Nicolas BernardPauline FlipoMélanie TilteFlorent Zoonekynd
1990  AeternaLaboratories formation
90/09/12: creation of Aeterna Laboratories by Eric and Luc Dupont     Aim: developing a medicine against cancer           ...
Cancerous cellBlack/Common Spiny Dog Fish                         Fractions of cartilage: anti-angiogenesis power     Anti...
New entity     •Water-soluble extract     •Concentrated in biologically-relevant molecules           Effect of Æ-941 on em...
New entity     •Water-soluble extract     •Concentrated in biologically-relevant molecules           Effect of Æ-941 on em...
Renal and non-small cell  Oncology      Neovastat®                             lung cancer development Dermatology    Psov...
October 2002Orphan drug status in renal cancer (FDA)                         September 2003Phase III study for metastatic ...
December 2003     Clinical development stopped in renal cancer                                                       Febru...
1990          2002  AeternaLaboratories formation               Zentaris AG               acquisition
Degussa AG                                          Asta-Medica GmbH                                                      ...
New portfolio•Oncology:   o6 products in clinical trials (phases I to III)   o2 products in preclinical phase•Endocrinolog...
Atrium Biotechnologies                                                              Inc. acquired Pure                    ...
Atrium Biotechnologies     Inc. acquires    Multichem Inc.              January                2005 Echelon Biosciences   ...
Atrium voting shares                                   distributionAtrium Biotechnologies     Inc. acquired    Multichem I...
October 2006: Beginning of Atrium shares distribution    3,485 million voting shares                            $47 millio...
Atrium voting shares                       distributionAtrium Biotechnologies     Inc. acquired    Multichem Inc.        J...
80          Aeterna Zentaris Inc.                                                Canada                                   ...
Therapeutic areas  Productdevelopment         Oncology          Endocrinology                 Colorectal cancer       Adul...
Investor Presentation, February 14th, 2012, www.aezsinc.com
Approval                          EU: 1999                          US: 2001                          JP: 2006            ...
Marketed        In Vitro fertilization             LHRH antagonist      Dose-dependent action            Pr Andrew Schally...
Hypothalamus          14 days                                             LH-RH                                           ...
Hypothalamus          14 days                                   14 days           LH-RH                                   ...
Hypothalamus                                                    -         LH-RH                                           ...
FSH or hMG (Gonal-F®)              Stimulates growth of eggs                              Cetrotide®                      ...
March 2009                                         Association with Sanofi                                                ...
Investor Presentation, February 14th, 2012, www.aezsinc.com
Oral anticancer          treatment  PI3K (phosphoinositide 3-       kinase) pathway                                       ...
+ Perifosine
Phase 3       Multiple Myeloma             Perifosine                             Bortezomib   Dexamethasone             P...
Phase 3             Colon cancer             Perifosine                            Capecitabine           April 2010      ...
Phase 3               Colon cancer                      Phase 2 : Time to Progression and Overall SurvivalInvestor Present...
Phase 2       Waldenstrom’s Macroglobulinemia                     Renal cell carcinoma                                Sarc...
NIH/NCI : Cooperative Research and Development Agreement    May 2000                           Access Oncology, Inc./Keryx...
Cooperation and license agreement for the          United States, Canada and Mexico      Free access to all data from Kery...
NIH/NCI : Cooperative Research and Development Agreement    May 2000                           Access Oncology, Inc./Keryx...
Development, manufacture and      commercialization of Perifosine in all human         uses, excluding leishmaniasis in Ja...
NIH/NCI : Cooperative Research and Development Agreement    May 2000                           Access Oncology, Inc./Keryx...
Commercialization and license agreement for         the MENA (Middle East and North Africa)                         region...
Investor Presentation, February 14th, 2012, www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
Cancer Tissue             LHRH receptor                                    (e.g. breast, endometrial, ovarian,            ...
Phase 2             Refractory Ovarian Cancer                        Positive efficacy and                                ...
Phase 2             Refractory Ovarian Cancer                        Positive efficacy and                                ...
