French pharmaceutical company Sanofi-Aventis (SNY), which has been unsuccessful recently in its courtship of U.S. giant biotech Genzyme (GENZ), announced another setback today. Sanofi said a late-stage trial of its investigational therapy NV1FGF in patients with critical limb ischemia did not meet its primary goal of preventing a major amputation or death from any cause over 12 months.
Critical limb ischemia, or CLI, is a severe obstruction of the arteries that seriously decreases blood flow to the extremities (hands, feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
In earlier trials, Sanofi's gene-based drug showed promise in restoring blood vessel growth in damaged limbs by inducing the formation of new blood vessels that could improve blood flow. But in this study, it was no better than a placebo and didn't prevent limb amputation or patient deaths over 12 months. The full results of the over 500-patient trial will be presented at the American Heart Association Congress, on Nov. 16.
"We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial and for patients who are suffering from the dramatic consequences of this disease and are hoping for new treatments" says Dr. Marc Cluzel, and executive VP at Sanofi research and development. "We are evaluating all options on the NV1FGF development."
Partner Vical (VICL) shares traded down more than 40% at the open, while Sanofi shares rose 1.2%.
Unable to improve its drug lineup internally, Sanofi has been seeking to boost it by acquiring rare-disease drugmaker Genzyme. But that plan has hit snags as well, mainly the large gap in price that the two companies think Genzyme is worth. Meanwhile, Bloomberg reported that Genzyme said it expects to complete sales of its diagnostics and pharmaceutical-ingredients units by the end of the year and that its drug business has six bidders -- further complicating things for Sanofi.