SNY Sanofi

By Denise Roland 

A ruling by a U.S. judge to permanently block the sale of Sanofi SA's new cholesterol-lowering drug could deal a blow to the French drugmaker's ambitions for what it hoped would become a blockbuster product.

Sanofi shares were down 2.8% at EUR76.07 ($80.63) Friday afternoon in Paris.

The drug, called Praluent, was found late Thursday to infringe a patent held by Amgen Inc. for the U.S. company's rival medicine Repatha. Both drugs belong to a new, powerful class of cholesterol-lowering medicines known as PCSK9s and were approved within weeks of each other in 2015.

For Sanofi, the stakes are high: It is leaning heavily on Praluent and a clutch of other recently launched drugs to offset a sharp decline in sales from its best-selling insulin medication Lantus. Analysts expect Praluent eventually will generate around $3 billion a year, though that revenue would be shared with Regeneron Pharmaceuticals Inc., who co-developed the drug.

The French drugmaker said it would immediately appeal the decision, a move that could delay any block from the U.S. market by up to one year, according to Citi analyst Peter Verdult.

In a worst-case scenario for Sanofi, that appeal would be unsuccessful and it would be forced to withdraw Praluent from the market, but analysts have placed a higher likelihood on a ruling that Sanofi must pay Amgen a royalty of 15% to 20% on sales of Praluent.

Even so, Praluent hasn't lived up to its initial promise. Both it and Repatha have struggled to gain momentum in the U.S. market, in part because the PCSK9s have yet to prove that they are more effective at reducing the risk of heart attack, stroke and other serious cardiovascular problems than the much less costly statins.

Sanofi is running a large clinical trial that it hopes will show Praluent significantly lowers cardiovascular risk compared with statins and drive higher demand for the drug. But should that trial fail, it may not be financially worthwhile for Sanofi to consider a high royalty payment to Amgen, according to Leerink analyst Seamus Fernandez.

Write to Denise Roland at Denise.Roland@wsj.com

(END) Dow Jones Newswires

January 06, 2017 08:26 ET (13:26 GMT)

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