Groupe Grimaud – Vivalis

About

– Virus manufacturing: Production of a large amount of viral vectors and viruses for the manufacture of viral vaccines, such as poxviruses (vaccinia, MVA, fowl pox…), influenza viruses (human, avian and swine strains), adenoviruses (Celo virus…), reoviruses, birnaviruses (Gumboro virus), etc.
– Protein manufacturing: Production of preclinical and clinical lots of recombinant proteins in animals cell lines, including EB66 cells and CHO cells, in cGMP facility at bioreactor scale.
– Development and commercialization of the EBx technology to manufacture viral vaccines (the vaccine market was worth $8.7 billions in 2005 and $10 billions in 2006), and therapeutic proteins and monoclonal antibodies (the protein market was worth $76 billions in 2006).
– Revenues: €5.444 millions in 2008; €0.996 million in 2007; €2.751 millions in 2006.
– Cash Position: €22.712 millions in 2008; €24.956 millions in 2007; €1.796 million in 2006.
– R&D Expenses: €8.159 millions in 2008; €5.498 millions in 2007; €3.967 millions in 2006.
– Number of Patents/Licenses: 116/24 in 2008; 74/22 in 2007; 54/16 in 2006.

Business

1999
– Vivalis is founded by Groupe Grimaud, following the acquisition of exclusive rights of Drs. B. Pain and J. Samarut patents on avian embryonic stem cells.

2000
– Master all steps of avian embryonic stem cells manipulation.

2001
– Research agreement with Aventis Pasteur covering a joint research programme in the field of avian embryonic stem cells to be used in vaccine production.

2002
– Vivalis, BioProtein Technologies (French biotechnology company specialising in the production of therapeutic proteins in the milk of transgenic rabbits), and INRA (French Agronomy Research Institute) announce the world’s first cloned rabbit.
– Agreement with Merial covering a joint research programme in the field of avian stem cells to be used for Merial avian vaccine production.

2003
– Commercial research, option and license agreement with Aventis Pasteur to combine the ALVAC canarypox virus platform of Aventis Pasteur and Vivalis’ proprietary avian stem cell platform to enable Aventis Pasteur to improve the large-scale production of several ALVAC vaccine candidates in the fields of HIV and cancer, and for the production of another major virus vaccine.
– Research agreement with Intervet (former Akzo Nobel) covering a joint research programme in the field of avian embryonic stem cells to be used in vaccine production.
– Research agreement with Oxxon Pharmaccines covering a joint research programme in the field of avian embryonic stem cells to be used in vaccine production.
– Agreement with INRA, CNRS and ENS-Lyon covering an exclusive joint research programme in the field of embryonic stem cells.
– License for North Carolina State University patents on avian embryonic stem cells that grants Vivalis the exclusive rights for all human and veterinary pharmaceutical applications.

2004
– Launch of a CMO business unit dedicated to the manufacture of preclinical and clinical batches of vaccines and proteins.
– Granted Medimmune Inc. rights to the EBx cell lines (chicken embryonic derived stem cell lines) for testing in vaccine production.
Merial for the renewal of the non-exclusive, global license for EBx technology for research and clinical development of products, with an option for a commercial license.
– Collaboration with JRH Biosciences for developing serum free media specifically designed for the EBx cell lines.

2005
– Granted Ceva Sante Animale rights to the EBx cell lines (chicken embryonic derived stem cell lines) to evaluate Vivalis EBx platform for the production of several animal health vaccines.
– Granted Geovax rights to the EBx cell lines (chicken embryonic derived stem cell lines) to evaluate Vivalis EBx platform for the production of Geovax‘s MVA based AIDS vaccines.
– Granted Kaketsuken rights to the EBx cell lines (chicken embryonic derived stem cell lines) to evaluate Vivalis EBx platform for the production of Kaketsuken‘s human and animal vaccines.
– License to Merial exclusively the EB14 avian cell line for the propagation of the Canary Pox and Fowlpox viruses for use in Merial‘s vaccines.
– Partnership agreement with Clean Cells to offer bio-manufacturing services of preclinical and clinical lots of therapeutic proteins and viral vaccines.
– Agreement with Ceva Sante Animal and Intervet International BV to develop a new duck EBx cell line for viral vaccines production.

