Alnylam lays down plans for commercial RNAi manufacturing plant
In its end of year report, Alnylam Pharmaceuticals announced it bought the undeveloped land in Norton, Massachusetts, for around $8m (€7.2m) last week where it intends to build a manufacturing facility for its clinical and commercial drug products, including siRNAs (small interfering RNA) and siRNA conjugates.
The firm said in the filing it expects the transaction to close in the first quarter 2016, and to incur approximately $100m in expenditures related to the planned facility during the year, something management reiterated during a call discussing results last week.
Dawn of siRNA commercialisation
The news comes as Alnylam prepares to submit its lead therapy patisiran (ALN-TTR02), an intravenously administered RNAi therapeutic to treat the inherited disease Transthyretin (TTR)-mediated amyloidosis.
“We're entering the dawn of our commercial transition with planned regulatory submissions in 2017 for patisiran approval,” said CEO John Maraganore.
If successful, Alnylam would become the first company to commercialise an siRNA therapy, something predicted by drug discovery pioneer Kathryn Whitehead from Carnegie Mellon University in Pittsburgh, PA.
“Alnylam’s work has been exciting and validating for those in the siRNA delivery field, because it shows that a long-term commitment to a challenging therapeutic platform can result in new therapies for patients in need,” she told this publication in October last year.
A new facility also represents the latest stage in a turnaround for Alnylam which – following the ending of its alliance with Novartis – spent the first part of this decade reducing its headcount.
Furthermore, the company has grown through the acquisition of Merck & Co. subsidiary Sirna Therapeutics for $175m, and been boosted by investments from French Biopharma firm Sanofi who owns a 12% stake in Alnylam.
