Patent dispute could force Sanofi's Praluent off market

A legal challenge by Amgen against Sanofi and Regeneron could be so successful it could end in its rivals' PCKS9 drug Praluent forced off the market.

Amgen has just won its patent case in the Federal Court in Delaware, a jury deciding that Sanofi and Regeneron's Praluent (alirocumab) infringed on two patents on Amgen's competing drug Repatha (evolucumab).

The decision gives Amgen the upper hand in a hard fought battle for dominance in the new drug class, with both drugs having been forecast to earn billions in peak sales revenues.

Sanofi and Regeneron say they will appeal against the decision, but one analyst from Chardan says there is a 'reasonably likely' chance that Praluent could be pushed out of the market entirely.

If a royalty agreement between both pharma companies is not reached, a further case for a permanent injunction that could block Praluent sales in the US will take place later this month.

The Chardan analyst, Gbola Amusa, believes this could ultimately mean Praluent will be forced off the market altogether. Amusa had already correctly predicted that Sanofi and Regeneron may have to pay Amgen royalties because of patent disputes.

However many analysts believe Amgen's injunction bid will fail, with an eventual royalty agreement between both parties somewhere between 5% and 20% a more likely outcome.

Were a royalty agreement to be reached, and Praluent sales to increase as expected, Sanofi and Regeneron may be forced to pay up to 20% of its revenues to Amgen.

Although both drugs are highly effective at lowering LDL cholesterol, both Repatha and Praluent sales have so far failed to take off. Restrictions from payers in the US are a factor, with patients having to prove they cannot be treated with the much cheaper generic statin drugs. Both Repatha and Praluent are priced around $14,000, but currently lack data to prove they can prevent heart attacks and stroke.