Novo Nordisk, already active in capital improvements to add manufacturing capacity to meet growing demand for its metabolic medicines, is now building infrastructure for the production of rare disease drugs with a new 8.5 billion Danish kroner (about $1.2 billion) site.
In the Monday announcement, the Copenhagen-based pharmaceutical giant said the planned new facility marks the first time in this century that the company has broken ground for a new production site in the company’s home country. The production facility and warehouse in Odense, Denmark, will span more than 40,000 square meters (about 430,556 square feet). Construction is already underway and is scheduled to finish in 2027. When complete, the site is expected to have 400 permanent jobs.
“The facility will utilize advanced technology and innovative equipment to ensure the highest quality to patients and meet the growing global demand for our life-changing medicines,” Henrik Wulff, Novo Nordisk executive vice president, product supply, quality & IT, said in a prepared statement.
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Novo Nordisk said the new production facility is designed to be modular and flexible, enabling it to accommodate multiple types of drugs within rare disease both now and in the future. At the BIO Conference this past June, John McDonald, Novo Nordisk’s global head of business development and M&A, said the company’s rare disease focus includes blood disorders such as sickle cell disease and hemophilias.
Novo Nordisk’s hemophilia portfolio includes engineered versions of clotting proteins that patients lack. The company has also developed concizumab, an antibody drug designed to bind to TFPI, preventing that protein from blocking factor Xa, a different protein that plays a role in blood clotting. The FDA turned down Novo Nordisk’s application for the drug last year, asking for more information. But concizumab has won regulatory approval for treating both hemophilia A and hemophilia B in Canada, where it is marketed as Alhemo. The drug also recently received a recommendation for approval from a European Medicines Agency committee.
Novo Nordisk’s recent manufacturing efforts have focused on metabolic medicines, specifically the GLP-1 agonists Ozempic and Wegovy. A little more than a year ago, Novo Nordisk announced plans to invest more than 42 billion Danish kroner (about $6.1 billion) to expand an existing manufacturing facility in Kalundborg, Denmark. Soon after, the company announced a 16 billion Danish kroner (about $2.3 billion) investment to expand an existing manufacturing site in France.
More manufacturing capacity is coming to Novo Nordisk in Europe and the U.S. Novo Holdings, the investment arm of the foundation that holds a controlling stake in Novo Nordisk, early this year struck a $16.5 billion deal to acquire contract manufacturer Catalent. In a separate but related transaction, Novo Nordisk agreed to acquire from Novo Holdings three Catalent sites. These sites in Italy, Belgium, and Indiana, already handle filling of vials for Novo Nordisk’s GLP-1 drugs.
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The Catalent transactions are on their way to completion. In early December, the European Commission signed off on Novo Holdings’ acquisition of Catalent. That approval also includes Novo Nordisk’s proposed acquisition of the three Catalent manufacturing sites. The commission concluded that following the merger, customers of pre-filled syringes and orally disintegrating tablets will continue to have access to other significant and credible CDMOs. Over the weekend, Novo Nordisk said the requirements for U.S. regulatory review of the deal have been fulfilled. The company said it expects the acquisition will be complete in the coming days.
Image by Novo Nordisk