Press release
Alnylam to Invest $250 Million to Add Enzymatic Ligation Platform to U.S. Manufacturing Facility to Meet Growing Global Demand for RNAi Therapeutics
New platform is expected to substantially increase manufacturing capacity and lower production costs, enabling investment in expanding pipeline FDA has
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nNew platform is expected to substantially increase manufacturing capacity and lower production costs, enabling investment in expanding pipeline\n\n\nFDA has accepted Alnylam’s enzymatic ligation manufacturing platform into its Emerging Technology Program, fast-tracking global regulatory engagement\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the planned expansion of its state-of-the-art manufacturing facility in Norton, Massachusetts. The Company is preparing to invest $250 million to advance what is poised to become the industry’s first fully dedicated, proprietary, siRNA enzymatic-ligation manufacturing facility. This investment is expected to meaningfully expand capacity, significantly reduce production costs, and position Alnylam to support future launches across its growing pipeline of potential new medicines.\n\nAs part of the expansion, Alnylam also announced that this next-generation, scalable, enzymatic ligation manufacturing platform, siRELIS™, has been accepted into the U.S. Food and Drug Administration’s (FDA) Emerging Technology Program, accelerating dialogue with global health authorities on innovative manufacturing approaches for oligonucleotide-based medicines. This acceptance follows successful demonstration of Alnylam’s enzymatic ligation platform through production of pilot-scale batches of zilebesiran, which is being studied to reduce the risk of major adverse cardiovascular events in patients with hypertension (high blood pressure), and nucresiran, which is in development for the treatment of transthyretin-mediated amyloidosis (ATTR).\n\n“At this pivotal time with our expanding pipeline of RNAi therapeutics, Alnylam is accelerating development of siRNA manufacturing and changing what’s possible in a single facility,” said Yvonne Greenstreet, M.D., MBA, Chief Executive Officer of Alnylam. “This advance will be a critical enabler in the scaling of our pipeline to include potential treatments for diseases such as hypertension, type 2 diabetes, and obesity.”\n\nExpansion in Norton, MA\nThe $250 million expansion of Alnylam’s 200,000 sq. ft. Norton facility will increase its capabilities to locally produce both clinical and commercial supply of siRNA oligonucleotide drug substance for patients around the world. ...