Pardoprunox (SLV308) phase III results

UPDRS : Unified Parkinson’s disease rating scale

LOCF : last observation carried forward

P=0.0006P=0.0044

P=0.0397



-12,0

-10,0

-8,0

-6,0

-4,0

-2,0

0,0

2,0

0 5 10 15 20 25 30 35 40 < titration > < ------ maintenance 24 weeks -------------> Endp

12-42 mgPPX -4.5 mgPlacebo

end of titration


Phase III study in early Parkinson (monotherapy)

Mean change from baseline UPDRS, part 3 (LOCF)

UPDRS : Unified Parkinson’s disease rating scale PPX : pramipexole

LOCF : last observation carried forward

P=0.0091

P=0.0020



Phase III study in advanced Parkinson (in combination with L-Dopa)

Hours off-time : estimates with 95% CI of SLV308 versus placebo

p-value: 0.0424 0.0215

ANCOVA model with baseline score, pooled center, and treatment group

-4

-3

-2

-1

0

1

SLV308 12-42 mg

Placebo SLV308 vsPla

SLV308 12-42 mg

Placebo SLV308 vsPla

Observed case LOCF


CI : confidence interval



■ 3 pivotal placebo-controlled phase III studies have demonstrated the efficacy of pardoprunox in patients suffering from early and advanced Parkinson’s Disease

■ Efficacy achieved over a broad dose range but minimal effective dose has not been established

■ Main adverse events are gastrointestinal symptoms and CNS effects (dose dependent)

■ Further clinical studies will evaluate a lower dose range which will improve the adverse event profile as well

■ Small and clinically not relevant QTc prolongation




SLV334

■ From new class of the ‘lutrils’ (daglutril SLV 306) next endopeptidase inhibitor NEP & ECE* is SLV334

■ Compound is neuro- and cellprotective in preclinical models

■ Target indication: Traumatic Brain Injury (TBI)

■ Intravenous administration

■ Preparations for Phase II ongoing, clinical development plan designed together with key opinion leaders

■ Compound patent 2016 with second use patent on TBI 2025

* Neutral Endo-Peptidase & Endothelin Converting Enzyme



SLV313

■ D2 antagonist + 5HT1A agonist

■ Bipolar disorder, schizophrenia

■ Preclinical data supporting potential effect on cognition


■ Phase II trials ongoing

Cardio-Metabolic

Neuroscience

Influenza VaccinesInfluenza Vaccines

Pancreatic Enzymes



Growth strategy

■ Capacity increases→ Egg-based→ Cell-based

■ Differentiation→ Novel production technology – cell

culture→ Virosomal vaccine – Invivac for the

elderly→ Adjuvanted vaccine – GRIPPOL®

→ Alternative routes of administration■ Geographical expansion

→ US→ Russia,Brazil,India,China

■ Pandemic Preparedness→ Pandemic vaccine



Cell Culture Technology

■ Egg independent process/faster start-up for pandemic

■ Clinical material produced in cell-culture facility→ Seasonal: Phase I studies US and Russia completed→ Seasonal: Phase II/III studies planned for 2009→ Pandemic: Phase I planned for Q2/2009

■ Submission for EU and US planned in Q4/2010■ Complete process validation in 2009■ First commercialization planned for 2009 (Russia)



■ Solvay’s influenza vaccines in 68 countries→ Launch China season 2009

■ US development of cell culture vaccine→ First RFP (US government contract 298 MUSD) ongoing→ No participation in second RFP for production facility (economics)→ Clinical development activities ongoing

■ Petrovax Pharm, Russia constructed a new formulation plant near Moscow with Solvay technical support. Authorization received in Aug 2008→ Solvay will supply cell-based antigens → Petrovax formulates with adjuvant polyoxidonium (PO)→ Marketing authorisation for Grippol® Plus (egg-based) received in

