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20 mars 2009

20 mars 2009. A renewal story. Safe Harbor. This is an independent study performed by students from the Faculté des Sciences Pharmaceutiques de Lille The opinions expressed are our own and not necessarily those of Ipsen. Sales in comparison. A family business.

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20 mars 2009

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  1. 20 mars 2009 A renewal story

  2. SafeHarbor This is an independent study performed by students from the Faculté des Sciences Pharmaceutiques de Lille The opinions expressed are our own and not necessarily those of Ipsen

  3. Sales in comparison

  4. A family business • French independent laboratory • Owned by Beaufour family • More than 20 products marketed in more than 100 countries • Third Independent pharmaceutical firm in France • Historical presence in primary care

  5. Key figures: 2008 • €971M Sales • 4000 employees worldwide • €203M cash generated • 18.8% of sales allocated to R&D

  6. PROFILE • Primary care product: • Gastroenterology • Cardiovasular • Cognitive disorders • Specialized therapies : 3 areas • Oncology • Endocrinology • Neuromuscular disorders • CA 2008: 971,0 M€ (+5,5% vs 2007)

  7. AN INTERNATIONAL COMPANY

  8. Key figures

  9. BACKGROUND • 1929: Dr Henri Beaufour • « Beaufour laboratories » (Dreux) • Romarène® (1929) • Citrate de betaïne® (1954)

  10. BACKGROUND • 1970 : Expansion years • « Beaufour-IPSEN » : Institut des Produits de Synthèse et d’ExtractionNaturelle • WillmarSchwabe • Ginkor® (1972) • Tanakan® (1975) Gingko Biloba

  11. PRIMARY CARE GINKOR Fort® 1972 • Active substances Troxerutin A, heptaminol chlorhydrate, Ginkgo biloba extract • Indications: Cardiovascular • venous insufficiency of the lower limbs • acute haemorrhoid episodes

  12. PRIMARY CARE TANAKAN® 1975 • Active substance EGb 761® (Ginkgo biloba) • Indications : Cognitive disorders • Age-related cognitive disorders • pathophysiological deficiency • cochleovestibular disorders

  13. PRIMARY CARE SMECTA ® 1977 • Active substance : Diosmectite (natural clay) • Indications : Gastroenterology • Chronic and acuate diarrhoea • Pain associated with gastric and colonic disorders

  14. PRIMARY CARE FORLAX® 1996 • Active substance : Macrogol 4000, a linear polyethylene glycol polymer • Indications : Gastroenterology Treatment of constipation for both adults and children

  15. A WILL TO GO FURTHER PRIMARY CARE  TARGETED THERAPY

  16. GOING FURTHER • Albert Beaufour: biotechnology research • 1976 : Biomeasure Boston A. Beaufour research institute: Peptide-focused engineering • Research relations with American universities

  17. ONCOLOGY DECAPEPTYL® 1980 PartnershipwithDebiopharm® • Active substance: Triptorelin : decapeptide, analogue of the natural hormone : GnRH • Indications : • Prostate cancer • Uterin fibroids • Endometriosis • Early-onsetpuberty • Femaleinfertility

  18. NEUROMUSCULAR DISORDERS DYSPORT® 1994 IPSEN bought Speywood (UK) • Active substance: Botulinum neurotoxin type A complex ( acts at the level of the neuromuscular junction in the targeted muscle) • Indications: • Cervical dystonia • Cerebral palsy in children • Blepharospasm

  19. ENDOCRINOLOGY SOMATULINE® 1995 • Active substance: • Lanreotide (somatostatin analogue -> octapeptide) • Inhibits secretion and growth endocrine/paracrine/exocrine functions (growth hormone) • Indications: Acromegaly Neuroendocrine tumours

  20. 1996 - 2002 IS IPSEN RESTING ON ITS LAURELS ?

  21. R&D STRATEGY ? • Dr Pierre BRAQUET • R&D manager form 1982 – 1995 •  he participated to the discovery of the first antagonists of PAF from an extract of the Chinese tree Ginkgo biloba •  Directed research works related to somatulin •  Since 1985, his researches got nowhere • Atrial natriuretic factor • Endothelin • …

  22. A FAMILY AFFAIR • 1998 : Albert beaufour wants to stay independent. • Buys his brother’s participations (50%) • Alliance with CDC and Paribas AI • Albert Beaufour 75,5% • CDC and Paribas AI  24,5% • 2000 : Albert entrusts his son-in-law, Stephane François, with the direction of the group

  23. A FAMILY AFFAIR • February 2000 : Albert Beaufour died (76 years old) • His participation (75,5%) is shared among his 3 children • November 2001 : Family conflict • Stephane François is relieved from his duties

  24. A FAMILY AFFAIR • December 2001 • J.L. Belingard

  25. FromBeaufourIpsen to Ipsen • 2003: The Group haditsnamechangedfromBeaufourIpsen to Ipsen • RenewedExecutiveCommitee 2008 2007 2003 2001 2003 1997 2007

  26. A NEW TEAMA NEW STRATEGY

  27. A NEW STRATEGY Ipsen faces up to regulation Geographic expansion Optimize its primary care portfolio Focus on targeted therapeutic areas

  28. STRATEGY • HOW ? • Product life cycle management • Strong R&D • Partnershippolicy • Initial Public Offering

  29. PRODUCT LIFE CYCLE MANAGEMENT PRIMARY CARE

  30. PRODUCT LIFE CYCLE MANAGMENT Tanakan® • 12% of sales Many trials trying to proveefficacy HAS: insufficient SMR Price cut: -10% in july 2007 Threatened by disreimbursement Life cycle management • GuidAgestudy: • 8000 patients enrolled • Currentlyunderway • prevention Alzheimer disease

