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  • 28
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  • In long-term extension studies, 20–30% more patients achieved target blood pressure if treated with eprosartan (800 mg) plus HCTZ (12.5–25 mg) than monotherapy. 1 In comparative studies of eprosartan (400–600 mg) or enalapril, plus HCTZ in patients with mild, 2 moderate 2 and severe 3 hypertension, the response rate after combined treatment was found to be higher for eprosartan than enalapril. In another study comparing eprosartan with sustained-release nifedipine, an additional antihypertensive effect was seen when combination therapy was administered to patients not achieving normalisation of blood pressure with monotherapy. 4 These combination regimens have a good safety and tolerability profile. 1. Solvay Pharmaceuticals. Data on file. Studies 050 and 052. 2. Gavras I, Gavras H. Effects of eprosartan versus enalapril in hypertensive patients on the renin-angiotensin-aldosterone system and safety parameters: results from a 26-week, double-blind, multicentre study. Curr Med Res Opin 1999;15(1):13–24. 3. Ponticelli C (on behalf of the Eprosartan Study Group). Comparison of the efficacy of eprosartan and enalapril in patients with severe hypertension [abstract]. Presented at the American Society of Hypertension Twelfth Scientific Meeting, San Francisco, USA, 27–31 May 1997. Am J Hypertens 1997;10:128A. 4. Solvay Pharmaceuticals. Data on file. Study 041. A 12-week, double-blind, parallel, multicentre trial to compare regimens of SK&F 108566 and nifedipine SR, given alone and combined, in patients with essential hypertension.
  • Claus Steinborn will repond “in a few days”

[EN] [EN] Presentation Transcript

  • Brussels - September 14, 2001 Analysts and Investors Meeting « A FUNDAMENTAL STRATEGIC CHANGE FOR SOLVAY »
    • PHARMACEUTICALS
  • VALUE CREATING IN PHARMACEUTICALS
  • SOLVAY PHARMACEUTICALS OUR VISION “ Our aim is to find, produce and deliver pharmaceutical products to help physicians to treat diseases in our 4 therapeutic areas and improve the quality of life for patients”
  • SOLVAY PHARMACEUTICALS midsize company thrives by focusing on specialty areas “ The giants’ disdain for small drugs could work to the advantage of midsize pharmaceutical companies” McKinsey, 2001
  • PHARMACEUTICALS SECTOR Targets by 2005+
    • Sales > EUR 2.5 Bn from 2005 onward
    • EBIT/sales margin > 15%
    • ROI > 20%
    • North American sales at 50% of total sales
  • PHARMACEUTICALS SECTOR Targets by 2005+ 15%/y (+23% in US) World + 10%/y required to achieve EUR 2.5 Bn
    • Growth of existing drugs
    • Recent launch of new drugs
    • Contribution of molecules under development
    PHARMACEUTICALS : FINANCIAL OBJECTIVE by 2005  sales of EUR 2.5 Bn  EBIT/sales margin of 15%
    • Strengthened by alliances and partnerships
  • « Expansion of global commercial platform » J. Wessolowski, Head of Pharmaceuticals Marketing & Operations
  • PHARMACEUTICALS WORLDWIDE PRESENCE Total 2000 sales : EUR 1,548 M Tokyo (Japan) Brussels (B) Hannover (D) Weesp (NL) Atlanta (USA)
  • STRONG WORLDWIDE MARKET POSITION Europe US World Solvay (11) Worldwide Market Share Digestives/Enzymes 1 2 1 33% Laxatives 1 - 3 6% Irritable Bowel Syndrome 1 - 1 28% Hormone Replacement Therapy female 5 2 2 9% male (*) - 1 1 22% Antidepressants + OCD 13 8 9 2% Vertigo (Ménière’s disease) 1 - 1 39% * only sold in the US IMS data
  • STRONG GROWTH IN 4 THERAPEUTIC AREAS
    • HRT* PRODUCTS 470 + 21 %
      • Estratest ® 145 + 17%
      • Duphaston ® 56 + 7%
      • Prometrium ® 49 + 93%
      • AndroGel ® (**) 29 n.a.