2006
– Contract for the production of a preclinical batch of monoclonal antibody produced on its proprietary avian cell line, EB14 and another contract for the production of a GMP batch of monoclonal antibody from CHO cells.
SAFC Biosciences, member of the Sigma-Aldrich Group, and Vivalis, announce successful completion of the first stage of their on-going collaboration with the launch of their EX-CELL EBx platform, which includes EX-CELL EBx viral growth and production media, designed exclusively to support EBx cells, a chicken embryonic derived stem cell line, for growth and production of viral vaccines for therapeutic use.
– French Medical Agency (AFSSAPS) approves the opening of GMP biomanufacturing facility for pharmaceutical operations at Saint Herblain, Nantes, to manufacture clinical lots of recombinant proteins and viral vaccines for clinical trials.

2007
– Granted Sanofi Pasteur additional rights to chicken and duck embryonic stem cell derived EBx cell lines for the testing, production and marketing of undisclosed vaccine candidates.
– Granted Fort Dodge Animal Health, division of Wyeth, rights to the embryonic stem cell derived EBx cell lines to evaluate EBx cells for the production of viral vaccines.
– Granted Bavarian Nordic rights to the embryonic stem cell derived EBx cell lines to evaluate EBx cells as a production platform of MVA-BN based vaccines.
– Extended the research licence with Geovax for the production of MVA based AIDS vaccines.
– Agreement with GlaxoSmithKline to develop and commercialise new human influenza vaccines based on Vivalis’ proprietary EBx cell line technology. Under this worldwide collaboration and license agreement, Vivalis participates in the vaccine process development, and GlaxoSmithKline Biologicals, global vaccine division, is entitled to use Vivalis’ avian embryonic stem cell derived EBx cell lines and related technologies to produce seasonal and pandemic human flu vaccines.
– Agreement with CSL Limited to develop and commercialise new human influenza vaccines based on Vivalis’ proprietary EBx cell lines technology. World-wide commercial license that covers the development, production and marketing of seasonal and pandemic human flu vaccines produced in Vivalis’ avian embryonic stem cell derived EBx cell lines.
Nobilon (part of Organon, the human health care business unit of Akzo Nobel) acquires rights from Vivalis to EBx cell lines (derived from avian embryonic stem cells) and related technology platform for the development, production and marketing of human influenza vaccines, including seasonal and pandemic.
– Evaluation and option of commercial licence agreement to use Vivalis EBx cell lines derived from avian embryonic stem cells as a production platform of Virbac‘s biological products.
– Liquidity Contract with Natixis Securities.
– New phase of Mat Biopharma collaboration in order to produce pre-clinical batch.
– License platform technology from North Carolina State University describing a method of producing undifferentiated avian cell cultures using avian primordial germ cells.
– Collaboration with Innate Pharma to evaluate Vivalis EBx cell lines, derived from avian embryonic stem cells, for the production of monoclonal antibodies.
– Granted rights to Sanofi-Aventis to evaluate EBx cell lines, cell substrates derived from avian embryonic stem cells, for the production of monoclonal antibodies.

