Pharmaceutical Business review

Novo Nordisk to invest $2bn in new manufacturing facilities in US and Denmark

The investment made into these facilities will see creation of about 700 new production and engineering jobs in Clayton, North Carolina where it now employs more than 700 people who make insulin products, as well as around 100 jobs are planned for the new Danish facility.

The North Carolina manufacturing plant will produce active pharmaceutical ingredients (API) for both oral semaglutide and a range of the company’s current and future GLP-1 and insulin products.

The new Danish facility will be responsible for tableting and packaging of oral semaglutide and future oral products.

Novo Nordisk Product Supply head and executive vice-president Henrik Wulff said: "With the new plant in Clayton and continuous investments in our current API production plants in Kalundborg, Denmark, we will have sufficient API capacity for diabetes products well into the next decade.

"We decided to place the new API facilities in the US for strategic reasons. The US is by far our largest market and there are many logistical and economic advantages of having a larger part of our manufacturing in our main market.

"After a thorough evaluation of multiple sites and an extensive vetting process, Clayton ended up being our preferred location.

"We already have a large and very professional organisation there and an excellent collaboration with city, local and state leadership, and we appreciate the incentives they have secured in connection with this investment."

In 2016, the company’s board of directors will present the final design and cost of the new production facilities, which are expected to be operational during 2020.

Separately, the company has announced its decision to start a phase IIIa program with oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide for the treatment of type 2 diabetes.

The global phase IIIa program, called PIONEER, includes seven trials with about 8,000 people with type 2 diabetes, including six safety and efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide.

As part of the PIONEER program, the first trial is planned for initiation in first quarter of next year and will investigate the efficacy and safety of once-daily oral semaglutide doses of 3mg, 7mg and 14mg, compared to once-daily oral anti-diabetic sitagliptin dose of 100mg.

The remaining six trials of the program are all expected to be initiated next year.


Image: Novo Nordisk Danish headquarters in Bagsværd. Photo courtesy of Jens Lindhe / Novo Nordisk.