Sanofi has agreed to a $315 million payout in an aging lawsuit alleging that the drugmaker failed to use "diligent efforts" to advance development of a former Genezyme multiple sclerosis drug that would have resulted in payouts to shareholders.
When Sanofi merged with Genzyme Corporation in 2011, Genzyme had been conducting clinical trials for the multiple sclerosis drug, Lemtrada. Per a Contingent Value Rights Agreement, Sanofi agreed to make up to approximately $3.8 billion in payments to former shareholders upon the completion of certain milestones relating to Lemtrada, including getting FDA approval of Lemtrada on or before March 31, 2014, and obtaining specific sales volumes in defined periods.
The lawsuit, filed in 2015, claimed Sanofi submitted a poor application to the FDA that triggered an initial rejection — leading to the missed approval deadline — and then failed to support Lemtrada commercially so it would miss sales targets.
Under the settlement agreement, Sanofi has agreed to fully and completely resolve the claims without any admission of liability or wrongdoing.
Read the press release