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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 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.
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