2012 04 05 corporate pres sfaf 2011 - valneva · anticorps monoclonal humain b lymphocytes...

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


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)


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


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


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


• 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


~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


• 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€


• 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


• 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


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$


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


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


� 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


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

2012 04 05 corporate pres sfaf 2011 - valneva · anticorps monoclonal humain b lymphocytes...

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