THOUSAND OAKS (dpa-AFX) - The European Patent Office ruled in in favor of Sanofi (SNYNF, SNY) and Regeneron concerning Praluent or alirocumab. The ruling also invalidates Amgen's European patent claims directed to PCSK9 antibodies relevant to Praluent, Sanofi said in a statement.
Praluent will continue to be available in European countries where it is approved for use and for sale.
Sanofi possesses sole rights for Praluent outside the U.S. Regeneron has sole rights for Praluent inside the U.S. Each party is solely responsible for funding development and commercialization expenses in their respective territories.
Praluent is not available in Germany, following an injunction granted by the Düsseldorf Regional Court in July 2019. Sanofi has appealed the decision, and a hearing for the appeal is scheduled for November 5, 2020.
Praluent is approved in more than 60 countries worldwide across the European Union (EU), North and South Americas, Asia, Africa and Australia.
In the European Union, Praluent is approved for use in adults: with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin.
Copyright RTT News/dpa-AFX
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