Novo ramping up hemophilia drug production with $100M investment in Danish site
- Novo Nordisk plans to invest 650 million Danish krones, or about $100 million, in its production site in Kalundborg, Denmark, to upgrade and expand the facilities. The company expects the project to complete in 2020.
- Currently manufacturing diabetes treatments such as insulin, the rebuilt facility will produce active pharmaceutical ingredients for Novo's hemophilia drug NovoSeven and future products for treating the blood disorder, according to Novo's most recent annual report.
- The Kalundborg site also houses production facilities for Novozymes, a Novo spinout that manufactures industrial enzymes, microorganisms and biopharmaceutical ingredients.
Novo Nordisk Kalundborg is the largest insulin production facility in the world, manufacturing around half of the global insulin supply. The site, with its 1.2 million square meters of production area across 14 factories, received 14.1 billion Danish krones in investments between 2000 and 2016, according to Novo.
Investments over the last few years have come as pressures from the diabetes market squeezed Novo's bottom line. Like other diabetes drug developers, the company has faced declining sales as well as backlash over insulin pricing. Toward the end of last year, Novo reduced its workforce by more than 600, while north of 2,000 planned or carried out layoffs have come about since September 2016.
Along with those diabetes headwinds, Novo is contending with fierce competition in another core business area: hemophilia.
Analysts expect Roche's Hemlibra (emicizumab) — which is approved in both the U.S. and Europe as prophylaxis for hemophilia A patients with or without Factor VIII inhibitors — to disrupt the hemophilia market and diminish sales for products like NovoSeven (coagulation Factor VIIa [Recombinant]) and Takeda's Feiba (anti-inhibitor coagulant complex).
Gene therapies and the promise of a one-time treatment for hemophilia are advancing as well, creating even more competitive threats.
One such therapy from BioMarin Pharmaceutical has dramatically reduced bleeding rates in clinical tests of hemophilia A patients. Roche, meanwhile, almost has its hands on two last-stage hemophilia gene therapies through a planned acquisition of Spark Therapeutics.
Novo isn't sitting idle in hemophilia, however. The Food and Drug Administration in Februrary approved the company's long-acting Factor VIII concentrate, Esperoct (turoctocog alfa), though it can't launch before 2020 because of third-party intellectual property agreements.
Also in Novo's pipeline is a monoclonal antibody called concizumab, which targets both hemophilia A and B and is in Phase 2 testing.
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