LONDON, July 11 Silence-Therapeutics
LONDON, July 11 /PRNewswire/ -- Silence Therapeutics plc
(London AIM: SLN), a leading European RNA interference (RNAi) focused
biotechnology company, announced today the successful opposition of a
fundamental Alnylam Pharmaceuticals, Inc. European patent resulting in the
patent being revoked in its entirety.
The Opposition Division of the European Patent Office, following a three
day hearing, announced its decision to revoke European Patent EP 1 230 375,
exclusively licensed to Alnylam Pharmaceuticals from Cancer Research
Technology, Ltd (UK). The Patent, commonly referred to as the "Glover"
patent, broadly relates to medicaments comprising an RNA interference
mediating RNA molecule.
Opposition briefs to the Glover patent had been filed by Silence
Therapeutics AG, Sanofi-Aventis Deutschland GmbH, Quark Biotech, Inc., Sirna
Therapeutics, and Nucleonics, Inc. In the course of the oral hearing which
lasted from July 08 to July 10, 2008, Cancer Research Technology Ltd. filed a
total of seven auxiliary requests so as to defend the patent in a limited
manner. None of these requests was able to overcome the concerns of the
Opposition Division that the patent was legally invalid. Cancer Research
Technology and Alnylam are expected to appeal the decision.
Jeff Vick, Chief Executive Officer of Silence Therapeutics, said, "The
Glover patent was arguably Alnylam's broadest patent and the successful
opposition represents an important victory for us in allowing us to maintain
our Freedom to Operate. We have long believed that this patent would be
revoked and are very pleased with the outcome. This decision by the European
Patent Office further strengthens our leading position in the field of RNA
interference."
Notes to Editors:
About Silence Therapeutics plc (http://www.silence-therapeutics.com)
Silence Therapeutics plc (AIM: SLN) is a leading European RNAi focused
biotechnology company. RNAi can selectively 'silence' genes linked to the
onset of disease. RNAi is a Nobel Prize winning technology and one of the
most promising areas of drug discovery and development today.
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.
Silence's lead internal product, Atu027, is a proprietary AtuRNAi molecule
in preclinical 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.
Silence plans a regulatory filing in 2008 to commence clinical trials for
Atu027.
In March 2008 Silence Therapeutics announced a collaboration with
AstraZeneca (LSE: AZN) 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.
In July 2007, Silence Therapeutics formed its first research and
development collaboration with AstraZeneca to develop novel AtuRNAi
therapeutics against five specific targets, including those in respiratory
indications. 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 the clinic in early 2007. Silence Therapeutics also has
licensed to Quark rights to the AtuRNAi structure for Quark's proprietary
compound, AKIi-5, which is in a Phase I human clinical study for treatment of
acute kidney injury. In May 2008 the U.S. Food and Drug Administration (FDA)
approved an Investigational New Drug application (IND) from Quark for another
siRNA product based on Silence's unique proprietary chemistry. The product,
DGFi, which uses the same AtuRNAi molecule as AKIi-5, was discovered and is
being developed by Quark for use in prevention or treatment of delayed graft
function in kidney transplantation.
Silence Therapeutics is based in London, UK, and Berlin, Germany, and is
listed on AIM.
About RNAi
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.
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.
SOURCE Silence Therapeutics plc