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Brussels April 23, 2002

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Gastroenterology AND integrate better with central nervous system. Adapt efforts in Psychiatry ... Gastroenterology. 29% (Irritable Bowel Syndrome, Delayed ... – PowerPoint PPT presentation

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Title: Brussels April 23, 2002


1
  • LOOKING AT SOLVAY DIFFERENTLY
  • STRATEGIC STRENGTH to be a less cyclical
    company in the current economic uncertainty
  • FLUORINATED SPECIALTIES ACQUISITION OF AUSIMONT
  • approved by the EU
  • subject to US regulatory approval
  • Brussels - April 23, 2002
  • Analysts and Investors Meeting

2
More focused Pharmaceuticals RDW. Cautreels,
Worldwide Head ofRD Pharmaceuticals sector
3
RD EFFECTIVENESS IMPROVEMENTS
Weesp (Nl), Hannover (D), Marietta and Chicago
(US), Tokyo (J)
  • handle the improved output from biotechnology
    based discovery programsmore compounds in
    development ? New biotech platform implemented
  • accelerate the development process by working
    more effectively with expert Clinical Research
    Organisations as partnersreduce  time to
    market  ? Quintiles agreement implemented
  • concentrate one function on one site
  • improve efficiency by avoiding duplications ?
    Implementation completed
  • shift internal RD costs to external costs
    towards 50/50 as soon as possible(compared to
    60/40 in 2000)
  • increased portfolio development spending ?
    Implementation completed (e.g. cilansetron)

RD EFFORTS MORE FOCUSED (not reduced)
4
STRATEGIC MILESTONES IN RD
Strategic Choices and Partnering intention to
register make and sell
Strategic Choices long-term strategy
Strategic Choices positioning
Programs
Projects
Products
D
POP
L
Clinical testing phase I II
Proof Of Principle available
Marketing and lifecycle management
Launch
Discovery
Clinical testing phase III
Animal studies
Registration submissions
5
AREAS OF RD FOCUS
Hormone Replacements
Cardiology
Gastroenterology
Psychiatry
Anxiety Depression Psychosis Parkinsons
Neurology
Arrhythmia Congestive Heart Failure Hypertension
Obesity
Motility Disorders Irritable Bowel
Syndrome Pancreatic Enzymes
Women HRT Endometriosis Men HRT
External collaborations
6
FOCUSED DISCOVERY EFFORTS
  • Maintain efforts in
  • Cardiology
  • Gastroenterology AND integrate better with
    central nervous system
  • Adapt efforts in Psychiatry
  • reduce efforts in depression and anxiety
  • reduce efforts in psychosis
  • maintain efforts in Parkinson and Neurology
  • Increase efforts in Women Health
  • New niches being investigated in Mens health,
    neurology and obesity

External collaborations
7
GROWTH THROUGH A SPECIALIZED RD PROGRAM
Hormone replacement therapies 23 (Women
HRT, Men HRT, Endometriosis)
Gastroenterology 29 (Irritable Bowel Syndrome,
Delayed Gastric Emptying, Gastro
Esophageal Reflux Disease)
Psychiatry 31 (Anxiety Depression, Psychosis,
Parkinson)
Cardiology 17 (Ischaemic Heart Disease,
Congestive Heart Failure, Hypertension)
- in of pharma RD expenses in 2001 EUR 222 M
8
R D SUMMARY
Gastro-
CNS
HRT
Cardiology
Enterology
3(IBS (2), Enzyme Insufficiency)
2 (Parkinsons, Psychosis)
Pre-Clinical
2 (Hypertension/CHF)
7
Phase I
3 (Psychosis)
3
Phase II
4 (Parkinsons, Psychosis, Pain/ Spasticity,
Depression)
2(Motility Disorders, enzyme insufficiency)
7
1 (Hypertension/CHF)
2 (IBS, Enzyme Insufficiency)
1(OCD/Social anxiety disorders)
3 (female HRT, male HRT)
Phase III
3 (arrhytmia, hypertension)
9
Total26 7 10 3 6
Hormone Replacement Therapy, Irritable
Bowel Syndrome, Obsessive Compulsive
Disorder
9
PSYCHIATRYportfolio
Proof of principle
Registration
Research
Depression OCD OCD/Social Anxiety
Disorders Chemotherapy Appetite Multiple
Sclerosis
LUVOX
fluvoxamine CR
THC (MARINOL)

