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 accepted Alnylam's enzymatic ligation manufacturing platform into its Emerging Technology Program, fast-tracking global regulatory engagement
Alnylam 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.
As 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).
"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."
Expansion in Norton, MA
The $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. The facility, which opened in 2021, has played a key role in the growth of Alnylam's clinical pipeline and acts as a pipeline accelerator for early-stage programs, including programs targeting different tissue types (e.g., liver, CNS, muscle, adipose, etc.). This expansion will strengthen Massachusetts' position as a global hub of life sciences innovation. Construction is underway, with new capabilities expected to become fully operational by late 2027.
"Alnylam represents the world-class health care innovation Massachusetts is known for. Alnylam has been a leader in life sciences in our state for over two decades," said Governor Maura Healey. "Their scientific breakthroughs in siRNA manufacturing have transformed care by providing RNAi therapeutics to people who need it most, while creating thousands of jobs across our state. We're excited to support their growth through the expansion of a manufacturing facility in Southeastern Mass., and we're grateful for their continued investment in Massachusetts."
"Alnylam's continued investment in Massachusetts underscores the Commonwealth's role as a global leader in biomanufacturing," said Dr. Kirk Taylor, President and CEO of the Massachusetts Life Sciences Center (MLSC). "This expansion will bring high-quality jobs to this area and ensure patients worldwide have the opportunity to benefit from medicines made right here in Massachusetts. We look forward to deepening our partnership as we work together to advance the thriving life sciences ecosystem here in the Commonwealth."
A Breakthrough in Manufacturing at Scale
Alnylam's siRELIS™ platform builds RNAi therapeutics more efficiently using fewer materials and plant resources, and greatly expands capacity – making large-scale, sustainable production possible.
"Manufacturing oligonucleotide-based medicines is highly complex, and the current manufacturing technology will struggle to meet increased demand. We have successfully applied a reproducible, less time-intensive process that increases throughput while maintaining the highest quality standards," said Timothy Maines, Chief Technical Operations and Quality Officer at Alnylam. "The expansion of our Norton facility presents an opportunity to reinvent what's possible in oligonucleotide manufacturing."
About Enzymatic Ligation
Alnylam's siRELIS™ (siRNA Enzymatic Ligation Synthesis) platform is a next-generation approach to siRNA manufacturing that assembles short, high-quality RNA fragments called "blockmers" into complete molecules more efficiently than traditional methods. This scalable, sustainable platform reduces use of starting materials and reliance on organic solvents and plant time, increasing capacity in a single facility. A brief video about enzymatic ligation can be viewed here.
About Alnylam Manufacturing
Alnylam has pioneered small interfering RNA (siRNA) manufacturing at scale, building world-class capabilities in chemistry, engineering, and quality. With a legacy of firsts and a commitment to speed, safety, and sustainability, Alnylam delivers innovative RNAi therapeutics to patients worldwide. To learn more, please visit the "Making Our Medicines" page on Alnylam's website.
About RNAi Therapeutics
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 new class of medicines known as RNAi therapeutics is now a reality. 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 or disease pathway 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.
About Alnylam Pharmaceuticals
Alnylam (NASDAQ:ALNY) has led 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 and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam's commercial RNAi therapeutic products include AMVUTTRA® (vutrisiran), ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO® (lumasiran), which are being developed and commercialized by Alnylam, and Leqvio® (inclisiran) and Qfitlia™ (fitusiran), which are being developed and commercialized by Alnylam's partners, Novartis and Sanofi, respectively. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its "Alnylam P5x25" strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or Instagram.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam's expectations, beliefs, goals, plans or prospects, including, without limitation, statements regarding the planned expansion of Alnylam's manufacturing facility in Norton, Massachusetts, including Alnylam's planned $250 million investment in the expansion; the ability of Alnylam's Norton, Massachusetts facility to meet the global demand for Alnylam's RNAi therapeutics; Alnylam's ability to advance the industry's first fully dedicated, proprietary, siRNA enzymatic-ligation manufacturing facility; the potential for Alnylam's enzymatic ligation based manufacturing platform to expand manufacturing capacity, reduce production costs, enable more efficient production of RNAi therapeutics, make large-scale, sustainable production possible, and position Alnylam to invest in its pipeline and support future launches; Alnylam's ability to accelerate development of siRNA manufacturing and to change what's possible in a single facility; the potential for enzymatic ligation to be a critical enabler in the scaling of Alnylam's portfolio to include potential treatments for diseases such as hypertension, type 2 diabetes and obesity; the potential for the expansion of Alnylam's Norton facility to increase its capabilities to locally produce both clinical and commercial supply of siRNA oligonucleotide drug substance; the potential for Alnylam's new manufacturing capabilities to become fully operational by late 2027; the potential for the expansion of Alnylam's Norton facility to bring high quality jobs to the area and to ensure that patients worldwide have the opportunity to benefit from medicines made in Massachusetts; and the potential for the expansion of Alnylam's Norton facility to reinvent what's possible in oligonucleotide manufacturing should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam's ability to successfully execute on its "Alnylam P5x25" strategy; Alnylam's ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam's product candidates; actions or advice of regulatory agencies and Alnylam's ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam's approved products globally; delays, interruptions or failures in the manufacture and supply of Alnylam's product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam's ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future; Alnylam's ability to maintain strategic business collaborations; Alnylam's dependence on third parties for the development and commercialization of certain products, including Roche, Novartis, Sanofi, and Regeneron; the outcome of litigation; the risk of future government investigations; and unexpected expenditures; as well as those risks and uncertainties more fully discussed in the "Risk Factors" filed with Alnylam's 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam's subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.
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Alnylam Pharmaceuticals, Inc.
Christine Akinc
(Investors and Media)
+1-617-682-4340
Josh Brodsky
(Investors)
+1-617-551-8276