FRENCH RENOWNED SCIENTISTS ANNOUNCE WORLD’S FIRST CLONED RABBIT FROM ADULT CELLS

Paris, France… The world’s first cloned rabbit is announced by BioProtein Technologies, the French biotechnology Company specialising in the production of therapeutic proteins in the milk of transgenic rabbits, in collaboration with Vivalis, the French biomanufacturing Company specialising in embryonic stem cells (ES cells) and in the production of therapeutic proteins in eggs, together with INRA, the French Agronomy Research Institute. The cloning was achieved using nuclear transfer from adult somatic cells and was carried out by the Developmental Biology and Biotechnology Unit of INRA, headed by Dr Jean-Paul Renard. The results of this scientific breakthrough are published in Nature Biotechnology, April 2002, volume 20, and will contribute to extending the use of rabbits for the production of biopharmaceutical products, as well as for models for biomedical research.
“The rabbits are in good health and the first two have already given birth to respectively seven and eight kits. Despite the rabbit’s pioneering role in defining nuclear transfer methods in mammalians, cloning in the rabbit has previously always led to disappointing results despite numerous attempts by different groups over the world. To achieve this success, we have designed a specific cloning procedure adapted to the physiological characteristics of rabbit oocytes and early embryonic development,” commented Jean-Paul Renard. “ We consider that rabbit is one of the most appropriate animal models to increase our knowledge of the still poorly understood process of nuclear reprogramming in mammals.”
INRA scientists waited several months before submitting their results, in order to ensure that their clones become fertile adult animals of normal physiological appearance. They will now use genetically modified cells as a source of nuclei for their cloning experiments.
BioProtein Technologies benefits from this exciting breakthrough via an exclusive licence option from INRA to apply this new cloning method to produce recombinant proteins in the milk of transgenic rabbits.
Vivalis has also received an exclusive rights option from INRA for applications of this technology in animal models for research purposes and for other therapeutic applications except the production of therapeutic recombinant proteins in milk of transgenic rabbits.
The rabbit is gaining growing recognition as an ideal animal to produce molecules of pharmaceutical interest. This species also offers several advantages over other laboratory species in the study of several human physiological disorders. Because of its larger size, physiological manipulations can be more easily carried out in rabbits than in mice. Furthermore, in term of evolutionary terms, lagomorphs (rabbits and hares) are closer to primates than rodents.
Both Bioprotein Technologies and Vivalis, in conjunction with INRA, are clear that this cloning technology requires careful step-by-step validation of its applications including ethical implications. This process will include a large public consultation over its innovative potential and its use.
Marc Le Bozec, BioProtein Technologies’ CEO declared: “Today’s announcement highlights the cutting edge cloning science that we are able to access from our scientific partner INRA. Thus, we are able, by using transgenic rabbits, to offer our customers a number of commercially important advantages over other animal or cell based systems currently used for therapeutic protein production.”
Franck Grimaud, Vivalis’s CEO declared: “This new development achieved by one of the world leading teams in cloning will allow us to offer our customers rabbit models genetically identical for experimental purposes. We are also conducting further research into the use of this technology for specific therapeutic applications.”

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Notes to the Editors

About BioProtein Technologies
www.bioprotein.com
BioProtein Technologies is the world leader in the production of recombinant proteins in the milk of transgenic rabbits. The company’s unique contract manufacturing capabilities have been designed to meet the increasing demands of the pharmaceutical and the biotechnology industries for therapeutic protein production. Rabbits offer great advantages in terms of scale-up and time-to-market and can produce up to 6-8 litres of milk per year. From the annual production of 400 rabbits, 5-10 kg of protein can be isolated and purified to a very high quality.BioProtein Technologies has a strong expertise through the entire manufacturing process from genes or cDNA expression to animal production. The Company is using high quality science, for example from INRA, as the foundation for building BioProtein Technologies into a world leading producer of therapeutic proteins. The Company has produced complex and difficult-to-express proteins, including monoclonal antibodies, hormones and vaccinating antigens, all of which demonstrates BioProtein Technologies’ ability to fulfil the most rigorous specifications in protein production.
As a corporation, Bioprotein Technologies recognizes that it has a specific responsibility towards the animals that it generates and breeds for the production of therapeutic proteins. The Company conducts its animal research and development according to the highest ethical standards.
The Company was founded in 1998 and successfully completed its first € 8 million financial round in May 2001.

About Vivalis
www.vivalis.com
Vivalis, a biomanufacturing company created in 1999, is one of the world's specialists in embryonic stem cells (ES cells) and in avian and rabbit transgenesis. Vivalis know-how and proprietary technologies are focused on two main areas:
- Production of therapeutic recombinant proteins (antibodies, peptides, cytokines, etc) in eggs of transgenic chickens. The Company is working with pharmaceuticals manufacturers and biotechnology companies from insertion of their target gene right through to industrial expression and purification of their protein. Vivalis' technology should allow the Company to meet the manufacturing industry's current requirements for large-scale production of complex proteins (from several kg to 1 ton).
- Production of stem cells, primary cells or cell lines for the pharmaceutical industry, in particular for vaccine production.
Based in Nantes (France), Vivalis has the backing of its industrial shareholders and several research partnerships with INRA, CNRS and INSERM.