THC (MARINOL)
DU127090
Schizophrenia Psychosis Parkinsons Schizophreni
a Psychosis Schizophrenia Psychosis Schizophre
nia Psychosis Schizophrenia Psychosis
SLV308
SLV310
SLV313
SLV314
SLV319
preclinical SLV318
10
PSYCHIATRY
Proof of principle
Registration
Research
DEPRESSION EU/JPNOCD
US/EU/JPN SAD JPNOCD/SAD
US/EU
LUVOX immediate release
fluvoxamine CR
  • ELAN manufacture CR formulation
  • SOLVAY trademark for CR (to be decided)
  • positive pivotal studies with CR in both OCD
    Social Anxiety Disorders (SAD)
  • submission 2002 US, 12 months delay for
    validation of manufacturing
  • SAD Japan started
  • launch date 2003 onwards
  • peak sales potential under 100 MEUR

11
PSYCHIATRY
Proof of principle
Registration
Research
Cancer chemotherapy appetite stimulation
THC (MARINOL)
THC (MARINOL)
Multiple Sclerosis
  • cannabinoid receptor agonist, tetrahydrocannabinol
    (THC)
  • launched in US for appetite stimulation in
    HIV/AIDS and nausea/vomiting in cancer
    chemotherapy
  • 2002 start European registrations in HIV/AIDS
    and nausea/vomiting
  • 2002 start aerosol formulation (global) with
    Inhale Therapeutic Systems
  • multiple sclerosis clinical studies ongoing in
    relief of pain and spasticity

12
PSYCHIATRY
Proof of principle
Registration
Research
DU127090
DU127090
SCHIZOPHRENIA/ PSYCHOSIS
SLV310 Phase II decision 2002
SLV313
DU127090
SLV314
SLV319
  • Launch date 2006
  • Peak sales potential above 250 MEUR
  • DU127090
  • Solvay Pharma/Lundbeck partner development and
    marketing
  • Partial D2 antagonist with additional 5HT1A
    agonism
  • Proof of principle as antipsychotic is ongoing
  • Solvay/Lundbeck like early phase II results,
    deciding to continue - start in May 2002
  • SLV310/313/314/319
  • different mechanism mixes D2, 5HT1A, SSRI
  • SLV310 Phase II decision in 2002
  • SLV 313/314/319 into phase I now
  • SLV318 preclinical

13
PSYCHIATRY
Proof of principle
Registration
Research
SLV308
PARKINSONS
  • SLV308
  • Partial D2 agonist plus 5HT1A agonism plus
    alpha-1 / alpha-2 agonism
  • Parkinsons first target co-morbid depression
  • Proof of principle studies on motor and mood
    disorders ongoing
  • Co-development Japan with Meiji-Seika
  • Backup SLV318 a preclinical potential candidate

14
PSYCHIATRY
Proof of principle
Registration
Research
DEPRESSION
DU125530
  • Is a potent, full 5HT1A antagonist
  • Atypical potential antidepressant
  • Early clinical findings confirm antagonism in man
    with opposite effects to buspirone, an agonist,
    on night time temperature and sleep
  • Licensed to NEUROKORR, Berlin for the indication
    Alzheimers disease

15
CARDIOLOGYportfolio
Proof of principle
Registration
Research
PHYSIOTENS EU
HYPERTENSION
TEVETEN EU / US
ACEON US
HYPERTENSION
TEVETENHCT
moxonidine HCT
CHF/ HYPERTENSION
SLV306
ARRHYTHMIAS
tedisamil IV-PO
Preclinical SLV316, SLV320
16
CARDIOLOGY
Proof of principle
Registration
Research
CHF/ HYPERTENSION
SLV306
  • Dual endopeptidase inhibitor NEP(1) ECE(1)
  • Selectively inhibits hSEP target (patent filed)
  • discovered with Innogenetics
  • Concept proven in both animals and man
  • Clinical proof of principle achieved for both
    uses
  • SLV306 is the front runner of this class
  • Development and marketing partnerships under
    consideration
  • (1) neutral endopeptidase (NEP) endothelin
    converting enzyme (ECE)
  • Launch date 2006 Peak sales potential above
    250 MEUR

17
CARDIOLOGY
Proof of principle
Registration
Research
ARRHYTHMIAS
tedisamil IV-PO
  • potassium channel blocker
  • intravenous use to convert atrial fibrillation to
    sinus rhythm followed by oral use to maintain it
  • proof of principle achieved
  • earliest launch 2004 intravenous and 2006 oral
  • Phase III decision November 2001
  • Launch date 2004-2006
  • Peak sales (IVPO) potential 100-250 MEUR

