Pharmaceutical Business review

Sanofi to terminate investigational program with iniparib, otamixaban

Under the randomized Phase 3 ECLIPSE trial of iniparib in squamous non-small cell lung cancer (Sq NSCLC), patients treated with combination of iniparib and chemotherapy could not achieve improvement in overall survival compared to those who received chemotherapy alone.

Its Phase 2 study in platinum-resistant ovarian cancer also does not support further development of iniparib in this patient population, and subsequently the company has decided to close the internal development program with the drug.

The company also announced that the results of Phase 3 study of the anticoagulant otamixaban failed to meet its primary endpoint of superiority against the current therapy, due to lower efficacy than expected.

In the Treatment of non-ST elevation Acute coronary syndrome with otamixaban (TAO study), the medicine had not shown superior benefit/risk to the combination of unfractionated heparin (UFH) +/- eptifibatide in non-ST elevation acute coronary syndrome (NSTE-ACS) patients.

An investigational, rapid-onset/offset, direct selective injectable inhibitor of the blood clotting factor Xa, Otamixaban was the first intravenous factor Xa anticoagulant tested against UFH +/- GP IIb/IIIa inhibitor in the event of death or new heart attack.