SLN.L Regulatory News (SLN)

15 Jun 2006 12:00

SR Pharma plc establishes GMP production with partners for its lead RNAitherapeutic product, Atu027.June 15 2006 - London - SR Pharma plc (London LSE: SPA) announces that itsoperating subsidiary Atugen AG, has established collaborations with Genzyme,BioSpring and OctoPlus to manufacture and formulate its lead RNAi therapeuticproduct Atu027 to GMP standards.Atu027 is a siRNA based anti-cancer drug, that is on track to enter initialclinical trials in the first half of 2007. Establishing GMP manufacturing ofthis complex drug is a major step forward in the product's development andpotential out-licensing.Genzyme Pharmaceuticals, is an experienced US based manufacturer of liposomalproducts. It has successfully completed the GMP production of two of the maincomponents of the delivery system for Atu027, namely the cationic lipid AtuFECTand the fusiogenic lipid.BioSpring GmbH, is a well established German based oligonucleotidemanufacturer. It is conducting the GMP standard manufacturing of theproprietary siRNA molecules that are the main active ingredients of Atu027.OctoPlus Development B.V.is a Dutch based, world leading pharmaceuticalformulation operation. It will scale-up the GMP formulation of the componentingredients within Atu027.In combination, these suppliers will provide product for the forthcomingpharmacokinetic and toxicology studies as well as the planned clinical studies.Completion of the pre-clinical trials of Atu027 later this year will providethe basis for the Company to progress third party out-licensing deals for thegeneral RNAi delivery system (AtuPLEX) used in Atu027 as well as permitting SRPharma to start the first phase I clinical trial of Atu027 during the firsthalf of 2007.Iain Ross, Executive Chairman of SR Pharma, stated: "Atugen is rapidly movingforward towards testing the clinical applications of Atu027 and towardsdelivering some potential commercial out-licensing applications for its drugdelivery system AtuPLEX. Consultation with the German regulatory agency fordrug approval (BfArM) will be held shortly to define the final steps beforeentering the clinic with Atu027."SR Pharma (www.srpharma.com)SR Pharma plc is a European biopharmaceutical company, listed on AIM. TheCompany has two operating subsidiaries Atugen AG (www.atugen.com) based inBerlin, Germany and Stanford Rook Ltd based in London, UK.Atugen is a leader in RNAi therapeutics. This Company has developed novel,chemically modified proprietary siRNA molecules ("AtuRNAi") and a proprietarydelivery system ("AtuPLEX") both of which have advantages over conventionalsiRNA molecules and their delivery systems. Currently Atugen and itscollaboration partners have lead molecules in pre-clinical development for avariety of therapeutic indications. Clinical development of AtuRNAi therapeuticmolecules for systemic applications in Atugen's oncology programs are targetedto start in 2007. Other AtuRNAi therapeutic programs of Atugen's collaboratorsare scheduled to commence in 2H 2006.Stanford Rook Ltd is an immunotherapy based company which owns a proprietaryMycobacterium vaccae-based technology and related products, which have beenevaluated in clinical trials for the treatment of asthma, cancer andtuberculosis. In addition this Company has a number of other proprietaryimmunotherapeutic compounds and related intellectual property. Currently theCompany is in discussions with third parties regarding the co-development andout-licensing of M. vaccae and related products.Forward-Looking StatementsThis press release includes forward-looking statements that are subject torisks, uncertainties and other factors. These risks and uncertainties couldcause actual results to differ materially from those referred to in theforward-looking statements. All forward--looking statements are based oninformation currently available to SR Pharma and SR Pharma assumes noobligation to update any such forward-looking statements.Enquiries:For further information, please contact the following:SR Pharma plc Atugen AG +44(0)20 7307 1620 +49(0)30 9489 2800 Iain Ross, Executive Chairman Thomas Christĩly, CEO Melvyn Davies, Finance Director Dr. Klaus Giese, CSO Northbank communication +44(0)20 7886 8150 Sue Charles Rowan Minnion ENDSR PHARMA PLC