Sanofi, Regeneron ordered to cease Praulent sales

Two pharmaceutical giants — Sanofi and Regeneron — face a forced marketing shutdown of a high-priced cholesterol medication following a decision recently handed down by a U.S. District Court in Delaware ruling patent infringement of another medication.
Marketing of Praulent (alirocumab), a drug designed to lower cholesterol, was ruled to violate patents owned by competing firm Amgen for its Repatha (evolocumab) product, said a U.S. District Court judge. Consequently, policy governing the distribution and pricing of Repatha — the only other drug on the market of that class — stands to be impacted, with potential challenges to keep Repatha’s costs affordable.
While both brands have been demonstrated more effective in lowering LDL cholesterol levels than statin-type drugs, JAMA published a report last summer indicating that “the price would need to be reduced by more than two-thirds to meet acceptable cost-effectiveness thresholds.”
Politico reported that the permanent injunction against the drug will take effect in 30 days to allow Sanofi and Regeneron a chance to appeal or reach a settlement with Amgen.
Praulent was the first PCSK9 inhibitor approved in the U.S. for cardiovascular patients; the companies both plan to appeal the Jan. 5 ruling.
"We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position," Regeneron senior vice president, general counsel and secretary Joseph LaRosa.