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Sanofi-aventis settles Eloxatin lawsuits

Sanofi-aventis has announced it has settled lawsuits with three companies regarding generic versions of colon cancer drug, Eloxatin

Sanofi-aventis (S-A) has announced it has settled lawsuits with three companies regarding generic versions of colon cancer drug, Eloxatin (oxaliplatin) in the US.

Settlement agreements have been reached with drugs manufacturers Teva Pharmaceuticals, Fresenius Kabi and Sandoz, with the sale of generic Eloxatin products to be ceased by June 30, 2010. Selling will be able to resume on August 9, 2012 under a license to re-enter the market.

In their own statement though, Israeli based Teva said this market re-entry date "is subject to acceleration under certain contingencies".

The agreements follow a US appeal court ruling in August 2009 to suspend approvals of generic versions of Eloxatin. This was after French pharmaceutical company, S-A contested the US Food and Drug Administration's (FDA) decision to approve copies of the treatment – at the time, its fifth biggest selling medicine.

S-A, who hold patent rights for the drug along with Swiss-based Debiopharm, did not give any other details regarding the recent settlements, including financial.

The settlement agreements are subject to review by the Federal Trade Commission, the US Department of Justice and the Attorney General for the State of Michigan.

Eloxatin is used to treat advanced forms of colon cancer, as well as in post-surgical treatment of the disease, and remains one of S-A's biggest sellers in the US.

1st April 2010

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