Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
CORPORATE PRESENTATION
At the forefront of innovation in vaccines & monoclonal antibodies
April 2012
®
VIVALIS MODELA unique positioning in fast growing markets
Corporate OverviewVivalis in a snapshot
•• Founded in Nantes in 2000
• A Team of 11 employees in Nantes, Lyon & Toyama
• Listed on NYSE EuronextParis since June 2007
• Missions:
1.Discovery, development & Licensing of human
monoclonal antibodies (VIVA|SCREEN™) for diseases
�NANTES
�HQ + R&D + Biomanufacturing
�91 employees
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL3®
monoclonal antibodies (VIVA|SCREEN™) for diseases
with unmet medical needs
2. Development & Licensing of cell-based solutions for the
industrial manufacture of monoclonal antibodies with
enhanced biological activity (ADCC) & Vaccines (EB66®)
3.Contract Manufacturing services: Process development
& preclinical/Clinical manufacturing services for vaccines
& antibodies
• 30 licensees & 6 manufacturing contracts with
Pharma/Biotech companies worldwide
� LYON
� Antibody
discovery
� 14 employees
� TOYAMA
� Antibody discovery
� BD for Asia
� 7 employees
A value creating model
TECHNOLOGY TECHNOLOGY
TECHNOLOGY
VIVA|Screen®
ANTIBODY
DISCOVERY
FULLY HUMAN
ANTIBODIES
IP RIGHTS
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL4®
TECHNOLOGY
EB66®
VACCINES
(18 commercial
license)
TECHNOLOGY
EB66®
PROTEINS
(1 commercial
license)
DISCOVERY
(1
Commercial
agreement)
PROPRIETARY TECHNOLOGY
PLATFORMSPIPELINE OF PROPRIETARY
PRODUCTS
SERVICE ACTIVITIES
CONTRACT
MANUFACTURING
Limited risk :
• Short-term revenues (research phase)
• Royalties on products produced on EB66® : 15 ans years since first sales
1 2 3
Serving Fast Growing MarketsAntibodies and Vaccines are fastest growing markets
Therapeutic
protein
12%
Monoclonal
antibody
6%
Vaccine
3% 18
1415
20
Pharmaceutical market by
molecule type(total 2008: 516 Md$)
Compound Annual Growth
Rates in % (2008-2014)
Total sales of the monoclonal
antibody market(2002-2014)
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL5®
Source: datamonitor, October 2009
Small
molecule
79%
12%
1
0
5
10
VACCINES ANTIBODIES SMALL
MOLECULES
Our Assets
AN EXPERIENCED DEDICATED TEAM
• 112 employees of which 80% in R&D in Nantes, Lyon and Toyama
• Team led by Franck Grimaud, MBA and Majid Mehtali, Ph.D.
A GROWING POOL OF INDUSTRIAL PARTNERS
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL6®
A GROWING POOL OF INDUSTRIAL PARTNERS
• 30 Biotech & Pharma licensees of our technologies around the world
A HEALTHY FINANCIAL SITUATION
• Generated commercial revenues in 2011: € 10.3M (+112%)
• Cash position December 31, 2011: € 30.6M
®
THE EB66® STEM CELL TECHNOLOGYTowards a new industrial standard for the production of vaccines
HUMAN VACCINESWILD TYPE
(killed or live-attenuated)RECOMBINANT
(prophylactic & therapeutic
Influenza Influenza (Reassorted)
Measles Measles
Herpes Simplex (HSV) Herpes Simplex (HSV)
Smallpox Vaccinia (MVA, Lister…); Fowlpox
VETERINARY VACCINESAVIAN
(Wild Type & Recombinant)CANINE &
FELINESWINE, EQUINE, BOVINE
Influenza Distemper Influenza virus
Reovirus Parainfluenza Eastern Equine Encephalitis
Poxvirus(fowlpox, pigeon pox, canary pox)
Poxvirus(canary pox)
Western Equine Encephalitis
Inclusion Body Hepatitis (IBH) Equine Encephalomyelotis
Egg Drop Syndrome (EDS) Bovine Parainfluenza
The chicken eggA standard platform for the manufacture of a wide spectrum of vaccines
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL8®
Smallpox(Vaccinia, MVA, Lister…)
Vaccinia (MVA, Lister…); FowlpoxCanarypox (ALVAC…)
Mumps Avian viruses (NDV / IBDV…)
Rubella Sendai virus
Rabies
Thick-Borne Encephalitis
Yellow fever
Sindbis
Semliki Forest
Venezuelan EEV
Egg Drop Syndrome (EDS) Bovine Parainfluenza
