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IPSEN

Le 05/03/10. IPSEN. Sophie Compagnon, Melodie Debacker , Gaelle Datchoua , Catherine Lucas. INTRODUCTION. About IPSEN . Specialized world pharmaceutical group More than 20 products marketed in the world Originally, French independent company Headed by Beaufour Family

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IPSEN

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  1. Le 05/03/10 IPSEN Sophie Compagnon, MelodieDebacker, GaelleDatchoua, Catherine Lucas

  2. INTRODUCTION

  3. About IPSEN • Specialized world pharmaceutical group • More than 20 products marketed in the world • Originally, French independent company • Headed by Beaufour Family • Third independent pharmaceutical firm in France (sales)

  4. G5 pharma five major actors in the French pharmaceutical industry Motor of economic growth

  5. Key figures CA (EN MILLIONS €) IPSEN workforce CA (EN MILLIONS €) + 6,4% + 5,5% R&D INVESTMENT (in M€) CA / employee 19,1% 2009: 197.3 2009 : 233 243 € 18,8% + ratio important, + value added for job 2008 : 227 028 € 20,1% 2007 : 236 876 € 20,7% Global average : 15 - 16 %

  6. Key figures Sales by therapeutic area 2006

  7. IPSEN sites in Europe Research centers: France, Spain, England Industrial sites : France, Swizerland, Ireland, England, Spain Commercial presence : Other European country

  8. Other IPSEN sites US : research, industrial site and commercial presence South America : commercial presence China : industrial site and commercial presence Rest of Asia : commercial presence

  9. Key figures Sales by geographical area 2006 Five major western european countries 53,7% France 31,3% Italie 7% Spain 5,7% Germany 5,5% UK 4,1% Othereuropean countries 22,7% North of America 4,4% Rest of the world 19,2%

  10. BACKGROUND

  11. IPSEN background • BeaufourLaboratories • Founded by Dr Henri Beaufour (pharmacist) in Dreux 1929 • Launchof Romarène® • digestive disorders • Launchof Citrate de bétaïne® Beaufour • dyspepsia 1954 • Integration of Henri’s sons, Gerard and Albert, in BeaufourLaboratories • Launch of Actapulgite® • antacid, gastric demulcentand anti-diarrhoeal 1963

  12. 70’s 70’s IPSEN background Start marketing products of naturalorigin. 1970 « IPSEN » creation Subsidiarycompany of « BeaufourLaboratories » = Institut des Produits de Synthèse et d’Extraction Naturelle Gingkobiloba Primary care

  13. 70’s 70’s IPSEN background Start marketing products of naturalorigin. 1972 Ginkor® • Indications: Cardiovascular • chronicvenousinsufficiency • acute haemorrhoid episodes • superficialphlebitis • Active substances: • Ginkgo bilobaextract • Heptaminol chlorhydrate • Troxérutine 1987: GinkorProcto® 1988: Ginkor Fort® Primary care

  14. 70’s 70’s IPSEN background Start marketing products of naturalorigin. 1972 Tanakan® • Indications: Cognitive disorders • Age-related cognitive disorders (excepted Alzheimer’s disease) • Anti-ischemic (atreritis, Raynaud’s phenomenon) • cochleovestibular disorders • Active substances: • EGb 761® (Ginkgo bilobastandardizedextract) Primary care

  15. 70’s 70’s IPSEN background Start marketing products of naturalorigin. Smecta® 1977 • Active substances: • diosmectite (clay) • Indications: Gastroenterology • Digestive coating (pain ofœsopagus, stomach, duodenum and colon) • Acute and chronicdiarrhea 1980 Bedelix® • Active substances: • montmorillonite beidellitique (clay) • Indications: Gastroenterology • Digestive coating • Symptomatictreatment of functionnal colopathies Primary care

  16. 90’s 90’s IPSEN background 1996 Forlax® • Active substances: • Macrogol 4000 (polyethylène glycol 4000) • Indications: Gastrointestinal • constipation (adults and children) Primary care

  17. Start in research • Albert beaufour : biotechnologyresearch Biomeasure Boston A. Beaufourresearchinstitute : peptide focused engineering • Research relations with americanuniversities. 1976

  18. 80’s 80’s IPSEN background Interest in specializedtherapies 1980 Partnershipwith • International development • Launch of Decapeptyl ®(1986) • Active substances: • triptoreline (GnRHagonist) • Indications: Oncology • Prostate cancer • Uterinfibroids • Endometriosis • Early-onsetpuberty • Femaleinfertility Decapeptyl® 1mois (1995) Decapeptyl® 3mois (1996) Decapeptyl® 6mois (2009, november) Targetedtherapy

