Transcript Diapositive 1 - Moodle Lille 2

Nicolas Bernard
Pauline Flipo
Mélanie Tilte
Florent Zoonekynd
1990
Aeterna
Laboratories
formation
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
Paul Burroughs, Communication
Director, Aeterna Zentaris Inc.
Commercial earnings reinvest
in cancer R&D
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.
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.
Oncology
Neovastat®
Dermatology
Psovascar®
Ophthalmology
Neoretna®
Rheumatology
Arthrovas®
Renal and non-small cell
lung cancer development
Discontinued
October 2002
Orphan drug status in renal cancer (FDA)
September 2003
Phase III study for metastatic renal cancer doesn’t achieve its goal
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)
1990
2002
Aeterna
Laboratories
formation
Zentaris AG
acquisition
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
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
Atrium Biotechnologies
Inc. acquired Pure
Encapsulations Inc.
1990
Aeterna
Laboratories
formation
March
2003
2002
Aeterna GmbH &
Zentaris AG
merger
Zentaris AG
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
March
2004
May
2004
New name:
Aeterna Zentaris Inc.
Atrium Biotechnologies
Inc. acquires
Multichem Inc.
January
2005
Echelon Biosciences
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
Atrium voting shares
distribution
Atrium Biotechnologies
Inc. acquired
Multichem Inc.
January
2005
2006
2007
Echelon Biosciences
acquisition
Aeterna Zentaris, Thomson Reuters Pharma ™company report
October 2006: Beginning of Atrium shares distribution
3,485 million voting shares
$14,12 each share
$47 million (24% of
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
Atrium voting shares
distribution
Atrium Biotechnologies
Inc. acquired
Multichem Inc.
January
2005
Echelon Biosciences
acquisition
2006
2007
November
2007
Echelon
Biosciences sale
80
Aeterna Zentaris Inc.
Canada
10
Aeterna Zentaris GmbH
Germany
Aeterna Zentaris Inc.
New Jersey, USA
Zentaris IVF GmbH
Germany
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
10
Product
development
Own product
discovery unit
Therapeutic areas
Oncology
Endocrinology
Colorectal cancer
Adult Growth
Hormone Deficiency
Multiple Myeloma
Endometrial cancer
Ovarian cancer
Prostate cancer
Bladder cancer
In vitro fertilization
Investor Presentation, February 14th, 2012, www.aezsinc.com
Approval
EU: 1999
US: 2001
JP: 2006
Marketed
World: Merck Serono
JP: Shionogi
JP: Nippon Kayaku
www.aezsinc.com, Products in the market, Cetrotide®
> 90
countries
In Vitro fertilization
Marketed
LHRH antagonist
Dose-dependent action
Pr Andrew Schally
Benign Prostatic Hyperplasia
Endometriosis
Uterine myoma
www.aezsinc.com, Products in the market, Cetrotide®
Development
Hypothalamus
14 days
LH-RH
Hypophysis
LH & FSH
-
Ovarian
Estrogens
Follicular phase
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
Hypothalamus
14 days
14 days
LH-RH
Hypophysis
LH & FSH
+
Ovulation
Ovarian
Estrogens
Ovulation
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
-
Hypothalamus
LH-RH
Hypophysis
LH & FSH
Ovarian
+LH surge too soon
http://fr.wikipedia.org/wiki/Am%C3%A9norrh%C3%A9e
Estrogens
Follicular phase
FSH or hMG (Gonal-F®)
Stimulates growth of eggs
Cetrotide®
Prevents early
release of
eggs
hCG
Induces
maturation of
eggs
Start of
stimulation
cycle
www.aezsinc.com
Possibility of
LH surge
begin
Eggs nearly
mature
Eggs retrieved
for fertilization
with sperm
Embryos transferred
(3 to 5 days after
egg retrieval)
March 2009
Association with Sanofi
2009
Study results: primary endpoints not
matched
December, 18th 2009
End of the association
Discontinuation of Cetrorelix in BHP
December,
7th
80,000
R&D
Sales
Thousands $
60,000
-56.2%
40,000
-54.7%
20,000
0
2006
www.aezs.com Financial report 2010 and 2008
2007
2008
2009
2010
Investor Presentation, February 14th, 2012, www.aezsinc.com
Oral anticancer
treatment
PI3K (phosphoinositide 3kinase) pathway
Alkylphosphocholine
Inhibition of Akt activation
Induction of apoptose
www.aezs.com ANNUAL INFORMATION FORM ON FORM 20-F 2010
+ Perifosine
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
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
Phase 3
Colon cancer
Phase 2 : Time to Progression and Overall Survival
Perifosine
Capecitabine
April 2010
FDA : Fast Track designation
July 2011
EPO : Patent for the association
Until July 28th, 2023
Investor Presentation, February 14th, 2012, www.aezsinc.com
Waldenstrom’s Macroglobulinemia
Phase 2
Renal cell carcinoma
Sarcoma
Gliomas
Leukaemia
Non-Small Cells Lung Cancer
+ Radiation therapy
Neuroblastoma
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
Phase 1
May 2000
NIH/NCI : Cooperative Research and Development Agreement
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
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