2008
– Extended the research licence with Kaketsuken to 2 new viruses, one in the field of human disease, the other in the veterinary field.
Virbac exercises option for a commercial license to use Vivalis’ EBx platform for the production of companion animal vaccines.
Bavarian Nordic exercises option to extend the EBx embryonic stem cell line research license.
– Granted Acambis Inc. (member company of the Sanofi Pasteur Group) rights to the avian embryonic stem cell derived EB66 cell line to evaluate it as a production platform of viral vectors and vaccines.
– Commercial license with Intervet/Schering-Plough Animal Health related to the avian embryonic stem cell derived EBx technology for the production and marketing of a veterinary vaccine.
– Joint collaboration and commercial license with GeoVax on the use of Vivalis’ EBx technology to manufacture the MVA component of the GeoVax HIV-1 vaccine.
– Research licence and option for a commercial agreement with CSL Limited to assess the EBx platform to test the EB66 cell line for the development and manufacturing of a therapeutic protein candidate.
– Commercial licenses with Kaketsuken to use the Vivalis proprietary EB66 cell line, for the production of several veterinary and human vaccines, including Vaccinia virus-based recombinant human vaccines, inactivated and live viral human vaccines.

2009
– Joint collaboration and commercial license agreement with Innate Pharma related to the use of Vivalis EB66 cell line, for the set up of an industrial process and the manufacturing of clinical batches of Innate Pharma‘s IPH 4101, a novel cytotoxic monoclonal antibody for the treatment of rare cutaneous lymphomas such as Sezary Syndrome and Transformed Mycosis Fungoides. Supported by a grant from the French innovation agency OSEO amounting €6.7 millions.
– Research license with Novavax to use the Vivalis proprietary EB66 cell line for the production of VLP based vaccines against several new potential viruses.
– Worldwide collaboration and license agreement with GSK devoted to developing a new way of producing both seasonal and pandemic human influenza vaccines. Milestones included the designing of a manufacturing process capable of obtaining a high level of virus productivity compatible with industrial development and an important step in the characterization of the sanitary status of the EB66 cell line.
– Research license agreement with Boehringer Ingelheim Animal Health, the animal health division of the global pharmaceutical company Boehringer Ingelheim, to use the EB66 cell line, proprietary of Vivalis, for the production of several veterinary vaccines.
– Commercial license with Fort Dodge Animal Health, a division of Wyeth, to use the EB66 cell line, a proprietary product of Vivalis, for the production of several veterinary vaccines.
SAFC Biosciences, a business segment within SAFC, a member of the Sigma-Aldrich Group, announces the introduction of EX-CELL EBx cell growth and viral production media designed exclusively to support Vivalis’ EB66 duck cells used in the commercial production of prophylactic and therapeutic vaccines.
– Commercial license agreement with The Oxford-Emergent Tuberculosis Consortium Ltd., a joint venture between the University of Oxford and Emergent BioSolutions Inc.,to evaluate large scale commercial production capabilities for MVA85A, the Consortium’s new TB vaccine candidate.
– New research license with Merial to use the EB66 cell line, a Vivalis proprietary technology, for the production of 10 different pathogens for veterinary vaccines.
– Agreement with Intervet/Schering-Plough Animal Health grants rights to test the EB66 cell line for the production of 12 different pathogens.
– Agreement between GlaxoSmithKline and Kaketsuken to co-develop influenza vaccines, including pandemic influenza vaccines, produced using EB66 cell-culture technology in Japan.
– Agreement with Louis J. Cantolupo to accelerate the marketing of the EB66 cell line in North America, principally in monoclonal antibodies and the therapeutic proteins. Cantolupo: previously Associate Director of Business Development with GenVec Inc., where responsible for partnering early stage products and platform technologies; responsible for developing and executing strategy for licensing the PER.C6 technologies developed by Crucell in the field of monoclonal antibodies and recombinant proteins; BS in biotechnology from the Rochester Institute of Technology and MBA from the Robert H. Smith School of Business at the University of Maryland, College Park.
– Renewed rights granted to Sanofi-Aventis to test EB66 cell line for production of monoclonal antibodies and extended it to the production of recombinant proteins.

Executive Committee

Franck Grimaud
– Co-founder and CEO since 1999.
– Responsable for the creation of new subsidiaries of Grimaud Group in China, Malaysia and Thailand since 1995.
– Vice-president of the Atlantic-Biotherapies cluster.
– MBA from the University of Ottawa (Canada).