  19. 90’s 90’s IPSEN background Interest in specializedtherapies Dysport® 1994 Purchase of KEYWOOD (UK) • Active substances: • botiliumneurotoxin,type A toxin-haemagglutinincomplex. > 75 countries • Indications: Neuromuscular • hemifacialspasticity • Cervical dystonia • blepharospasm • (glabellaireswrinkles) Targetedtherapy

  20. 90’s 90’s IPSEN background Interest in specializedtherapies 1995 Somatuline® • Active substance: • Lanréotide = an octapeptidesomatostatinanalog • Inhibition of Insulin-like growth factor-1 (IGF-1) and growth hormone (GH). • Indications: Endocrinology • Acromegaly • Neuroendocrine tumours Somatuline Depot ® 1st product from IPSEN R&Dapproved by the FDA and available at international level Targetedtherapy

  21. Family business 90’s 90’s IPSEN background 1996 Disagreementsbeetwen Albert and Gerard, at last Albert boughtGerard’s parts (50%) Still an independentfamilycompany Progressively, StephaneFrancois, son-in-law of Albert, has more importance.

  22. IPSEN background 90’s 90’s 2001 Death of Albert. StephaneFrancoisisrenowned CEO, but Anne and Henri Beaufourdon’tagreewiththat. StephaneFrancoisisfired. 2002 Welcome to Jean-Luc Bélingard !

  23. New team

  24. New boss.... Newstrategy 1 • Optimize its primary care portfolio • Geographic expansion • Focus on targetedtherapeutic areas 2 3

  25. 1 Optimize its primarycare portfolio Life Cycle Management to develop new indications or confirm the medical benefits of selected products In-licensingof new medicines to sustain Ipsen’s primary care franchise Cash cow R & D $ $ $ $

  26. 1 Optimize its primarycare portfolio Life cycle Management Tanakan® • Principal indication: Cognitive disorders • Age-related cognitive disorders (excepted Alzheimer’s disease) 35% 35% 15% Reimbursement + Price cut: -15% April 2010 1972 2007 IPSEN intention: obtain AMM for Alzheimer’sdisease indication GuidAgestudy, for 5years (beginning :2006) Efficacy and Tolerance of EGb 761® A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled.

  27. 1 Optimize its primarycare portfolio Life cycle Management Ginkor Fort® 35% 0% 15% Reimbursement + Price cut: -15% 1972 2006 2008 2005 2007 Turnover decrease 39.7% Marketing authorizations in France, Andorra and Monaco relinquished to in august 2007

  28. 1 Optimize its primarycare portfolio Life cycle Management Smecta® • Bad reputation: taste 2008: new clinical results were released at international congresses orange vanilla flavour new packaging trend of natural products INTERNATIONAL EXPANSION China: 1st global market SMECTA SALES UP BY 4,8% in 2008

  29. 1 Optimize its primarycare portfolio In-licensing of new medicines Co-promotion agreements Hypertension 2003 Nisis® and Nisisco ® France Exforge® 2009 Non steroidal anti-inflammatory drug France 2006 Artotec® Post-menopausal osteoporosis France 2007 Adrovance® Hyperuricemia Europe Adenuric ® 2008

  30. New boss.... Newstrategy 1 • Optimize its primary care portfolio • Geographic expansion • Focus on targetedtherapeutic areas 2 3

  31. 2 Geographic expansion Decrease reimbursement, generics Big progression

  32. 2 Example of partnership with Inspiration • mission: revolutionize treatment for hemophilia • Wide portfolio in hemophilia and haemorrhage • OBI-1 : porcine FVIII treatment of hemophilia A • Reminder: Hemophilia A = deficit in FVIII controlled by injections of human FVIII ( 2 – 3t/ week) Pb: 1/3 of cases, immune reaction (Ac anti human FVIII) preventing reinjection of human FVIII • So OBI-1 : porcine origin low cross-reactivity to Ac anti hFVIII therapeutic benefit for these patients IPSEN ambition: engage in a niche sector founded in 2004

  33. Example of partnership with Inspiration 2 OBI-1: porcine F VIII belongs IPSEN IPSEN INSPIRATION Sublicence OBI-1 50M $ in cash or convertible bond 50 M$ + 27,5 % sales 85 M$ = initial investment 85 M$ financing Shares representing 20% of Ins. equity  1 member of IPSEN in Board of directors of Inspiration 259 M$ of funding for development and marketing of its portfolio in hemophilia Based on the successful development of OBI-1 & IB1001 Until 174 M$ 1 convertible bond into equity/payment IPSEN could hold up to 47% of Inspiration equity!

