Sanofi cuts outlook after FDA approves Lovenox copy

Sanofi-Aventis SA said profit may fall this year after US regulators approved a generic rival to its Lovenox blood thinner. Earnings per share at France’s biggest drugmaker will be unchanged at best and may decline as much as 4 per cent at constant exchange rates this year, Sanofi said in an e-mailed statement late Friday. The Paris-based company’s previous estimate was for a gain of 2 per cent to 5 per cent. Novartis AG and Momenta Pharmaceuticals Inc. won US permission on Friday for a lower-cost copy of Lovenox, ending a five-year wait to challenge the $3.9bn-a-year product. Lovenox, an injection used to help prevent blood clots that can cause strokes, was Sanofi’s second-biggest product last year.

The French drugmaker “has reservations” about the approval, Sanofi said in the statement. The company “is concerned by potential implications to patient safety, since the product approved has not been subjected to extensive clinical trials to demonstrate its efficacy and safety.” Chief Executive Officer Chris Viehbacher, who joined Sanofi in 2008, sought new products, shut plants and canceled the least promising research projects in a bid to trim €2bn ($2.46bn) in costs as competition from generic drugs hurts sales. He pledged that 2013 earnings would be at least equal to 2008 profit.