  31. PRODUCT LIFE CYCLE MANAGMENT Ginkor Fort® Price cut: -15% in february 2006 Successive reimbursement rate cuts in France: -31.8% -11.5% Marketing authorizations transferred to GTF (France, Monaco, Andorra) in august 2007

  32. Otherdevelopments • Adrovance®, from MSD • Osteoporosis • Comarketingalongwith MSD • Adenuric®, fromTeijin • Chronic hyperuricemia in gout • Ipsenobtained MA in Europe in may 2008 • Exforge®, from Novartis • ARA II + ICa2+ • BA058, fromIpsen • PTHrPanalog • Licensed to Radius and Teijin

  33. STRONG R&D

  34. R&D original model 2007: R&D division now organised around 2 entities: « Discovery and Innovation » « CorporateDevelopment » Bring a coherent portfolio of molecules to the market Bothinternalresearch and external business development In-licensing • Dedicated to discover new chemicalentities • Targeteddisease areas • Out-licensing

  35. R&D original model Discovery and innovation 4 R&D centres: • PARIS • Medicinalchemistry • BOSTON • Peptide engineering • Protein engineering: improve the therapeutic • BARCELONA: • Advancedrugdelivery • BATH: Steroid Engineering

  36. R&D original model Discovery and innovation • Collaboration withacademicresearch centres worldwide: • Erasmus UniversityMedical Center Rotterdam • ERINE endocrinologye, diabete and metabolism • Salk Institute • proliferative and degenerativediseases

  37. R&D original model Corporate Development • clinical development • pharmaceutical development • business development • regulatoryaffairs • LONDON, PARIS, BOSTON: CLINICAL DEVELOPMENT AND REGISTRATION • DREUX: PHARMACEUTICAL DEVELOPMENT • BARCELONA: PHARMACOKINETICS

  38. STRONG R&D Focus on targeted therapeutic areas

  39. Endocrinology Oncology Neuromusculardisorders Focus on targetedtherapeutic areas

  40. ENDOCRINOLOGY SOMATULINE AUTOGEL® • A major technologicaladvance: • first sustained-release formulation for injection withoutany excipient  6 months • 1 injection per month (vs 2 or 3) • Patent: • direct holder of the patent • expiration date: in 2015 in Europe and US (Somatuline® : 2005)

  41. ENDOCRINOLOGY SOMATULINE AUTOGEL® • Product’s Life cycle Managmentprogrammes: • phase III: coadministration with pegvisomantacromegaly in Europe • phase III: Asymptomatic neuroendocrinetumours in Europe • Phase II: in Japan, partnership with Teijinacromegaly • International expansion : • FDA approval in 2007 for the treatment of acromegaly (=Somatuline Depot) • Group’s competitor: • Sandostatin® LAR® Depot (octreotide) Novartis • painless and easy to use, gives it a competitive advantage

  42. ENDOCRINOLOGY SOMATULINE AUTOGEL®

  43. ONCOLOGY DECAPEPTYL® • Group’s competitors : • Takeda/Pfizer-Wyeth/Abbott • Enantone : worldwide leader, 6 months formulation expected in 2008 • Astellas • Eligard : 6 months formulation : 2007 in Germany, 2008 in France • Sandoz/Hexal • Leuprone (1 month) and Leupro (3 months) : 2007 in Germany

  44. ONCOLOGY DECAPEPTYL® • Life cycle management • 3 phase III studies (International Breast Cancer Study Group) • Combined hormonal therapy: breast cancer in premenopausal women  Decapeptyl®/ Aromasin® Pfizer • a 6 month sustained release formulation: filed in 2008 • Partnership with Debiopharm • licence of know-how and marketing

  45. STRONG R&D RESEARCH PROGRAMS

  46. Research programs ONCOLOGY Newapproaches in cancer treatmentunder hormonal control: • Anticancer agents Angiomates multitarget antiproliferative anti-angiogenicacquisition (February 2004) BIM 46187 Cell signalisation: G-Protein signal CDC25 Phosphatase inhibitors regulation of cell cycle

  47. Research programs ONCOLOGY • Post-menopausal breast cancer expressingestrogenicreceptors BN 83495 (STX 64) Phase I • Treatment of sideeffectsfromLHRH-abasedandrogen-deprivation Acapodene® Phase III (2008)

  48. Research programs ENDOCRINOLOGY • Ghrelinagonist Regulatingfoodintake and the gastro-intestinal function and treatingcachexia • 11ßHSD enzyme inhibitors Metabolic syndromes associatedwith obese patients withhyperinsulinemia • Sustained-release growth hormone Long-termtreatment of growthfailure in children and growth hormone deficiency in adults

  49. Developmentprograms ENDOCRINOLOGY • Pituitary and neuroendocrine tumours • Dopastatine : Second-generation somatostatin analogues and growth hormone antagonists • Phase I • Glycaemia control in diabetic patients • BIM 51077 / R1583 • Analogue of peptide hormone Glucagon Like Peptide-1Phase II • Sustained-release formulations Phase I (with Teijin) • October 2003: exclusive licence to the rights to develop and marketworldwide ( exceptJapan and France)

  50. Research programs HEMATOLOGY • OBI-1 • recombinant version of porcine factor VIII • congenital or acquiredhaemophiliaresistant to human factor VIII • phase II trials in USA EmoryUniversity and 17 July 2008 Ipsencompletespurchase of all of OBI-1 assetsfromOctagen Corporation

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