  34. 2 Example of partnership with Inspiration: Advantages IPSEN INSPIRATION • Robust portfolio • Engage in a niche industry • Few competitors • Low risk-taking (payment based on results) • Benefit from the expertise of specialists in hematology • If all goes well, can acquire the entire equity of Inspiration Biopharmaceuticals • Enjoy a worldwide group to implement its products • Addition of OBI-1 in their portfolio • Become the world leader in the field of hemophilia • Thanks to OBI-1, Insp. Portfolio could generate sales exceeding $ 1 billion within 10 years

  35. 2 So … Realize partnership permits to IPSEN: • sell products that are not in its field (little knowledge) • engage with partners only if it can make a profit • eventually buy out his partner / no longer care

  36. 2 PartnershipwithMedicis and Galderma Botulinumneurotoxin, type A, boughtfromOctagen. • Therapeutic indications: • hemifacialspasticity • cervical dystonia • blepharospasm • Esthetic indication: • glabellaireswrinkles Keepsitsrights Market estimated to $ 760 – 800 M BUT Not part of Ipsen’s expertise Partnerships

  37. 2 PartnershipwithMedicis and Galderma UE, Russia, East Europe, Central Asia, Israël, Liban. USA, Canada and Japan $ 10M $ 90.1 M $ 20M $ 26.5 M $ 75 M $ X M 30% of turnover 40% of turnover $ 2 M Supplies. Fixedprice. $ 35 M Supplies. Fixedprice. Min $ 30 M $ 228.6 M Developpement, distribution and marketrights Developpement, distribution and promotion rights 2006, until 2036 2007, until 2019

  38. 2 PartnershipwithMedicis and Galderma Advantages IPSEN GALDERMA MEDICIS • Develop a productwhichisalreadywell-known as a medecine • No bad surprises, lessrisky • Be sure to besupplied • Be sure to sellitsproduct for a long period of time • Reachunknownmarketsthrough • locallywell-knownpartners

  39. 2 Partnership policy Hematology Endocrinology Neurology Primary Care Oncology 2009 2004 2006 2003 2007 2008 Taspoglutide (GLP-1 analog, antidiabetic): developpement and marketing Acapodene ( SERM, Prostate Cancer): developpement and marketing in EU

  40. New boss.... Newstrategy 1 • Optimize its primary care portfolio • Geographic expansion • Focus on targetedtherapeutic areas 2 3

  41. 3 Focus on targetedtherapies Wilde impact of : ≈ 139,2% of growth ≈ 299,3% of growth

  42. 3 R&D • Earlycommitment, since 1969 • More 800 personnes in R&D • About 20% of CA for R&D everyyear • Currently20 programs

  43. 3 Internationalknowledge 4 researchcenters: • Paris : medicinalchemistry and development • Boston : engineering of peptides and proteins • Londres : synthesis of steroid hormones • Barcelona : drug formulation

  44. 3 Partnershipagreements • Salkinstitute (USA) : « the Ipsen Life Sciences Program » for proliferative and degenerativediseases. • CEA (France) : for Alzheimer and Parkinson diseases. • ERINE (Netherland) : therapeutic concepts of endocrinology, diabetes and metabolismdisorders. • INSERM : breast, prostate tumors

  45. 3 Pipeline Theiridentity

  46. 3 Preclinical Oncology : • Angiomates : anticancer agent, anti-angiogenic • acquisition of Sterix • BIM 46187 : Cell signalisation, G-protein signal • for prostate and lung cancer • Cd25 inhibitors phosphatases : regulation of cell cycle • Licencied out to Debiopharm for world exclusive right

  47. 3 Preclinical Endocrinology : • MSH agonists for the MC4 receptor : • metabolicdisorderslikeobesity Growing markets • Ghrelinagonists (BIM28131) : regulation • of foodintake and gastro intestinal function • and treatment of cachexia • Inhibitor of 11βHSB : for metabolicdisorders • NutropinAp® : treatment of growthfailure, new formulation for prolonged release • Life cycle management

  48. 3 Phase 1 Oncology : • Elomotecan : cytotoxic agent, advancedmetastasic cancer. • Partnershipwith Roche in dec 2002, but Roche quits in may 2005.

  49. 3 Phase 2 Oncology : • Diflomotecan : topoisomeraseinhibitorless SE thanother • BN 83495 : breast cancer expressingoestrogenreceptors • partnershipwithBiomérieux for diagnosis Endocrinology : • IGF-1 and growth hormone : combinationtherapy for the treatment of idiopathic short stature. Combo • BIM 23A760 : somatostatine analog and dopamine agonist for acromegaly and neuroendocrine tumors • Betterwideactivitywithsynergy

  50. 3 Phase 3 Oncology : • Decapeptyl® : combined hormone therapy for premenopausalbreast cancer wirhAromasin® PfizerCombo • Toremifene® : GTX licence buyoutDevelopment of new indications Hematology : • OBI-1 : hemophiliaPigfact VIII

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