Investor Presentation, February 14th, 2012, www.aezsinc.com
Phase 1                          Two Mecanisms of action                                                    Tubulin polyme...
Investor Presentation, February 14th, 2012, www.aezsinc.com
Diagnostic test for                                 Adult Growth                              Hormone Deficiencies        ...
Phase 3                Diagnostic test for                  Adult Growth               Hormone Deficiencies               ...
Hypothalamus                                     GH-RH               Ghrelin agonist                                  Hypo...
Phase 3                           Diagnostic test for                             Adult Growth                          Ho...
Phase 1                    Tumor induced                  cachexia and others                     Ghrelin agonistwww.aezsi...
Hypothalamus                                         GH-RH                  Ghrelin agonist                               ...
Phase 1                    Tumor induced                  cachexia and others                     Ghrelin agonist         ...
Number of shares                                                                80                                        ...
Net operating incomes               40,000               20,000 Thousands $                    0                         2...
Gleevec®                   Zometa®                   Femara®                   Afinitor®                   Exjade®        ...
Pipeline in 2011www.novartis.com Annual Report 2011
Oncology leader        Sales by therapeutic area                               Phase III and registration                 ...
Oncology leader               MabThera®                            Protropin®                             Avastin®        ...
Aezs-108 (diagnosis                                                  Protropin®           companion test)                 ...
Focused R&D    Promising pipeline    Debts   Focused on 2 areas     Financial dependence   Multiple indications   1 produc...
AEterna Zentaris
AEterna Zentaris
AEterna Zentaris
AEterna Zentaris
AEterna Zentaris
AEterna Zentaris
AEterna Zentaris
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AEterna Zentaris

  1. 1. Nicolas BernardPauline FlipoMélanie TilteFlorent Zoonekynd
  2. 2. 1990 AeternaLaboratories formation
  3. 3. 90/09/12: creation of Aeterna Laboratories by Eric and Luc Dupont Aim: developing a medicine against cancer Financial need: creation of Atrium Biotechnologies Commercial division: cosmetics and nutritional supplement Commercial earnings reinvest in cancer R&DPaul Burroughs, CommunicationDirector, Aeterna Zentaris Inc.
  4. 4. Cancerous cellBlack/Common Spiny Dog Fish Fractions of cartilage: anti-angiogenesis power Anti-collagenase activities: MMP inhibitors Problem: quality of the powder composition •Adequate extraction of the anti-angiogenic molecules •Preservation of biological activities during extraction and storageShark cartilage extracts as anti-angiogenic agents: smart drinks or bitter pills? D. Gingras, A. Renaud, N.Mousseau, R. B´eliveau, Cancer and Metastasis Reviews 19: 83–86, 2000.
  5. 5. New entity •Water-soluble extract •Concentrated in biologically-relevant molecules Effect of Æ-941 on embryonic neovascularization. Chick embryoShark cartilage extracts as anti-angiogenic agents: smart drinks or bitter pills? D. Gingras, A. Renaud, N.Mousseau, R. B´eliveau, Cancer and Metastasis Reviews 19: 83–86, 2000.
  6. 6. New entity •Water-soluble extract •Concentrated in biologically-relevant molecules Effect of Æ-941 on embryonic neovascularization. Chick embryoShark cartilage extracts as anti-angiogenic agents: smart drinks or bitter pills? D. Gingras, A. Renaud, N.Mousseau, R. B´eliveau, Cancer and Metastasis Reviews 19: 83–86, 2000.
