Aeterna Zentaris
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Transcript of Aeterna Zentaris
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WAITING FOR SUCCESS...
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WHEN?
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33
1990
Aeterna Laboratories
formation
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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.
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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
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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
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AE941
Oncology
Dermatology
Ophthalmology
Rheumatology
Neovastat®
Psovascar®
Neoretna®
Arthrovas®
Discontinued
Renal and non-small cell lung cancer development
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AE941
Orphan drug status in renal cancer (FDA)
October 2002
Phase III study for metastatic renal cancer doesn’t achieve its goal
September 2003
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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)
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1010
1990
Aeterna Laboratories
formation
2002
Zentaris AG acquisition
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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
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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
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1313
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
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January 2005
Atrium Biotechnologies Inc. acquires
Multichem Inc.
Echelon Biosciences acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
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AEZS IN 2005...
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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
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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
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November 2007
Echelon Biosciences sale
20062007
Atrium voting shares distribution
January 2005
Atrium Biotechnologies Inc. acquired
Multichem Inc.
Echelon Biosciences acquisition
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WHERE?
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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
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WHAT?
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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
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PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
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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
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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®
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HORMONAL CYCLE
Hypothalamus
Hypophysis
LH-RH
LH & FSH
Ovarian
Estrogens
-
Follicular phase
14 days
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
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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
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+
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
-
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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
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302006 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
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PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
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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
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THE PI3K PATHWAY
+ Perifosine
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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
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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
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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
Investor Presentation, February 14th, 2012, www.aezsinc.com
Phase 2 : Time to Progression and Overall Survival
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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
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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
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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
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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
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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
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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
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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
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POTENTIAL MARKET VOLUME
Investor Presentation, February 14th, 2012, www.aezsinc.com
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PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
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AEZS-108
Investor Presentation, February 14th, 2012, www.aezsinc.com
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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
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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
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PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
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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
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PIPELINE
Investor Presentation, February 14th, 2012, www.aezsinc.com
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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
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MACIMORELIN SOLOREL®
Ghrelin agonist
Diagnostic test for Adult Growth
Hormone Deficiencies
Phase 3
www.aezs.com
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MACIMORELIN SOLOREL®
Hypothalamus
Hypophysis
GH-RH
GH
Ghrelin agonist
www.aezs.com
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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
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AEZS-130
Tumor induced cachexia and others
Ghrelin agonist
Phase 1
www.aezsinc.com
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AEZS-130
Hypothalamus
Hypophysis
Metabolic activationTissue growth
MusclesBones
GH-RH
GH
IGF I/II
Liver
Ghrelin agonist
www.aezsinc.com
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AEZS-130
Tumor induced cachexia and others
Ghrelin agonist
↓ loss of weight ↓ muscle atrophy ↓ fatigue ↓ weakness ↓ loss of appetite
Phase 1
www.azesinc.com
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AND WHAT ABOUT THE MONEY?
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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
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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
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THE FUTURE (S)…
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NOVARTIS
Exjade®
Femara®
Gleevec®
Tasigna®
Afinitor®
Zometa®Sales 10 b$
www.novartis.com
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ROCHE
Sales by therapeutic areaOncology leader
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
Phase III and registration
Roche in Brief 2011 by Roche
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ROCHE
Avastin®
Herceptin®
Tarceva®
Rituxan®
Protropin®
Nutropin®
Oncology leader
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
www.gene.com
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Aezs-108 (diagnosis companion test)
Oncology leader
ROCHE
Protropin®
Nutropin®
MabThera®
Xeloda®
Avastin®
Tarceva®
Herceptin®
www.aezsinc.com Press Release January, 5th 2012
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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
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THANKS FOR YOUR ATTENTION