Sanofi has suffered a clinical setback and is pulling the plug on two late-stage drugs, iniparib for lung cancer and the anticoagulant otamixaban.
First up, the French drugmaker revealed the Phase III ECLIPSE trial of iniparib plus chemotherapy in squamous non-small cell lung cancer did not meet its primary endpoint of overall survival compared to patients who received chemotherapy alone.
Sanofi added that the topline results of a Phase II study of iniparib in platinum-resistant ovarian cancer do not support further development either, so it has decided to terminate its internal development programme with the drug. This will result in an after-tax charge of $285 million but will have no major impact on earnings.
Sanofi also said that it is also giving up on otamixaban, an injectable factor Xa inhibitor. Top-line results of the completed Phase III study of the anticoagulant showed it did not meet its primary endpoint of superiority over current therapy.
Specifically, in the treatment of non-ST elevation acute coronary syndrome, otamixaban did not show superior benefit/risk to the combination of unfractionated heparin +/- eptifibatide, a GP IIb/IIIa inhibitor) in non-ST elevation acute coronary syndrome patients planned for early invasive strategy. The primary endpoint of the study was the reduction of all-cause mortality or new heart attacks.
This is clearly a blow, although the company still has high hopes for its pipeline, not least in cancer. Speaking to PharmaTimes World News at the American Society of Clinical Oncology meeting in Chicago, Tal Zaks, head of oncology development at Sanofi, outlined the progress the firm is making, details of which we will publish in the coming days.