Novo Nordisk said today it will build a $100 million purification pilot plant in Bagsværd, Denmark, in order to ramp up its capacity for producing the quantity of active pharmaceutical ingredients needed as the company’s diabetes drug development activity expands.
The project initially involves establishment of a pilot plant with one purification line. The facility can be expanded to the double size to further increase its capacity. Some 5 km (3 miles) of steel pipes will be used in the purification pilot plant with a total area of 2,700 square meters (29,000 square feet).
The pilot plant will be fully operational by late 2016 and be run by a unit within Novo Nordisk R&D, CMC Supply. “CMC” stands for Chemistry, Manufacturing, and Control Supply.
“The new purification pilot plant will significantly increase our capacity for early-phase diabetes projects,” Jesper Bøving, svp, CMC Supply, said in a statement. “It will create up to 35 new jobs over a two-year period, in addition to the 100 new employees CMC Supply will hire in Denmark in 2014.”
The new plant reflects renewed attention on manufacturing at the company, following a shuffle of its pipeline after FDA effectively delayed by two years the launch of two late-stage drug candidates Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).
Tresiba and Ryzodeg are two key components in Novo Nordisk’s plans for a beachhead in the long-acting basal insulin segment of the diabetes drug market. The segment is now dominated by Sanofi, whose Lantus (insulin glargine) has grown to blockbuster-level annual sales, which ni 2013 reached €5.7 billion (about $8 billion).
Novo Nordisk responded by stepping up promotion of a runner-up to Lantus, Levemir (insulin detemir), and shifting resources back into R&D from manufacturing. The company is also focusing on bringing additional pipeline drugs to market, including a revamped version of fast-acting insulin product NovoLog/NovoRapid (insulin aspart), the long-acting GLP-1 analog semaglutide, and Tresiba-based combination therapy IDegLira, which incorporates insulin degludec plus liraglutide.
[This report has been corrected from an earlier edition that included incorrect conversions for the plant's length of pipe and total area.]
