Sanofi-Aventis' riferminogen pecaplasmid fails Ph III endpoints; partner Vical's shares decimated; provides opportunity for Aastrom?

There was a big disappointment for French drug major Sanofi-Aventis (EURONEXT: SAN) when it had to announce yesterday that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint of restoring blood vessel growth in damaged limbs.

The impact of the news was much greater, however, on USA-based Vical (Nasdaq: VICL), which licensed rights to its patent DNA delivery technology for the drug to Sanofi in 2007, and saw its shares plummet 35% to $2.49 in pre-open trading Wednesday, while the French firm’s stock dipped just 1.5% to 49.90 euros by close on the Paris bourse..

The primary endpoint was to demonstrate the superiority of NV1FGF versus placebo in the prevention of major amputation or death from any cause over 12 months, whichever came first, in critical limb ischemia (CLI) patients who were not eligible for revascularization.