Aeterna Zentaris
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WAITING FOR SUCCESS...
Nicolas BernardPauline FlipoMélanie TilteFlorent Zoonekynd
2
WHEN?
33
1990
Aeterna Laboratories
formation
4
Commercial division: cosmetics and nutritional supplement
Aim: developing a medicine against cancer
AETERNA FORMATION
90/09/12: creation of Aeterna Laboratories by Eric and Luc Dupont
Commercial earnings reinvest in cancer R&D
Financial need: creation of Atrium Biotechnologies
Paul Burroughs, Communication Director, Aeterna Zentaris Inc.
5
SHARK CARTILAGE AND CANCERS
Cancerous cell
Anti-collagenase activities: MMP inhibitors
Fractions of cartilage: anti-angiogenesis power
•Adequate extraction of the anti-angiogenic molecules•Preservation of biological activities during extraction and storage
Problem: quality of the powder composition
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.
Black/Common Spiny Dog Fish
6
AE941
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.
Effect of Æ-941 on embryonic neovascularization.Chick embryo
•Water-soluble extract•Concentrated in biologically-relevant molecules
New entity
7
AE941
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.
Effect of Æ-941 on embryonic neovascularization.Chick embryo
•Water-soluble extract•Concentrated in biologically-relevant molecules
New entity
8
AE941
Oncology
Dermatology
Ophthalmology
Rheumatology
Neovastat®
Psovascar®
Neoretna®
Arthrovas®
Discontinued
Renal and non-small cell lung cancer development
9
AE941
Orphan drug status in renal cancer (FDA)
October 2002
Phase III study for metastatic renal cancer doesn’t achieve its goal
September 2003
10
AE941
Clinical development stopped in renal cancer
December 2003
Clinical development stopped in non-small cells lung cancer
February 2006
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)
1111
1990
Aeterna Laboratories
formation
2002
Zentaris AG acquisition
12
Marketing alliances and strategic partnerships: •Serono•Solvay•Baxter
ZENTARIS AG
Zentaris AG
Degussa AG Asta-Medica GmbH
New opportunities
Aeterna acquires German biopharmaceutical Zentaris from Degussa, PR Newswire
13
ZENTARIS AG
•Oncology:o6 products in clinical trials (phases I to III)o2 products in preclinical phase
New portfolio
•Endocrinology:o1 product approved and commercializedo1 product in clinical trialso2 products in preclinical phase
1414
1990
Aeterna Laboratories
formation
2002
Zentaris AG acquisition
March 2003
Aeterna GmbH & Zentaris AG
merger
May 2004
New name: Aeterna Zentaris Inc.
March 2004
Atrium Biotechnologies Inc. acquired Pure Encapsulations Inc.
Aeterna Zentaris, Thomson Reuters Pharma ™company report
15
January 2005
Atrium Biotechnologies Inc. acquires
Multichem Inc.
Echelon Biosciences acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
16
AEZS IN 2005...
17
THE END OF ATRIUM
20062007
Atrium voting shares distribution
January 2005
Atrium Biotechnologies Inc. acquired
Multichem Inc.
Echelon Biosciences acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
18
3,485 million voting shares $47 million (24% of $14,12 each share the company’s ownership)
SHARES DISTRIBUTION
October 2006: Beginning of Atrium shares distribution
Aeterna Zentaris, Thomson Reuters Pharma ™company report
Last 11 million sharesShareholders would receive 0.2079 of an Atrium share for each Aeterna share
January 2007: End of Atrium shares distribution
19
November 2007
Echelon Biosciences sale
20062007
Atrium voting shares distribution
January 2005
Atrium Biotechnologies Inc. acquired
Multichem Inc.
Echelon Biosciences acquisition
20
WHERE?
21
AEZS AROUND THE WORLD
Aeterna Zentaris Inc.Canada
Aeterna Zentaris GmbHGermany
Zentaris IVF GmbHGermany
Aeterna Zentaris Inc.New Jersey, USA
10
10
80
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
22
WHAT?
