SR Pharma plc Announces a Key Technical Breakthrough With its Lyophilized (Dry Powder) Liposomal-Based siRNA Formulation - siRNA

SR Pharma plc Announces a Key Technical Breakthrough With its Lyophilized (Dry Powder) Liposomal-Based siRNA Formulation
June 6, 2006
Sr Pharma
LONDON, June 6 /PRNewswire/ -- SR Pharma plc (LSE: SPA), a leader in the development of RNAi Therapeutics, has announced that it has made a technical breakthrough in the formulation of siRNA drugs, that enables its proprietary lyophilized (freeze dried) liposomally formulated siRNA (AtuRNAi) drugs to be stored at room temperature and reconstituted in one simple step, thus providing significant benefits, most notably extended shelf life and ease of administration.
To date, the AtuRNAi and liposomal components of AtuRNAi drugs have needed to be separately lyophilized (freeze-dried), reconstituted and then combined, in a multi-step process. The new SR Pharma process enables siRNA drugs pre-formulated as liposomal nanoparticles to be freeze-dried and then simply reconstituted with water immediately prior to patient administration with no additional preparation steps such as sonication being required.
"This is a significant breakthrough in the manufacture of siRNA drugs. A dry powder formulation extends the shelf-life and simplifies the distribution chain, with the one-step reconstitution process enhancing ease of administration. We will be applying this technology to the manufacture of our products as we take our siRNA drugs forward towards the clinic." said Dr Klaus Giese, 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 drug formulation only required the addition of water to rehydrate the drug and prepare it for injection. (see www.srpharma.com/science/presentations.htm).
Iain Ross, Executive Chairman of SR Pharma, stated: "This new breakthrough in the manufacturing process of liposomal-based formulations of siRNA based products underlines the leadership position of SR Pharma in the emerging sector of RNA interference and drug delivery".
SR Pharma (www.srpharma.com)
SR Pharma plc is a European biopharmaceutical company, listed on AIM. The Company has two operating subsidiaries Atugen AG (www.atugen.com) based in Berlin, 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 proprietary delivery system ("AtuPLEX") both of which have advantages over conventional siRNA molecules and their delivery systems. Currently Atugen and its collaboration partners have lead molecules in pre-clinical development for a variety of therapeutic indications. Clinical development of AtuRNAi therapeutic molecules for systemic applications in Atugen's oncology programs are targeted to start in 2007. Other AtuRNAi therapeutic programs of Atugen's collaborators are scheduled to commence in 2H 2006.
Stanford Rook Ltd is an immunotherapy based company which owns a proprietary Mycobacterium vaccae-based technology and related products, which have been evaluated in clinical trials for the treatment of asthma, cancer and tuberculosis. In addition this Company has a number of other proprietary immunotherapeutic compounds and related intellectual property. Currently the Company is in discussions with third parties regarding the co-development and out-licensing of M. vaccae and related products.
Forward-Looking Statements
This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward-??looking statements are based on information currently available to SR Pharma and SR Pharma assumes no obligation to update any such forward-looking statements.