Sanofi and Regeneron will be able to continue to sell their cholesterol-lowering drug Praluent in the US while its legal dispute with rival Amgen wends its way through the courts.
That was the verdict of the Federal Court of Appeals yesterday, when it suspended a permanent injunction on Praluent sales, awarded last month, which followed an earlier victory for Amgen as it defended patents on its rival drug Repatha (evolocumab).
Both drugs are PCSK9 inhibitors that have been approved in the US to help patients who cannot meet their cholesterol targets with existing therapy, such as statin drugs, or who have inherited disorders that cause elevated cholesterol.
Praluent was approved in the US first, but Amgen has so far won the key rounds in the legal dispute over PCSK9 inhibitor intellectual property rights. If the injunction had not been suspended, Sanofi would have had to cease marketing Praluent on 21 February.
"This decision is important for patients in the US who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments to best meet their individual needs," said Karen Linehan, Sanofi's general counsel.
Aside from taking issue with Amgen's patent infringement claims, Sanofi and Regeneron have argued that driving Praluent off the market will do patients a disservice, as it will deprive some of a lower-cost 75mg formulation of a PCSK9 inhibitor.
Repatha comes as a biweekly 140mg injection or a 420mg monthly injection while Praluent is offered in biweekly injections of either 75mg or 150mg in the US. A monthly 300mg formulation was approved in the EU last November but has been delayed by three months in the US, with a verdict now due in April. Regeneron says most of its sales are currently for the low-dose form.
Net sales of Praluent reached $41m in the fourth quarter of 2016, with $33m of that total coming from the US, with full-year sales reaching $116m and $94m respectively. At the moment the two drugs are pretty evenly matched, with Amgen reporting $141m in sales in 2016.
Failure in the appeal process would mean Praluent being prohibited from sale for 12 years, unless the three parties could come to an agreement to keep the drug available to patients, such as a licensing and royalty arrangement.
Sanofi said during its fourth-quarter results presentation this week that its 2017 guidance covers both scenarios - Praluent staying on the market or being withdrawn.