Regulatory Affairs

Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims

Published 23 April 2018

Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.

The settlement also resolves claims asserted by Dicerna in a lawsuit against Alnylam in the United States District Court for the District of Massachusetts. Each party has agreed to dismiss all pending litigation between the companies, with prejudice.

Under the terms of the agreement, Dicerna will pay $25 million comprised of cash and stock to Alnylam, and Dicerna will be restricted in its development and other activities relating to oligonucleotide-based therapeutics directed toward a defined set of Alnylam targets, for periods ranging from 18 months up to four years.

The settlement does not include any license to Alnylam’s GalNAc conjugate intellectual property (IP) or any licenses to any other IP from either party. Nor does the settlement include any admission of liability or wrongdoing by either company. All other settlement terms are confidential.

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today.

Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a major new class of medicines, known as RNAi therapeutics, is on the horizon.

Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made.

This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

Alnylam is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, and hepatic infectious diseases.

Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases.

Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including four product candidates that are in late-stage development.

Source: Company Press Release