Sanofi admits $285m failure
pharmafile | June 4, 2013 | News story | Research and Development, Sales and Marketing | Sanofi, its benzamide iniparib, otamixaban
Sanofi has consigned two investigational drugs to the corporate dustbin, preferring a $285 million dent in its coffers to continuing with research which seems to be going nowhere.
It is dropping its benzamide iniparib and injectable factor Xa inhibitor otamixaban after Phase II and III trial failures.
Researchers at Sanofi have been left scratching their heads as iniparib – designed as a poly (ADP-ribose) polymerase (PARP) 1 inhibitor – simply proved inadequate for the job.
In the Phase III ECLIPSE trial, patients with newly-diagnosed, metastatic squamous non-small cell lung cancer (Sq NSCLC) treated with iniparib plus chemotherapy did not achieve improvement in overall survival, compared to patients who received chemotherapy alone.
Previously untreated patients received iniparib with gemcitabine/carboplatin versus gemcitabine/carboplatin alone: primary endpoint was OS, while secondary endpoints were progression-free survival and response rate.
Nearly 800 patients with metastatic Sq NSCLC in 16 countries were randomised to receive carboplatin AUC 5 on Day 1 and gemcitabine 1000 mg/m2 on Day 1 and 8 of each 21-day cycle, with or without iniparib 5.6 mg/kg on Day 1, 4, 8 and 11.
Meanwhile, the topline results of a Phase II study of the compound in platinum-resistant ovarian cancer also “do not support further development of iniparib in this patient population”, the company admitted.
As if this were not enough, initial results of a completed Phase III study of the investigational anticoagulant otamixaban showed it too did not meet its primary endpoint – in this case superiority over current therapy.
The drug did not show superior risk/benefit in patients with non-ST elevation acute coronary syndrome when compared to treatment with unfractionated heparin (UFH) +/- eptifibatide (a GP IIb/IIIa inhibitor).
The idea was that patients in the study were earmarked for early invasive strategy, with the goal of reducing death by any means or new heart attacks.
More than 13,000 moderate-to-high-risk patients in 55 countries were randomised to receive UFH plus downstream eptifibatide (started before PCI and continued as per label) or otamixaban (0.08 mg/kg intravenous bolus at randomization then 0.100 or 0.140 mg/kg per hour intravenous infusion).
Adam Hill
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