Dr Majid Mehtali
– Management Board and Managing Director.
– Vice President Research of Crucell NV (The Netherlands).
– Scientific Director at Deltagen-Europe (France).
– Head of the Virology-Immunology Department and head of the Gene Therapy Research Department of Transgene S.A. (France).
– Started career at Rhone-Merieux (Merial) in 1985.
– Graduate of the European School of Biotechnology in Strasbourg, and PhD at the University of Strasbourg, France.

Philippe Rousseau
– Chief Financial Officer since September 2009.
– Chief Financial Officer (2002-2009); Member of the Management Board (2004-2009); Chairman of the Management Board (2008) at ExonHit Pharmaceuticals S.A.
– Responsible of Investor Relations (1998); Vice President of Finance at Genset, pioneering company in human genome research.
– Various positions at Paribas Bank in France and USA, and at Mars & Co in Paris (1994-1998).
– Majored in finance from Hautes Etudes Commerciales in France.

Dr Stephen Brown, PhD
– Director of Manufacturing since 2004.
– Director Biological Process Development, resposible for global biologics vaccine process development with teams in USA and France, at Merial.
– Head of GMP manufacturing at Transgene for 17 years.

Dr Pierre Miniou
– Business Development and Intellectual Property manager since December 2003.
– Worked for Transgene at the Wistar Institute, USA.
– Patent engineer at Cabinet Regimbeau and subsequently in charge of the Patents Department at Laboratories Pierre Fabre.
– Postdoctoral position at Institut de Genetique et de Biologie Moleculaire et Cellulaire.
– Degree in intellectual property for the Certre for Interational Industry Property Studies (France).
– Engineering diploma in biotechnology and PhD in molecular biology.

Celine Breda
– Qualified Person (Pharmacist in charge) and head of the Quality Control group since 2005.
– In charge of the analytical development and Quality Control of gene therapy products at Centelion (formerly Gencell), Gene Therapy division of Rhone Poulenc Rorer.
– In charge of analytical developments for investigational vaccines and the transfer of bioanalytical methods to the North-American site in Swiftwater; in charge of the characterisation of recombinant proteins (France) at Sanofi-Aventis (fromerly Pasteur Merieux Connaught).
– Management Board and Managing Director and Doctor of Pharmacy at University of Paris XI.

Dominique Mary
– Legal advisor since 2000.
– Master degree and post graduate in law.

Supervisory Board

Frédéric Grimaud (1967)
– Commercial service (1988); General Manager; Chairman of the Management Board (2000) of Groupe Grimaud.

Joseph Grimaud (1943)
– Co-founder; Chairman of the Management Board; Chairman of the Supervisory Board of Groupe Grimaud.
– Vice President of the Chamber of Commerce and Industry of Maine et Loire.

Renée Grimaud (1942)
– Co-founder; in charge of marketing and external communication; Vice-Chairman of the Supervisory Board (2000-2005); Member of the Supervisory Board of Groupe Grimaud.

Thomas Grimaud (1980)
– Information Technology department; Member of the Management Board and Director of computer systems of Groupe Grimaud.

Alain Muñoz (1952)
– Member of the Management Board of several European biotechnological companies.
– Former member of the Scientific Council of the Drugs Agency.
– Senior Vice-Chairman of the pharmaceutical division of Fournier Group for 10 years.
– Vice-Chairman for international development at Sanofi.
– Graduate in cardiology and anaesthesia/resuscitation, doctor, former staff doctor and hospital clinic manager.

