Sanofi's case for R&D turnaround includes a few setbacks for cancer, MS

Elias Zerhouni, Sanofi R&D chief

Sanofi R&D chief Elias Zerhouni will take to the center stage at the J.P. Morgan conference in San Francisco today to spotlight a group of 17 late-stage drug programs that will ultimately make or break the pharma giant's case that it has reenergized its multibillion-dollar R&D effort. And it's using the occasion to provide last rites for some of its work that didn't measure up to expectations, burying a Phase III sarcoma drug along with a midstage program for endometrial cancer for a drug in-licensed four years ago in a billion-dollar deal with Exelixis ($EXEL).

Sanofi ($SNY) announced this morning that work on ombrabulin, once considered a hot prospect, was being halted after it flopped in a Phase III sarcoma study and investigators had to halt a midstage trial for ovarian cancer following a disappointing interim analysis. The drug, partnered with Ajinomoto, hit its primary endpoint on progression-free survival, but Sanofi concluded that the drug wouldn't pass regulatory muster. The Phase II trial of SAR245408--formerly XL147--was discontinued after investigators determined that the study had failed to demonstrate sufficient clinical benefit. A Phase II breast cancer trial in combination with letrozole continues alongside an early-stage combo study with SAR256212.      

Sanofi also noted that it decided to slam the brakes on a Phase III study of Aubagio, an MS drug its subsidiary Genzyme wrested an approval for late last year. The study had combined the oral drug--which has modest market expectations--with interferon, which Sanofi concluded isn't a promising approach to MS these days.

In the next 6 months Sanofi says it will post late-stage results for a head-to-head study of eliglustat with Cerezyme for Gaucher disease; otamixaban, the first intravenous direct and selective factor Xa inhibitor; SAR302503 for myelofibrosis; a new glargine formulation for diabetes; and iniparib, its high-profile non-small cell lung cancer treatment.

One of the lead roles in Sanofi's Phase III revival effort now goes to SAR236553, its high-profile PCSK9 drug partnered with Regeneron ($REGN) and engaged in a slate of studies for dangerously high levels of LDL cholesterol. Two months ago Sanofi launched a monster Phase III trial for this drug that will recruit 18,000 patients suffering from acute coronary syndrome. Zerhouni's pipeline update also focused on:

  • Its Clostridium difficile toxoid vaccine, which is headed into Phase III in Q3 under a fast-track designation from the FDA.
  • SAR231893, also partnered with Regeneron, which will start a Phase IIb study in the middle of this year in asthma and atopic dermatitis.
  • And SAR302503, its JAK2 inhibitor in myelofibrosis, for which Phase III recruitment has been completed.

"Sanofi has made significant progress in the transformation of its R&D over the last couple of years," said Zerhouni in a statement, "including advances in late stage projects and early stage pipeline as well as talent recruitment. We feel we have the ingredients to ensure R&D contributes to Sanofi's goal of sustainable growth in the coming years while rigorously managing R&D costs."

- here's the press release

Special Report: Sanofi - The Biggest R&D Spenders In Biopharma


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