7 Aug 2018 07:00
Silence Therapeutics litigation: patisiran EU marketing authorisation imminent
7 August 2018
Silence Therapeutics plc, (AIM:SLN) ("Silence" or "the Company") a leader in the discovery and development of novel RNA therapeutics, announces today an update on litigation matters.
On 3 August 2018, Alnylam Pharmaceuticals Inc. ("Alnylam") announced that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) had granted its RNAi medicine, patisiran, a positive scientific opinion through the Early Access to Medicines Scheme. Further to this decision, Alnylam can provide eligible adults in the UK with access to patisiran before the drug is granted EU marketing authorisation by the European Commission. Grant of the EU marketing authorisation for patisiran is imminent.
Patisiran remains accused of infringement of Silence's Intellectual Property (IP) in the United Kingdom and Portugal. Silence is still seeking injunctive relief in these territories. The UK trial is to be held in December 2018, with a decision expected early 2019.
Dr David Horn Solomon, Chief Executive Officer of Silence Therapeutics, commented: "Silence Therapeutics is a leading RNAi company, developing highly innovative medicines with life-saving potential for patients with serious and rare diseases, based upon its proprietary technology platform in GalNAc-conjugated siRNA. The Company is in a strong position to maximise the potential of its IP and technology through collaborations and the advancement of internal programmes toward the clinic. Silence's lead candidate SLN124 will move into clinical development in the coming year. With regards to IP and patents, Silence will vigorously enforce its patent estate where third parties are considered to be infringing the Company's patent rights."
Enquiries:
Silence Therapeutics plc David Horn Solomon, Chief Executive Officer Annalisa Jenkins, Executive Chair David Ellam, Chief Financial Officer
| Tel: +44 (0) 20 3457 6900 |
Peel Hunt LLP (Nominated Adviser and Broker) James Steel/ Oliver Jackson
| Tel: +44 (0) 20 7418 8900 |
Media & IR Enquiries Optimum Strategic Communications Mary Clark/ Eva Haas/ Hollie Vile silence@optimumcomms.com
| Tel: +44 (0) 20 3714 1788 |
IR Enquiries - US Burns McClellan John Grimaldi Silence.Therapeutics@burnsmc.com | Tel: +1 (212) 213 0006 |
About Silence Therapeutics plc
Silence Therapeutics is developing a new modality of genetic medicines by harnessing the body's natural mechanism of RNA interference, or RNAi, within its cells. Its proprietary technology can selectively inhibit any gene in the genome and be engineered to specifically silence the production of disease-associated proteins. Using enabling delivery systems, Silence has achieved an additional level of specificity by delivering therapeutic RNA molecules exclusively to target cells. Silence's proprietary technology platform provides an effective, safe and highly potent modular approach well suited to tackling life-threatening diseases. Silence aims on being a clinical stage company in 2019, while progressing a pipeline of earlier stage candidates against important gene targets directed at areas of high unmet medical need. In parallel, Silence continues to evolve its patent portfolio as new discoveries emerge from its innovative efforts to develop the next generation of RNAi medicines.
Silence has out-licensed technology to Quark Pharmaceuticals for use in Delayed Graft Function and Acute Kidney Injury. Both programmes are now in phase III. For more information, please visit: https://www.silence-therapeutics.com/