      • Femoston ® 19 + 60%
    • GASTROENTEROLOGY 473 + 11 %
      • Creon ® 119 + 6%
      • Duphalac ® 81 0
      • Duspatal ® 59 + 2%
      • Pantoloc ® 54 + 101%
      • Rowasa ® 47 + 8%
      • Dicetel ® 34 + 9%
    • PSYCHIATRY 419 + 13 %
      • Luvox ® 271 + 19%
      • Serc ® 72 + 2%
    • C ARDIOLOGY 106 + 6 %
      • Physiotens ® 39 + 26%
      • Teveten ® 16 + 20%
    (*) Hormone Replacement Therapy (**) marketed since June 2000 Therapeutic fields/ Sales in 2000 2000/1999 Products (M EUR) (%)
  • + 19% SALES in H1/01 (+34% in the US) HRT 267 + 46% GASTRO 247 + 12% CARDIO 73 + 47% PSY 181 - 10% H1/01 vs H1/00
    • Estratest ® 89 + 62%
    • AndroGel ® 51 n.s.
    • Prometrium ® 31 + 45%
    • (Cenestin (Duramed) 15 + 112%)
    • Creon ® 65 + 10%
    • Pantoloc ® 37 + 65%
    • Rowasa ® 27 + 29%
    • Dicetel ® 20 + 21%
    • Physiotens ® 23 + 20%
    • Teveten ® 17 + 157%
    • Aceon ® 9 (*)
    • Luvox ® (world) 86 - 28%  US down  Japan up
    • Marinol ® 24 + 178%
    Success of recently launched drugs M EUR H1/01 M EUR vs H1/00 (*) Aceon ® sales were negligible in H1/00
  • 1999 2000 2001 Line extension: First launch of Femoston (conti.) in UK and Switzerland Launch of Femoston (conti.) in Germany, further launches to follow Poland, South Africa, Norway, Hungary, Sweden, Belgium, Russian Fed. Lithuania, Croatia, Czech Rep., Slovak Rep., Malta, Bulgaria Lebanon, Jordan, Saudi Arabia, Kuwait, U.A.E., Romania, Ukraine First launch of Teveten (in Germany and US followed by further launches through the world The Netherlands, Austria, UK, Ire, Switzerland, Australia, Poland, Italy, France, Russian Fed. Fin, Gr, Canada, Sweden, Denmark, Norway, Spain, Belgium First SSRI launched in Ja-pan; marketed by Fujisawa and Meiji Seika for depression and OCD MAJOR RECENT PRODUCT LAUNCHES (1) Femoston® Physiotens® Teveten® Luvox®
  • USA Aceon ® Androgel ® (marketing agreement with TAP since June 2001) Cenestin ® (with Duramed Inc.) MAJOR RECENT PRODUCT LAUNCHES (2) 2000 2001 Launch of Teveten Marinol ® (100% Solvay)
  • 2001 2003 2004 2005 2006 Teveten + HCT, Europe and U.S. Presomen Conti, (Germany only) Moxonidine + HCT (Europe) Luvox CR Creon (Japan) Estrogel US cilansetron, Europe and U.S. Tedisamil IV Combigel E + P-gel Influvac-Intranasal SLV 306 DU 127090 Tedisamil PO FUTURE PRODUCT LAUNCHES
  • GEOGRAPHICAL EXPANSION ROW NAFTA 1996 In % of total pharma sales 2005+ ROW = Rest of the World target : 50/50 balance between NAFTA / Rest of the world ROW NAFTA ROW NAFTA 2000
  • GEOGRAPHIC GROWTH OBJECTIVES
    • To increase global market share up to 0.8 - 1 % of the world market (Market share currently 0.5%)
    • To get 1% in countries where Solvay has a presence
  • Countries in Billion USD Solvay market share * USA Market Estimates include audited US Mail Order data, **data for the Netherlands is based on estimated sales only (IMS data) THE WORLDWIDE MARKET Rank % of worldwide market 1 USA* 149.8 41.3% <1% 2 Japan 57.8 15.9% <1% 3 Germany 17.3 4.8% >1% 4 France 16.8 4.6% >1% 6 Italy 11.0 3.0% <1% 5 UK 11.1 3.0% <1% 10 Spain 6.2 1.7% >1% 8 Brazil 6.7 1.8% <1% 7 China 6.8 1.9% <1% 9 Canada 6.3 1.7% <1% 11 Mexico 6.0 1.7% not present 12 Argentina 3.7 1.0% not present 13 South Korea 3.7 1.0% not present 14 India 3.6 1.0% <1% 15 Australia 3.1 0.9% <1% 16 Turkey 3.1 0.9% not present 19 Belgium 2.5 0.7% >1% 17 Netherlands ** 2.6 0.7% <1% 18 Poland 2.5 0.7% <1% 20 Taiwan 2.5 0.7% not present
