CORPORATE PRESENTATION

Transcription

1 CORPORATE PRESENTATION At the forefront of innovation in vaccines & monoclonal antibodies April 2012

2 VIVALIS MODEL A unique positioning in fast growing markets

3 Corporate Overview Vivalis in a snapshot NANTES HQ + R&D + Biomanufacturing 91 employees LYON Antibody discovery 14 employees TOYAMA Antibody discovery BD for Asia 7employees Founded in Nantes in 2000 A Team of 11 employees in Nantes, Lyon & Toyama Listed on NYSE Euronext Paris since June 2007 Missions: 1.Discovery,development & Licensing of human 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 3

4 A value creatingmodel IP RIGHTS FULLY HUMAN ANTIBODIES TECHNOLOGY VIVA Screen CONTRACT MANUFACTURING TECHNOLOGY EB66 VACCINES (18 commercial license) TECHNOLOGY EB66 PROTEINS (1 commercial license) ANTIBODY DISCOVERY (1 Commercial agreement) SERVICE ACTIVITIES PROPRIETARY TECHNOLOGY PLATFORMS Limited risk: Short-term revenues (research phase) Royalties on productsproducedon EB66 : 15 ans yearssincefirst sales PIPELINE OF PROPRIETARY PRODUCTS

5 Serving Fast Growing Markets Antibodies and Vaccines are fastest growing markets Pharmaceutical market by molecule type (total 2008: 516 Md$) Monoclonal antibody Therapeutic 6% protein 12% Vaccine 20 3% Compound Annual Growth Rates in % ( ) 14 Total sales of the monoclonal antibody market ( ) 10 Source: datamonitor, October 2009 Small molecule 79% 5 0 VACCINES ANTIBODIES SMALL MOLECULES 1 5

6 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 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 6

7 THE EB66 STEM CELL TECHNOLOGY Towards a new industrial standard for the production of vaccines

8 The chicken egg A standard platform for the manufacture of a wide spectrum of vaccines 8 WILD TYPE (killed or live-attenuated) Influenza Measles Herpes Simplex (HSV) Smallpox (Vaccinia, MVA, Lister ) Mumps Rubella Rabies Thick-Borne Encephalitis Yellow fever Sindbis Semliki Forest Venezuelan EEV HUMAN VACCINES RECOMBINANT (prophylactic& therapeutic Influenza (Reassorted) Measles Herpes Simplex (HSV) Vaccinia(MVA, Lister ); Fowlpox Canarypox(ALVAC ) Avianviruses(NDV / IBDV ) Sendai virus AVIAN (Wild Type & Recombinant) VETERINARY VACCINES CANINE & FELINE SWINE, EQUINE, BOVINE Influenza Distemper Influenza virus Reovirus Parainfluenza Eastern Equine Encephalitis Poxvirus (fowlpox, pigeon pox, canary pox) Inclusion Body Hepatitis (IBH) Egg Drop Syndrome (EDS) Newcastle Disease Virus (NDV) Infectious Bursal Disease (IBDV) Duck Parvovirus Herpes(pigeon, turkey, falcon, parrot) Infectious Bronchitis Virus (IBV) Encephalomyelotis Chicken Anemia Marek's Disease Fowl Adenovirus Duck Adenovirus Duck Enteritis Virus Polyoma Poxvirus (canary pox) Western Equine Encephalitis Equine Encephalomyelotis Bovine Parainfluenza Bovine Ibaraki Rabies Swine Japanese Encephalitis

9 The chicken egg A need for alternative modern cell-based production platforms IDEAL CELL PLATFORM 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 Broad virus susceptibility Immortal Genetically stable Industrially Scalable High yielding Cost effective 9

10 The EB66 cell line technology A modern high performance industrial alternative to chicken eggs VIRUS INFLUENZA 1000L BIORACTOR Replacement of ~3-5 millions eggs EB66 CELL LINE EMBRYONIC STEM CELL BIOPRODUCTION VACCINES MEASLES 10L BIOREACTOR Production of 10 millions doses 10

11 The EB66 cell line A 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 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 embryonatedchicken 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,

12 The EB66 Technology Exemple of application 1 : DELTA-VIR Newcastle virus (NDV) SITUATION Client : DELTA-VIR, biopharmaceuticalcompanyfounded2011 to developnew anti-tumoral vaccines including oncolytic viruses. Based in Koln, Germany, DELTA-VIR is a spin-off from IOZK (Immunologisches undoncologischeszentrumköln) Product : Oncolytic NDV vaccine Promising results during compassionate use in cancer patients Objectives : Obtain regulatory authorization to treat a broader patient population Target filingfor the orphanstatusfor thisdrugin 2013 Market potential for first indication : 100 M Need: a reproductible production tool, totally secured and enabling a rapid production of batches Batchesto bereadyfor 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 12 Commercial agreement signedin 2011 for the production On the EB66 cellline

13 The EB66 Technology Example 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, lungcancer «non smallcells» -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, chronichcv -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 13

14 The EB66 cell line A 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: M/agreement % royalties on sales 2 Phase I clinical trials ongoing for flu vaccines in the USA and Japan 14

15 THE VIVA SCREEN TM TECHNOLOGY A unique integrated platform for the discovery & manufacture of native human monoclonal antibodies

16 Monoclonal antibodies therapeutics A therapeutic revolution and a fast growing market A FAST GROWING MARKET Number of antibodies and sales ($m) RAPIDLY CHANGING TECHNOLOGIES From mice to humans Source: Genmab Source: Data Monitor,

17 Human monoclonal antibodies Several technologies developed over the last 30 years ABGENIX AMGEN: 2.2 Md$ MEDAREX BMS : 2.4 Md$ HUMANIZED TRANSGENIC MICE CAT -AZN: 1Md $ MORPHOSYS: NOVARTIS: >600M B LYMPHOCYTES 17 BACTERIAL VIRUSES (PHAGE DISPLAY) ANTICORPS MONOCLONAL HUMAIN

18 NATIVE HumanMonoclonal Antibodies General conceptl PATHOGENS SELF ANTIGENS AN OPTIMAL PHARMACEUTICAL FORMAT 1. Natural responseagainstdiseaseseitherfromexternalor internal origin by the production of antibodies 2. Natural therapeutic candidates for the treatment of diseases B LYMPHOCYTES 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 18

19 Discovery of Native Human Monoclonal Antibodies From Human Lymphocytes to Human Monoclonal Antibodies A TECHNOLOGY PLATFORMS THAT ALLOWS 1. Access to a Large Pool of Human Donors 3. High-Throughput Massive Screening of Large Populations of Primary B Cells 3. Rapid Single Cell Screening of Primary B Cells 4. Selection of rareb cells (<1/million) secreting antigen-specific & biologically active antibodies 5. Industrial manufacture of antibodies with enhanced biological activity Healthy donor Vaccinated donor Patient 19

20 HumanDonors Rapid access to a large pool of donors STRATEGIC COLLABORATION WITH BLOOD TRANSFUSION CENTERS & HOSPITALS 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) 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 20