Orphan Drug Designation

22 Jun 2006 07:00

VASTox plc22 June 2006 VASTOX RECEIVES POSITIVE ORPHAN DRUG DESIGNATION OPINION FROM THE EMEA FOR ITS DUCHENNE MUSCULAR DYSTROPHY THERAPY Oxford, UK, 22 June 2006 - VASTox (AIM: VOX), a leading chemical genomicscompany, announces today that the European Medicines Agency (EMEA) hasrecommended awarding orphan drug designation for the company's initial compoundfor the treatment of Duchenne muscular dystrophy (DMD). The orphan drug application has received a positive opinion from the Committeefor Orphan Medicinal Products (COMP) of EMEA. VASTox expects the formal approvalfrom the European Commission within the next 30 days. The European Commissionhas never failed to ratify a positive opinion from EMEA. Orphan drug designation in Europe provides VASTox with ten years of marketexclusivity following market approval. This protection is in addition to anyintellectual property rights that cover the product which is marketed. Inaddition, the designation provides VASTox with support and assistance throughoutthe drug development process, including waiving significant regulatory costsbefore a drug reaches the market. EMEA grants orphan drug designation to medical products that satisfy a number ofcriteria, including the severity of the disease for which they will be used, theprevalence of the disease in Europe and the lack of alternative treatments.Duchenne muscular dystrophy satisfies these criteria and VASTox was able to showthat the company's approach to treat this condition (i.e. the up-regulation ofutrophin) could be of significant benefit to these patients for which there areat present very limited treatment options. DMD is the company's most advanced drug development programme. At present thecompany is working on selecting a lead drug candidate. This important milestoneis expected to be reached by Q1 2007, with clinical trials forecast to start ayear afterwards. Steven Lee, PhD, CEO of VASTox said: "I am very pleased that VASTox has receivedthis positive opinion from the Committee for Orphan Medicinal Products.Receiving orphan drug designation is an important step for the company; itvalidates our unique approach to the treatment of Duchenne muscular dystrophywhile at the same time it will reduce the costs of developing what we hope willbe a major advance in the treatment of this devastating neuromuscular disease." - ends - For more information please contact: VASToxSteven Lee, PhD, Chief Executive Officer Tel: +44 (0)1235 443910Darren Millington, Chief Financial Officer Citigate Dewe Rogerson Tel: +44 (0)207 638 9571David Dible / Mark Swallow / Valerie Auffray About VASTox plc VASTox is a chemical genomics technology company that discovers and developsproprietary novel drugs and provides services to the pharmaceutical industry.The company's most advanced drug development programme is focused on developinga new treatment for Duchenne muscular dystrophy based on the up-regulation ofutrophin. A second drug development programme for spinal muscular atrophy isalso progressing rapidly. VASTox has three additional programmes focused onosteoarthritis, cancer and tuberculosis that are expected to be out-licensedprior to entering the clinic. The company's technology platform, which uses zebrafish and fruitflies, has thepotential to dramatically decrease the time and cost of drug discovery anddevelopment. This is because using whole organisms allows it to carry out highvolume, high content screening that delivers data which is highly predictive ofthe efficacy and toxicity of potential drug compounds in humans. VASTox isgrowing revenues based on marketing its unique technology platform and itschemistry expertise. The company listed on the AIM market of the London StockExchange in October 2004. Further information about the company is available at www.vastox.com. 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