Alnylam picks Agilent to make API for lead RNAi candidate
Alnylam Pharmaceuticals noted in an SEC filing it has entered into a five-year manufacturing services agreement for commercial supply of patisiran drug substance with Agilent.
“Agilent has agreed to manufacture and supply to the Company [Alnylam], and the Company has agreed to purchase from Agilent… a specified percentage of the active pharmaceutical ingredients [APIs] required for patisiran for commercial sale,” Alnylam said.
Alnylam will be required to provide an initial payment to cover raw material purchases and reserve appropriate resources, though figures were not disclosed.
Technology and manufacturing firm Agilent has a 69,000 sq ft GMP commercial API facility located in Boulder, Colorado.
Patisiran (ALN-TTR02), an intravenously administered RNAi therapeutic to treat the inherited disease Transthyretin (TTR)-mediated amyloidosis, is Alnylam’s lead therapy and is being developed in a $700m alliance with Sanofi’s Genzyme division inked in 2014.
Designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made, the Phase III therapy received US Food and Drug Administration (FDA) breakthrough designation last November.
Alnylam holds the commercialisation rights to patisiran in the US, Canada and Western Europe, while Sanofi Genzyme aims to commercialise the product in the rest of the world.
