Gene Therapy for Blindness

Oxford Biomedica PLC 02 October 2006 For immediate release 2 October 2006 Oxford BioMedica OXFORD BIOMEDICA EXPANDS ITS OCULAR PROGRAMME THROUGH COLLABORATION AND INVESTMENT LED BY THE FOUNDATION FIGHTING BLINDNESS Oxford, UK - 2nd October 2006: Oxford BioMedica (LSE:OXB), a leading gene therapy company, and The Foundation Fighting Blindness (FFB) through its translational research arm National Neurovision Research Institute (NNRI) announced today that they have signed a research and collaboration agreement to develop a portfolio of gene therapy products for the treatment of eye diseases. This builds on the existing agreement with FFB signed in November 2003 for the pre-clinical development of RetinoStat(R), Oxford BioMedica's product for the treatment of age-related macular degeneration (AMD) and for which Oxford BioMedica expects to file an IND application in 2007. The first product in the expanded portfolio will be StarGen(TM)for the treatment of Stargardt disease, the most common juvenile degenerative retinal disease. Under the collaboration agreement and a separate share subscription agreement, FFB and a consortium of investors will make an undisclosed upfront payment and will also subscribe for up to $3.9m of Oxford BioMedica ordinary shares of 1penny each ('Ordinary Shares') to fund the development of StarGen. The share subscription will be made in stages and priced at a 10% premium to the market price at the time of investment. In return FFB and the consortium of investors will receive a royalty on sales of StarGen. Upon signing of the share subscription agreement, the Company has allotted and issued 485,185 new Ordinary Shares at 33.0 pence per share. These new ordinary shares rank pari passu in all respects with the existing issued Ordinary Shares. Application will today be made to the UK Listing Authority and to the London Stock Exchange for these 485,185 new Ordinary Shares to be admitted to the Official List and to trading on the London Stock Exchange's market for listed securities respectively. Admission is expected to become effective and dealings in the new Ordinary Shares are expected to commence on 6 October 2006. Commenting on the news, Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: 'We have a strong and successful working relationship with FFB and we are delighted that they, together with a consortium of investors, have recognised the broad potential of Oxford BioMedica's LentiVector(R) gene delivery system for the treatment of a range of eye diseases. FFB support will ensure that our expanded ocular programme will move quickly towards clinical evaluation' Gordon Gund, Co-founder and Chairman of the Board for the Foundation Fighting Blindness, added: 'We are delighted that this partnership with Oxford BioMedica is accelerating promising treatments for AMD, Stargardt disease, and other retinal degenerative diseases into clinical trials. Our collaborations with innovative biopharmaceutical companies such as Oxford BioMedica are greatly enhancing our ability to get preventions, treatments, and cures out to the millions of people who need them.' -Ends- For further information, please contact: Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: Lisa Baderoon/Mark Court/Mary-Jane Johnson Buchanan Tel: +44 (0)20 7466 5000 Communications Scientific/Trade Press Enquiries: Katja Stout/Gemma Bradley/Susan Yu Tel: +44 (0)20 7886 8150 Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes two candidates in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. A Phase III trial in renal cancer with TroVax, the lead cancer immunotherapy candidate, is expected to start in the second half of 2006. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical development in 2006, and four further preclinical 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 in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, VIRxSYS and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. RetinoStat(R) RetinoStat is Oxford BioMedica's novel gene-based treatment for wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). The product uses the LentiVector system to deliver genes to the retina that block the formation of new blood vessels. Oxford BioMedica has exclusive rights to two proprietary anti-angiogenic genes, angiostatin and endostatin, for use in treatments of ocular diseases under a licensing agreement with Entremed Inc. The Company has evaluated both genes in its RetinoStat programme. The optimised version of the product, which will proceed to clinical development, carries both the angiostatin and endostatin anti-angiogenic genes and shows significantly greater efficacy than versions containing single genes. Preclinical development is being conducted in collaboration with the Institute of Ophthalmology, London, UK, and Johns Hopkins University School of Medicine, Baltimore, Maryland, USA, with support from the Foundation Fighting Blindness. The Company plans to start clinical trials with RetinoStat in wet AMD in 2007. 3. Age-related macular degeneration and other retinopathies Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are major causes of blindness in the developed world. AMD affects an estimated 25-30 million people in the western world and DR affects approximately 50% of all Americans diagnosed with diabetes. It is estimated that there are 17 million diabetics in the USA. AMD is the most common cause of visual loss in the elderly. DR is the most common cause of visual loss in the working population and is the most common cause of acquired blindness in people under 60 in the developed world. Both wet AMD, the form of AMD which accounts for 90% of all severe vision loss from the disease, and DR are caused by aberrant growth of leaky and disruptive blood vessels in the retina. This growth is caused by a hyper-response to localised regions of low oxygen arising from compromised blood supply within the retina. Oxford BioMedica has shown that its LentiVector technology can target these regions of the eye with great accuracy and deliver anti-angiogenic proteins to treat these diseases. Analysts' estimates, published in the Wall Street Journal, suggest that sales of an effective treatment for macular degeneration could exceed US$1 billion per annum. 4. The Foundation Fighting Blindness The Foundation Fighting Blindness, Inc. (FFB) has a mission to drive the research that will provide preventions, treatments and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases. The Foundation has funded thousands of research studies at hundreds of prominent institutions. The Foundation funds leading-edge research in promising areas such as genetics, gene therapy, retinal cell transplantation, artificial retinal implants, and pharmaceutical and nutritional therapies. Since its inception in 1971, the Foundation has raised over US$240 million. FFB is ranked as a 'Top-Rated' charity by the American Institute of Philanthropy and was named one of Worth Magazine's '100 Best Charities.' Further information is available at www.fightblindness.org 5. The National Neurovision Research Institute The mission of the National Neurovision Research Institute (NNRI) is to accelerate the translation of laboratory based research into clinical trials for treatments and cures of retinal degenerative diseases. NNRI is a newly established non-profit entity, a support organization of the Foundation Fighting Blindness (FFB). The mission of the NNRI is to accelerate the translation of laboratory based research into clinical trials for treatments and cures of retinal degenerative diseases. It is a medical research institute that will obtain support from government agencies, corporations and private foundations. It may also receive royalties or licensing fees from the drug discovery processes and commercialization of new therapies. Further information is available at www.nnri.info/index.htm 6. Stargardt disease (STGD) STGD is the most common juvenile degenerative retinal disease with a US and EU population of approx. 50 000 cases and an incidence of 1/10 000 (= 600 new cases /year). Autosomal recessive STGD is a juvenile-onset macular dystrophy. Age of onset is typically 8-12 years with severely decreased visual acuities developing within nine years of onset. Presentation includes increased blindspots, and reduced ability to adapt to dark after sunlight exposure. Impact is confined to loss of central vision analogous to AMD. This information is provided by RNS The company news service from the London Stock Exchange
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