  • ACQUISITIONS NEW PRODUCTS/NEW COMPANIES Recent/Short term Medium term Long term 0 - 2 years > 2 - < 5 years > 5 - years USA Unimed X X EUROPE Italy X UK X Poland (X) + Continuous growth Central/Eastern Europe, especially Russia + geographical expansion in Turkey AMERICAS Brazil Sintofarma Argentina X Mexico X Canada X ASIA Japan X + geographical expansion in India
    • USA
    • Androgel® : with TAP Phamaceutical Co
    • Cenestin® : with Duramed
    • Remeron® sol-tab : with Organon
    • CANADA
    • Pantoloc® : with Byk-Gulden
    • Teveten ® : with Fournier
    • SOUTH AMERICA
    • Mexico : with Byk Gulden
    • Argentina : with Byk Gulden
    • EUROPE
    • Germany : with Aventis for Teveten®
    • Spain : with Roche for Cilazapril®
    • Italy : with Upjohn for Frontal®
    • with Almirall/Prodesfarma for Dumirox® /Almotrex®
    • ASIA
    • Japan : with Meiji and Fujisawa for Luvox®
    • Japan : with Amano and with Meiji for Creon® (under negotiation)
    • China : with Hexal (hostpartnership)
    ALLIANCES WITH SOUND PARTNERS IN CO-PROMOTION/LICENSES
  • EXPANSION OF COMMERCIAL SALES FORCE About 5,300 sales representatives worldwide (versus 2,900 in 1998) including sales force partners or third parties
    • SOLVAY SALES FORCE 3,800
    • United States 1,000  twofold increase between 98 and 2000
    •  establishment of a primary care network
    •  acquisition of Unimed Pharmaceuticals Inc
    •  + alliance with Duramed (female HRT) and TAP (male HRT, Androgel))
    • Brazil 180  Acquisition of Sintofarma in Brazil
    • Canada 64
    • Western Europe 1,355
    • Central/Eastern Europe 300
    • Asia/Middle East 907
    • THIRD PARTIES
    • Japan 1,500  distribution agreement with Fujisawa/Meiji Seika
  • DOUBLE DIGIT GROWTH
    • 96 97 98 99 00 H1/01
    over the last 5 years Sales 922 1,049 1,167 1,349 1,548 830 Sales Growth (yoy) +15% +14% +11% +16% +15% +19% EBIT 97 118 135 157 134 * 59 EBIT growth (yoy) +38% +22% +14% +16% -15%* +157% EBIT/SALES 10% 11% 12% 12% 9% * 7% ** * due to voluntary marketing investments for the launch of 5 new drugs ** with H1 lower than H2 due to seasonal effect
  • « Pharmaceuticals R&D for tomorrow ’s success » W. Cautreels, Worldwide Head of R&D Pharmaceuticals
    • Promising Development Projects
        • an update by therapeutic area
    • But First An Update on Actions Announced Earlier
        • towards optimal decision making, output and effectiveness in R&D
        • strategic partnerships for biotech, special skills and value optimization
    CONTENT OF PRESENTATION
  • R&D EFFECTIVENESS IMPROVEMENTS
    • handle the improved output from biotechnology based discovery programs: more compounds in development  New biotech platform implemented
    • accelerate the development process by working more effectively with expert Clinical Research Organisations as partners: reduce « time to market »  Quintiles agreement implemented
    • concentrate one function on one site:
    • improve efficiency by avoiding duplications  Implementation started
    • shift internal R&D costs to external costs towards 50/50:
    • increased portfolio development spending  Implementation started (e.g. cilansetron)
    R&D EFFORTS BETTER FOCUSED (not reduced) Weesp (Nl), Hannover (D), Marietta and Chicago (US), Tokyo (J)
