The plant in Bagsværd, Denmark is set to be fully operational by the end of 2016 and will be run by the Chemistry, Manufacturing and Control Supply (CMC) department of Novo Nordisk.
Jesper Bøving, CMC Supply Senior Vice President told Biopharma-Reporter.com the project is an expansion of the Denmark-based pharma firm’s pilot purification-capacity and will add filtration, HPLC (high performance liquid chromatography) and centrifugation equipment.
“It is purely a facility that will purify potentially new diabetes NBE’s [New Biological Entities] – no small molecules,” he confirmed. “The plant will be making smaller batch-sizes of up to approximately 2kg.”
The investment is driven by the Novo Nordisk’s diabetes pipeline, which includes three insulin analogue compounds – Tresiba, Ryzodeg and IDegLira – that have been filed for registration, and twelve GLP-1 analogue and basal insulins for type 1 and type 2 diabetes currently in clinical trials.
“More projects and more complex projects demands more capacity as current capacity is already fully booked,” Bøving said.
GLP-1
Glucagon Like Peptides (GLPs) are used to facilitate glucose control in patients with type 2 diabetes by increasing insulin secretion, suppressing pancreatic release of glucagon and reducing liver fat content.
Novo Nordisk already has the 71% of the market in GLP-1s, with its product Victoza reporting worldwide sales of 1.6bn Danish Kroner ($2.1bn) in 2013.
However, AstraZeneca is looking to increase its market share with its product Bydureon, whilst Eli Lilly is hoping to make an impact with its dulaglutide GLP-1 drug predicted by the firm to be approved later this year.