Sanofi, a global healthcare company, announced topline results of two phase III clinical studies of investigational compounds iniparib and otamixaban and, as a result, has announced it will discontinue both programs.
The randomized phase III ECLIPSE trial of iniparib in squamous non-small cell lung cancer did not meet its primary endpoint. In the study, newly diagnosed, metastatic patients treated with iniparib plus chemotherapy did not achieve improvement in overall survival compared to patients who received chemotherapy alone. There were no clinically meaningful differences in the main safety parameters between the two arms.
The topline results of a phase II study of iniparib in platinum-resistant ovarian cancer do not support further development of iniparib in this patient population. Following these findings, Sanofi has decided to terminate the internal development program with iniparib. As a consequence, the intangible assets related to iniparib will be fully impaired on the June 30 consolidated balance sheet. The related charge will have an estimated net impact of $285 million after tax on consolidated net income. This non-cash charge will have no impact on Business Net Income.
Topline results of the completed phase III study of anticoagulant otamixaban showed the study did not meet its primary endpoint of superiority over current therapy. In the TAO study (Treatment of non-ST elevation Acute coronary syndrome with otamixaban), due to efficacy lower than expected, otamixaban did not show superior benefit/risk to the combination of unfractionated heparin (UFH) +/- eptifibatide (a GP IIb/IIIa inhibitor) in non-ST elevation acute coronary syndrome patients planned for early invasive strategy. The primary endpoint of the phase III TAO study was the reduction of all-cause mortality or new heart attacks.
Following these results, Sanofi has decided to discontinue the investigational program with otamixaban, an injectable factor Xa inhibitor.