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
Clinical Development
May 2000
NIH/NCI : Cooperative Research and Development Agreement
Access Oncology, Inc./Keryx : Cooperation and license
agreement for the United States, Canada and Mexico
September
2002
April 2009
Handok : Agreement to out-license the rights of Perifosine in
South Korea
Yakult : development, manufacture and commercialization of
Perifosine in Japan
March 2011
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
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
Aeterna Zentaris ANNUAL INFORMATION FORM ON FORM 20-F 2010
Development, Manufacture,
Commercialization in Japan
May 2000
NIH/NCI : Cooperative Research and Development Agreement
Access Oncology, Inc./Keryx : Cooperation and license
agreement for the United States, Canada and Mexico
September
2002
April 2009
March 2011
Handok : Agreement to out-license the rights of Perifosine in
South Korea
Yakult : development, manufacture and commercialization of
Perifosine in Japan
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
Commercialization and license agreement for
the MENA (Middle East and North Africa)
region
Initial up-front payment
Milestone payments : up to $2
million
Royalties on future net sales of
perifosine in the MENA region
Supply perifosine to Hikma
Pharmaceuticals on a cost-plusbasis
Aeterba Zentaris Press Release – November 23rd, 2011
Leading drug company in the MENA region
Registration and marketing of
perifosine
Investor Presentation, February 14th, 2012, www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
LHRH receptor
Cancer Tissue
(e.g. breast, endometrial, ovarian,
prostate and bladder cancer)
Reproductive Tissue
Hypophysis
Healthy Tissue
AEZS-108
Consequence for the cytotoxic agent :
↑ Efficacy
Investor Presentation, February 14th, 2012, www.aezsinc.com
↓ Side-Effects
Phase 2
Refractory Ovarian Cancer
Recurrent Endometrial Cancer
Positive efficacy and
safety data
Phase 1
Refractory Prostate Cancer
Bladder Cancer
Investor Presentation, February 14th, 2012, www.aezsinc.com
Positive efficacy and
safety data
Investor Presentation, February 14th, 2012, www.aezsinc.com
Phase 1
Two Mecanisms of action
Tubulin polymerisation
inhibition
Topoisomerase II inhibition
Advanced solid tumors
Colon/rectum
Lung
Trachea
Pancreas
Prostate
Thyroide
No clinically relevant drug-related adverse events
www.aezsinc.com
Investor Presentation, February 14th, 2012, www.aezsinc.com
Diagnostic test for
Adult Growth
Hormone Deficiencies
Low energy levels
Emotional changes
Impaired sleep
Anxiety
Decreased strength and
exercise tolerance
Increased weight or
difficulty losing weight
www.aezsinc.com
Diagnostic test for
Adult Growth
Hormone Deficiencies
Ghrelin agonist
www.aezs.com
Phase 3
Hypothalamus
GH-RH
Ghrelin agonist
Hypophysis
GH
www.aezs.com
Diagnostic test for
Adult Growth
Hormone Deficiencies
Phase 3
Ghrelin agonist
Secretion of growth
hormone (GH)
No secretion of growth
hormone (GH)
No growth hormone
deficiencies
Growth hormone
deficiencies
www.aezsinc.com
Tumor induced
cachexia and others
Ghrelin agonist
www.aezsinc.com
Phase 1
Hypothalamus
GH-RH
Ghrelin agonist
Hypophysis
GH
Liver
IGF I/II
www.aezsinc.com
Metabolic activation
Tissue growth
Muscles
Bones
Tumor induced
cachexia and others
Ghrelin agonist
↓ loss of weight
↓ muscle atrophy
↓ fatigue
↓ weakness
↓ loss of appetite
www.azesinc.com
Phase 1
Million
Number of shares
80
75
70
65
60
55
50
2006
2007
2008
2009
2010
Sanofi
partnership
Studies good results
announcement
http://www.nasdaq.com/symbol/aezs/interactive-chart
Net operating incomes
40,000
Thousands $
20,000
0
2006
2007
2008
2009
2010
-20,000
-40,000
Long-term liabilities
-60,000
64697
70000
57768
50648
60000
50000
40000
30000
20000
12517
10000
0
2007
Audited Annual Financial Statements 2010 and 2008
2008
2009
2010
Gleevec®
Zometa®
Femara®
Afinitor®
Exjade®
Tasigna®
www.novartis.com
Pipeline in 2011
www.novartis.com Annual Report 2011
Oncology leader
MabThera®
Avastin®
Herceptin®
Xeloda®
Tarceva®
Roche in Brief 2011 by Roche
Sales
Phaseby
IIItherapeutic
and registration
area
Oncology leader
MabThera®
Protropin®
Avastin®
Avastin®
Herceptin®
Nutropin®
Herceptin®
Tarceva®
Xeloda®
Rituxan®
Tarceva®
www.gene.com
Oncology leader
MabThera®
Aezs-108 (diagnosis
companion test)
Avastin®
Protropin®
Nutropin®
Herceptin®
Xeloda®
Tarceva®
www.aezsinc.com Press Release January, 5th 2012
Focused R&D
Promising pipeline
Focused on 2 areas
Multiple indications
Cetrotide® sales better
than expected
2 products in phase 3
Oncology : growing
market
Companion test
Fast Track processes
2 NDA for 2012
Orphan Drugs
Debts
Financial dependence
1 product marketed
Dependent on third
parties
Failure in Phase 3 or
SAE : detrimental
Low-value shares :
tender offer?
Purchase?
Bankrupt?