Michel Greco (1946)
– Chairman and Chairman of the Management Board of Intercell and Glycovaxym.
– Member of the Management Board of Immutep, Vaxgen and Argos Therapuetics.
– Chairman of the Management Board of International AIDS Vaccine Iniciative, Aeras Global TB Vaccine Foundation and International Vaccine Institute.
– Chairman of the Biological Committee of the International Federation of Pharmaceutical Manufacturers Associations and member of the Strategic Advisory Group of Experts which advises the World Health Organization on immunization policy (1999-2002).
– President and Chief Operating Officer; Deputy Managing Director and member of the Management Board of Aventis Pasteur (1998-2003).
– President of the European Vaccine Manufacturers (1994-1998).
– President and Chief Executive Officer of Pasteur Mérieux MSD (1993-1998).
– Senior management responsibilities at Institut Mérieux (1988-1993).
– Graduate of the Institute of Political Science in Paris (1965) and MBA from Western Ontario University, Richard Ivey Business School (1968).

Informe Anual 2007

– 21 EBx licences: 8 commercial and 13 research licences for the manufacture of vaccines.
– 2 research agreements and 1 EBx research licence for the manufacture of proteins.
– 2 programmes for the development of anti-hepatitis C proprietary molecules in the dicovery stage.
– Partnerships with Sanofi Pasteur, GlaxoSmithKline, Novartis Vaccines, CSL limited, Kaketsuken, Nobilon (Schering Plough Group), Merial and SAFC Biosciences.

– The influenza market will represent a turnover of 4 billion dollars in 2012.
– Vivalis is expecting that the first influenza vaccine, produced on EBx cell lines, will be launched on the market by 2012-2013.
– New research licensing agreement with the Danish company Bavarian Nordic to develop several human vaccines, and a commercial licence with the French company Virbac for the development of biological products in the veterinary sector.
– Second commercial licence with Sanofi Pasteur signed following the fist commercial licence in April 2003 in the field of vaccines against several types of cancer and AIDS.

– In addition to the vaccine market which comes to 12 billion dollars, the therapeutic protein market represents over 76 billion, and is the second strategic focus for Vivalis.
– Partnership agreements with Innate Pharma and MAT Biopharma, and the first research licensing agreement with the world’s Nº4 pharmaceutical company, Sanofi-Aventis.

– Vivalis started in 2005 investing in proprietary products in the antiviral sector, its area of interest. By relying on a proprietary platform of screening, the 3D-Screen platform, and a chemical library of 25,000 original molecules, Vivalis has started up 2 programmes to identify and develop anti-hepatitis C molecules, aiming for 2 validated viral targets, polymerase and protease.

– Agreements in the field of anti-hepatitis C molecules:


Informe Anual 2008

– 24 licences the EB66 cell line: 14 commercial + 10 research licenses ; 16 for human applications + 8 for veterinary applications.
– Agreements with 21 global partners (75% of the worldwide vaccine players).
– >50 products tested or developed on the EB66 line Manufacturing 2 collaboration agreements for the production of clinical batches of vaccines or antibodies on the EB66 line.




OSEO funding of €6m
– Objective: co-develop a vaccine and antibody up to the clinical phases.
– MVA HIV vaccine with Geovax (US): development of production processes based on EB66; production of BPF (GMF-equivalent) pre-clinical batches; clinical trials planned for end 2010.
– Anti-cancers antibodies with Innate Pharma (France): development of production processes based on EB66; production of BPF pre-clinical batches; clinical trials planned for end 2011.

Vaccines: 1st injection in humans in 2010
– Signature of new commercial licenses or transformation of research licenses.
– Market launch of the first veterinary vaccine produced on the EB66 platform.
– Authorisation for clinical trials on humans.
– Production and purification on the EB66 platform of a first clinical vaccine batch.

Proteins
– Acceleration of commercial development with the signature of new licenses.
– Increase productivity in 2 to 3 years: > 1 g/l
– 2011: Production of a first clinical batch of antibodies produced on the EB66 line with a target for a clinical trial on humans.

Manufacturing
– Launch of a business unit focusing on clinical batches for third parties.
– 2009-2010: Production of a first clinical vaccine batch.
– 2010-2011: Production of a first clinical batch for antibodies.

Proprietary Products
– 2009: identify and in-license a program to develop a proprietary vaccine or antibody.
– 2010-2011: Out-licensing of the first antihepatitis C molecule.

Licenses


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