4. 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&D
Paul Burroughs, Communication
Director, Aeterna Zentaris Inc.
5. Cancerous cell
Black/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 storage
Shark 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. New entity
•Water-soluble extract
•Concentrated in biologically-relevant molecules
Effect of Æ-941 on embryonic neovascularization.
Chick embryo
Shark 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. New entity
•Water-soluble extract
•Concentrated in biologically-relevant molecules
Effect of Æ-941 on embryonic neovascularization.
Chick embryo
Shark 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.
8. Renal and non-small cell
Oncology Neovastat®
lung cancer development
Dermatology Psovascar®
Ophthalmology Neoretna® Discontinued
Rheumatology Arthrovas®
9. October 2002
Orphan drug status in renal cancer (FDA)
September 2003
Phase III study for metastatic renal cancer doesn’t achieve its goal
10. December 2003
Clinical development stopped in renal cancer
February 2006
Clinical development stopped in non-small cells lung cancer
Chemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase III
Trial, Charles Lu and Al, JNCI, 2010 102 (12)
11. 1990 2002
Aeterna
Laboratories
formation
Zentaris AG
acquisition
12. Degussa AG Asta-Medica GmbH
Zentaris AG
New opportunities
Marketing alliances and strategic partnerships:
•Serono
•Solvay
•Baxter
Aeterna acquires German biopharmaceutical Zentaris from Degussa, PR Newswire
13. 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
14. 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
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
15. Atrium Biotechnologies
Inc. acquires
Multichem Inc.
January
2005
Echelon Biosciences
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
16.
17. Atrium voting shares
distribution
Atrium Biotechnologies
Inc. acquired
Multichem Inc.
January 2006
2005 2007
Echelon Biosciences
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
18. 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 share
Aeterna Zentaris, Thomson Reuters Pharma ™company report
19. Atrium voting shares
distribution
Atrium Biotechnologies
Inc. acquired
Multichem Inc.
January 2006 November
2005 2007 2007
Echelon
Echelon Biosciences Biosciences sale
acquisition
20.
21. 80 Aeterna Zentaris Inc.
Canada
10
Aeterna Zentaris GmbH Aeterna Zentaris Inc.
Germany New Jersey, USA
Zentaris IVF GmbH
Germany
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010 10
22.
23. Therapeutic areas
Product
development Oncology Endocrinology
Colorectal cancer Adult Growth
Hormone Deficiency
Multiple Myeloma
Own product In vitro fertilization
Endometrial cancer
discovery unit
Ovarian cancer
Prostate cancer
Bladder cancer
25. Approval
EU: 1999
US: 2001
JP: 2006
Marketed
World: Merck Serono > 90
countries
JP: Shionogi
JP: Nippon Kayaku
www.aezsinc.com, Products in the market, Cetrotide®
26. Marketed
In Vitro fertilization
LHRH antagonist
Dose-dependent action
Pr Andrew Schally
Development
Benign Prostatic Hyperplasia
Endometriosis
Uterine myoma
www.aezsinc.com, Products in the market, Cetrotide®
30. 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 transferred
stimulation LH surge mature for fertilization (3 to 5 days after
cycle begin with sperm egg retrieval)
www.aezsinc.com
31. 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 2010
www.aezs.com Financial report 2010 and 2008
33. Oral anticancer
treatment
PI3K (phosphoinositide 3-
kinase) pathway
Alkylphosphocholine
Inhibition of Akt activation
Induction of apoptose
www.aezs.com ANNUAL INFORMATION FORM ON FORM 20-F 2010
35. 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 drug
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
36. Phase 3
Colon cancer
Perifosine Capecitabine
April 2010 FDA : Fast Track designation
July 2011 EPO : Patent for the association
Until July 28th, 2023
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
Press release July 12th, 2011
37. Phase 3
Colon cancer
Phase 2 : Time to Progression and Overall Survival
Investor Presentation, February 14th, 2012, www.aezsinc.com
38. Phase 2
Waldenstrom’s Macroglobulinemia
Renal cell carcinoma
Sarcoma
Gliomas
Leukaemia
Non-Small Cells Lung Cancer
+ Radiation therapy Phase 1
Neuroblastoma
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
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
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
40. 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 Perifosine
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
41. 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
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
42. 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 market
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
43. 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
2011
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
Aeterba Zentaris Press Release – November 23rd, 2011
44. 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-
basis
Aeterba Zentaris Press Release – November 23rd, 2011
49. 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-Effects
Investor Presentation, February 14th, 2012, www.aezsinc.com
50. Phase 2
Refractory Ovarian Cancer Positive efficacy and
safety data
Recurrent Endometrial Cancer
Phase 1
Refractory Prostate Cancer Positive efficacy and
safety data
Bladder Cancer
Investor Presentation, February 14th, 2012, www.aezsinc.com
51. Phase 2
Refractory Ovarian Cancer Positive efficacy and
safety data
Recurrent Endometrial Cancer
Phase 1
Refractory Prostate Cancer Positive efficacy and
safety data
Bladder Cancer
Investor Presentation, February 14th, 2012, www.aezsinc.com