Newcastle Disease Virus (NDV) Bovine Ibaraki
Infectious Bursal Disease (IBDV) Rabies
Duck Parvovirus Swine Japanese Encephalitis
Herpes (pigeon, turkey, falcon, parrot)
Infectious Bronchitis Virus (IBV)
Encephalomyelotis
Chicken Anemia
Marek's Disease
Fowl Adenovirus
Duck Adenovirus
Duck Enteritis Virus
Polyoma
IDEAL CELL PLATFORM
The chicken eggA need for alternative modern cell-based production platforms
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL9®
• Broad virus susceptibility
• Immortal
• Genetically stable
• Industrially Scalable
• High yielding
• Cost effective
ISSUES� Cumbersome manufacturing process� Slow reactivity in case of pandemics� Exposure to risks of outbreak of bird diseases & eggs penury� Egg-component allergies� Susceptible to contaminations (e.g. Shortage of Influenza
vaccines in the US in 2004)� Investments by governments in cell-based solutions
The EB66® cell line technologyA modern high performance industrial alternative to chicken eggs
INFLUENZA
1000L BIORACTOR
Replacement of
VIRUS
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL10®
~3-5 millions eggs
MEASLES
10L BIOREACTOR
Production of
10 millions dosesVACCINESBIOPRODUCTIONEMBRYONIC STEM CELL
EB66® CELL LINE
The EB66® cell lineA breakthrough technology for the production of vaccines
Main advantages
• Avian origin: easy replacement of chicken eggs for the production of human & animal vaccines
• Stem cell properties: immortal, genetically stable
• Industrial properties: growth in suspension, full traceability, high productivity
Only widely available cell line indepent to pharma companies
• Unique Broad application: applicable to > 25 different families of viruses
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL11®
• Unique Broad application: applicable to > 25 different families of viruses
• Independent from Pharma: MDCK belongs to Novartis, PERC.6 belongs to J&J
Health authorities “proof”• US FDA cleared first clinical trial for a vaccine produced on EB66 late 2010
• Japan authorities cleared first clinical trial for a vaccine produced on EB66 early 2011
“Currently, our MVA vaccine is grown in cells derived from embryonated chicken eggs. The EB66 cell line is a much
more practical and cost effective method to manufacture commercial-scale recombinant MVAs.” Robert McNally, Ph.D., GeoVax’ president and CEO – GEN Oct 19, 2011
The EB66® TechnologyExemple of application 1 : DELTA-VIR – Newcastle virus (NDV)
SITUATION• Client : DELTA-VIR , biopharmaceutical company founded 2011 to develop new anti-tumoral vaccines
including oncolytic viruses. Based in Koln, Germany, DELTA-VIR is a spin-off from IOZK (Immunologisches
und Oncologisches Zentrum Köln)
• Product : Oncolytic NDV vaccine – Promising results during compassionate use in cancer patients
• Objectives :
• Obtain regulatory authorization to treat a broader patient population
• Target filing for the orphan status for this drug in 2013
• Market potential for first indication : 100 M€
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL12®
• Market potential for first indication : 100 M€
• Need : a reproductible production tool, totally secured and enabling a rapid production of batches
Batches to be ready for injection in 2013
SOLUTION BROUGHT BY VIVALIS• Fully characterized cell line in clinical trial
• Strong expertise in the development of production processes
• Ability to produce clinical batches in its GMP facility in Nantes
Commercial agreement signed in 2011 for the production
On the EB66® cell line
The EB66® TechnologyExample of application 2 : TRANSGENE- virus MVA
SITUATION• Client : TRANSGENE Integrated biopharmaceutical company that develops immunotherapeutic products
for the treatment of cancers and chronic infectious diseases.
