WASHINGTON (dpa-AFX) - Novo Nordisk A/S (NVO) said Wednesday it secured a preliminary injunction from the District Court of The Hague against Ceban Ziekenhuisfarmacie B.V., ordering the company to immediately stop selling a compounded semaglutide nasal spray that the court found infringes Novo Nordisk's supplementary protection certificate covering semaglutide.
The court also ordered Ceban to remove references to the product from relevant listings and websites, disclose information about its commercial supply chain, and reimburse Novo Nordisk's legal costs.
Novo Nordisk said the ruling protects patients from unapproved semaglutide formulations and reinforces regulatory standards for medicine quality, safety and efficacy.
'Protecting patients means protecting the integrity of the medicines they rely on,' said John F. Kuckelman, Group General Counsel at Novo Nordisk. He added that the company will continue to pursue legal action against parties marketing unapproved semaglutide products or unlawfully exploiting its innovations.
The company noted that compounded medicines are not reviewed or approved by regulatory authorities such as the European Medicines Agency or the U.S. Food and Drug Administration and do not undergo the clinical testing required to demonstrate safety, efficacy and manufacturing consistency.
Novo Nordisk said it does not manufacture, distribute or endorse compounded semaglutide products and emphasized that no nasal spray formulation of semaglutide has been approved by any regulatory authority.
Semaglutide is the active ingredient in Novo Nordisk's approved medicines Wegovy, Ozempic and Rybelsus.
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