  7. 7. Renal and non-small cell Oncology Neovastat® lung cancer development Dermatology Psovascar®Ophthalmology Neoretna® DiscontinuedRheumatology Arthrovas®
  8. 8. October 2002Orphan drug status in renal cancer (FDA) September 2003Phase III study for metastatic renal cancer doesn’t achieve its goal
  9. 9. December 2003 Clinical development stopped in renal cancer February 2006 Clinical development stopped in non-small cells lung cancerChemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase IIITrial, Charles Lu and Al, JNCI, 2010 102 (12)
  10. 10. 1990 2002 AeternaLaboratories formation Zentaris AG acquisition
  11. 11. Degussa AG Asta-Medica GmbH Zentaris AG New opportunities Marketing alliances and strategic partnerships: •Serono •Solvay •BaxterAeterna acquires German biopharmaceutical Zentaris from Degussa, PR Newswire
  12. 12. New portfolio•Oncology: o6 products in clinical trials (phases I to III) o2 products in preclinical phase•Endocrinology: o1 product approved and commercialized o1 product in clinical trials o2 products in preclinical phase
  13. 13. Atrium Biotechnologies Inc. acquired Pure Encapsulations Inc. March March May 1990 2002 2003 2004 2004 Aeterna GmbH & Aeterna Zentaris AG New name: Laboratories merger Aeterna Zentaris Inc. formation Zentaris AG acquisitionAeterna Zentaris, Thomson Reuters Pharma ™company report
  14. 14. Atrium Biotechnologies Inc. acquires Multichem Inc. January 2005 Echelon Biosciences acquisitionAeterna Zentaris, Thomson Reuters Pharma ™company report
  15. 15. Atrium voting shares distributionAtrium Biotechnologies Inc. acquired Multichem Inc. January 2006 2005 2007 Echelon Biosciences acquisitionAeterna Zentaris, Thomson Reuters Pharma ™company report
  16. 16. October 2006: Beginning of Atrium shares distribution 3,485 million voting shares $47 million (24% of $14,12 each share the company’s ownership) January 2007: End of Atrium shares distribution Last 11 million shares Shareholders would receive 0.2079 of an Atrium share for each Aeterna shareAeterna Zentaris, Thomson Reuters Pharma ™company report
  17. 17. Atrium voting shares distributionAtrium Biotechnologies Inc. acquired Multichem Inc. January 2006 November 2005 2007 2007 EchelonEchelon Biosciences Biosciences sale acquisition
  18. 18. 80 Aeterna Zentaris Inc. Canada 10 Aeterna Zentaris GmbH Aeterna Zentaris Inc. Germany New Jersey, USA Zentaris IVF GmbH GermanyAeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010 10
  19. 19. Therapeutic areas Productdevelopment Oncology Endocrinology Colorectal cancer Adult Growth Hormone Deficiency Multiple MyelomaOwn product In vitro fertilization Endometrial cancerdiscovery unit Ovarian cancer Prostate cancer Bladder cancer
  20. 20. Investor Presentation, February 14th, 2012, www.aezsinc.com
  21. 21. Approval EU: 1999 US: 2001 JP: 2006 Marketed World: Merck Serono > 90 countries JP: Shionogi JP: Nippon Kayakuwww.aezsinc.com, Products in the market, Cetrotide®
  22. 22. Marketed In Vitro fertilization LHRH antagonist Dose-dependent action Pr Andrew Schally Development Benign Prostatic Hyperplasia Endometriosis Uterine myomawww.aezsinc.com, Products in the market, Cetrotide®
  23. 23. Hypothalamus 14 days LH-RH Hypophysis LH & FSH Ovarian - Estrogens Follicular phasehttp://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
  24. 24. Hypothalamus 14 days 14 days LH-RH Hypophysis LH & FSH Ovarian + Estrogens Ovulation Ovulationhttp://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
  25. 25. Hypothalamus - LH-RH Hypophysis LH & FSH Ovarian + - Estrogens LH surge too soon Follicular phasehttp://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
  26. 26. FSH or hMG (Gonal-F®) Stimulates growth of eggs Cetrotide® Prevents early release of hCG eggs Induces maturation of eggs Start of Possibility of Eggs nearly Eggs retrieved Embryos transferredstimulation LH surge mature for fertilization (3 to 5 days after cycle begin with sperm egg retrieval)www.aezsinc.com
