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).

In a statement issued yesterday, Sanofi said its 2003 petition urging the FDA to delay generic versions of Lovenox was legal and “brought legitimate and important patient safety facts and considerations” to the agency’s attention.