  • Programs D Proof of Principle Projects L Products
    • Discovery and Biotech
    • for Compounds (Arqule + Evotec + Syncom)
    • for Screening Technologies (Euroscreen + Cerep)
    • for Targets (Innogenetics + Euroscreen )
    • Development
    • in psychosis: Lundbeck
    • in HRT: several projects, E/P gel with Antares
    • Lipase with Meristem
    • Intranasal influenza vaccine with West
    • In preparation: preferred partner
    • for execution of clinical trials
    • with established quality global network
    • and state-of-the-art IT systems  QUINTILES
    • Business
    • Fujisawa/Meiji Seika (Jp)for LUVOX  & DEPROMEL 
    • Byk-Gulden (D): PANTOLOC  in Canada
    • Several companies for TEVETEN  co-marketing
    • ANDROGEL  co-marketing with TAP in the US
    Strategic Partnering makes us stronger! some examples:
  • AREAS OF R&D FOCUS Psychiatry Cardiology Gastroenterology Anxiety & Depression Psychosis Parkinsons* Arrhythmia Congestive Heart Failure Hypertension Obesity* Motility Disorders Irritable Bowel Syndrome Pancreatic Enzymes Hormone Replacements Women HRT* Endometriosis* Men HRT* * External collaborations
  • Hormone replacement therapies 17 % Cardiology 22 % Psychiatry 34 % Gastroenterology 27% - in % of 2000 pharma R&D expenses : EUR 248 M (16% of pharma sales) GROWTH THROUGH A SPECIALIZED R&D PROGRAM
  • R & D SUMMARY - NUMBER OF PROJECTS Gastro- Enterology CNS HRT Cardiology Pre-Clinical = 7 3 (IBS (2), Enzyme Insufficiency) 2 (Parkinson’s, Psychosis) 2 (Hypertension/CHF) Phase I = 3 3 (Psychosis) Phase II = 8 2 (Motility Disorders, enzyme insufficiency) 4 (Parkinson’s, Psychosis, Pain/ Spasticity, Depression) 2 (arrhythmia, Hypertension/CHF) Phase III = 8 2 (IBS, Enzyme Insufficiency) 1 (OCD/Social anxiety disorders) 3 (female HRT, male HRT) 2 (Hypertension) Total=26 7 10 3 6
  • PSYCHIATRY portfolio SLV308 Registration Proof of principle Research LUVOX® fluvoxamine CR DEPRESSION EU/JPN OCD US/EU/JPN OCD/Social Anxiety Disorders SCHIZOPHRENIA/PSYCHOSIS Multiple Sclerosis Pain/Spasticity PARKINSON’S SCHIZOPHRENIA PSYCHOSIS DU127090 SLV310 SLV313 SLV314 DEPRESSION DU125530 preclinical SLV318, SLV319 THC ( MARINOL®)
  • PSYCHIATRY LUVOX® DEPRESSION EU/JPN OCD US/EU/JPN OCD/Social Anxiety Disorders
    • ELAN manufacture
    • SOLVAY trademark (to be decided)
    • positive pivotal studies in both OCD + Social Anxiety Disorders
    • submission 2002 US, 12 months delay after validation of manufacturing
    • launch date 2003 onwards
    • peak sales potential under 100 MEUR
    fluvoxamine CR Registration Proof of principle Research
  • PSYCHIATRY
    • cannabinoid receptor agonist, t etra h ydro c annabinol (THC)
    • launched in US for appetite stimulation in HIV/AIDS and nausea/vomiting caused by cancer chemotherapy
    • clinical studies ongoing in relief of pain and spasticity in multiple sclerosis sufferers
    Multiple Sclerosis pain/Spasticity THC ( MARINOL®) Registration Proof of principle Research
  • PSYCHIATRY
    • DU127090
    • Solvay Pharmaceuticals partnership with Lundbeck for joint developments and marketing
    • Partial D2 antagonist with additional 5HT1A agonism
    • Proof of principle as antipsychotic is completed
    • SLV310/313/314
    • different mechanism mixes D2, 5HT1A, SSRI
    • SLV319 : a preclinical potential candidate
    SCHIZOPHRENIA/ PSYCHOSIS DU127090 SLV310 SLV313 SLV314