• Important portfolio of vaccines in Phase II:
• TG4010, lung cancer « non small cells » - Market : 1.9 Bn€
• JX594/TG6006, hepatocellular primary carcinoma (HCC) and metastatic colorectal cancer (mCRC) –
Market : 700 M€ in Europe
• TG4001, cervical pathologies linked to human papilloma virus (HPV).
• TG4040, chronic HCV - Market : several $ Bn
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL13®
• TG4040, chronic HCV - Market : several $ Bn
• Need : a production process compatible with production at commercial scale
VIVALIS SOLUTION• Fully characterized EB66® cell line with a proven track record of producing this type of vaccines
• Expertise in the development of production processes and capability to produce clinical batches
Commercial license and production agreement signed 2011 on EB66®
The EB66® cell lineA new standard for the production of vaccines and proteins
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL14®
19 Commercial licenses + ~10 research licenses
• Human: €9-20M/agreement + 4-6% royalties on sales
• Veterinary: €0.5-1.5M/agreement + 1.5-4% royalties on sales
2 Phase I clinical trials ongoing for flu vaccines in the USA and Japan
®
THE VIVA|SCREENTM TECHNOLOGYA unique integrated platform for the discovery & manufacture
of native human monoclonal antibodies
A FAST GROWING MARKET
Monoclonal antibodies therapeutics A therapeutic revolution and a fast growing market
Number of antibodies and sales ($m) From mice to humans
RAPIDLY CHANGING TECHNOLOGIES
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL16®Source: Data Monitor, 2009
Source: Genmab
Human monoclonal antibodies Several technologies developed over the last 30 years
• CAT - AZN: 1Md $
• MORPHOSYS: NOVARTIS: >600M€
HUMANIZED TRANSGENIC MICE
• ABGENIX – AMGEN: 2.2 Md$
• MEDAREX – BMS : 2.4 Md$
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL17®
ANTICORPS MONOCLONAL HUMAIN
B LYMPHOCYTES
BACTERIAL VIRUSES
(PHAGE DISPLAY)
• MORPHOSYS: NOVARTIS: >600M€
AN OPTIMAL PHARMACEUTICAL FORMAT
1. Natural response against diseases either from external or
internal origin by the production of antibodies
2. Natural therapeutic candidates for the treatment of diseases
PATHOGENS
SELFSELF
ANTIGENSANTIGENS
NATIVE Human Monoclonal AntibodiesGeneral conceptl
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL18®
2. Natural therapeutic candidates for the treatment of diseases
3. Ready to use: industrial development does not require
further modifications
4. But the B lymphocytes producing these antibodies are very
rare
5. VIVA|SCREEN™ gives access to these very rare and high
value human antibodies
B LYMPHOCYTES
1. Access to a Large Pool of Human Donors
A A TECHNOLOGY PLATFORMS THAT TECHNOLOGY PLATFORMS THAT ALLOWSALLOWS
3. High-Throughput Massive Screening of Large
Populations of Primary B Cells
Discovery of Native Human Monoclonal AntibodiesFrom Human Lymphocytes to Human Monoclonal Antibodies
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL19®
� Healthy donor
� Vaccinated donor
� Patient
4. Selection of rare B cells (<1/million) secreting
antigen-specific & biologically active antibodies
Populations of Primary B Cells
3. Rapid Single Cell Screening of Primary B Cells
5. Industrial manufacture of antibodies with
enhanced biological activity
� Blind screening of thousands of healthy donors in a week
� Access to patients through specific agreements with hospitals
� Consolidated legal framework, including for future
commercial applications (IRB, ministry of health, agreement with blood
transfusion center, Informed consent from blood donors)
Human DonorsRapid access to a large pool of donors
•• STRATEGIC COLLABORATION WITH BLOOD TRANSFUSION CENTERS & HOSPITALSSTRATEGIC COLLABORATION WITH BLOOD TRANSFUSION CENTERS & HOSPITALS
April 2012© 2000-2012 Vivalis — All rights reserved — CONFIDENTIAL20®
transfusion center, Informed consent from blood donors)
� Examples of donors already selected in past studies
• Healthy blood donors
• Patients infected by viral or bacterial pathogens
• Patients with specific pathologies (inflammatory diseases)
• Parents of infants with specific viral infections
• Medical staff exposed to patients with specific viral infections