23
PRODUCTS
Product development
Therapeutic areas
Oncology
Own product discovery unit
Colorectal cancer
Multiple Myeloma
Endometrial cancer
Ovarian cancer
Prostate cancer
Bladder cancer
Endocrinology
Adult Growth Hormone Deficiency
In vitro fertilization
24
PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
25
World: Merck Serono
JP: Shionogi
JP: Nippon Kayaku
EU: 1999
US: 2001
JP: 2006
CETRORELIX - CETROTIDE®
Approval
Marketed
www.aezsinc.com, Products in the market, Cetrotide®
> 90 countries
26
CETRORELIX - CETROTIDE®
MarketedIn Vitro fertilization
LHRH antagonist
Pr Andrew Schally
Dose-dependent action
DevelopmentBenign Prostatic Hyperplasia
Endometriosis
Uterine myomawww.aezsinc.com, Products in the market, Cetrotide®
27
HORMONAL CYCLE
Hypothalamus
Hypophysis
LH-RH
LH & FSH
Ovarian
Estrogens
-
Follicular phase
14 days
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
28
HORMONAL CYCLE
Hypothalamus
Hypophysis
LH-RH
LH & FSH
Ovarian
Estrogens
+
Ovulation
Ovulation
14 days 14 days
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
29
+
DEFICIENT HORMONAL CYCLE
LH surge too soon
Hypothalamus
Hypophysis
LH-RH
LH & FSH
Ovarian
Estrogens
Follicular phase
-
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
-
30
CETROTIDE® IN THE TYPICAL OVARIAN STIMULATION CYCLE
Start of stimulation
cycle
Possibility of LH surge
begin
Eggs nearly mature
Eggs retrieved for fertilization
with sperm
Embryos transferred (3 to 5 days after
egg retrieval)
FSH or hMG (Gonal-F®)
Stimulates growth of eggs
Cetrotide®
Prevents early release of
eggshCG
Induces maturation of
eggs
www.aezsinc.com
312006 2007 2008 2009 2010
0
20,000
40,000
60,000
80,000R&D Sales
Thou
sand
s $ -56.2%
-54.7%
Association with Sanofi
CETROTIDE® IN BHP
March 2009
Study results: primary endpoints not matchedDecember, 7th 2009
End of the association Discontinuation of Cetrorelix in BHP December, 18th 2009
www.aezs.com Financial report 2010 and 2008
32
PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
33
PERIFOSINE
Oral anticancer treatment
PI3K (phosphoinositide 3-kinase) pathway
Inhibition of Akt activation
Alkylphosphocholine
Induction of apoptose
www.aezs.com ANNUAL INFORMATION FORM ON FORM 20-F 2010
34
THE PI3K PATHWAY
+ Perifosine
35
FDA : Orphan drug
PERIFOSINE
Multiple Myeloma
Perifosine Bortezomib Dexamethasone
Perifosine Lenalidomid Dexamethasone
Phase 3
September 2009
December 2009 FDA : Fast Track designation
March 2010 EMA : Orphan drug
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
36
PERIFOSINE
Colon cancer
Perifosine Capecitabine
Phase 3
April 2010 FDA : Fast Track designation
PATENT
E
D
July 2011 EPO : Patent for the association
Until July 28th, 2023
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010Press release July 12th, 2011
37
Phase 2 : Time to Progression and Overall Survival
PERIFOSINE
Colon cancerPhase 3
Investor Presentation, February 14th, 2012, www.aezsinc.com
38
PERIFOSINE
Waldenstrom’s Macroglobulinemia
Renal cell carcinoma
Phase 2
Sarcoma
Gliomas
Neuroblastoma
Phase 1
Leukaemia
Non-Small Cells Lung Cancer+ Radiation therapy
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
39
DEVELOPMENT PARTNERSHIP
NIH/NCI : Cooperative Research and Development AgreementMay 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
ACCESS ONCOLOGY, INC/KERYX
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
Scale-up royalties to be paid on future net sales of Perifosine
Clinical Development
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
41
DEVELOPMENT PARTNERSHIP
NIH/NCI : Cooperative Research and Development AgreementMay 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
Handok : Agreement to out-license the rights of Perifosine in South Korea
April 2009Yakult : development, manufacture and commercialization of
Perifosine in Japan
March 2011
42
YAKULT
Development, manufacture and commercialization of Perifosine in all human
uses, excluding leishmaniasis in Japan
Initial up-front payment of €6 million ($8.3 million)
Milestone payments : up to €44 million ($60.9 million)
Royalties on future net sales of Perifosine in the Japanese market
Development, Manufacture, Commercialization in Japan
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
43
DEVELOPMENT PARTNERSHIP
NIH/NCI : Cooperative Research and Development AgreementMay 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 2010Aeterba Zentaris Press Release – November 23rd, 2011
Handok : Agreement to out-license the rights of Perifosine in South Korea
April 2009Yakult : development, manufacture and commercialization of