Sept 2008→ Submission of Grippol® TC planned 2009→ For Russia & CIS countries

Geographical strategy

Cardio-Metabolic

Neuroscience

Influenza Vaccines

Pancreatic EnzymesPancreatic Enzymes



CREON® - Strategy: Growth and market expansion

■ Established product in EU and US since many years→ Global market leader

■ All enzyme class progressing towards formal FDA approval in the United States → response to 2007 “approvable”

letter submitted→ Review by FDA Advisory Committee

expected by year end■ Working towards submission in Japan

(2009), one of the largest markets for pancreatic enzymes→ First prescription high dose

pancreatic enzyme replacement therapy in that market

■ Strong growth in emerging markets

0

100

200

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

M EUR

Creon®



Bioengineered Enzymesfor Pancreatic Insufficiency

■ Collaboration with Novozymes Denmark

■ Biotechnologically engineered microbial enzymes for treating pancreatic exocrine insufficiency

■ Non-animal sourced product, increasing treatment options for patients

■ Two projects :→ SLV339 : lipase only→ SLV340 : mixture of lipase, protease, amylase

■ Clinical trials phase II with SLV339 ongoing

■ SLV339 orphan drug designation obtained in EU



AndroGel® : US progress

■ Continuing strong success of AndroGel® in US

■ WATSON & PAR US copromote

■ Additional presentation: AndroGel® Flexible Dosing Pump successfully launched in late 2004

■ Pediatric exclusivity obtained in August 2007, close interaction with FDA on pediatric indication after non approvable letter

■ AndroGel® low volume : submission H109

■ IP 2020 on formulation + 6 months for pediatric

0

100

200

300

2000 2001 2002 2003 2004 2005 2006 2007

M USD

AndroGel® (US)



2007 2008 2009 2010 2011

Overview Solvay Product Submissions

CREON® JPNCREON® JPN

DUODOPA® USDUODOPA® US

InfluenzaGRIPPOL® TC (Russia)

InfluenzaGRIPPOL® TC (Russia) INFLUVAC®TC USINFLUVAC®TC US

INFLUVAC®TC EUINFLUVAC®TC EU

Zolip EUZolip EU

LUVOX® melt JapanLUVOX® melt Japan

ANDROGEL® low volume USANDROGEL® low volume US

FEMOSTON® low doseFEMOSTON® low dose



TriLipix/Crestor®

(by Abbott/AstraZeneca)

TriLipix/Crestor®

(by Abbott/AstraZeneca)

TrilipixTM

US

TrilipixTM

US

Pulzium®

EU

Pulzium®

EU

Fluvoxamine IR + ER (US)

Fluvoxamine IR + ER (US)

ANDROGEL® pediatric USANDROGEL® pediatric US

CREON® US (answer to FDA letter)

CREON® US (answer to FDA letter)





Priorities MovingFoward

■ Confirm 2008 guidance → operating results for 2008 higher

than 2007

■ Confirm commitment towards 2010 objectives

■ Prepare organization to address industry drivers



INSPIRE2010

2010: committed toour targets




Industry Drivers & Solvay actions

Processes, interfaces, relationships

Trial registration

Publication of trial results

Innogenetics acquisition

Biomarker approach in clinical developmentAdaptation of R&D activities

to new requirements

Use of external expertise (advisory panels)

Inspire project

Further increase R&D and product sourcing spend

Solvay actions Solvay actions


“To the extent that any statements made in this presentation contain information that is not historical, these statements are essentially forward-looking. The achievement of forward-looking statements contained in this presentation is subject to risks and uncertainties because of a number of factors, including general economic factors, interest rate and foreign currency exchange rate fluctuations; changing market conditions, product competition, the nature of product development, impact of acquisitions and divestitures, restructurings, products withdrawals; regulatory approval processes, all-in scenario of R&D projects and other unusual items. Consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Forward-lookingstatements can be identified by the use of words such as "expects," "plans," "will," "believes," "may," "could" "estimates," "intends", "goals", "targets", "objectives", "potential", and other words of similar meaning. Should known or unknown risks or uncertaintiesmaterialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Companyundertakes no obligation to publicly update any forward-looking statements"

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Solvay Pharmaceuticals Performance, Priorities and Pipeline · 2018-07-03 · P H A R M A C E U T I C A LS 9 Solvay Investors Days October 1, 2008 R-POP in Gastroenterology and Women’s/Men’s