15th Oct 2009 07:05
Silence Therapeutics' core patent upheld by the European Patent Office
London, UK, 15 October 2009 - Silence Therapeutics plc , the leading European biopharmaceutical company focused on RNA interference (RNAi), announced today that the Opposition Division of the European Patent Office (EPO) has upheld its core AtuRNAi patent EP 1 527 176 (`176) in amended form.
The amended form of patent `176 covers Silence's proprietary blunt-ended small interfering RNA (siRNA) molecules containing alternating 2'-OMethyl modifications. Silence refers to this technology as AtuRNAi.
The amended claims no longer cover chemical modifications and molecular designs not used by Silence and which therefore do not have an impact on Silence's core business. The Company will consider whether to appeal this aspect of the EPO's decision, which followed two days of oral hearings.
Iain Ross, Chairman of Silence Therapeutics, said: "We are pleased that the EPO has confirmed the validity of Silence's patent claims to its core AtuRNAi chemistry. The AtuRNAi patent portfolio is just one part of Silence's strong intellectual property estate. The Company has always pursued a robust and comprehensive IP strategy based on seeking patent protection at four different levels - chemistry, RNA sequence, molecular target and delivery mechanism."
AtuRNAi molecules form the basis of Silence's therapeutic research and development collaboration with AstraZeneca, as well as the Company's licence and collaboration agreements with Quark Pharmaceuticals Inc. In addition, Silence is developing an internal, proprietary pipeline of systemically delivered AtuRNAi molecules that are initially focused on oncology indications.
Silence considers AtuRNAi to be the best-in-class siRNA molecules with important advantages over conventional alternatives. These include increased stability, lower manufacturing costs and increased yield.
On 29 September 2009, Silence confirmed that it has entered into merger discussions with another company. Those discussions are continuing. Dealings in Silence's shares will remain suspended pending the publication of an Admission Document.
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For further information, please contact the following:
Silence Therapeutics plc Powerscourt +44(0)20 7491 6520 +44(0)20 7250 1446 Iain Ross, Chairman & CEO Paul Durman Melvyn Davies, Finance Director Kay Larsen Nominated Advisers Nomura Code Securities Limited +44(0)20 7776 1200 Richard Potts Chris Collins Notes to Editors:
About Silence Therapeutics plc (www.silence-therapeutics.com )
Silence Therapeutics plc (AIM: SLN) is a leading European RNAi-focused biotechnology company.
RNA interference (RNAi), is a Nobel Prize winning technology and one of the most exciting areas of drug discovery today. It represents a completely new approach to selectively 'silence' or inactivate disease relevant genes and as such it has the potential to create a new class of therapeutic products. RNAi could therefore offer a therapeutic approach to a broad range of diseases (cancer, infectious diseases, inherited diseases), many of which have been regarded as incurable and are not addressed by current therapeutics, therefore providing a large market opportunity.
Silence Therapeutics has developed a platform of novel short interfering RNA ('siRNA') molecules, AtuRNAi, which provide a number of advantages over conventional siRNA molecules, including increased stability against nuclease degradation. In addition, the Company has developed a proprietary systemic delivery system, AtuPLEX. This system enables the functional delivery of siRNA molecules to targeted diseased tissues and cells, while increasing their bioavailability and intracellular uptake.
Following the granting of its patents in Europe, the USA and Australia, Silence Therapeutics is one of only two companies worldwide with a proprietary position on composition of matter for siRNA therapeutics.
Silence's lead internal product, Atu027, is a proprietary AtuRNAi molecule in clinical development for systemic cancer indications. Atu027 has successfully completed single and repeat dose toxicology and geno-toxicology studies, as well as a 28-day toxicology study using multiple dosing regimens. In June 2009, the Company started an open-label, single-centre, dose-escalation Phase I study with Atu027 in patients with advanced solid (malignant) tumours involving single as well as repeated intravenous administration. Atu027 specifically targets PKN3, a molecule involved in cancer growth and metastasis formation. Atu027 is Silence's most advanced clinical candidate for a systemically delivered short interfering RNA (siRNA) using the Company's proprietary AtuPLEX delivery technology.
In March 2008 Silence Therapeutics announced a collaboration with AstraZeneca
focused on the development of a range of novel delivery approaches for siRNA molecules. Under the terms of the agreement both Silence Therapeutics and AstraZeneca will be allowed to commercialize the truly novel delivery systems that the two partners develop together.
Silence Therapeutics has granted a licence to AstraZeneca to develop novel AtuRNAi therapeutics against five specific targets. This collaboration was the first industry validation of the potential application of Silence Therapeutics' proprietary AtuRNAi molecules and solidified the Company's leadership position in field of RNAi therapeutics.
The Company's AtuRNAi technology also has been sublicensed to Pfizer via Quark's license to them of the compound RTP-801i-14 for the treatment of age-related macular degeneration (AMD) and a number of other indications. This compound entered a phase II clinical study in July 2008. Silence Therapeutics also has licensed to Quark rights to the AtuRNAi structure for Quark's proprietary compound, AKIi-5 and DGFi, which are both in Phase I human clinical studies for treatment of acute kidney injury and delayed graft function in kidney transplantation respectively.
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 Silence Therapeutics and Silence Therapeutics assumes no obligation to update any such forward-looking statements.
Silence Therapeutics is based in London, UK, and Berlin, Germany, and is listed on AIM.
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