Novo Nordisk invests in haemophilia franchise

Novo Nordisk has started work on a 1.5 billion kroner ($225 million) manufacturing facility in Denmark to support the expected growth in its haemophilia franchise.

Once fully operational in 2020, the 7,500 sq. m. facility in Kalundborg will add 100 production and engineering jobs in the town, where more than 2,800 Novo Nordisk workers are already employed, said the company.

The unit will be the primary production unit for the active ingredient in NovoSeven (recombinant human coagulation factor VIIa), which is used to treat several bleeding disorders and achieved sales of more than 9 billion kroner last year, said the company.

In time the plant will also be used to make products in Novo Nordisk’s haemophilia pipeline, which includes long-acting factor VIII product N8-GP (turoctocog alfa) for haemophilia A and N9-GP (glycopegylated recombinant factor IX) for haemophilia B, both of which are in phase III testing.

The company said in its first-quarter results presentation that a marketing application for N8-GP will depend on an increase in production capacity and is expected in 2017/2018, while N9-GP is due to be filed later this year.

The investment comes at a time of considerable disruption in the haemophilia market, with well-established therapies from the likes of Baxter and Pfizer facing competition from new players such as Biogen, which secured approval for long-acting haemophilia A therapy Eloctate and Alprolix for haemophilia A last year.

NovoSeven was Novo Nordisk’s first haemophilia drug to get approved and over many years has carved out a niche treating haemophilia patients who stop responding to other drugs, as well as some rare indications such as congenital factor VII deficiency and Glanzmann’s thrombasthenia.

It is, however, starting to show its age, prompting the company to try to expand its franchise with the launch of new products including NovoEight for haemophilia A – currently available in Japan and Europe – and NovoThirteen/Tretten (catridecacog) for congenital Factor XIII A-subunit deficiency.

The company suffered a disappointment in 2012 when it was forced to drop a long-acting Factor VIIa therapy called vatreptacog alfa after patients in trials developed inhibitory antibodies to the drug.

Novo Nordisk’s first-quarter sales rose 24 per cent to 25.2 billion kroner – driven by its modern insulin franchise and Victoza (liraglutide) for diabetes – with haemophilia sales rising 21 per cent.

The Danish drugmaker recently narrowed its R&D to focus more on core projects in diabetes, obesity and haemophilia, exiting autoimmune and inflammation research.

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