SLN.L Regulatory News (SLN)

6 Jun 2006 07:00

SR Pharma plc announces a key technical breakthrough with its lyophilized (dry powder) liposomal-based siRNA formulation June 6th, 2006 - London - SR Pharma plc (London LSE: SPA), a leader in thedevelopment of RNAi Therapeutics, has announced that it has made a technicalbreakthrough in the formulation of siRNA drugs, that enables its proprietarylyophilized (freeze dried) liposomally formulated siRNA (AtuRNAi) drugs to bestored at room temperature and reconstituted in one simple step, thus providingsignificant benefits, most notably extended shelf life and ease ofadministration.To date, the AtuRNAi and liposomal components of AtuRNAi drugs have needed tobe separately lyophilized (freeze-dried), reconstituted and then combined, in amulti-step process. The new SR Pharma process enables siRNA drugspre-formulated as liposomal nanoparticles to be freeze-dried and then simplyreconstituted with water immediately prior to patient administration with noadditional preparation steps such as sonication being required."This is a significant breakthrough in the manufacture of siRNA drugs. A drypowder formulation extends the shelf-life and simplifies the distributionchain, with the one-step reconstitution process enhancing ease ofadministration. We will be applying this technology to the manufacture of ourproducts as we take our siRNA drugs forward towards the clinic." said Dr KlausGiese, CSO of SR Pharma."Details of the new process were presented at recent scientific conferences(TIDES in Carlsbad, CA, May 1-4 2006 and RNAi in Boston, MA, April 3-5 2006).The presentations showed how this stable and lyophylised dry powder drugformulation only required the addition of water to rehydrate the drug andprepare it for injection. (see www.srpharma.com/science/presentations.htm).Iain Ross, Executive Chairman of SR Pharma, stated: "This new breakthrough inthe manufacturing process of liposomal-based formulations of siRNA basedproducts underlines the leadership position of SR Pharma in the emerging sectorof RNA interference and drug delivery". - ends- 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