French drugmaker Sanofi (SNY,SNYNF.PK) Monday announced that Phase 3 studies of iniparib in squamous non-small cell lung cancer, and investigational anticoagulant otamixaban, an injectable factor Xa inhibitor, did not meet their respective primary endpoints. The firm has decided to terminate the internal development programs.
Following the study result, Sanofi will fully impair the intangible assets related to iniparib on the June 30, 2013 consolidated balance sheet. The related charge will have an estimated net impact of $285 million after tax on consolidated net income, or about 219 million euros. However, the company noted that the non-cash charge will have no impact on business net income.
According to the company, the randomized Phase 3 ECLIPSE trial of iniparib in squamous non-small cell lung cancer, or Sq NSCLC, failed to meet its primary endpoint. During the study, newly diagnosed, metastatic Sq NSCLC patients treated with iniparib plus chemotherapy did not achieve improvement in overall survival compared to patients who received chemotherapy alone.
The two arms showed no clinically meaningful differences in main safety parameters. The topline results of a Phase 2 study of iniparib in platinum-resistant ovarian cancer do not support further development of iniparib in this patient population, the company said.
Further, Sanofi stated that topline results of the completed Phase 3 study of investigational anticoagulant otamixaban showed that the study did not meet its primary endpoint of superiority over current therapy.
In the Treatment of non-ST elevation Acute coronary syndrome with otamixaban, or TAO study, 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 3 TAO study was the reduction of all-cause mortality or new heart attacks.
Sanofi stated that the results of both of the studies will be presented at upcoming scientific meetings and submitted for publication in peer-reviewed journals.
In Paris, Sanofi shares are currently trading at 82.65 euros, up 0.17 percent, on a volume of 1.51 million shares.
SNY closed Friday's regular trading at $53.09 on the NYSE. In the pre-market activity, the shares are currently up 0.60 percent.
by RTT Staff Writer
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