Oxford Biomedica Regulatory News (OXB)

18 Jan 2006 16:13

Oxford Biomedica PLC18 January 2006 IMMEDIATE RELEASE 18 JANUARY 2006 OXFORD BIOMEDICA AND VIRAGEN REPORT AVIAN TRANSGENIC BREAKTHROUGH - OVA(TM) System Expresses Interferon Beta - Oxford, UK: 18 January 2006 - Oxford BioMedica (LSE: OXB) announced today thatits partner Viragen, Inc (AMEX: VRA), along with Viragen's collaborators at theRoslin Institute, have successfully achieved expression of significantquantities of the human protein, interferon beta-1a, in the whites of eggs laidby transgenic hens using the OVA(TM) System (Avian Transgenic Biomanufacturing)that employs Oxford BioMedica's LentiVector(R) technology. Interferon-beta is akey component of the human immune system and is the active ingredient in severalleading multiple sclerosis (MS) therapies. These results are the first in aseries of anticipated milestones demonstrating "Proof-of-Principle" with anavian-expressed version of interferon beta, and it is expected that the OVA(TM)System will be capable of cost-effectively expressing many types of therapeuticproteins. Viragen and Roslin are conducting avian expression studies on various proteincandidates including interferon beta-1a, which is currently marketed under twocompeting brand names for the treatment of MS. These MS products are Avonex(R)*,marketed by Biogen Idec, and Rebif(R)**, marketed by Serono, with combinedannual global sales over $2.5 billion. The Project's Scientific Leader, Dr. Helen Sang of Scotland's Roslin Institute,commented, "We are extremely pleased to report this key advance in our programmeto develop a preferred platform for the production of selected biopharmaceuticalproteins, having now successfully developed transgenic hens that aresynthesising significant quantities of interferon beta as a component of theiregg white. This is the second protein candidate with which we have achievedpromising results, as we previously reported expression and recovery of afunctional humanised antibody. As we fully characterize the interferon beta thatis recovered, both biochemically and by functional tests, we expect such resultswill confirm our progress." "This is a truly remarkable achievement for our team in Scotland and representsa major event towards our goal to definitively position the OVA(TM)System as arevolutionary transgenic bio-manufacturing alternative," stated Dr. KarenJervis, Vice President and Managing Director of Viragen (Scotland) Ltd. "We willcontinue to collect eggs from these hens and subsequent generations to confirmquality and quantity of the protein. In addition, we will be analysing thecarbohydrate profile of the product, which may represent another key advantageto OVA(TM)expressed proteins. Certain biotech drugs require post-translationalmodifications in order that the drug retains its full efficacy and is welltolerated when used as a human therapeutic. Although we must confirm the natureof the modifications conferred by the OVA(TM)System, we are hopeful that aviantransgenic production may be able to retain these beneficial modifications,which may in turn translate to a lower cost of goods and a more economicalprocess." While more data are required to provide a precise economic model, Viragen'sPresident & CEO, Charles A. Rice, stressed the significance of this achievement,"We are continuing to report historic scientific breakthroughs, as we achievethe essential prerequisites to develop a viable, cost-effective, transgenicbio-manufacturing system. To imagine the potential, based on the highestexpression levels we have found, it is conceivable that a small flock of acouple of hundred hens could satisfy the entire US market demand for interferonbeta-1a. These figures are preliminary, but certainly suggest why thistechnology might be so desirable to a company seeking new benefits in themanufacturing of current and future products. We congratulate our Scotland teamsat VSL and the Roslin Institute for their commitment, patience, perseverance andfine work on this important project, and we look forward to even more dramaticresults throughout this year." *Avonex(R) (interferon beta-1a) is a registered trademark of Biogen Idec, Inc.** Rebif(R) (interferon beta-1a) is a registered trademark of Serono, Inc. Viragen has no agreements with Biogen Idec or Serono and did not collaboratewith either company in connection with these avian expression studies.-Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief Executive Viragen, Inc: Tel: (954) 233 8746Director of Communications, Doug Calder City/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150Katja Stout/ Gemma BradleyNorthbank Communications Notes to editors: 1. Oxford BioMedicaOxford BioMedica (LSE: OXB), the leading gene therapy company, is abiopharmaceutical company specialising in the development of novel gene-basedtherapeutics with a focus on the areas of oncology and neurotherapy. The Companywas established in 1995 as a spin out from Oxford University, and is listed onthe London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes an immunotherapy and a gene therapy in multiple Phase II trials, and apreclinical targeted antibody therapy in collaboration with Wyeth. Inneurotherapy, the Company's lead product is a gene therapy for Parkinson'sdisease, which is expected to enter clinical trials in 2006, and four furtherpreclinical candidates. The Company is underpinned by over 80 patent families,which represent one of the broadest patent estates in the field. The Company has a staff of approximately 70 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet,Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to anumber of companies including Merck & Co, Biogen Idec and Pfizer.Further information is available at www.oxfordbiomedica.co.uk 2. Viragen, IncWith global operations in the USA, Scotland and Sweden, Viragen is abiotechnology company engaged in the research, development, manufacture andcommercialization of pharmaceutical proteins for the treatment of viral diseasesand cancers. Viragen's product portfolio includes: Multiferon(R) (multi-subtype,natural human alpha interferon) targeting a broad range of infectious andmalignant diseases; and humanised monoclonal antibodies targeting specificantigens over-expressed on many types of cancers. Viragen is also pioneering thedevelopment of Avian Transgenic Technology, with the renowned Roslin Institute,as a revolutionary manufacturing platform for the large-scale, efficient andeconomical production of human therapeutic proteins and antibodies. For more information, please visit www.viragen.com 3. Oxford BioMedica and Viragen collaborationOxford BioMedica licensed its LentiVector gene delivery system to Viragen inJuly 2004 for use of the technology in the development of Avian Transgenics. Theagreement includes upfront and annual licence payments in addition to milestonepayments on the achievement of technical goals and royalties oncommercialisation. 4. LentiVector(R) technologyOxford BioMedica's LentiVector gene delivery technology, based on lentiviruses,is arguably the most potent system currently available for treating a range ofdiseases, particularly those of the central nervous system. Oxford BioMedica hasshown that its lentiviral vectors are able to deliver genes with high efficiencyto a variety of both dividing and non-dividing cells, including neurons in thebrain. Oxford BioMedica has three issued US patents and a European patent for itsLentiVector technology. These include broad composition of matter claims andmethods of production claims for lentiviral vector gene delivery systems of bothhuman and non-human origin. The patents also cover derivatives of lentiviralvector systems that, unlike many versions of lentiviral vectors, have realclinical utility because of their safety. The Company has established a neurotherapy pipeline of product candidates basedon its LentiVector technology, which includes ProSavin(R) for Parkinson'sdisease, RetinoStat(R) for retinopathy, MoNudin(R) for motor neuron disease,SMN1-G for spinal muscular atrophy and Innurex(R) for nerve repair. 5. OVA(TM)SystemViragen holds the worldwide exclusive license to commercialise the OVA(TM) System(Avian Transgenic Biomanufacturing) as granted by the Roslin Institute(Scotland). The project is designed to develop the chicken into a pharmaceuticalbioreactor, one that can meet the growing need for protein-based humantherapeutics. Based on the creation of lines of transgenic hens which have beenengineered to produce a target protein in their eggs using the LentiVector genedelivery system licensed from Oxford BioMedica, this technology is beingdeveloped as an efficient and economical alternative to standardbio-manufacturing techniques, having many apparent advantages in ease ofscale-up, lower costs of production and quality of product produced. This project has been funded in part from a grant awarded by the ScottishExecutive's "SPUR Plus Program", designed to support significant technologicaladvances being made in Scotland. 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