Perifosine in Japan
March 2011
November 2011
Hikma pharmaceuticals : Commercialization and license agreement for the MENA region
44
HIKMA
Commercialization and license agreement for the MENA (Middle East and North Africa)
region
Initial up-front payment
Milestone payments : up to $2 million
Supply perifosine to Hikma Pharmaceuticals on a cost-plus-
basis
Registration and marketing of perifosine
Aeterba Zentaris Press Release – November 23rd, 2011
Leading drug company in the MENA region
Royalties on future net sales of perifosine in the MENA region
45
POTENTIAL MARKET VOLUME
Investor Presentation, February 14th, 2012, www.aezsinc.com
46
PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
47
AEZS-108
Investor Presentation, February 14th, 2012, www.aezsinc.com
48
AEZS-108
Investor Presentation, February 14th, 2012, www.aezsinc.com
49
AEZS-108
Reproductive Tissue
Hypophysis
Cancer Tissue(e.g. breast, endometrial, ovarian,
prostate and bladder cancer)LHRH receptor
AEZS-108
↑ Efficacy ↓ Side-Effects
Consequence for the cytotoxic agent :
Healthy Tissue
Investor Presentation, February 14th, 2012, www.aezsinc.com
50
AEZS-108
Refractory Ovarian Cancer
Phase 2
Recurrent Endometrial Cancer
Positive efficacy and safety data
Phase 1
Refractory Prostate Cancer
Bladder Cancer
JANUARY 5, 2012 : COLLABORATION WITH VENTANA
MEDICAL
Positive efficacy and safety data
Investor Presentation, February 14th, 2012, www.aezsinc.com
51
PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
52
AEZS-112
Phase 1
Topoisomerase II inhibition Tubulin polymerisation inhibition
Two Mecanisms of action
Advanced solid tumors
Colon/rectum
Pancreas
Lung Trachea
Prostate Thyroide
No clinically relevant drug-related adverse events www.aezsinc.com
53
PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
54
MACIMORELIN SOLOREL®
Diagnostic test for Adult Growth
Hormone Deficiencies
Low energy levels
Decreased strength and exercise tolerance
Increased weight or difficulty losing weight
Emotional changes
AnxietyImpaired sleep
www.aezsinc.com
55
MACIMORELIN SOLOREL®
Ghrelin agonist
Diagnostic test for Adult Growth
Hormone Deficiencies
Phase 3
www.aezs.com
56
MACIMORELIN SOLOREL®
Hypothalamus
Hypophysis
GH-RH
GH
Ghrelin agonist
www.aezs.com
57
MACIMORELIN SOLOREL®
Secretion of growth hormone (GH)
No secretion of growth hormone (GH)
No growth hormonedeficiencies
Growth hormonedeficiencies
Ghrelin agonist
Diagnostic test for Adult Growth
Hormone Deficiencies
Phase 3
www.aezsinc.com
58
AEZS-130
Tumor induced cachexia and others
Ghrelin agonist
Phase 1
www.aezsinc.com
59
AEZS-130
Hypothalamus
Hypophysis
Metabolic activationTissue growth
MusclesBones
GH-RH
GH
IGF I/II
Liver
Ghrelin agonist
www.aezsinc.com
60
AEZS-130
Tumor induced cachexia and others
Ghrelin agonist
↓ loss of weight ↓ muscle atrophy ↓ fatigue ↓ weakness ↓ loss of appetite
Phase 1
www.azesinc.com
61
AND WHAT ABOUT THE MONEY?
62
THE « AFTER ATRIUM »
http://www.nasdaq.com/symbol/aezs/interactive-chart
Sanofi partnership
Studies good results announcement
2006 2007 2008 2009 201050000000550000006000000065000000700000007500000080000000
Number of shares
Mill
ion
63
FINANCIAL DIFFICULTIES
2006 2007 2008 2009 2010
-60,000
-40,000
-20,000
0
20,000
40,000
Net operating incomes
Thou
sand
s $
2007 2008 2009 20100
10000
20000
30000
40000
50000
60000
70000
12517
6469757768
50648
Long-term liabilities
Audited Annual Financial Statements 2010 and 2008
64
THE FUTURE (S)…
65
NOVARTIS
Exjade®
Femara®
Gleevec®
Tasigna®
Afinitor®
Zometa®Sales 10 b$
www.novartis.com
67
ROCHE
Sales by therapeutic areaOncology leader
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
Phase III and registration
Roche in Brief 2011 by Roche
68
ROCHE
Sales by therapeutic areaOncology leader
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
Phase III and registration
Roche in Brief 2011 by Roche
69
ROCHE
Avastin®
Herceptin®
Tarceva®
Rituxan®
Protropin®
Nutropin®
Oncology leader
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
www.gene.com
70
Aezs-108 (diagnosis companion test)
ROCHE
Protropin®
Nutropin®
www.aezsinc.com Press Release January, 5th 2012
71
O
W
T
DebtsFinancial dependence1 product marketedDependent on third partiesFailure in Phase 3 or SAE : detrimentalLow-value shares : tender offer?Purchase? Bankrupt?
2 products in phase 3Oncology : growing
marketCompanion test
Fast Track processes2 NDA for 2012
Orphan Drugs
Focused R&DPromising pipeline
Focused on 2 areasMultiple indications
Cetrotide® sales better than expected
S
72
THANKS FOR YOUR ATTENTION
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