    • Launch date 2006
    • Peak sales potential above 250 MEUR
    Registration Proof of principle Research
  • The Lundbeck Example of partnership
    • We created DU 127090 and described its anti-psychotic potential by animal work and phase I clinical studies, phase II is ongoing
    • DU127090 shows promising anti-psychotic activity
    • Lundbeck has very relevant skills with CNS project and product experience
    • Solvay and Lundbeck share costs, programs & marketing (Solvay : US+other countries, Lundbeck : Europe)
  • PSYCHIATRY
    • SLV308
    • Partial D2 agonist plus 5HT1A agonism plus alpha-1 / alpha-2 agonism
    • Parkinson’s first target + co-morbid depression
    • Proof of principle studies on motor and mood disorders ongoing
    • Backup : SLV318 a preclinical potential candidate
    PARKINSON’S SLV308 Registration Proof of principle Research
  • PSYCHIATRY
    • 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
    DEPRESSION DU125530 Registration Proof of principle Research
  • CARDIOLOGY portfolio CHF/ HYPERTENSION ARRHYTHMIAS TEVETEN®HCT TEVETEN® EU / US ACEON® US PHYSIOTENS® EU HYPERTENSION tedisamil IV-PO preclinical SLV316, SLV320 moxonidine HCT SLV306 Registration Proof of principle Research
  • CARDIOLOGY
    • eprosartan plus h ydro c hloro t iazide (HCT) diuretic combinations
    • angiotensin II receptor antagonist
    • to be marketed everywhere when registrations and price agreements achieved
    • “ approvable letter” received from FDA
    HYPERTENSION
    • Launch date : 2001-2002
    • Peak sales potential under 100 MEUR
    Registration Proof of principle Research
  • EFFICACY OF EPROSARTAN AND COMBINATIONS
    • eprosartan monotherapy works well for many hypertensive patients
    • eprosartan + HCT works well for some who need more than eprosartan alone
    • better response rate with eprosartan + HCT than with enalapril + HCT
  • CARDIOLOGY
    • moxonidine plus HCT diuretic combination
    • to be marketed in EU when registrations and price agreements achieved
    moxonidine HCT
    • Launch date : 2003
    • Peak sales potential under 100 MEUR
    Registration Proof of principle Research HYPERTENSION
  • CARDIOLOGY CHF/ HYPERTENSION SLV306
    • Dual endopeptidase inhibitor NEP (1) and ECE (1)
    • hSEP is a novel ECE target (patent filed)
    • selectively inhibited by SLV306
    • 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
    Registration Proof of principle Research
  • CARDIOLOGY ARRHYTHMIAS
    • 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
    tedisamil IV-PO
    • Launch date : 2004-2006
    • Peak sales (IV+PO) potential :100-250 MEUR
    Registration Proof of principle Research
  • GASTROENTEROLOGY portfolio cilansetron US/EU DICITEL® EU COLOFAC® EU IRRITABLE BOWEL SYNDROME CREON® EU/US CREON® JPN PANCREATIC ENZYMES gastric lipase MOTILITY DISORDERS KC11458 preclinical SLV317, SLV321, enzymes Registration Proof of principle Research
  • GASTROENTEROLOGY cilansetron US/EU DICITEL® EU COLOFAC® EU IRRITABLE BOWEL SYNDROME
    • 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
    Registration Proof of principle Research
    • Start of the phase III program after constructive discussions with the US FDA
    • Agreement signed with QUINTILES TRANSNATIONAL
      • access to state-of-the-art clinical trial execution with certain priority claim on QUINTILES resources