18
CARDIOLOGY
Proof of principle
Registration
Research
HYPERTENSION
  • eprosartan plus hydrochlorothiazide (HCT)
    diuretic combinations
  • angiotensin II receptor antagonist
  • to be marketed everywhere when registrations and
    price agreementsachieved
  • Solvay does the world, except US where it is
    licensed to Biovail
  • FDA approval achieved, Europe ongoing
  • Launch date 2002
  • Peak sales potential under 100 MEUR

19
GASTROENTEROLOGY portfolio
Proof of principle
Registration
Research
IRRITABLE BOWELSYNDROME
COLOFAC EU
DICITEL EU
cilansetron US/EU
PANCREATICENZYMES
CREON EU/US
CREON JPN
gastric lipase
KC11458
MOTILITYDISORDERS
preclinical SLV317, SLV321
20
GASTROENTEROLOGY
Proof of principle
Registration
Research
IRRITABLE BOWELSYNDROME
COLOFAC EU
DICITEL EU
cilansetron US/EU
  • cilansetron
  • 5HT3 antagonist
  • diarrhea-predominant IBS in men and women
  • July 2001 decision to complete the phase III
    program
  • Quintiles contract signed for clinical trials
  • development and marketing commercial partnerships
    now open for discussion
  • Launch date 2004
  • Peak sales potential above 250 MEUR

21
Cilansetron Program
  • Overview
  • 7 studies
  • 3 pivotal efficacy studies
  • 4 long term safety studies
  • In total more than 3500 patients to be randomized
  • 6000 patients to be screened
  • More than 500 study centers recruiting patients

22
Cilansetron Program
  • AT ANYTIME SOMEWHERE IN THE WORLD SOMEBODY IS
    WORKING ON CILANSETRON
  • 24 countries
  • all five continents
  • Africa (South-Africa)
  • America (USA Canada)
  • Asia (India Israel)
  • Australia/Pacific (Australia New Zealand)
  • Europe (17 countries)

23
Cilansetron Program
  • Timelines
  • First Patient included October 2001 (done!)
  • Complete program Q3 2003
  • Consequences
  • 10 patients/calendar day to be entered
  • 17 patients/calendar day to be screened

24
HORMONE REPLACEMENTS portfolio
Proof of principle
Registration
Research
ESTRATEST
US
FEMOSTON
EU
PRESOMEN
EU
ESTROGEL
US
EP PATCH
US
WOMENS HRT
EP GEL
US/EU
MENS HRT
ANDROGEL US

Evaluation testosterone for female use
25
HORMONE REPLACEMENTS
Proof of principle
Registration
Research
WOMENS HRT
ESTROGEL US
  • New Drug Application submitted to FDA 1999
  • Launch date 2003
  • Peak sales potential under 100 MEUR
  • Administrative issues holding up FDA processing

26
HORMONE REPLACEMENTS
Proof of principle
Registration
Research
WOMENS HRT
EP GEL US/EU
  • Estradiol NETA (progestogen) gel
  • Solvay has obtained licenses for US/Canada and
    Europe
  • Clinical studies necessary to start
    full-development have been completed
  • Stability of formulation and regulatory review
    of program size ongoing
  • Launch date 2005 ?
  • Peak sales potential under 100 MEUR

27
INFLUENZA VACCINES
  • INFLUVAC our current product was manufactured
    by Fort Dodge/AHP. We bought the factory mid
    2001 in order to secure and expand manufacturing
  • WEST PHARMACEUTICALS intranasal formulation
    technology license obtained mid 2001 for use with
    our INFLUVAC launch expected 2005. First data
    in-house
  • BERNA collaboration in virosomes, submit
    registrations May 2002
  • MDCK process approved by Dutch authorities mid
    2001, launch dates depend on future partnerships
    (or do in-house?)

28
RD PORTFOLIO ADDING VALUE FASTER
  • Significant progress with in-house RD projects
  • with Phase II III projects
  • 5 phase I and 2 phase II decisions in 2002
  • Creative use of skilled partners(e.g. Quintiles,
    Lundbeck, ...)
  • Creative use of shelved project (e.g. DU 125530
    Neurokorr in Alzheimers disease)

29
Visit our Internet site specifically designed for
Investors www.solvay-investors.com and become
member of our Shareholders Club
30
FORWARD LOOKING STATEMENT
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 and other unusual items. Consequently,
actual results may differ materially from those
expressed or implied by such forward-looking
statements. Forward-looking statements can be
identified by the use of words such as "expects,"
"plans," "will," "believes," "may," "could"
"estimates," "intends", "targets", "objectives",
"potential", and other words of similar meaning.
Should known or unknown risks or uncertainties
materialize, or should our assumptions prove
inaccurate, actual results could vary materially
from those anticipated. The Company undertakes no
obligation to publicly update any forward-looking
statements"
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