  27. 27. March 2009 Association with Sanofi Study results: primary endpoints not December, 7th 2009 matched End of the association December, 18th 2009 Discontinuation of Cetrorelix in BHP 80,000 R&D Sales 60,000 -56.2% Thousands $ 40,000 -54.7% 20,000 0 2006 2007 2008 2009 2010www.aezs.com Financial report 2010 and 2008
  28. 28. Investor Presentation, February 14th, 2012, www.aezsinc.com
  29. 29. Oral anticancer treatment PI3K (phosphoinositide 3- kinase) pathway Alkylphosphocholine Inhibition of Akt activation Induction of apoptosewww.aezs.com ANNUAL INFORMATION FORM ON FORM 20-F 2010
  30. 30. + Perifosine
  31. 31. Phase 3 Multiple Myeloma Perifosine Bortezomib Dexamethasone Perifosine Lenalidomid Dexamethasone September 2009 FDA : Orphan drug December 2009 FDA : Fast Track designation March 2010 EMA : Orphan drugAeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  32. 32. Phase 3 Colon cancer Perifosine Capecitabine April 2010 FDA : Fast Track designation July 2011 EPO : Patent for the association Until July 28th, 2023Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010Press release July 12th, 2011
  33. 33. Phase 3 Colon cancer Phase 2 : Time to Progression and Overall SurvivalInvestor Presentation, February 14th, 2012, www.aezsinc.com
  34. 34. Phase 2 Waldenstrom’s Macroglobulinemia Renal cell carcinoma Sarcoma Gliomas Leukaemia Non-Small Cells Lung Cancer + Radiation therapy Phase 1 NeuroblastomaAeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  35. 35. NIH/NCI : Cooperative Research and Development Agreement May 2000 Access Oncology, Inc./Keryx : Cooperation and license agreement for the United States, Canada and Mexico September 2002Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  36. 36. Cooperation and license agreement for the United States, Canada and Mexico Free access to all data from Keryx and its partner’s studies Milestone payments Clinical Development Scale-up royalties to be paid on future net sales of PerifosineAeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  37. 37. NIH/NCI : Cooperative Research and Development Agreement May 2000 Access Oncology, Inc./Keryx : Cooperation and license agreement for the United States, Canada and Mexico September 2002 Handok : Agreement to out-license the rights of Perifosine in South Korea April 2009 Yakult : development, manufacture and commercialization of Perifosine in Japan March 2011Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  38. 38. Development, manufacture and commercialization of Perifosine in all human uses, excluding leishmaniasis in Japan Initial up-front payment of €6 million ($8.3 million) Development, Manufacture, Com Milestone payments : up to €44 mercialization in Japan million ($60.9 million) Royalties on future net sales of Perifosine in the Japanese marketAeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
  39. 39. NIH/NCI : Cooperative Research and Development Agreement May 2000 Access Oncology, Inc./Keryx : Cooperation and license agreement for the United States, Canada and Mexico September 2002 Handok : Agreement to out-license the rights of Perifosine in South Korea April 2009 Yakult : development, manufacture and commercialization of Perifosine in Japan March 2011 Hikma pharmaceuticals : Commercialization and license agreement for the MENA region November 2011Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010Aeterba Zentaris Press Release – November 23rd, 2011
  40. 40. Commercialization and license agreement for the MENA (Middle East and North Africa) region Initial up-front payment Leading drug company in the MENA region Milestone payments : up to $2 million Registration and marketing of perifosine Royalties on future net sales of perifosine in the MENA region Supply perifosine to Hikma Pharmaceuticals on a cost-plus- basisAeterba Zentaris Press Release – November 23rd, 2011