    • ongoing talks with potential alliance and marketing partners
    PROMISING and HIGH-POTENTIAL R&D PROJECT CILANSETRON FOR IBS IN PHASE III
  • KEY DATA FROM CILANSETRON IBS STUDIES
    • 2 large studies with similar results, 471 and 435 patients
    • cilansetron phase II pivotal studies show clear separation from placebo both in men and women, fall 2000
  • GASTROENTEROLOGY CREON® EU/US CREON® JPN PANCREATIC ENZYMES
    • CREON® JPN
    • Launch date : 2003
    • Peak sales potential under 100 MEUR
    • gastric lipase
    • non-animal-sourced range of enzymes sought
    • “ Molecular Pharming” technology expresses mammalian gastric-lipase in corn (MERISTEM)
    • in-licensed for development, phase II ongoing
    • other non-animal-sourced enzyme products : preclinical
    gastric lipase Registration Proof of principle Research
  • GASTROENTEROLOGY MOTILITY DISORDERS
    • motilin agonist
    • KC11458 is a non-peptide macrolide
    • intended to be of use in the delayed gastric emptying found in some diabetic gastroparesis patients and functional dyspepsias
    • clinical studies show dose dependent effects in man confirming faster gastric emptying
    • phase II ongoing
    KC11458 Registration Proof of principle Research
  • HORMONE REPLACEMENTS portfolio ESTROGEL® US PRESOMEN® EU FEMOSTON® EU WOMEN’S HRT ANDROGEL® US MEN’S HRT ESTRATEST® US E+P GEL US/EU Registration Proof of principle Research Evaluation : testosterone for female use
  • HORMONE REPLACEMENTS ESTROGEL® US
    • Launch date : 2003
    • Peak sales potential under 100 MEUR
    Registration Proof of principle Research
    • New Drug Application submitted to FDA 1999
    WOMEN’S HRT
  • HORMONE REPLACEMENTS WOMEN’S HRT E+P 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
    • Phase III program to be started in Q1 2002
    Registration Proof of principle Research
    • Launch date : 2005
    • Peak sales potential under 100 MEUR
  • 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
    • MDCK process approved by Dutch authorities mid 2001, launch dates depend on future partnerships
  • 2001 2003 2004 2005 2006 Teveten + HCT, Europe and U.S. < 100 MEUR Moxonidine + HCT (Europe) <100 MEUR Luvox CR <100MEUR Creon (Japan) <100MEUR Estrogel US <100MEUR Cilansetron, Europe and U.S. > 250MEUR Tedisamil IV Combigel E + P-gel <100MEUR Influvac-Intranasal <100MEUR SLV 306 >250MEUR DU 127090 >250MEUR Tedisamil PO 100-250MEUR VALUATION OF R & D PORTFOLIO Peak sales POTENTIAL (3 years or more after launch) This represents an all-success scenario, individual projects are subject to industry standard probabilities of success for their respective stage of development LAUNCH DATES
  • PHARMACEUTICALS R&D
    • A Discovery with Proven Output Ability
        • and a continuing search for external technologies and alliances
    • A Development with Proven Abilities to Proof Of Principle
        • recent examples being cilansetron and SLV306
    • An Ability to Complete Full Developments
        • recent examples being ESTROGEL® and fluvoxamine CR
    • And A Willingness to Work with Skilled Partners
        • Lundbeck on DU127090 and
        • Discussion ongoing for cilansetron, SLV306 and others
  • and … Innovation Visit our Internet site specifically designed for Investors www.solvay-investors.com and become member of our Shareholders’ Club