US Senators accuse Sanofi over lobbying FDA on generic Lovenox

US Senate Finance Committee Chairman Max Baucus (Democrat, Montana) and senior Committee Member Chuck Grassley (Republican, Iowa) have sent a letter and a new Committee Report to the Food and Drug Administration detailing the financial relationship between the French pharmaceutical company Sanofi (Euronext: SAN) and physicians’ groups that lobbied the agency against approving generic drugs that would compete with Sanofi products.

The allegations concern Sanofi’s blockbuster drug Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), that had generated revenues of around $4.57 billion for the French drug major in 2009 but, as a result of generic competition, saw turnover drop to 583 million euros ($825 million) in the first quarter of this year. Last summer, despite Sanofi’s arguments to protect its product from competition citing safety concerns for a copy version, the FDA approved a generic version of Lovenox for Swiss drug major Novartis’ subsidiary Sandoz, which, with partner Momenta Pharmaceuticals, had been vying for five years with Amphastar Pharmaceuticals to be first to get a copy version of the blockbuster drug cleared in the USA (The Pharma Letter July 26, 2010).