  41. 41. Investor Presentation, February 14th, 2012, www.aezsinc.com
  42. 42. Investor Presentation, February 14th, 2012, www.aezsinc.com
  43. 43. Investor Presentation, February 14th, 2012, www.aezsinc.com
  44. 44. Investor Presentation, February 14th, 2012, www.aezsinc.com
  45. 45. Cancer Tissue LHRH receptor (e.g. breast, endometrial, ovarian, prostate and bladder cancer) Reproductive Tissue Hypophysis Healthy Tissue AEZS-108 Consequence for the cytotoxic agent : ↑ Efficacy ↓ Side-EffectsInvestor Presentation, February 14th, 2012, www.aezsinc.com
  46. 46. Phase 2 Refractory Ovarian Cancer Positive efficacy and safety data Recurrent Endometrial Cancer Phase 1 Refractory Prostate Cancer Positive efficacy and safety data Bladder CancerInvestor Presentation, February 14th, 2012, www.aezsinc.com
  47. 47. Phase 2 Refractory Ovarian Cancer Positive efficacy and safety data Recurrent Endometrial Cancer Phase 1 Refractory Prostate Cancer Positive efficacy and safety data Bladder CancerInvestor Presentation, February 14th, 2012, www.aezsinc.com
  48. 48. Investor Presentation, February 14th, 2012, www.aezsinc.com
  49. 49. Phase 1 Two Mecanisms of action Tubulin polymerisation Topoisomerase II inhibition inhibition Advanced solid tumors Colon/rectum Lung Trachea Pancreas Prostate Thyroide No clinically relevant drug-related adverse eventswww.aezsinc.com
  50. 50. Investor Presentation, February 14th, 2012, www.aezsinc.com
  51. 51. Diagnostic test for Adult Growth Hormone Deficiencies Low energy levels Emotional changes Impaired sleep Anxiety Decreased strength and Increased weight or exercise tolerance difficulty losing weightwww.aezsinc.com
  52. 52. Phase 3 Diagnostic test for Adult Growth Hormone Deficiencies Ghrelin agonistwww.aezs.com
  53. 53. Hypothalamus GH-RH Ghrelin agonist Hypophysis GHwww.aezs.com
  54. 54. Phase 3 Diagnostic test for Adult Growth Hormone Deficiencies Ghrelin agonist Secretion of growth No secretion of growth hormone (GH) hormone (GH) No growth hormone Growth hormone deficiencies deficiencieswww.aezsinc.com
  55. 55. Phase 1 Tumor induced cachexia and others Ghrelin agonistwww.aezsinc.com
  56. 56. Hypothalamus GH-RH Ghrelin agonist Hypophysis GH Liver IGF I/II Metabolic activation Tissue growth Muscleswww.aezsinc.com Bones
  57. 57. Phase 1 Tumor induced cachexia and others Ghrelin agonist ↓ loss of weight ↓ muscle atrophy ↓ fatigue ↓ weakness ↓ loss of appetitewww.azesinc.com
  58. 58. Number of shares 80 75 70 Million 65 60 55 50 2006 2007 2008 2009 2010 Sanofi partnership Studies good results announcementhttp://www.nasdaq.com/symbol/aezs/interactive-chart
  59. 59. Net operating incomes 40,000 20,000 Thousands $ 0 2006 2007 2008 2009 2010 -20,000 -40,000 Long-term liabilities -60,000 64697 70000 57768 60000 50648 50000 40000 30000 20000 12517 10000 0 2007 2008 2009 2010Audited Annual Financial Statements 2010 and 2008
  60. 60. Gleevec® Zometa® Femara® Afinitor® Exjade® Tasigna®www.novartis.com
  61. 61. Pipeline in 2011www.novartis.com Annual Report 2011
  62. 62. Oncology leader Sales by therapeutic area Phase III and registration MabThera® Avastin® Herceptin® Xeloda® Tarceva®Roche in Brief 2011 by Roche
  63. 63. Oncology leader MabThera® Protropin® Avastin® Avastin® Herceptin® Nutropin® Herceptin® Tarceva® Xeloda® Rituxan® Tarceva®www.gene.com
  64. 64. Aezs-108 (diagnosis Protropin® companion test) Nutropin®www.aezsinc.com Press Release January, 5th 2012
  65. 65. Focused R&D Promising pipeline Debts Focused on 2 areas Financial dependence Multiple indications 1 product marketedCetrotide® sales better Dependent on third than expected parties 2 products in phase 3 Failure in Phase 3 or Oncology : growing SAE : detrimental market Low-value shares : Companion test tender offer? Fast Track processes Purchase? 2 NDA for 2012 Bankrupt? Orphan Drugs

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